Important aspects to be kept in mind while preparing ... - Efresh India
Important aspects to be kept in mind while preparing ... - Efresh India
Important aspects to be kept in mind while preparing ... - Efresh India
You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
<strong>Important</strong> <strong>aspects</strong> <strong>to</strong> <strong>be</strong> <strong>kept</strong> <strong>in</strong> m<strong>in</strong>d <strong>while</strong> prepar<strong>in</strong>g Food Safety &<br />
Quality Manual:<br />
Policy: Organizations policies <strong>to</strong> <strong>be</strong> framed<br />
Organizations overall and departmental Quality Objectives <strong>in</strong> measurable terms <strong>to</strong> <strong>be</strong><br />
framed<br />
Identify<strong>in</strong>g the positions and competencies (education ,relevant experience) needed<br />
for perform<strong>in</strong>g the work <strong>to</strong> <strong>be</strong> documented<br />
Recruit<strong>in</strong>g the personnel meet<strong>in</strong>g the requirements as documented above<br />
Organization chart and roles & responsibilities <strong>to</strong> <strong>be</strong> documented<br />
Total layout of the plant <strong>in</strong> build<strong>in</strong>g <strong>to</strong> <strong>be</strong> <strong>kept</strong> <strong>in</strong>clud<strong>in</strong>g men and material movement<br />
Identify<strong>in</strong>g each mach<strong>in</strong>e <strong>in</strong> plant and prepar<strong>in</strong>g <strong>in</strong>puts <strong>to</strong> the mach<strong>in</strong>e and output<br />
from the mach<strong>in</strong>e <strong>to</strong> <strong>be</strong> documented<br />
Process flow chart for manufactur<strong>in</strong>g process from raw material <strong>in</strong>puts <strong>to</strong> the f<strong>in</strong>ished<br />
products and its s<strong>to</strong>rage and dispatch <strong>to</strong> <strong>be</strong> documented<br />
Tra<strong>in</strong><strong>in</strong>g programs needed <strong>to</strong> the personnel as per manufactur<strong>in</strong>g processes and<br />
process<strong>in</strong>g of tra<strong>in</strong><strong>in</strong>g as per these documented requirements <strong>to</strong> <strong>be</strong> ensured<br />
Handl<strong>in</strong>g of cus<strong>to</strong>mer compla<strong>in</strong>ts on the products and its mechanism <strong>to</strong> <strong>be</strong><br />
documented<br />
Ensure that all the requirements of the respective standard is addressed <strong>in</strong> the<br />
manual. To ensure this it is <strong>be</strong>tter <strong>to</strong> prepare a matrix <strong>in</strong>dicat<strong>in</strong>g the requirements on<br />
the one side and compliance documents <strong>in</strong> the manual can <strong>be</strong> given<br />
Normally the follow<strong>in</strong>g procedures will <strong>be</strong> documented irrespective of the standard<br />
<strong>be</strong><strong>in</strong>g implemented.<br />
• Document control
• Control of records<br />
• Recruitment of personnel<br />
• Tra<strong>in</strong><strong>in</strong>g of personnel<br />
• Management review meet<strong>in</strong>g<br />
• Internal audits<br />
• Handl<strong>in</strong>g cus<strong>to</strong>mer compla<strong>in</strong>ts<br />
• Corrective action<br />
• Preventive action<br />
• Handl<strong>in</strong>g of potentially unsafe product / non conform<strong>in</strong>g product<br />
• Verification & validation<br />
Raw material and f<strong>in</strong>ished product specifications has <strong>to</strong> framed<br />
Procedure for supplier evaluation<br />
eFresh Portal made an effort <strong>to</strong> prepare a Food Safety Manual Structure based<br />
on HACCP guidel<strong>in</strong>es, which is generic and the same can <strong>be</strong> considered as a first<br />
step <strong>to</strong>wards preparation of the Food Safety Manual and <strong>in</strong>corporat<strong>in</strong>g the<br />
requirements as applicable <strong>in</strong> <strong>in</strong>dividual case.
SAMPLE -FOOD SAFETY<br />
MANAGEMENT SYSTEM MANUAL<br />
ISO 22000:2005<br />
Prepared by:<br />
Approved by:<br />
Effective from:<br />
TABLE OF CONTENTS<br />
S. No Documents Document No Clause No. Pages<br />
1 Contents FSMS – C -<br />
2 Abbreviations FSMS-A -<br />
3 Company Profile FSMS –C P -<br />
4 Declaration FSMS – D -<br />
5 Distribution List FSMS – DL -<br />
6 Amendment List FSMS – AL -<br />
7 Recognitions/Licenses by Govt. Agencies FSMS – R -
8 Scope of the FSMS FSMS – S 01<br />
9 References FSMS – R 02<br />
10 Terms and Def<strong>in</strong>itions FSMS – TD 03<br />
11 Documentation Requirement FSMS – DR 4.2<br />
12 Control of Documents FSMS – CD 4.2.2<br />
13 Control of Records FSMS – CR 4.2.3<br />
14 Management Responsibility FSMS – MR 5.0<br />
15 Food Safety Policy FSMS – FSP 5.2<br />
16 FSMS Plann<strong>in</strong>g FSMS – FSMSP 5.3<br />
17 Responsibility & Authority FSMS – RA 5.4<br />
18 Food Safety Team Leader FSMS – FSTL 5.5<br />
19 Communication FSMS – C 5.6<br />
20 Emergency Preparedness & Response FSMS – EPR 5.7<br />
21 Management Review FSMS – MR 5.8<br />
22 Resource Management FSMS – RM 6.0<br />
23 Competence Awareness & Tra<strong>in</strong><strong>in</strong>g FSMS – CAT 6.2.2<br />
24 Tra<strong>in</strong><strong>in</strong>g & Tra<strong>in</strong><strong>in</strong>g Plan FSMS – T&TP 6.2.2.3<br />
25 Infrastructure & Work Environment FSMS – IWE 6.3-6.4<br />
26 Plann<strong>in</strong>g & Realization of Safe Product FSMS – PRSF 7.0<br />
27 Pre- Requisite Programs FSMS – PRP 7.2<br />
28 Pre. Steps <strong>to</strong> Enable Hazard Analysis FSMS – PSEHA 7.3<br />
29 Product Characteristics FSMS – PC 7.3.3<br />
30 Intended Use FSMS – IU 7.3.4<br />
31 Flow Diagram FSMS – FD 7.3.5<br />
32 Hazard Analysis FSMS –HA 7.4<br />
33 Hazard Assessment FSMS –HA 7.4.3<br />
34 Control Measures FSMS –CM 7.4.4<br />
35 Operational PRPs FSMS –OPRP 7.5<br />
36 HACCP Plan FSMS –HP 7.6<br />
37 Updat<strong>in</strong>g-Verification- Traceability FSMS –UVT 7.7-7.8-7.9<br />
38 Control of Non-Conform<strong>in</strong>g Product FSMS –CNCP 7.10<br />
39 Validation, Verification & Imprv. of FSMS FSMS –VVIF 8.1-8.2<br />
40 Control of Moni<strong>to</strong>r<strong>in</strong>g and Measurement FSMS-CMM 8.3<br />
41 FSMS verification FSMS-FSMSV 8.4<br />
42 Improvement FSMS-I 8.5
ABBREVIATIONS<br />
ABBREVIATION<br />
ACCT<br />
ADMN<br />
AMDT<br />
AMT<br />
ANNX<br />
APPX<br />
ATT<br />
BAL<br />
B/F<br />
EXPANSION<br />
ACCOUNT<br />
ADMINISTERATION<br />
AMMENDMENT<br />
AMOUNT<br />
ANNEXURE<br />
APPENDIX<br />
ATTACHMENT<br />
BALANCE<br />
BROUGHT FORWARD
BIO<br />
C<br />
CP<br />
CCP<br />
CHEM<br />
CONTD<br />
DT<br />
EFF<br />
ENCL<br />
FSM<br />
FSMS<br />
FSSP<br />
FSTL<br />
GMP<br />
I/C<br />
HACCP<br />
HR<br />
IDEN<br />
INFRA<br />
ISO<br />
L<br />
MAINT<br />
MAX<br />
MIN<br />
OPRP<br />
BIOLOGICAL<br />
CONSEQUENCES<br />
CONTROL POINT<br />
CRITICAL CONTROL POINT<br />
CHEMICAL<br />
CONTINUED<br />
DATE/ DATED<br />
EFFECTIVE<br />
ENCLOSURE/ ENCLOSED<br />
FOOD SAFETY MANUAL<br />
FOOD SAFETY MANAGEMENT SYSTEM<br />
FOOD SAFETY STANDARD PROCEDURES<br />
FOOD SAFETY TEAM LEADER<br />
GOOD MANUFACTURING PRACTICES<br />
INCHARGE<br />
HAZARD ANALYSIS AND CRITICAL CONTROL POINT<br />
HUMAN RESOURCE<br />
IDENTIFICATION<br />
INFRASTUCTURE<br />
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION<br />
LIKELIHOOD<br />
MAINTENANCE<br />
MAXIMUM<br />
MINIMUM<br />
OPERATIONAL PRE-REQUISITE PROGRAMS
PHY<br />
PRP<br />
PREP<br />
P & S<br />
PROD<br />
QC<br />
QMS<br />
QTY<br />
R<br />
SOP<br />
SSOP<br />
STD<br />
SUPVSR<br />
TPT<br />
VR<br />
WE<br />
WT<br />
YR<br />
PHYSICAL<br />
PRE-REQUISITE PROGRAMS<br />
PREPERATION<br />
PROCUREMENT & SUPPLIES<br />
PRODUCTION<br />
QUALITY CONTROL<br />
QUALITY MANAGEMENT SYSTEMS<br />
QUANTITY<br />
RISK<br />
STANDARD OPERATING PROCEDURES<br />
STANDARD SAFETY OPERATING PROCEDURES<br />
STANDARD<br />
SUPERVISOR<br />
TRANSPORT<br />
VOUCHER<br />
WORK ENVIRONMENT<br />
WEIGHT<br />
YEAR
AMENDMENT LIST<br />
Sl.<br />
No<br />
Document<br />
Name<br />
Document<br />
Num<strong>be</strong>r<br />
Date of<br />
Amendment<br />
Clause No. Reason for Change Authorization
COMPANY PROFILE<br />
• About Company: Should cover Geographical details<br />
• Num<strong>be</strong>r of branches if any<br />
• About production facility<br />
• At this hotel, all three meals are served – Breakfast, Lunch and D<strong>in</strong>ner. Variety of cuis<strong>in</strong>es - South<br />
<strong>India</strong>n, North <strong>India</strong>n and International with both Vegetarian and Non-Vegetarian options are<br />
prepared at the Kitchen and served <strong>in</strong> the Cafe. The Kitchen also has a live counter where Pizzas<br />
and Pastas are made <strong>to</strong> order with options. The Menus are displayed <strong>in</strong> the restaurant so that<br />
guests get <strong>to</strong> know the options available for the day.<br />
• At this hotel, we are committed <strong>to</strong> mak<strong>in</strong>g constant improvements <strong>to</strong> the quality and hygiene<br />
standards of the food served <strong>to</strong> our guests.
DECLARATION<br />
XYZ Hotels br<strong>in</strong>gs out this Food Safety Management System Manual as part of the food safety system under<br />
the authority of the Manager. This Manual is the orig<strong>in</strong>al and authenticated one and the activities detailed<br />
<strong>in</strong> this Manual are true and correct. This FSMS Manual is <strong>in</strong> compliance with the <strong>in</strong>ternational standard, ISO<br />
22000:2005 which it is based on. The criteria outl<strong>in</strong>ed <strong>in</strong> this Manual are manda<strong>to</strong>ry and shall <strong>be</strong> complied<br />
with by all the facility staff of this hotel.<br />
Any changes or modifications <strong>to</strong> <strong>be</strong> <strong>in</strong>corporated <strong>in</strong> this manual shall <strong>be</strong> made only upon authorization by<br />
the MR and the details of the modifications by the food safety team leader will <strong>be</strong> <strong>in</strong>dicated <strong>in</strong> the record of<br />
Amendments.<br />
Date:<br />
Signed by: MR<br />
Signature:
DISTRIBUTION LIST<br />
The Controlled copies of the FSMS Manual are distributed <strong>to</strong> the follow<strong>in</strong>g holders:<br />
Controlled copy no.<br />
Authorized Holders<br />
01 Executive Chef<br />
02 Manager QC<br />
03 Manager (F & B)<br />
The MR holds the “Master Copy” of the FSMS Manual.<br />
AMENDMENT LIST<br />
Sl.<br />
No<br />
Document<br />
Name<br />
Document<br />
Num<strong>be</strong>r<br />
Date of<br />
Amendment<br />
Clause<br />
No.<br />
Reason for<br />
Change<br />
Authorization<br />
1<br />
2<br />
RECOGNITIONS / LICENSES BY GOVERNMENT AGENCIES
a. Form of License No. (PFA)<br />
SCOPE OF THE FSMS<br />
The FSMS system <strong>in</strong> xyz is applicable <strong>to</strong> the activities undertaken <strong>in</strong> the food service establishment at……,<br />
Hyderabad. The scope is as follows:<br />
“Food Production and service”<br />
• ISO 22000:2005 SYSTEM<br />
We have developed an ISO 22000 based Food Safety Management System which assures the safety of meals<br />
prepared at xyz premises .Process control plans developed and operated for all <strong>aspects</strong> that are applicable<br />
<strong>to</strong> the safety of foodstuffs are descri<strong>be</strong>d/ referenced <strong>in</strong> the appropriate ISO 22000 Food Safety System<br />
documentation.<br />
The Scope of the ISO 22000 System at xyz has <strong>be</strong>en def<strong>in</strong>ed as per the position with<strong>in</strong> the food cha<strong>in</strong>, as per<br />
process location and l<strong>in</strong>e, and per product and <strong>in</strong>cludes all classes of hazards viz. Physical, Chemical &<br />
Biological.<br />
REFERENCES<br />
• Food Safety Management Systems – Requirements for organizations through out the food cha<strong>in</strong>. – ISO<br />
22000 : 2005<br />
• Jo<strong>in</strong>t FAO/WHO Codex Alimentarius Commission
− General Pr<strong>in</strong>ciples of Food Hygiene, CAC/RCP 1-1969, Rev. 4 (2003), amended 2003.<br />
− Hazard Analysis and Critical Control Po<strong>in</strong>t (HACCP) System and Guidel<strong>in</strong>es for its Application,<br />
Annex <strong>to</strong> CAC/RCP 1-1969, Rev. 4 (2003).<br />
• The Prevention of Food Adulteration [PFA 1954 Act]<br />
TERMS AND DEFINITIONS<br />
• Action-limit value - A value for the product or process parameter under consideration, deduced<br />
from the critical limit value, which <strong>in</strong>dicates that an <strong>in</strong>tervention <strong>in</strong> the process is required.<br />
• Aspect- An element of the food bus<strong>in</strong>ess operation (products, processes, PRP, services) that can<br />
<strong>in</strong>teract with the food safety.<br />
• Clean<strong>in</strong>g - Removal of soil, food residue, dirt, grease or other objectionable matter
• Contam<strong>in</strong>ant - Any biological or chemical agent, foreign matter, or other substances not<br />
<strong>in</strong>tentionally added <strong>to</strong> food which may compromise food safety or suitability<br />
• Contam<strong>in</strong>ation - Introduction or occurrence of a contam<strong>in</strong>ant <strong>in</strong> food or food environment.<br />
• Control (verb) - To take all necessary actions <strong>to</strong> ensure and ma<strong>in</strong>ta<strong>in</strong> <strong>in</strong> compliance with criteria<br />
established <strong>in</strong> the Food Safety Plan.<br />
• Control (noun)- The state where<strong>in</strong> correct procedures are <strong>be</strong><strong>in</strong>g followed and criteria are <strong>be</strong><strong>in</strong>g<br />
met.<br />
• Control measure- Any action and activity that can <strong>be</strong> used <strong>to</strong> prevent or elim<strong>in</strong>ate a food safety<br />
hazard or reduce it <strong>to</strong> an acceptable level.<br />
• Control measure, general- A measure <strong>to</strong> control a specific part of the PRP.<br />
• Control measure, specific- A measure <strong>to</strong> control a CCP.<br />
• Corrective Action - Any action <strong>to</strong> <strong>be</strong> taken when the result of moni<strong>to</strong>r<strong>in</strong>g at the CCP <strong>in</strong>dicate a loss<br />
of control.<br />
• Critical Control Po<strong>in</strong>t (CCP) - A step at which it is essential that a specific control measure is<br />
applied <strong>to</strong> prevent or elim<strong>in</strong>ate a Food Safety Hazard or reduce the risk <strong>to</strong> an acceptable level.<br />
• Critical Limit - A criterion, which separates acceptability from unacceptability.<br />
• Note- This criterion def<strong>in</strong>es the limit<strong>in</strong>g values for the product or process parameters under<br />
consideration for moni<strong>to</strong>r<strong>in</strong>g (see action- limit vales and target value).<br />
• Dis<strong>in</strong>fection - The reduction, by means of chemical agents and/or physical methods, of the num<strong>be</strong>r<br />
of micro-organisms <strong>in</strong> the environment, <strong>to</strong> a level that does not compromise food safety or<br />
suitability<br />
• Establishment - Any build<strong>in</strong>g or area <strong>in</strong> which food is handled and the surround<strong>in</strong>gs, under the<br />
control of the same management.<br />
• Flow Diagram - A systematic representation of the sequence of steps or operations used <strong>in</strong> the<br />
preparation, process<strong>in</strong>g, manufactur<strong>in</strong>g, packag<strong>in</strong>g, s<strong>to</strong>rage, transportation, distribution, handl<strong>in</strong>g<br />
or offer<strong>in</strong>g for sale of a particular food item.
• Food bus<strong>in</strong>ess opera<strong>to</strong>r- The person or persons responsible for ensur<strong>in</strong>g that the requirements of<br />
the food legislation are met with<strong>in</strong> the food bus<strong>in</strong>ess under his/ their control.<br />
• Food handler - Any person who directly handles packaged or unpackaged food, food equipment<br />
and utensils, or food contact surfaces and is therefore expected <strong>to</strong> comply with food hygiene<br />
requirements<br />
• Food Hygiene – All conditions and measures necessary <strong>to</strong> ensure the safety and suitability of food<br />
at all stages of the food cha<strong>in</strong>.<br />
• Food safety - Assurance that food will not cause harm <strong>to</strong> the consumer when it is prepared and/or<br />
eaten accord<strong>in</strong>g <strong>to</strong> its <strong>in</strong>tended use.<br />
• Food suitability - Assurance that food is acceptable for human consumption accord<strong>in</strong>g <strong>to</strong> its<br />
<strong>in</strong>tended use.<br />
• HACCP- A system, which identifies, evaluates and controls hazards which are significant for food<br />
safety.<br />
• HACCP audit- A systematic and <strong>in</strong>dependent exam<strong>in</strong>ation <strong>to</strong> determ<strong>in</strong>e whether the HACCP system,<br />
<strong>in</strong>clud<strong>in</strong>g the HACCP plan and related results, comply with planned arrangements, are implemented<br />
effectively and are suitable for the achievement of its objectives.<br />
Note- Exam<strong>in</strong>ation of the Hazard Analysis is an essential element of the HACCP audit.<br />
• Food safety Plan- A document prepared <strong>in</strong> accordance with the pr<strong>in</strong>ciples of HACCP <strong>to</strong> ensure<br />
control of hazards, which are significant for food safety <strong>in</strong> the segment of the food cha<strong>in</strong> under<br />
consideration.<br />
• HACCP based food safety system (a HACCP system) - The organizational structure, procedures,<br />
processes and resources needed <strong>to</strong> execute the HACCP plan and meet its objectives.<br />
• Food Safety Team- Group of <strong>in</strong>dividuals (multi- discipl<strong>in</strong>ary) who develop, implement and<br />
ma<strong>in</strong>ta<strong>in</strong> a Food Safety Management system.<br />
• Hazard - A biological, chemical or physical agent <strong>in</strong> or condition of, food with the potential <strong>to</strong> cause<br />
an adverse health effect.<br />
• Hazard Analysis - The process of collect<strong>in</strong>g and evaluat<strong>in</strong>g <strong>in</strong>formation on hazards and conditions<br />
lead<strong>in</strong>g <strong>to</strong> their presence <strong>to</strong> decide which are significant for food safety and therefore is addressed<br />
<strong>in</strong> the Food safety plan.
• Moni<strong>to</strong>r<strong>in</strong>g - The act of conduct<strong>in</strong>g a planned sequence of observations or measurements of control<br />
parameters <strong>to</strong> assess whether a CCP is under control.<br />
• Pre-Requisite Program (PRP)- Any specified and documented activity or facility implemented <strong>in</strong><br />
accordance with the Codex General Pr<strong>in</strong>ciple of food hygiene, good manufactur<strong>in</strong>g practices and<br />
appropriate food legislation, <strong>in</strong> order <strong>to</strong> establish basic conditions that are suitable for the<br />
production and handl<strong>in</strong>g of safe food at all stages of the food cha<strong>in</strong>.<br />
• Preventive action- Any measure or activity that will <strong>be</strong> used <strong>to</strong> prevent, <strong>to</strong> elim<strong>in</strong>ate or <strong>to</strong> reduce<br />
the recurrence of causes for exist<strong>in</strong>g deviations, defects or any other undesired situation with<br />
respect <strong>to</strong> food safety.<br />
• Primary production - those steps <strong>in</strong> the food cha<strong>in</strong> up <strong>to</strong> and <strong>in</strong>clud<strong>in</strong>g, for example, harvest<strong>in</strong>g,<br />
• Products, unprocessed- Foodstuffs which have not undergone a treatment, <strong>in</strong>clud<strong>in</strong>g products<br />
which have <strong>be</strong>en, for example, divided, parted, severed, boned, m<strong>in</strong>ced, sk<strong>in</strong>ned, ground, cut,<br />
cleaned, trimmed, husked or milled, chilled, frozen or deep frozen.<br />
• Product, processed- Foodstuffs result<strong>in</strong>g from the application <strong>to</strong> unprocessed products of a<br />
treatment such as heat<strong>in</strong>g, smok<strong>in</strong>g, cur<strong>in</strong>g, matur<strong>in</strong>g, pickl<strong>in</strong>g, dry<strong>in</strong>g, mar<strong>in</strong>at<strong>in</strong>g, extraction,<br />
extrusion, etc or comb<strong>in</strong>ation of these processes and or products; substances necessary for their<br />
manufacture or for giv<strong>in</strong>g specific characteristics <strong>to</strong> the products may <strong>be</strong> added.<br />
• Risk- The probability of caus<strong>in</strong>g an adverse health effect caused by the occurrence and the severity<br />
of a particular hazard <strong>in</strong> food when prepared and consumed accord<strong>in</strong>g <strong>to</strong> its <strong>in</strong>tended use.<br />
• Target value- The value of the product or process parameter(s) <strong>to</strong> <strong>be</strong> moni<strong>to</strong>red, targeted with<strong>in</strong><br />
action- limit values (the range of acceptable variations) and certa<strong>in</strong>ly with<strong>in</strong> critical limit values,<br />
thus secur<strong>in</strong>g a safe product.<br />
• Step - A po<strong>in</strong>t, procedure, operation or stage <strong>in</strong> the food cha<strong>in</strong> <strong>in</strong>clud<strong>in</strong>g raw materials, from<br />
primary production <strong>to</strong> f<strong>in</strong>al consumption.<br />
• Validation - Obta<strong>in</strong><strong>in</strong>g evidence (<strong>in</strong> advance) that the specific and general control measures of the<br />
Food Safety plan are effective.<br />
• Verification - The application of methods, procedures, tests and other evaluation, <strong>in</strong> addition <strong>to</strong><br />
moni<strong>to</strong>r<strong>in</strong>g <strong>to</strong> determ<strong>in</strong>e compliance with the specification laid down <strong>in</strong> the HACCP Plan and the<br />
effectiveness of the HACCP – based food safety system.
Food Safety Management System Documentation Structure: The documentation structure<br />
consists of different hierarchical levels as follows:<br />
• Food Safety Policy Manual<br />
• Standard Operat<strong>in</strong>g Procedures<br />
• Work Instructions / operat<strong>in</strong>g Rules<br />
• HACCP Pr<strong>in</strong>ciples related documents<br />
• Miscellaneous documents<br />
• Formats and Records<br />
LOGIC SEQUENCE FOR THE APPLICATION OF HACCP
4.0 FOOD SAFETY MANAGEMENT SYSTEM<br />
4.1 General requirements:<br />
4.1.1 The Food Safety Management System (FSMS) documented by XYZ <strong>in</strong> this Food Safety<br />
Management System Manual is established, implemented, ma<strong>in</strong>ta<strong>in</strong>ed and updated as and
when required and also its effectiveness is cont<strong>in</strong>ually improved <strong>in</strong> accordance with the<br />
requirements of ISO 22000:2005.<br />
4.1.2 XYZ has def<strong>in</strong>ed the scope of the FSMS as <strong>in</strong> FSMS Manual – Clause1.0 and has identified the<br />
product categories, processes and production sites where this FSMS is implemented.<br />
4.1.3 As part of the FSMS, XYZ has<br />
• Ensured that all food safety hazards expected <strong>to</strong> occur <strong>in</strong> the products or processes with<strong>in</strong> the<br />
scope of activities of the system are adequately identified, evaluated and controlled based on<br />
the HACCP system developed so that the products produced are safe and do not harm the<br />
consumer.<br />
• Proper communication (external) throughout the food cha<strong>in</strong> with<strong>in</strong> its scope of activities and<br />
purview with respect <strong>to</strong> the food safety issues of the products it produces.<br />
• Proper communication (<strong>in</strong>ternal) throughout the organization regard<strong>in</strong>g the FSMS<br />
development, implementation and updat<strong>in</strong>g as required by the standard – ISO 22000:2005.<br />
• In place FSMS review meet<strong>in</strong>gs (once a year) <strong>to</strong> evaluate and update it on a regular basis<br />
and/or whenever required <strong>to</strong> <strong>in</strong>corporate the latest <strong>in</strong>formation on the hazards associated with<br />
its products and processes which need <strong>to</strong> <strong>be</strong> controlled.<br />
4.1.4 XYZ has outsourced some of the processes like external lab services, pest control, water and<br />
other materials and calibration of test<strong>in</strong>g and moni<strong>to</strong>r<strong>in</strong>g devices for mach<strong>in</strong>e test<strong>in</strong>g of food<br />
that are identified and are under the control of XYZ.<br />
4.2.1 General<br />
4.2 DOCUMENTATION REQUIREMENTS<br />
The Food Safety Management System documentation consists of<br />
• Documented statements of Food Safety Policy and Food Safety Objectives <strong>in</strong> this FSMS Manual.<br />
• Food Safety Management System Manual<br />
• Documented Food Safety Management System Procedures/Food Safety Manual as required by<br />
ISO 22000:2005 and other procedures needed <strong>to</strong> ensure effective plann<strong>in</strong>g, operation and control of<br />
the processes by the organization are <strong>in</strong>cluded <strong>in</strong> this FSMS Manual or referenced here as <strong>to</strong> where<br />
such procedures are documented. Forms and Formatted registers needed <strong>to</strong> generate records are
<strong>in</strong>dicated. List of records ma<strong>in</strong>ta<strong>in</strong>ed meet<strong>in</strong>g the requirements of ISO 22000:2005 are also part of<br />
the XYZ documentation requirements.<br />
• The FSMS Manual is prepared cover<strong>in</strong>g<br />
- Scope of FSMS, cover<strong>in</strong>g the exclusions, if any, with justification.<br />
Reference <strong>to</strong> Food Safety Management System Procedures and Food Safety Manual.<br />
4.2.2 Control of documents<br />
• Procedure for Document control is established for effective control of documents def<strong>in</strong><strong>in</strong>g the<br />
follow<strong>in</strong>g controls<br />
- To approve the documents for adequacy prior <strong>to</strong> the use.<br />
- To review and update as necessary and re approve documents<br />
- To ensure that changes and the current revision status of documents are identified.<br />
- To ensure that relevant versions of applicable documents are available at po<strong>in</strong>ts of use.<br />
- To ensure that documents rema<strong>in</strong> legible and readily identifiable.<br />
- To ensure that documents of external orig<strong>in</strong> are identified and their distribution<br />
controlled and<br />
− To prevent the un<strong>in</strong>tended use of obsolete documents, and <strong>to</strong> apply suitable identification<br />
<strong>to</strong> them if they are reta<strong>in</strong>ed for any purpose.<br />
• The documents are updated with PRPs and HACCP plan<br />
4.2.3 Control of records
• Records are considered <strong>to</strong> <strong>be</strong> a special type of document, which provide objective evidence <strong>to</strong><br />
fulfillment of requirements of the Food Safety Management Systems. Effort would <strong>be</strong> <strong>to</strong> ma<strong>in</strong>ta<strong>in</strong> the<br />
records <strong>in</strong> the electronic media<br />
• Records are established and ma<strong>in</strong>ta<strong>in</strong>ed <strong>to</strong> provide evidence of conformity <strong>to</strong> requirements and of<br />
the effective operation of the Food Safety Management System. The records are ma<strong>in</strong>ta<strong>in</strong>ed <strong>in</strong> such<br />
a way that they are legible, readily identifiable and retrievable.<br />
• At XYZ, the Procedure for Control of records has <strong>be</strong>en established with regard <strong>to</strong> :<br />
- identification<br />
- s<strong>to</strong>rage<br />
- protection<br />
- retrieval<br />
- retention time<br />
- disposition<br />
5.0 MANAGEMENT RESPONSIBILITY<br />
5.1 Management commitment<br />
The Management of XYZ demonstrates good commitment <strong>to</strong> the FSMS development and<br />
implementation and cont<strong>in</strong>ually improve its effectiveness<br />
• By communicat<strong>in</strong>g the importance of meet<strong>in</strong>g the cus<strong>to</strong>mer requirements as well as statu<strong>to</strong>ry<br />
and regula<strong>to</strong>ry requirements through meet<strong>in</strong>gs.<br />
• By ensur<strong>in</strong>g establishment of Food Safety Policy<br />
• By ensur<strong>in</strong>g that Food Safety/Quality Objectives are established<br />
• By conduct<strong>in</strong>g Management Review Meet<strong>in</strong>gs.<br />
• By ensur<strong>in</strong>g that all necessary resources are available <strong>to</strong> carry out the operations.<br />
5.2 Food Safety Policy
• XYZ has def<strong>in</strong>ed and documented its policy with regard <strong>to</strong> food safety, thereby demonstrat<strong>in</strong>g the<br />
organization’s commitment <strong>to</strong> safe food. It is focused on the safety of foodstuffs, and responds <strong>to</strong> the<br />
expectations and needs of its consumers.<br />
• XYZ ensures that the policy & objectives are unders<strong>to</strong>od, implemented and ma<strong>in</strong>ta<strong>in</strong>ed at all levels<br />
of the organization. This is done through suitable means like display<strong>in</strong>g on boards and conduct<strong>in</strong>g<br />
meet<strong>in</strong>gs, via departmental heads, etc. Employees are advised of the policy & objectives on jo<strong>in</strong><strong>in</strong>g<br />
the company and/or dur<strong>in</strong>g tra<strong>in</strong><strong>in</strong>gs. Food Safety Policy forms the basis for formulation of Food<br />
Safety/Quality Objectives.<br />
• Food Safety Policy and Food Safety/Quality Objectives are reviewed <strong>in</strong> Management Review<br />
Meet<strong>in</strong>gs once <strong>in</strong> 6 months <strong>to</strong> ensure their cont<strong>in</strong>u<strong>in</strong>g suitability.<br />
FOOD SAFETY POLICY<br />
Policy statement:<br />
The Food Safety Team <strong>in</strong> M/S.XYS Company is committed <strong>to</strong> serv<strong>in</strong>g food <strong>to</strong> its guests prepared under<br />
hygienic and safe conditions.<br />
Our Food Safety Practices shall:<br />
• Ensure that only Tra<strong>in</strong>ed and Skilled staff are <strong>in</strong>ducted <strong>in</strong><strong>to</strong> the kitchen<br />
• Reflect Food Safety Standards <strong>in</strong> relation <strong>to</strong> safety practices, premises and equipment<br />
standards<br />
• Re<strong>in</strong>force consistent food safety practices <strong>in</strong> the service<br />
• Aim at provid<strong>in</strong>g Safe and Hygienic food<br />
• Reduce the risk of potential food-borne illnesses<br />
• Comply with legislative requirements <strong>while</strong> ma<strong>in</strong>ta<strong>in</strong><strong>in</strong>g a flexible approach <strong>to</strong> meet the <strong>be</strong>st<br />
practices<br />
• Reflects cont<strong>in</strong>ual improvement <strong>in</strong> the Food Safety Standards.<br />
This commitment <strong>to</strong> Food Safety Policy will <strong>be</strong> demonstrated by the management conform<strong>in</strong>g <strong>to</strong><br />
Food Safety Management System based on ISO 22000:2005 requirements and the follow<strong>in</strong>g<br />
objectives as mentioned <strong>in</strong> the table on the next page.
Organization Chart<br />
Manag<strong>in</strong>g Direc<strong>to</strong>r<br />
Production<br />
Manager<br />
Manager QA<br />
Manager<br />
Procurement<br />
HR<br />
Manager<br />
lectrician<br />
Plant Ma<strong>in</strong>tenance<br />
Opera<strong>to</strong>rs Microbiologist S<strong>to</strong>res <strong>in</strong><br />
<strong>in</strong> charge<br />
charge<br />
Ripen<strong>in</strong>g shed<br />
<strong>in</strong> charge<br />
ervisor<br />
Supervisor<br />
Supervisor<br />
Hygiene<br />
Supervisor<br />
Highlighted is the HACCP team
Competency of each position <strong>in</strong> the organization can <strong>be</strong> documented <strong>in</strong> the <strong>be</strong>low<br />
format. Any of the employees work<strong>in</strong>g <strong>in</strong> the organization is not comply<strong>in</strong>g with the<br />
requirements set by the organization as per the standard if any, and the<br />
organization’s operational requirements, then the position is not confirm<strong>in</strong>g <strong>to</strong> the<br />
requirement.<br />
Therefore it is very important that the organization first determ<strong>in</strong>es the competency<br />
requirement of the personnel, as per the operational requirement and then recruit<br />
the people comply<strong>in</strong>g with this requirement.<br />
Format for COMPETENCY MATRIX<br />
Sl.<br />
No.<br />
Name of<br />
Employee<br />
Function<br />
/<br />
Designati<br />
on<br />
Academic<br />
Qualification<br />
REQUIRED<br />
Total<br />
Experien<br />
ce<br />
Skill<br />
set<br />
Academi<br />
c<br />
Qualifica<br />
tion<br />
ACTUAL<br />
Total<br />
Experien<br />
ce<br />
Skill<br />
set
FOOD SAFETY AND QUALITY OBJECTIVES AT FUNCTIONAL LEVELS FOR THE PERIOD OF<br />
2011-2012<br />
S.NO FUNCTION OBJECTIVE RESPONSIBILITY LEVEL<br />
(Functional Heads)<br />
1 HR To give employees, a m<strong>in</strong>imum<br />
of one tra<strong>in</strong><strong>in</strong>g program <strong>in</strong> a<br />
month <strong>in</strong> handl<strong>in</strong>g, process<strong>in</strong>g,<br />
and serv<strong>in</strong>g of the safe food.<br />
Manager QC<br />
2 Purchase / S<strong>to</strong>res Nonconform<strong>in</strong>g <strong>in</strong>put materials<br />
not more than 5% per supplier<br />
of the <strong>to</strong>tal consignment per<br />
month<br />
3 Production / Manufactur<strong>in</strong>g To br<strong>in</strong>g down the wastage of<br />
the food <strong>to</strong> 5 % of the <strong>to</strong>tal<br />
production.<br />
4 Production / Manufactur<strong>in</strong>g To moni<strong>to</strong>r and ma<strong>in</strong>ta<strong>in</strong> safe<br />
temperatures (>63°C) <strong>while</strong> hot<br />
hold<strong>in</strong>g of food.<br />
Manager S<strong>to</strong>res<br />
Executive Chef<br />
Executive Chef<br />
6 Quality Assurance Cus<strong>to</strong>mer compla<strong>in</strong>ts: Not more<br />
than 5% per month<br />
Manager F & B
5.3 Food Safety Management System Plann<strong>in</strong>g<br />
The Top Management of XYZ ensures that<br />
• The Plann<strong>in</strong>g of the Food Safety Management System is carried out <strong>in</strong> order <strong>to</strong> meet the<br />
requirements of ISO 22000 standard and Food Safety/Quality Objectives.<br />
• The FSMS Plann<strong>in</strong>g of XYZ ensures that the requirements (<strong>in</strong>puts) are clearly documented <strong>to</strong><br />
ultimately meet the acceptance criteria (output).<br />
• The FSMS Plann<strong>in</strong>g <strong>in</strong>cludes or refers <strong>to</strong> the Flowchart, Worksheets, Quality Control Plans, Food<br />
Product Specifications/Recipes and Hazard Identification.<br />
• The <strong>in</strong>tegrity of the Food Safety Management System is ma<strong>in</strong>ta<strong>in</strong>ed when changes <strong>to</strong> the Food Safety<br />
Management System are planned and implemented.<br />
• On conduct<strong>in</strong>g a hazard analysis and Determ<strong>in</strong>ation of the Critical Control Po<strong>in</strong>ts (i.e., meet<strong>in</strong>g the<br />
first two HACCP pr<strong>in</strong>ciples), the HACCP Plan <strong>be</strong>comes the <strong>in</strong>put for plann<strong>in</strong>g activities with focus on<br />
what areas need control and <strong>to</strong> what level.<br />
• The requirements of the product are analyzed and def<strong>in</strong>ed with regard <strong>to</strong> :<br />
- Documentation: Flowchart, Worksheets, Quality Control Plans, Food Product<br />
Specifications/Recipes and Hazard Identification with Critical Control Po<strong>in</strong>ts<br />
- Equipment: <strong>in</strong>cludes the manufactur<strong>in</strong>g / food production equipment<br />
- Human resources: All staff has the appropriate skills for the jobs / tasks<br />
- Purchased materials: Availability of the raw materials, <strong>in</strong>gredients <strong>to</strong> the specified<br />
requirements and manufactur<strong>in</strong>g aids
5.4 Responsibility and Authority<br />
• The Organization Chart <strong>in</strong>cluded <strong>in</strong> this manual shows the relationships <strong>be</strong>tween the respective<br />
functions.<br />
All staff and managers are responsible for the quality of their own work and for advis<strong>in</strong>g<br />
their respective workers of their work responsibilities, when satisfac<strong>to</strong>ry operation of the<br />
FSMS is adversely affected. Staff and managers are responsible and have the authority<br />
with<strong>in</strong> their def<strong>in</strong>ed areas of control for:<br />
- The quality of work carried out<br />
- Initiat<strong>in</strong>g action <strong>to</strong> prevent the occurrence of product non-conformance<br />
- Identify<strong>in</strong>g and record<strong>in</strong>g quality problems<br />
- Initiat<strong>in</strong>g, recommend<strong>in</strong>g and provid<strong>in</strong>g solutions <strong>to</strong> quality problems<br />
- Verify<strong>in</strong>g that solutions are effective<br />
- Controll<strong>in</strong>g further process<strong>in</strong>g until all conditions are satisfac<strong>to</strong>ry<br />
• Further details of responsibilities and authorities for personnel who manage and perform the<br />
work can <strong>be</strong> found <strong>in</strong> the relevant job descriptions or related documents.<br />
• In the event of absence, responsibility and authority passes <strong>to</strong> the next higher level of<br />
management, for subsequent delegation, as appropriate.
Food Safety Team Responsibilities<br />
• Mak<strong>in</strong>g of the flow charts, their hazard analysis and determ<strong>in</strong>ation of CCP, conduction of HACCP<br />
Verification and Validation.<br />
• Ensur<strong>in</strong>g that the HACCP system is operat<strong>in</strong>g and ma<strong>in</strong>ta<strong>in</strong>ed <strong>in</strong><br />
XYZ as per the ISO 22000:2005 standards.<br />
• Provid<strong>in</strong>g adequate guidance and tra<strong>in</strong><strong>in</strong>g <strong>to</strong> all for carry<strong>in</strong>g out their duties <strong>in</strong> the raw material<br />
reception, pre-preparation areas, process<strong>in</strong>g areas, raw material s<strong>to</strong>res and all other sections as per<br />
XYZ approved HACCP Plans, procedures, and operat<strong>in</strong>g methods.<br />
• Effective implementation and moni<strong>to</strong>r<strong>in</strong>g of clean<strong>in</strong>g schedule and strict personnel hygiene measures <strong>in</strong><br />
the XYZ<br />
• This is <strong>in</strong> addition <strong>to</strong> their exist<strong>in</strong>g responsibilities.
Validation Team Responsibilities<br />
• Ensur<strong>in</strong>g the adequacy, completeness, and (scientific) basis of the potential hazards identified and<br />
analysed.<br />
• Ensur<strong>in</strong>g that the <strong>aspects</strong> considered <strong>while</strong> determ<strong>in</strong><strong>in</strong>g the significance of hazards are evaluated<br />
us<strong>in</strong>g sound scientific and technical knowledge<br />
• Ensur<strong>in</strong>g that the control measures (general or specific) are appropriate and adequate <strong>to</strong> control the<br />
hazards<br />
• Ensur<strong>in</strong>g that the fluctuations of the control parameters (equivalent <strong>to</strong> process criteria) with<strong>in</strong> the<br />
def<strong>in</strong>ed critical limits will not affect the safety of the product<br />
• Ensur<strong>in</strong>g the appropriateness of the control measures’ moni<strong>to</strong>r<strong>in</strong>g system<br />
• Ensur<strong>in</strong>g the appropriateness of the corrective action systems def<strong>in</strong>ed, w.r.t. prevent<strong>in</strong>g the release<br />
of unsafe products, and that they provide evidence that the situation can <strong>be</strong> corrected immediately.<br />
• Ensur<strong>in</strong>g that the Food Safety System is validated first and every time prior <strong>to</strong> issue.<br />
• Ensur<strong>in</strong>g that all the validated activities are carried out <strong>in</strong> time and records of the same are<br />
ma<strong>in</strong>ta<strong>in</strong>ed.<br />
• This is <strong>in</strong> addition <strong>to</strong> their exist<strong>in</strong>g responsibilities.<br />
5.5 FOOD SAFETY TEAM LEADER<br />
Executive Chef of M/s.XYZ Company is the nom<strong>in</strong>ated FS Team Leader hav<strong>in</strong>g responsibility and<br />
authority <strong>to</strong>
• Ensure that processes needed for the Food Safety Management System are established,<br />
implemented, ma<strong>in</strong>ta<strong>in</strong>ed and updated.<br />
• Report <strong>to</strong> the <strong>to</strong>p management on the performance of the Food Safety Management System<br />
and any need for improvement<br />
• Ensure the promotion of awareness of cus<strong>to</strong>mer requirements throughout the organization.<br />
• Liaison with external agencies on matters relat<strong>in</strong>g <strong>to</strong> the Food Safety Management System<br />
• First ensure relevant tra<strong>in</strong><strong>in</strong>g and education <strong>to</strong> FST mem<strong>be</strong>rs<br />
• To organize <strong>in</strong>ternal food safety audits for FSMS and review corrective action if required,<br />
through follow up audits.<br />
5.6. COMMUNICATION<br />
5.6.1 External Communication<br />
• XYZ has ensured that appropriate communication processes are established with the cus<strong>to</strong>mer,<br />
Legal Authorities and External Certify<strong>in</strong>g Agencies.<br />
• XYZ communicates with the cus<strong>to</strong>mers <strong>in</strong> relation <strong>to</strong>:<br />
- Product <strong>in</strong>formation.<br />
- Cus<strong>to</strong>mer feedback, <strong>in</strong>clud<strong>in</strong>g cus<strong>to</strong>mer compla<strong>in</strong>ts through e-mail or verbal means.
- Cus<strong>to</strong>mer compla<strong>in</strong>ts and feedback are documented and Corrective and Preventive Actions are<br />
taken accord<strong>in</strong>gly.<br />
• All the data required for Legal authorities and External certify<strong>in</strong>g agencies is recorded and<br />
ma<strong>in</strong>ta<strong>in</strong>ed separately.<br />
5.6.2 Internal Communication<br />
• XYZ ensures that appropriate communication processes are established with<strong>in</strong> the organization and<br />
that communication takes place regard<strong>in</strong>g the effectiveness of the FSMS through:<br />
- Management Review Meet<strong>in</strong>gs, m<strong>in</strong>imum once <strong>in</strong> six months<br />
- Notices/Mail.<br />
- Circulars<br />
• The preventive actions identified under hazard analysis and the food product deviations with the<br />
related dispositions are made known by communicat<strong>in</strong>g at the appropriate levels and functions.<br />
• At XYZ communication takes place with regard <strong>to</strong> the follow<strong>in</strong>g <strong>to</strong> promote effective operation of the<br />
FSMS:<br />
- recipe improvisations / new recipes<br />
- changes <strong>in</strong> raw materials, <strong>in</strong>gredients<br />
- changes <strong>in</strong> food production, manufactur<strong>in</strong>g systems, equipment and surround<strong>in</strong>g environment<br />
- changes <strong>in</strong> the requirements (cus<strong>to</strong>mer, statu<strong>to</strong>ry / regula<strong>to</strong>ry)<br />
- changes <strong>in</strong> personnel qualification level and responsibilities<br />
- New food safety hazards with the new ways of handl<strong>in</strong>g and controll<strong>in</strong>g measures.<br />
- Changes <strong>in</strong> clean<strong>in</strong>g and sanitation programmes, s<strong>to</strong>rage and distribution systems<br />
- Compla<strong>in</strong>ts <strong>in</strong>dicat<strong>in</strong>g food safety hazards associated with the products.<br />
• The food safety team ensures that this <strong>in</strong>formation is <strong>in</strong>cluded <strong>in</strong> the updat<strong>in</strong>g of the FSMS.<br />
• Top management shall ensure that relevant <strong>in</strong>formation is <strong>in</strong>cluded as <strong>in</strong>put <strong>to</strong> the management<br />
review<br />
• The m<strong>in</strong>utes of the Management Review Meet<strong>in</strong>gs are ma<strong>in</strong>ta<strong>in</strong>ed by the MR.<br />
(Refer M<strong>in</strong>utes of Management Review meet<strong>in</strong>gs)<br />
• The m<strong>in</strong>utes of meet<strong>in</strong>gs are communicated <strong>to</strong> the participants of the meet<strong>in</strong>g for tak<strong>in</strong>g effective<br />
actions and demonstrat<strong>in</strong>g cont<strong>in</strong>ual improvement
5.7. EMERGENCY PREPAREDNESS AND RESPONSE<br />
• Objectives of the Plan<br />
To identify the possible hazard/ risk this can lead <strong>to</strong> environmental emergency, property damage<br />
and <strong>in</strong>jury <strong>to</strong> human <strong>be</strong><strong>in</strong>gs<br />
- To prevent, identified potential environmental, food safety related emergency<br />
scenarios<br />
- To m<strong>in</strong>imize /mitigate consequences wherever possible.<br />
- To provide relief <strong>to</strong> <strong>in</strong>jured persons.<br />
- To control the emergency as early as possible.<br />
• Potential Emergency Situations.<br />
Location<br />
Raw/pack<strong>in</strong>g<br />
Material<br />
s<strong>to</strong>rage<br />
Electrical<br />
Control<br />
Panel Area<br />
Fac<strong>to</strong>rs lead<strong>in</strong>g <strong>to</strong><br />
emergency<br />
Electrical Fire<br />
Bidi/Cigarette Fire<br />
Flash due <strong>to</strong> short<br />
Circuit<strong>in</strong>g<br />
Overload<strong>in</strong>g and water<br />
Spillage<br />
Hazard<br />
Injury <strong>to</strong> human<br />
Be<strong>in</strong>gs<br />
Air pollution<br />
Land Pollution<br />
Fire<br />
Injury <strong>to</strong> human<br />
<strong>be</strong><strong>in</strong>gs<br />
Air Pollution<br />
Preventive measures<br />
Proper connections<br />
‘NO SMOKING’ sign is displayed.<br />
Fire ext<strong>in</strong>guishers & pipel<strong>in</strong>es are<br />
provided<br />
Proper connections<br />
Proper load distribution<br />
Area <strong>to</strong> <strong>be</strong> <strong>kept</strong> dry<br />
‘NO SMOKING’ sign is displayed.<br />
Production<br />
Area<br />
Fire<br />
Manual handl<strong>in</strong>g of<br />
chemicals<br />
Accidental spray of hot CIP<br />
Solutions<br />
Steam burns<br />
Water Pollution<br />
Air pollution<br />
Injury <strong>to</strong> human<br />
<strong>be</strong><strong>in</strong>gs<br />
Proper ma<strong>in</strong>tenance of pipe<br />
Fitt<strong>in</strong>gs<br />
Use of safety wears etc.
Kitchen area<br />
Fire<br />
Leakage of LPG<br />
Electrical sparks<br />
Fitt<strong>in</strong>gs & electrical short<br />
Circuit<br />
Lighted cigarette, match<br />
Sticks.<br />
Fire & explosion<br />
Air pollution<br />
Property damage<br />
Injury <strong>to</strong> human<br />
Be<strong>in</strong>gs.<br />
Regular ma<strong>in</strong>tenance of gas<br />
Pipe fitt<strong>in</strong>gs.<br />
‘NO SMOKING’ sign is<br />
Displayed.<br />
Fire ext<strong>in</strong>guishers& Pipel<strong>in</strong>es are<br />
provided.<br />
Moni<strong>to</strong>r<strong>in</strong>g of LPG<br />
Admn.block.<br />
Sites of high rise<br />
Build<strong>in</strong>g<br />
Pa<strong>in</strong>t<strong>in</strong>g/<br />
Construction /<br />
Civil work<br />
Clean<strong>in</strong>g of<br />
glasses<br />
Slip or fall may lead <strong>to</strong> an<br />
accident<br />
Slip or fall may lead <strong>to</strong> an<br />
Accident<br />
breakage of glass<br />
Injury <strong>to</strong> human<br />
<strong>be</strong><strong>in</strong>gs<br />
Injury <strong>to</strong> human<br />
<strong>be</strong><strong>in</strong>gs<br />
Safety <strong>be</strong>lt, proper ladder,<br />
Proper scaffold<strong>in</strong>g<br />
Safety <strong>be</strong>lt, proper ladder<br />
• Potential Food Safety Emergency<br />
Location<br />
Fac<strong>to</strong>rs lead<strong>in</strong>g<br />
<strong>to</strong> emergency<br />
Hazard<br />
Preventive measures<br />
Production/<br />
Kitchen Area<br />
Service center<br />
Premises<br />
Bio-terrorism,<br />
sabotage, Bird flu<br />
Energy Failure<br />
Injury <strong>to</strong><br />
Human Be<strong>in</strong>gs<br />
Accidents<br />
Product Loss &<br />
Timely<br />
Delivery<br />
effects<br />
Entry restricted <strong>to</strong> Production / kitchen area<br />
Security Arrangements <strong>in</strong> the premises round the<br />
clock.<br />
Raw materials/commodities are accepted only<br />
after proper check<strong>in</strong>g.<br />
F<strong>in</strong>ished Product is released only after proper<br />
check<strong>in</strong>g.<br />
Microbiology lab is <strong>in</strong> the premises; however<br />
rout<strong>in</strong>e bacteriological used media / culture are<br />
disposed off only after au<strong>to</strong>-clav<strong>in</strong>g.<br />
Emergency Lights provided at the potential areas.<br />
Standby Genera<strong>to</strong>r/Transformer.
Service center<br />
Premises<br />
Flood<strong>in</strong>g<br />
Unhygienic<br />
Conditions and<br />
h<strong>in</strong>drances <strong>to</strong><br />
production.<br />
Proper Ma<strong>in</strong>tenance of dra<strong>in</strong>age system &<br />
periodically clean<strong>in</strong>g.<br />
Additional pumps provided around the premises<br />
<strong>to</strong> throughout s<strong>to</strong>rm water / additional water<br />
outside the premises.<br />
All the premises is covered with solid brick walls<br />
and entry gates are raised, then the road level <strong>to</strong><br />
s<strong>to</strong>p entry of water from outside.<br />
• Emergency Preparedness:<br />
- To deal with fire, the whole premises are equipped with fire ext<strong>in</strong>guisher pipel<strong>in</strong>es and<br />
fitt<strong>in</strong>gs etc... Which are <strong>in</strong>stalled at various locations as per the law.<br />
- Majority of the persons <strong>in</strong> the service centre tra<strong>in</strong>ed <strong>in</strong> fire fight<strong>in</strong>g and first aid is displayed<br />
prom<strong>in</strong>ently <strong>in</strong> every department.<br />
- All security guards are tra<strong>in</strong>ed <strong>in</strong> fire fight<strong>in</strong>g.<br />
- Adequate num<strong>be</strong>r of first aid boxes are <strong>in</strong>stalled and ma<strong>in</strong>ta<strong>in</strong>ed <strong>in</strong> the service centre.<br />
- All <strong>in</strong>flammable materials are s<strong>to</strong>red <strong>in</strong> isolated place and la<strong>be</strong>led accord<strong>in</strong>gly.<br />
- ‘NO SMOKING’ signs are displayed at all important locations<br />
- Intercom facilities are available all over the build<strong>in</strong>g for communication with security<br />
department.<br />
- Personal protective are <strong>kept</strong> near potential area by the concerned Section In charge such as hand<br />
gloves, masks etc.<br />
- List of emergency telephone num<strong>be</strong>rs is available <strong>in</strong> each department.<br />
• All types of wastages like raw material, packag<strong>in</strong>g material etc is taken by an external agency for disposal of<br />
the same.<br />
• Other waste like cooked lef<strong>to</strong>ver food items are taken by an external agency for disposal and records are<br />
ma<strong>in</strong>ta<strong>in</strong>ed.<br />
• For Product recall from cus<strong>to</strong>mer please refer clause 7.10.3 (handl<strong>in</strong>g of potentially unsafe products)of this<br />
manual<br />
• The Food Safety will act as an emergency team <strong>in</strong> such situations.
5.8 MANAGEMENT REVIEW<br />
5.8.1 General<br />
Top management reviews the organization’s Food Safety Management System at least once <strong>in</strong> every six<br />
months <strong>to</strong> ensure its cont<strong>in</strong>u<strong>in</strong>g suitability, adequacy and effectiveness. The review <strong>in</strong>cludes assess<strong>in</strong>g<br />
opportunities for improvement and the need for changes <strong>to</strong> the Food Safety Management System,<br />
<strong>in</strong>clud<strong>in</strong>g the Food Safety Policy and Food Safety Objectives. Records of management review are<br />
ma<strong>in</strong>ta<strong>in</strong>ed.<br />
• The mem<strong>be</strong>rs of the Management review committee <strong>in</strong>clude:<br />
Manager QC<br />
Manager Purchase & s<strong>to</strong>res<br />
Manager Production<br />
5.8.2 Review <strong>in</strong>put<br />
The <strong>in</strong>put <strong>to</strong> the Management review meet<strong>in</strong>g <strong>in</strong>cludes the follow<strong>in</strong>g <strong>in</strong>formation.<br />
• Follow-up actions from previous management reviews<br />
• Analysis of results of verification activities<br />
• Chang<strong>in</strong>g circumstances that can affect food safety<br />
• Emergency situations, accidents and withdrawals
• Results of review and system updat<strong>in</strong>g activities<br />
• Communication activities <strong>in</strong>clud<strong>in</strong>g cus<strong>to</strong>mer feedback and is reviewed monthly.<br />
• External audits or <strong>in</strong>spections<br />
5.8.3 Review output<br />
Output of the management review conta<strong>in</strong>s the decisions and actions related <strong>to</strong><br />
• Assurance of food safety<br />
• Improvement of the effectiveness of the Food Safety Management System<br />
• Resource needs<br />
• Revision of organization’s food safety policy and objectives<br />
Management Representative<br />
• The Management Representative, ensures the follow<strong>in</strong>g: As per standard<br />
- To establish, implement and ma<strong>in</strong>ta<strong>in</strong> the FSMS as per ISO22000: 2005 Standards.<br />
- To ensure that processes needed for the FSMS are established, implemented and ma<strong>in</strong>ta<strong>in</strong>ed<br />
understand<strong>in</strong>g the current and future needs of the cus<strong>to</strong>mers / clients<br />
- To report <strong>to</strong> the <strong>to</strong>p management on the cont<strong>in</strong>u<strong>in</strong>g suitability and effectiveness of the FSMS<br />
and the scope for improvement<br />
- To promote awareness of cus<strong>to</strong>mer requirements throughout the organization<br />
- To plan, schedule and conduct Internal Audits for FSMS<br />
- To select qualified Internal Audi<strong>to</strong>rs<br />
- To review the Audit Report and follow-up Corrective Action / Preventive Action Reports<br />
- To <strong>in</strong>itiate modifications of documents based on Corrective action / Preventive Action and <strong>to</strong><br />
control all the documents related <strong>to</strong> the FSMS<br />
- To schedule management review meet<strong>in</strong>gs at the def<strong>in</strong>ed <strong>in</strong>tervals and record m<strong>in</strong>utes of<br />
management review meet<strong>in</strong>gs for subsequent report<strong>in</strong>g on the performance / improvements<br />
of the FSMS<br />
- To liaison with the external agencies related <strong>to</strong> the FSMS Implementation and Certification<br />
• The Management Representative convenes the management review meet<strong>in</strong>gs after preparation of<br />
the agenda and ma<strong>in</strong>ta<strong>in</strong>s the m<strong>in</strong>utes of the meet<strong>in</strong>g.
6.0 RESOURCE MANAGEMENT<br />
6.1 Provision of Resources :<br />
• Resources (Human resources, Equipment resources and Work environment needs) required for<br />
implementation & ma<strong>in</strong>ta<strong>in</strong><strong>in</strong>g of Food Safety Management System are identified, and determ<strong>in</strong>ed<br />
by MR for carry<strong>in</strong>g out various activities as per budgeted plan.<br />
• Resources are provided <strong>to</strong> implement and ma<strong>in</strong>ta<strong>in</strong> the Food Safety Management System and<br />
cont<strong>in</strong>ually improve its effectiveness and enhance cus<strong>to</strong>mer satisfaction by meet<strong>in</strong>g cus<strong>to</strong>mer<br />
requirements. Resource requirements are reviewed <strong>in</strong> Management Review meet<strong>in</strong>gs.<br />
• The resources <strong>in</strong>clude :<br />
- Adequate tra<strong>in</strong>ed personnel for management, performance and verification activities.<br />
- <strong>in</strong>put materials of the requisite quality<br />
- Suitable process equipment, process control equipment and other <strong>in</strong>frastructure <strong>to</strong> meet the<br />
requirements for the quality of the product.<br />
- Work environment (physical and human) suitable for operation / processes <strong>to</strong> meet up<br />
Quantified Quality Objectives.<br />
6.2 HUMAN RESOURCES<br />
6.2.1 General<br />
• XYZ provides competent personnel for perform<strong>in</strong>g work affect<strong>in</strong>g product quality. Competency of<br />
the personnel is based on appropriate education, tra<strong>in</strong><strong>in</strong>g, skills and experience and is established <strong>in</strong><br />
l<strong>in</strong>e with the Food Safety and Quality Policy and Plans. All staff work<strong>in</strong>g <strong>in</strong> food areas is adequately<br />
tra<strong>in</strong>ed <strong>in</strong> hygiene procedures.
6.2.2 Competence, Awareness and Tra<strong>in</strong><strong>in</strong>g<br />
a. Competence of personnel for perform<strong>in</strong>g the activities hav<strong>in</strong>g Quality, Safety and Environment<br />
impacts has <strong>be</strong>en established on the basis of appropriate education, tra<strong>in</strong><strong>in</strong>g and or experience.<br />
b. Enhancement of competence is done through tra<strong>in</strong><strong>in</strong>g, education and learn<strong>in</strong>g <strong>in</strong>volv<strong>in</strong>g technical<br />
knowledge and skills, management skills and <strong>to</strong>ols, social skills, knowledge of markets and<br />
cus<strong>to</strong>mer needs and expectations, relevant statuary and regula<strong>to</strong>ry requirements, <strong>in</strong>ternal and<br />
appropriate external standards, and documentation for perform<strong>in</strong>g the work as appropriate.<br />
Efforts are made <strong>to</strong> <strong>in</strong>crease the awareness and <strong>in</strong>volvement of personnel through programs which covers:<br />
- the vision for the future of the organization,<br />
- the Organization’s policies and objectives,<br />
- organizational change and development,<br />
- The <strong>in</strong>itiation and implementation of improvement activities,<br />
- <strong>in</strong>troduc<strong>to</strong>ry programs for new personnel, and<br />
- Periodic refresher programs for personnel already work<strong>in</strong>g with the<br />
organization.<br />
c. Identification of tra<strong>in</strong><strong>in</strong>g needs<br />
- The Organization analyses the development needs of all its personnel and design tra<strong>in</strong><strong>in</strong>g plan<br />
for them. This is <strong>to</strong> provide personnel with knowledge which, <strong>to</strong>gether with skills and<br />
experience, leads <strong>to</strong> competence.<br />
Preparation of tra<strong>in</strong><strong>in</strong>g plan<br />
For identified tra<strong>in</strong><strong>in</strong>g, tra<strong>in</strong><strong>in</strong>g plans are prepared. The tra<strong>in</strong><strong>in</strong>g plan covers:<br />
- food safety tra<strong>in</strong><strong>in</strong>g,<br />
- personnel hygiene,<br />
- hygiene and sanitation,<br />
- pest control,<br />
- Operation of equipment<br />
(Refer: Tra<strong>in</strong><strong>in</strong>g Plan Tables <strong>in</strong> this Manual)<br />
d. Impart<strong>in</strong>g tra<strong>in</strong><strong>in</strong>g and keep<strong>in</strong>g records<br />
- In coord<strong>in</strong>ation with concerned function tra<strong>in</strong><strong>in</strong>g is imparted either by deput<strong>in</strong>g persons <strong>to</strong><br />
identified <strong>in</strong>stitutions outside or by organiz<strong>in</strong>g <strong>in</strong> house tra<strong>in</strong><strong>in</strong>g by engag<strong>in</strong>g tra<strong>in</strong>ers from<br />
outside agencies or from with<strong>in</strong> the organization.
- The technical personnel have <strong>be</strong>en tra<strong>in</strong>ed on pr<strong>in</strong>ciples of ISO: 22000-2005 and are also on<br />
the use of documentation related <strong>to</strong> the Organization's FSMS.<br />
- Competence and tra<strong>in</strong><strong>in</strong>g records of personnel are ma<strong>in</strong>ta<strong>in</strong>ed on prescri<strong>be</strong>d formats.<br />
Effectiveness of the tra<strong>in</strong><strong>in</strong>g is assessed and records are ma<strong>in</strong>ta<strong>in</strong>ed.<br />
e. It is the responsibility of the Department Heads <strong>to</strong> identify the tra<strong>in</strong><strong>in</strong>g needs of their personnel on<br />
the basis of work performance, <strong>in</strong>troduction of new process and technology and recommend them<br />
for tra<strong>in</strong><strong>in</strong>g such as external tra<strong>in</strong><strong>in</strong>g, sem<strong>in</strong>ars, workshops etc. The workers have also <strong>be</strong>en tra<strong>in</strong>ed<br />
on basic quality concepts, food hygiene and good manufactur<strong>in</strong>g practices and food safety.<br />
f. The food handlers have the necessary knowledge of food handl<strong>in</strong>g and preservation pr<strong>in</strong>ciples<br />
and practices <strong>to</strong> <strong>be</strong> able <strong>to</strong> judge potential risks and take the necessary actions by effective<br />
communications <strong>to</strong> remedy deficiencies.<br />
g. Tra<strong>in</strong><strong>in</strong>g Plan for Professional Skills for the Year 2011<br />
Topics <strong>to</strong> <strong>be</strong> covered Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec<br />
GMPs – facility issues, food<br />
flow, people flow, waste<br />
flow, build<strong>in</strong>g and<br />
structural issues,<br />
segregation, cross<br />
contam<strong>in</strong>ation due <strong>to</strong>
facility issues<br />
SSOPs – clean<strong>in</strong>g of all<br />
areas/equipments/utensils<br />
etc, personal hygiene, cross<br />
contam<strong>in</strong>ation, pest<br />
control, water safety,<br />
health issues etc<br />
CCP related –<br />
identification, critical<br />
limits, moni<strong>to</strong>r<strong>in</strong>g,<br />
corrective action, record<br />
keep<strong>in</strong>g, verification and<br />
validation<br />
Process related – Nonconformity,<br />
corrective<br />
actions, <strong>in</strong>ternal audits,<br />
unsafe product handl<strong>in</strong>g,<br />
control of documents and<br />
records, traceability,<br />
product recall and<br />
emergency situations.<br />
<br />
<br />
<br />
Production related –<br />
receiv<strong>in</strong>g, issu<strong>in</strong>g, s<strong>to</strong>rage,<br />
cook<strong>in</strong>g, steam<strong>in</strong>g, bak<strong>in</strong>g,<br />
fry<strong>in</strong>g, dispatch, hot/cold<br />
hold<strong>in</strong>g, etc<br />
Basic food hygiene – basic<br />
pr<strong>in</strong>ciples of handl<strong>in</strong>g food<br />
<br />
<br />
<br />
Personal hygiene – Hand<br />
wash procedures, Uniform,<br />
personal groom<strong>in</strong>g, proper<br />
use of accessories,<br />
report<strong>in</strong>g illness and<br />
medical health<br />
HACCP – as per Codex<br />
ISO 22000:2005 -<br />
Awareness Tra<strong>in</strong><strong>in</strong>g
ISO 22000:2005 – Internal<br />
Audi<strong>to</strong>r’s tra<strong>in</strong><strong>in</strong>g<br />
Basic Fire Safety Tra<strong>in</strong><strong>in</strong>g<br />
Basic First Aid Tra<strong>in</strong><strong>in</strong>g<br />
<br />
<br />
<br />
<br />
<br />
6.3 Infrastructure :<br />
• XYZ determ<strong>in</strong>es, provides and ma<strong>in</strong>ta<strong>in</strong>s the <strong>in</strong>frastructure needed <strong>to</strong> achieve conformity <strong>to</strong> product<br />
requirements.<br />
• Infrastructure at XYZ <strong>in</strong>cludes :<br />
- Build<strong>in</strong>g, workspaces and associated utilities like UPS, genera<strong>to</strong>rs, air–conditioners, aircompressors,<br />
etc.<br />
- Calibrated process equipment.<br />
- Support<strong>in</strong>g services like telephones, fax m/c, computers, etc.<br />
- Appropriate design and ma<strong>in</strong>tenance of the work area, which has a major effect on food safety.<br />
The ma<strong>in</strong>tenance of the equipment complies with the Good Manufactur<strong>in</strong>g Practice (GMP) and<br />
Good Labora<strong>to</strong>ry Practice (GLP)<br />
• Infrastructure is ma<strong>in</strong>ta<strong>in</strong>ed <strong>to</strong> ensure their suitability. Equipment ma<strong>in</strong>tenance is carried out as per<br />
schedule established.<br />
6.4 Work environment
• Work environment needed <strong>to</strong> achieve conformity <strong>to</strong> product requirements is provided at all<br />
work<strong>in</strong>g places <strong>in</strong> the organization.<br />
• To ensure safety of personnel, activities related <strong>to</strong> safety is carried out like periodic medical<br />
checkup and safety awareness tra<strong>in</strong><strong>in</strong>gs, hygiene tra<strong>in</strong><strong>in</strong>g programmes etc.<br />
PLANNING AND REALIZATION OF SAFE PRODUCT<br />
7.1 General<br />
• XYZ Plans and develops the processes needed for Product Realization. Plann<strong>in</strong>g of Product<br />
Realization is consistent with the requirements of the other processes of the FSMS. The processes<br />
are clearly def<strong>in</strong>ed with the measurement criteria and the <strong>in</strong>terfac<strong>in</strong>g with the other processes.<br />
• The results of HACCP study is taken as <strong>in</strong>put <strong>to</strong> Process Plann<strong>in</strong>g / Food Safety Plann<strong>in</strong>g, with the<br />
critical areas and shows the correct directions. The results from Food Safety Plann<strong>in</strong>g give an<br />
<strong>in</strong>dication of the typical controls needed with<strong>in</strong> a process. Food Safety Plann<strong>in</strong>g is l<strong>in</strong>ked <strong>to</strong> the<br />
HACCP Plan <strong>in</strong> which the CCP’s were identified.<br />
• To ensure Product Realization, consideration is given <strong>to</strong> associated support functions as well as<br />
desired outputs, materials, methods, equipment, control measures, <strong>in</strong>formation, tra<strong>in</strong><strong>in</strong>g needs and<br />
other resources. Support functions <strong>in</strong>clude :<br />
- Tra<strong>in</strong><strong>in</strong>g of people<br />
- Availability of <strong>in</strong>frastructure<br />
- Application of Industrial safety / Protective Equipment<br />
• XYZ determ<strong>in</strong>es the follow<strong>in</strong>g <strong>while</strong> plann<strong>in</strong>g for product realization:<br />
- Food Safety & Quality Objectives and requirements for the product.<br />
- The need <strong>to</strong> establish processes and documents and provide the resources specific <strong>to</strong> the<br />
manufactur<strong>in</strong>g of the food product.<br />
- The required verification, validation, moni<strong>to</strong>r<strong>in</strong>g, <strong>in</strong>spection and test activities of the food<br />
product and the criteria for the product acceptance.
• Records needed <strong>to</strong> provide evidence that the realization processes and the result<strong>in</strong>g product meet<br />
requirements.<br />
• In plann<strong>in</strong>g, the follow<strong>in</strong>g problems / risks are considered which can occur dur<strong>in</strong>g process<strong>in</strong>g :<br />
- Risk of contam<strong>in</strong>ation – for raw materials, additives. Work-<strong>in</strong>-progress, f<strong>in</strong>al products<br />
and packag<strong>in</strong>g materials<br />
.<br />
7.2 PRE-REQUISITE PROGRAMS<br />
7.2.1 XYZ has made available a complete and actual description of the pre-requisite program (PRP) of<br />
the organization. The PRPs establish<br />
- The likelihood of <strong>in</strong>troduc<strong>in</strong>g food safety hazards <strong>to</strong> the product through the work environment.<br />
- All classes of hazards (biological, physical and chemical) of the product/process, <strong>in</strong>clud<strong>in</strong>g cross<br />
contam<strong>in</strong>ation <strong>be</strong>tween the products.<br />
- The level of food safety hazards <strong>in</strong> the product and product process<strong>in</strong>g environment.<br />
7.2.2 XYZ has identified the PRP’s as per the organizational needs, appropriate <strong>to</strong> the type of operational<br />
and product manufacture along the production system. And PRP’s are approved by Food Safety Team <strong>in</strong><br />
compliance with PFA <strong>to</strong>o.<br />
7.2.3 XYZ has made available<br />
• The procedures <strong>be</strong>long<strong>in</strong>g <strong>to</strong> the PRP are well established (specified and documented), fully<br />
operational and <strong>in</strong>tegrated with the ISO 22000:2005 system, and verified. Their verification is<br />
addressed as a part of the Internal Audits and Verification activities.<br />
• XYZ has decided which food hygiene pr<strong>in</strong>ciples, good manufactur<strong>in</strong>g practices and food legislation<br />
are <strong>to</strong> <strong>be</strong> <strong>in</strong>cluded <strong>in</strong><strong>to</strong> its PRP.<br />
7.3 PRELIMINARY STEPS TO ENABLE HAZARD ANALYSIS<br />
7.3.1 General
• The products and the processes, (the procedures <strong>be</strong>long<strong>in</strong>g <strong>to</strong>) and the PRP are subjected <strong>to</strong> hazard<br />
analysis <strong>in</strong> order <strong>to</strong> identify potential hazards and <strong>to</strong> decide which way the hazards (risk) need <strong>to</strong> <strong>be</strong><br />
controlled. This is demonstrated <strong>in</strong> the Hazard Identification and Risk Analysis of related<br />
products/processes, <strong>in</strong> the related HACCP/Food Safety Plans, as applicable. All the relavant<br />
<strong>in</strong>formation is collected, ma<strong>in</strong>ta<strong>in</strong>ed, updated and documented. Records are available for the same.<br />
7.3.2 Food safety team<br />
• XYZ has assembled a Food Safety Team <strong>in</strong> order <strong>to</strong> develop, implement and ma<strong>in</strong>ta<strong>in</strong> the ISO 22000<br />
System. The team def<strong>in</strong>ition is available <strong>in</strong> the Food Safety Team document ma<strong>in</strong>ta<strong>in</strong>ed with the<br />
FSTL. The team mem<strong>be</strong>rs have the knowledge, expertise and cover different discipl<strong>in</strong>es available<br />
which are required <strong>to</strong> develop, implement and ma<strong>in</strong>ta<strong>in</strong> a Food Safety Management System cover<strong>in</strong>g<br />
the entire scope of their operation. The competency of Food Safety Team Mem<strong>be</strong>rs is available and<br />
ma<strong>in</strong>ta<strong>in</strong>ed with the FSTL, and is reviewed & updated periodically.<br />
• The assignment (<strong>in</strong>clud<strong>in</strong>g tasks, responsibilities and authorities) are documented for the team<br />
mem<strong>be</strong>rs of the Food Safety Team as a part of the Responsibility and Authority document<br />
ma<strong>in</strong>ta<strong>in</strong>ed with the FSTL.<br />
7.3.3. PRODUCT CHARACTERISTICS<br />
7.3.3.1 & 7.3.3.2 Raw materials, <strong>in</strong>gredients and product contact materials & characteristics of end<br />
products<br />
• The quality specifications are def<strong>in</strong>ed for raw materials and <strong>in</strong>gredients. The product description for<br />
various food groups is specified and documented. The description of the safety of the product group<br />
encompasses the food cha<strong>in</strong>, rang<strong>in</strong>g from raw materials used <strong>to</strong> the distribution of the f<strong>in</strong>ished<br />
products. This is further documented through the Flow Diagrams and Hazard Analysis Work Sheets<br />
for the product group respectively<br />
• An extensive specification of the end products ensures a comprehensive assessment of the food<br />
safety procedures. This specification clearly def<strong>in</strong>es the follow<strong>in</strong>g product characteristics:<br />
− Product identification and general product description.<br />
− Raw materials used and composition.<br />
− General product specifications as per recipe.<br />
− Specific requirements such as appropriate legislation.<br />
− General control of (chemical, microbiological and physical) for food safety.<br />
− Packag<strong>in</strong>g, s<strong>to</strong>rage conditions, la<strong>be</strong>l<strong>in</strong>g.<br />
− Identification of potential mishandl<strong>in</strong>g of the product.
7.3.4. INTENDED USE<br />
• The <strong>in</strong>tended use of the product is identified and documented for the product groups. S<strong>in</strong>ce this has<br />
a direct <strong>in</strong>fluence on the required product characteristics.<br />
• The <strong>in</strong>tended use of the product is cont<strong>in</strong>ually reviewed.<br />
7.3.5. FLOW DIAGRAMS, PROCESS STEPS AND CONTROL MEASURES<br />
7.3.5.1 Flow diagrams<br />
• XYZ has made available a complete and actual description of the operation <strong>in</strong> the form of flow<br />
diagrams (process steps), which are <strong>in</strong>cluded <strong>in</strong> Food Safety Manual for the Flow Diagram, and<br />
layouts (production facilities), which are available with the FST Leader. When apply<strong>in</strong>g ISO 22000<br />
<strong>to</strong> a given operation, consideration is given <strong>to</strong> steps preced<strong>in</strong>g and follow<strong>in</strong>g the specified operation,<br />
which is evidenced <strong>in</strong> the flow diagrams and Hazard Identification & Risk Analysis worksheet. These<br />
descriptions are drawn up and verified by the Food Safety and Validation Teams.<br />
• The Flow Diagrams provide a schematic overview of the operation, and descri<strong>be</strong> all the steps <strong>in</strong><br />
sufficient detail <strong>to</strong> provide the Food Safety Team with adequate <strong>in</strong>formation for the ISO 22000. They<br />
take <strong>in</strong><strong>to</strong> account all relevant process steps, such as the manufactur<strong>in</strong>g of the product, <strong>in</strong>clud<strong>in</strong>g<br />
critical po<strong>in</strong>ts like:<br />
−<br />
−<br />
−<br />
−<br />
Dis<strong>in</strong>fection of vegetables <strong>be</strong>fore use<br />
Pre-preparation<br />
Cook<strong>in</strong>g<br />
Serv<strong>in</strong>g<br />
• All facilities which are part of the <strong>in</strong>frastructure of XYZ, such as the production l<strong>in</strong>es, s<strong>to</strong>rage areas<br />
and personnel facilities are depicted <strong>in</strong> layout plans. In the layout plans, the follow<strong>in</strong>g items have<br />
<strong>be</strong>en <strong>in</strong>dicated:<br />
−<br />
−<br />
The rout<strong>in</strong>g of material, personnel. This is shown <strong>in</strong> the PLANT Layout.<br />
The areas and facilities for personnel use. This is shown <strong>in</strong> the PLANT Layout.<br />
7.3.5.2 Description of process steps and control measures
• Prior <strong>to</strong> the execution of changes <strong>in</strong> the production process and layout that could adversely affect<br />
food safety, these changes are reported <strong>to</strong> the Food Safety Team <strong>in</strong> order <strong>to</strong> evaluate potential<br />
hazards <strong>to</strong> food safety, and take preventive actions accord<strong>in</strong>gly. Prospective changes are reported <strong>to</strong><br />
Food Safety Team as per the Documentation Control Procedure and its support<strong>in</strong>g documents.<br />
• The accuracy and actuality of flow diagrams and layouts are verified by the Food Safety Team for<br />
compliance with the documented situation on a periodic basis (at least annually), <strong>in</strong> order <strong>to</strong><br />
identify and document modifications <strong>to</strong> the process <strong>in</strong>stallation and layout. Verified flow diagrams<br />
and layouts, with changes marked on them if applicable, are ma<strong>in</strong>ta<strong>in</strong>ed with the FSTL. These<br />
periodic verifications are a part of the Internal Audit cum Verification.<br />
7.4.1 General<br />
7.4 HAZARD ANALYSIS<br />
• XYZ has identified, analysed and evaluated all potential (biological, chemical and physical)<br />
hazards that can have an adverse effect on the safety of the products. Wherever XYZ’s<br />
operations change <strong>in</strong> a manner that could adversely affect food safety, all relevant steps of<br />
the Hazard Identification and Risk Analysis are updated (as necessary).<br />
7.4.2 Hazard Identification & Determ<strong>in</strong>ation of Acceptable Level<br />
7.4.2.1<br />
• XYZ Food Safety Team has identified and registered all potential (biological, chemical and<br />
physical) hazards that can have an adverse effect on the safety of the products. The<br />
identification <strong>in</strong>cludes all <strong>aspects</strong> of the operation with<strong>in</strong> the scope of the ISO 22000 system.<br />
Potential hazards have <strong>be</strong>en documented <strong>in</strong> the Hazard Analysis Worksheet.<br />
7.4.2.2<br />
• The operations evaluated <strong>in</strong>clude all products, all processes and the pre-requisite program of<br />
the legal owner of the products<br />
• FS Team Mem<strong>be</strong>rs shall identify and record all the potential hazards dur<strong>in</strong>g food<br />
preparation, process<strong>in</strong>g and deliver<strong>in</strong>g (biological, chemical and physical) that may have an<br />
adverse effect on the safety and hygiene of the food product.<br />
• The hazard identification <strong>in</strong>cludes <strong>aspects</strong> like:<br />
- Raw materials and <strong>in</strong>gredients: specifications, vendor approval, etc;<br />
- Characteristics of end products: product specifications, etc;<br />
- The Pre Requisite Program, <strong>in</strong>clud<strong>in</strong>g OPRP’s<br />
- Facilities Layout, Production L<strong>in</strong>es, Installations and Equipment<br />
- Locations of rooms, rout<strong>in</strong>g, s<strong>to</strong>rage and separation of raw materials, end products, etc.
- Production processes, like: purchas<strong>in</strong>g, clean<strong>in</strong>g and dis<strong>in</strong>fection, packag<strong>in</strong>g, ma<strong>in</strong>tenance, pest<br />
control, waste management, etc.<br />
- Personnel (<strong>in</strong>clud<strong>in</strong>g arrangements for visi<strong>to</strong>rs and external service providers, e.g.: mechanics):<br />
hygiene, knowledge with regard <strong>to</strong> food hygiene and food safety, requirement <strong>to</strong> notify diseases<br />
and <strong>in</strong>fections, etc.<br />
- Process Parameters<br />
• The identification of hazard with details of type, source, and process step and whether it is<br />
biological, chemical or physical hazard are def<strong>in</strong>ed <strong>in</strong> hazard analysis worksheet. The source of<br />
hazards (i.e, the root cause) at each process<strong>in</strong>g step is subsequently taken up for analysis for<br />
elim<strong>in</strong>ation of the same.<br />
7.4.2.3 Hazard Analysis (Risk)<br />
• FS Team Mem<strong>be</strong>rs shall identify, analyze and evaluate all potential hazards<br />
(biological/microbiological, chemical/ physical) that can have adverse effect on the safety of the<br />
food product.<br />
- The likely occurrence of hazards and severity of their adverse health effects<br />
- The qualitative and/or quantitative evaluation of the presence of hazards,<br />
- Survival or multiplication of microorganisms of concern,<br />
- Production or persistence <strong>in</strong> foods of <strong>to</strong>x<strong>in</strong>s, chemicals or physical agents, and<br />
- Conditions lead<strong>in</strong>g <strong>to</strong> the above.<br />
• The hazard analysis process is for identify<strong>in</strong>g hazards, determ<strong>in</strong><strong>in</strong>g the risks and control/ reduction<br />
of the risk is the risk management.<br />
RISK MANAGEMENT PROCESS<br />
Hazard Identification<br />
Resp: FS Team Mem<strong>be</strong>rs<br />
- shall list all hazards and def<strong>in</strong>e its characteristics<br />
(Refer Hazard Analysis worksheets)<br />
Hazard Analysis (Risk Assessment)<br />
Resp: FS Team Mem<strong>be</strong>rs<br />
- shall estimate the magnitude of the risk
Risk Control / Reduction<br />
Resp: FS Team Mem<strong>be</strong>rs<br />
- programme<br />
- control measures(Refer Hazard Analysis worksheets<br />
• Hazard analysis serves <strong>to</strong> identify the potential sources and specific po<strong>in</strong>ts of contam<strong>in</strong>ants by<br />
analysis of each step <strong>in</strong> the food manufactur<strong>in</strong>g process. Hazard analysis shall <strong>be</strong> applied at all<br />
po<strong>in</strong>ts from <strong>in</strong>com<strong>in</strong>g material <strong>in</strong>spection <strong>to</strong> consumer.<br />
• Hazard Analysis has <strong>be</strong>en conducted by the Food Safety Team based on the Flow Diagrams.<br />
Methodology followed for arriv<strong>in</strong>g a hazard is as follows:<br />
- Num<strong>be</strong>r all steps <strong>in</strong> the flow Diagrams<br />
- Verify each step of flow Diagrams for possible physical/chemical and Biological/Microbiological<br />
hazards<br />
- Assess the likelihood of the hazard<br />
- Asses the consequence / severity of the <strong>in</strong>cident.<br />
- Based on the above, level or risks have <strong>be</strong>en evaluated. All the risks are <strong>in</strong>cluded with the help<br />
of group discussions by Food Safety Team and other associates from relevant areas.<br />
- The likely occurrence of the identified hazard, evaluated quantitatively, <strong>in</strong> terms of Very<br />
High, High, Medium or Low and likelihood of occurrence, as follows:<br />
LIKELIHOOD/ PROBABILITY CONSEQUENCES/ SEVERITY RISK / LEVEL<br />
Improbable (eg. 5- 10 years)<br />
1 Rarely<br />
1-4/very Low<br />
Unlikely (eg. yearly)<br />
2<br />
Occational (eg. Monthly/4-6<br />
Monthly)<br />
3<br />
Likely (eg. Weekly/Monthly)<br />
4<br />
M<strong>in</strong>or (eg. Light <strong>in</strong>juries etc.)<br />
1<br />
Medium (eg. Injuries, s<strong>to</strong>mach<br />
pa<strong>in</strong>, uneas<strong>in</strong>ess )<br />
2<br />
Major(eg. Illness, Hospitalization)<br />
3<br />
5-6/Low<br />
7-9/ Medium<br />
10-12/ High
Frequently (eg. Daily/ Weekly)<br />
5<br />
Critical (eg. Death, Permanent<br />
disability)<br />
4<br />
15-20/Very High<br />
(Refer Hazard Analysis Worksheet Annexure-7.4 of this manual on follow<strong>in</strong>g pages)<br />
DETERMINATION OF RISK AND SEVERITY OF HAZARDS<br />
1. Probability of occurrence<br />
Very High > au<strong>to</strong>matically happen<br />
High<br />
Medium<br />
Low<br />
> Likely <strong>to</strong> happen<br />
> could happen<br />
> Not likely <strong>to</strong> happen<br />
2. Severity of each hazard<br />
Critical<br />
Major<br />
Medium<br />
M<strong>in</strong>or<br />
> Will frequently result <strong>in</strong> unsafe product<br />
> Will likely result <strong>in</strong> unsafe product<br />
> May result <strong>in</strong> unsafe product<br />
> Will not result <strong>in</strong> unsafe product<br />
Determ<strong>in</strong>ation of significance<br />
SEVERITY<br />
PROBABIL<br />
ITY<br />
MINOR MEDIUM MAJOR CRITICAL<br />
LOW XXXXX XXXXX //////////////////////<br />
///////<br />
MEDIUM XXXXX XXXXX //////////////////////<br />
///////<br />
//////////////////////<br />
///////<br />
//////////////////////<br />
///////<br />
HIGH XXXXX //////////////////////<br />
///////<br />
//////////////////////<br />
///////<br />
//////////////////////<br />
///////
SIGNIFICANCE: YES: //////////////// NO:<br />
XXXXX<br />
VERY<br />
HIGH<br />
/////////<br />
////<br />
//////////////////////<br />
///////<br />
//////////////////////<br />
///////<br />
//////////////////////<br />
///////<br />
7.4.3 Hazard Assessment<br />
• The severity of the hazard’s adverse health effects, evaluated quantitatively, <strong>in</strong> terms of critical,<br />
major or m<strong>in</strong>or impact severity, as follows:<br />
• The risk rat<strong>in</strong>g, <strong>in</strong> quantitative terms (arrived at by multiply<strong>in</strong>g the probability of occurrence with<br />
the severity of impact), and the classification of the identified hazard <strong>in</strong><strong>to</strong> significant or nonsignificant<br />
category based on the risk-rat<strong>in</strong>g fac<strong>to</strong>r. A risk rat<strong>in</strong>g of 10 or above <strong>in</strong>dicates that the<br />
control measure is required <strong>to</strong> control the identified hazard.<br />
SEVERITY<br />
PROBABILITY<br />
LOW<br />
(unlikely) 2<br />
MEDIUM<br />
(occasionally) 3<br />
HIGH<br />
(Likely) 4<br />
VERY HIGH<br />
(Frequently) 5<br />
MINOR<br />
1<br />
MEDIUM<br />
2<br />
MAJOR<br />
3<br />
5 9 10 12<br />
7 10 12 15<br />
9 12 15 17<br />
12 15 17 20<br />
CRITICAL<br />
4<br />
• An explanation / justification for the risk rat<strong>in</strong>g arrived at, <strong>to</strong>gether with the general control<br />
measures <strong>in</strong> place for that risk.<br />
• A risk level of <strong>be</strong>low 10 is generally considered as permissible and the rout<strong>in</strong>e OPRP’s and PRP’s are<br />
sufficient <strong>to</strong> control the hazard.<br />
7.4.4. Selection and assessment of control measures
• XYZ food safety team has identified and documented the control measures that are <strong>to</strong> <strong>be</strong> applied or<br />
implemented when the hazard identification and risk analysis exercise concludes that the risk of an<br />
identified hazard is significant and needs <strong>to</strong> <strong>be</strong> prevented, elim<strong>in</strong>ated or reduced <strong>to</strong> an acceptable<br />
level.<br />
• For each step, <strong>in</strong>clud<strong>in</strong>g all products, all processes and all parts of the PRP, the assessed <strong>aspects</strong><br />
have <strong>be</strong>en identified <strong>in</strong> the Hazard Analysis Worksheet and HACCP Plan. The reasons for decid<strong>in</strong>g<br />
whether or not the assessed aspect is a CCP or an Operational PRP, or a PRP have <strong>be</strong>en documented,<br />
as answers <strong>to</strong> the control measure assessment matrix.<br />
• In XYZ’s Food Safety System, more than one control measure may <strong>be</strong> required <strong>to</strong> control a hazard,<br />
and more than one hazard may <strong>be</strong> controlled by a control measure.<br />
• The food safety team has conducted an assessment of every step of the process, and has identified<br />
the significant hazards through the use of control measure assessment matrix. The assessment is<br />
based on, amongst other th<strong>in</strong>gs, the varied expertise with<strong>in</strong> the team, and has utilized external and<br />
<strong>in</strong>ternal <strong>in</strong>formation (as needed).<br />
CONTROL MEASURE ASSESSMENT MATRIX<br />
Probability of Failure of Control Measure<br />
Very High<br />
Frequently- Daily or weekly<br />
High<br />
Likely – Weekly or Monthly<br />
Medium<br />
Occasionally – Monthly or 4-6 Monthly<br />
Low<br />
Unlikely – Yearly<br />
Consequence <strong>in</strong> case of failure of Control Measure<br />
Very High<br />
Def<strong>in</strong>itely affects the end product<br />
High<br />
affects end product<br />
Medium<br />
May affect end product<br />
Low<br />
Marg<strong>in</strong>al impact on end product not affect<strong>in</strong>g the food safety<br />
Feasibility / Frequency of Moni<strong>to</strong>r<strong>in</strong>g<br />
Very High<br />
Cont<strong>in</strong>uous
High<br />
Cont<strong>in</strong>uous<br />
Medium<br />
At def<strong>in</strong>ed Frequency<br />
Low<br />
Once dur<strong>in</strong>g the process<br />
Is Control measure specifically designed<br />
Yes More than 10<br />
No Less than 10<br />
• If the rat<strong>in</strong>g of the control measure assessment exceeds 10 the process step is considered as a CCP. If<br />
the rat<strong>in</strong>g falls <strong>be</strong>tween 7– 10 it is considered as an Operational PRP. And the rat<strong>in</strong>g <strong>be</strong>low 7 is<br />
considered as PRP.<br />
• On completion of the hazard analysis, the hazards associated with each step of the food production<br />
shall <strong>be</strong> listed along with any measures <strong>to</strong> control the hazards. More than one control measure, if<br />
required <strong>to</strong> control a hazard, shall <strong>be</strong> identified and documented and more than hazard may <strong>be</strong><br />
controlled by a specific control measure.<br />
• The control measures shall <strong>be</strong> identified through the Pre-requisite Program/Operational Prerequisite<br />
Programs. Any additional measures shall <strong>be</strong> identified dur<strong>in</strong>g the HACCP implementation<br />
<strong>to</strong> ensure that the required control is achieved <strong>to</strong> elim<strong>in</strong>ate or reduce the identified hazard / risk.<br />
The reason for decid<strong>in</strong>g a CCP shall <strong>be</strong> documented.<br />
• The level of risk shall guide the Food Safety team <strong>in</strong> identify<strong>in</strong>g the level of control.<br />
Risk Level Level of Control<br />
15-20 Very High Avoidance/ Special Process<br />
10-12 High Physical control / Moni<strong>to</strong>r<strong>in</strong>g<br />
7-9 Medium Formal Control<br />
5-6 Low Informal Control<br />
1-4 Very Low Tra<strong>in</strong><strong>in</strong>g<br />
TRAINING: Tra<strong>in</strong><strong>in</strong>g and teach<strong>in</strong>g of the staff responsible for the process about what is <strong>to</strong> <strong>be</strong> done <strong>in</strong> order<br />
<strong>to</strong> prevent the hazard.<br />
INFORMAL CONTROL: Informal control is moni<strong>to</strong>r<strong>in</strong>g or checks of the process with out formal record<strong>in</strong>g.
FORMAL CONTROL: Formal control is management of the condition of an operation <strong>to</strong> ma<strong>in</strong>ta<strong>in</strong> the<br />
complaisance with documented criteria.<br />
PHYSICAL CONTROL/ MONITORING: Cont<strong>in</strong>uous control and moni<strong>to</strong>r<strong>in</strong>g of actual physical process.<br />
• The General Control Measures relate <strong>to</strong> the control measures as part of the Pre- requisite Program<br />
and operational Pre- requisite Program, <strong>to</strong> achieve control at acceptable levels.<br />
CONTROL MEASURES<br />
ACCEPTABLE PRACTICE<br />
Available knowledge & data<br />
Hazard analysis<br />
Validation<br />
Data & <strong>in</strong>formation<br />
Prerequisite<br />
Operational<br />
PRP’s<br />
HACCP Plan<br />
Updation<br />
Verification<br />
System Verification<br />
• The general control measures shall <strong>be</strong> documented <strong>in</strong> specifications, <strong>in</strong>structions and procedures or<br />
plans<br />
• The Diagrammatic representation for control measure is<br />
• Refer:
- Recipes for the food product specifications<br />
- Operations Instruction<br />
- Procedures / plans like purchase plan, hygiene plan, clean<strong>in</strong>g and dis<strong>in</strong>fection plan,<br />
ma<strong>in</strong>tenance plan, education and tra<strong>in</strong><strong>in</strong>g plan, etc..<br />
- Pest control plan<br />
- Personnel hygiene practices<br />
• The general control measures shall <strong>be</strong> validated and shall <strong>be</strong> subsequently approved by the Food<br />
Safety Team. The effectiveness of the general control measures shall <strong>be</strong> verified at def<strong>in</strong>ed <strong>in</strong>tervals<br />
through the Food Safety Audits.<br />
• Food safety team will identify critical control po<strong>in</strong>ts and parameters for ma<strong>in</strong>ta<strong>in</strong><strong>in</strong>g the critical<br />
po<strong>in</strong>ts <strong>in</strong> the specified i.e., PH, aW, temperature, time, pressure, which ever applicable.<br />
• The Food Safety Team has identified specific control measures that is CCPs at a step for the<br />
identified significant hazard dur<strong>in</strong>g hazard analysis by apply<strong>in</strong>g the decision tree (see Annex at<br />
7.62 of this Manual) and also general control measures related <strong>to</strong> pre-requisite programme. All<br />
hazards that may <strong>be</strong> reasonably expected <strong>to</strong> occur, or likely <strong>be</strong> <strong>in</strong>troduced at each step, have <strong>be</strong>en<br />
considered <strong>in</strong> identify<strong>in</strong>g the CCPs.. While select<strong>in</strong>g CCPs, care has <strong>be</strong>en exercised that on-l<strong>in</strong>e<br />
process related parameters which does not require elaborate and time consum<strong>in</strong>g test<strong>in</strong>g but<br />
ensures products safety only have <strong>be</strong>en selected.<br />
7.5 ESTABLISHING THE OPERATIONAL REQUISITE PROGRAMMES (PRPS)<br />
• The operational PRPs have <strong>be</strong>en documented as under:<br />
- Food Safety hazards<br />
- Control Measures<br />
- Moni<strong>to</strong>r<strong>in</strong>g Procedures<br />
- Corrective action <strong>to</strong> <strong>be</strong> taken if PRPs not <strong>in</strong> control<br />
- Responsibilities and authorities<br />
- Records of moni<strong>to</strong>r<strong>in</strong>g<br />
• Control measures related <strong>to</strong> control of process<strong>in</strong>g environment have <strong>be</strong>en classified as Operational<br />
PRP’s. These are actions or activities, often measurable <strong>in</strong> terms of physical or chemical parameters<br />
such as temperature, time, pH, and sensory parameters such as visual appearance.<br />
• Operational PRP’s based on subjective parameters, as <strong>in</strong> the case of visual <strong>in</strong>spection of a product,<br />
process, handl<strong>in</strong>g, etc, are supported by work <strong>in</strong>structions or specifications, education and tra<strong>in</strong><strong>in</strong>g.<br />
• The control measures <strong>in</strong> place for each identified Operational PRP’S have <strong>be</strong>en documented <strong>in</strong> the<br />
HACCP Plan Worksheets. Their moni<strong>to</strong>r<strong>in</strong>g mechanisms, corrective actions provided, validation and<br />
verification have also <strong>be</strong>en documented <strong>in</strong> the same.<br />
(Refer <strong>to</strong> the sections on Moni<strong>to</strong>r<strong>in</strong>g and Measur<strong>in</strong>g, Corrective Actions, Validation, and Verification<br />
of Hazard Analysis Worksheet <strong>in</strong>cluded <strong>in</strong> this Manual for more details).
• Control measures not related <strong>to</strong> CCPs and Operational PRP’s have <strong>be</strong>en classified as Prerequisite<br />
Programmes. In general, these measures achieve control at acceptable levels.<br />
• Prerequisite programmes are documented <strong>in</strong> the FSM Manual, specifications (<strong>in</strong>clud<strong>in</strong>g raw<br />
materials, products, etc), <strong>in</strong>structions (for process, control and operation) and procedures or plans,<br />
e.g. purchase procedures, hygiene procedures (<strong>in</strong>clud<strong>in</strong>g personal), ma<strong>in</strong>tenance schedules,<br />
clean<strong>in</strong>g and dis<strong>in</strong>fection schedules, and supported by tra<strong>in</strong><strong>in</strong>g plans, supervision, etc.<br />
• The effectiveness <strong>in</strong> controll<strong>in</strong>g the identified hazards of the Prerequisite Programmes is verified at<br />
pre-def<strong>in</strong>ed, regular <strong>in</strong>tervals, as further detailed <strong>in</strong> the section on verification <strong>in</strong> this Manual.<br />
(Refer PRP Table 1-9 of this Manual)<br />
S.No.<br />
HAZARD ANALYSIS WORKSHEET<br />
Product Process Step Hazard Type Parameter Critical Limit<br />
Name<br />
Target Acceptable Critical<br />
value level limit<br />
Incom<strong>in</strong>g Biological Visual <strong>in</strong>spection - - -<br />
material (Possibility of External Lab Absent Absent Absent<br />
<strong>in</strong>spection at microbial growth) Report (Pathogenic<br />
receiv<strong>in</strong>g<br />
m.o.)<br />
stage.<br />
1 Non<br />
Veg.<br />
Curry<br />
Wash<strong>in</strong>g<br />
Clean<strong>in</strong>g of<br />
cutt<strong>in</strong>g <strong>to</strong>ols &<br />
Biological<br />
(Possibility of<br />
microbial growth at<br />
low level of chlor<strong>in</strong>e)<br />
Biological<br />
(Microbial flora)<br />
Chlor<strong>in</strong>e level<br />
(ppm)<br />
Swab test for<br />
pathogenic Micro<br />
15-20 20 < 15 &<br />
>20<br />
Absent Absent Absent
chopp<strong>in</strong>g<br />
boards<br />
Cook<strong>in</strong>g<br />
Portion<strong>in</strong>g<br />
Serv<strong>in</strong>g<br />
Biological<br />
(Microbial<br />
contam<strong>in</strong>ation)<br />
Biological<br />
(Microbial flora)<br />
Biological<br />
(Microbial<br />
Contam<strong>in</strong>ation)<br />
organisms<br />
Cook<strong>in</strong>g Temp o C 80-100 95 100<br />
Cook<strong>in</strong>g time<br />
m<strong>in</strong>utes<br />
60 60 < 60<br />
Visual <strong>in</strong>spection - - -<br />
Swab test for Absent Absent Absent<br />
Pathogenic Micro<br />
organisms<br />
Temperature o C 50-60 55 < 50<br />
PRE-REQUISITE PROGRAM<br />
GOOD MANUFACTURING PRACTICES<br />
I Primary production<br />
1.1 Environmental hygiene Not applicable<br />
Justification: Inspection & test<strong>in</strong>g of <strong>in</strong>com<strong>in</strong>g s<strong>to</strong>res & raw<br />
materials by XYZ commence from receiv<strong>in</strong>g stage only; i.e.<br />
receiv<strong>in</strong>g the items from the suppliers<br />
1.2 Hygienic production of food sources Not applicable<br />
Justification : Inspection & test<strong>in</strong>g of <strong>in</strong>com<strong>in</strong>g s<strong>to</strong>res & raw<br />
materials by XYZ commence from receiv<strong>in</strong>g stage only; i.e.<br />
receiv<strong>in</strong>g the items from the suppliers<br />
1.3 Handl<strong>in</strong>g,<br />
S<strong>to</strong>rage, and<br />
Transport<br />
1.4 Clean<strong>in</strong>g, ma<strong>in</strong>tenance and personal Not applicable<br />
Not applicable<br />
Justification : Inspection & test<strong>in</strong>g of <strong>in</strong>com<strong>in</strong>g s<strong>to</strong>res & raw<br />
materials by XYZ commence from receiv<strong>in</strong>g stage only; i.e.<br />
receiv<strong>in</strong>g the items from the suppliers
hygiene Justification :<br />
Inspection & test<strong>in</strong>g of <strong>in</strong>com<strong>in</strong>g s<strong>to</strong>res & raw materials by<br />
XYZ commence from receiv<strong>in</strong>g stage only; i.e. receiv<strong>in</strong>g the<br />
items from the suppliers<br />
2 Establishment : design and facilities<br />
2.1 Location<br />
2.1.1 Establishments (PLANT LAYOUT) Plant located <strong>in</strong> a non polluted, environmentally clean area<br />
Refer :Facility(Kitchen) Layout<br />
2.1.2 Equipment / Mach<strong>in</strong>ery (DESIGN) Equipment ma<strong>in</strong>ta<strong>in</strong>ed shall<br />
- Permit adequate ma<strong>in</strong>tenance and clean<strong>in</strong>g;<br />
- Function <strong>in</strong> accordance with its <strong>in</strong>tended use;<br />
- Facilitate good hygiene practices, <strong>in</strong>clud<strong>in</strong>g<br />
moni<strong>to</strong>r<strong>in</strong>g.<br />
Refer :<br />
I. Plant equipment layout<br />
ii. Clean<strong>in</strong>g Schedules<br />
iii. Equipment Ma<strong>in</strong>tenance Records<br />
2.2 Premises and rooms<br />
2.2.1 Design and layout Process areas are clearly demarcated and separated from<br />
each other. Where ever there is an open<strong>in</strong>g / door self-clos<strong>in</strong>g<br />
doors with air curta<strong>in</strong> facility provided.<br />
Refer: Facility Layout<br />
2.2.2 Internal structures and fitt<strong>in</strong>gs Build<strong>in</strong>gs and walls are built <strong>in</strong> such a manner that there is no<br />
physical and chemical hazard with this.<br />
2.2.3 Temporary / mobile premises; Not applicable<br />
vend<strong>in</strong>g mach<strong>in</strong>es<br />
2.3 Equipment<br />
2.3.1 Food control and moni<strong>to</strong>r<strong>in</strong>g<br />
equipment<br />
2.3.2 Conta<strong>in</strong>ers for waste and <strong>in</strong>edible<br />
substances<br />
2.3.3 Conta<strong>in</strong>ers for waste and <strong>in</strong>edible<br />
substances<br />
Thermometers, humidity meters and pressure gauges will <strong>be</strong><br />
provided <strong>to</strong> check the control measures.<br />
Refer :<br />
(i) Records of calibration<br />
(ii) Temperature measur<strong>in</strong>g Records<br />
Plastic bags of wastes are disposed off daily from the location<br />
<strong>to</strong> distant place away from food process<strong>in</strong>g area.<br />
Conta<strong>in</strong>ers / Disposers for waste, by-products and <strong>in</strong>edible or<br />
hazardous substances shall <strong>be</strong> designed / constructed<br />
2.4 Facilities<br />
2.4.1 Water supply Water s<strong>to</strong>rage at different po<strong>in</strong>ts is <strong>in</strong>stalled with RO and UV<br />
System <strong>to</strong> prevent micro contam<strong>in</strong>ation and under strict<br />
supervision & control.<br />
Refer:<br />
(i) External lab reports.<br />
(ii) In house Water analysis reports<br />
2.4.2 Dra<strong>in</strong>age and waste disposal Dra<strong>in</strong>age system constructed so as they always flow from the<br />
process area <strong>to</strong> out side. Solid waste will <strong>be</strong> collected <strong>in</strong><br />
plastic garbage bags and moved <strong>to</strong> garbage collect<strong>in</strong>g area<br />
from there collect is done by the MCH.<br />
Refer : Plant Layout<br />
2.4.3 Clean<strong>in</strong>g (by clean<strong>in</strong>g detergent / Adequate facilities are provided for clean<strong>in</strong>g food utensils and
sanitizer) with surfactant<br />
equipment.<br />
Refer :<br />
Equipment clean<strong>in</strong>g and sanitation procedures<br />
2.4.4 Personnel hygiene facilities and <strong>to</strong>ilets Toilets, change rooms etc are provided away from the<br />
process block.<br />
Toilets are provided with Hand wash facility, dis<strong>in</strong>fectant<br />
soap solution and drier (Hand).<br />
2.4.5 Temperature control Facilities for heat<strong>in</strong>g, cool<strong>in</strong>g or freez<strong>in</strong>g food products, or<br />
s<strong>to</strong>r<strong>in</strong>g refrigerated or frozen foods are suitable <strong>to</strong> meet the<br />
specified condition for ensur<strong>in</strong>g food safety.<br />
2.4.6 Air quality and ventilation Ventilation systems are designed and constructed so that air<br />
does not flow from contam<strong>in</strong>ated areas <strong>to</strong> clean areas and<br />
they can <strong>be</strong> adequately ma<strong>in</strong>ta<strong>in</strong>ed and cleaned.<br />
2.4.7 Light<strong>in</strong>g The areas where food is <strong>be</strong><strong>in</strong>g processed does not have any<br />
w<strong>in</strong>dow panes and also glass fixtures are properly covered <strong>to</strong><br />
avoid the contam<strong>in</strong>ation<br />
2.4.8 S<strong>to</strong>rage The processed food is packed <strong>in</strong> sta<strong>in</strong>less steel vessels <strong>in</strong> hot<br />
conditions with proper lid/ closures. The articles are then<br />
transferred <strong>to</strong> Food Service area.<br />
3 Control of operation<br />
3.1 Control of food hazards FS System is <strong>be</strong><strong>in</strong>g implemented<br />
Refer :<br />
ISO:22000-2005<br />
3.2 Key <strong>aspects</strong> of hygiene control systems<br />
3.2.1 Time and temperature control Control systems for temperature and time dur<strong>in</strong>g heat<strong>in</strong>g,<br />
cool<strong>in</strong>g and s<strong>to</strong>rage are <strong>in</strong> place where necessary for the<br />
production and handl<strong>in</strong>g of safe food. Control systems <strong>in</strong>clude<br />
critical limits, registration and test<strong>in</strong>g of accuracy of<br />
measur<strong>in</strong>g equipment.<br />
Refer : Temperature calibration record<br />
3.2.2 Specific process steps Cook<strong>in</strong>g is the important/ major process step which is <strong>to</strong> <strong>be</strong><br />
considered.<br />
3.2.3 Microbiological and other<br />
specifications<br />
PFA specifications for physical and chemical parameters,<br />
general specifications for micro organisms are <strong>be</strong><strong>in</strong>g<br />
followed.<br />
Refer: HACCP Plan and Hazard analysis worksheet<br />
3.2.4 Microbiological cross - contam<strong>in</strong>ation Clean<strong>in</strong>g and sanitation procedures are <strong>in</strong> place tp prevent<br />
the microbiological cross contam<strong>in</strong>ation.<br />
Refer:<br />
(i) Facilities layout.<br />
(ii) production area enter<strong>in</strong>g procedure<br />
(iii) Clean<strong>in</strong>g Schedules
3.2.5 Physical and chemical contam<strong>in</strong>ation The material of construction for cutt<strong>in</strong>g trays & plastic crates<br />
where unprocessed food is <strong>kept</strong> are made of non- particle<br />
releas<strong>in</strong>g. The crates are washed thoughly <strong>to</strong> remove any<br />
lef<strong>to</strong>ver particles/ dust.<br />
Refer :<br />
(i) Decision tree, Hazard analysis worksheet and HACCP plan<br />
3.3 Incom<strong>in</strong>g materials requirements<br />
3.3.1 Specifications (of Limit of<br />
Microbiological organisms)<br />
3.3.2 Control at Receiv<strong>in</strong>g stage (of<br />
Pathogens and Tox<strong>in</strong>s)<br />
Supplies are XYZ approved; Raw materials are tested and<br />
accepted as per the specifications. A well- def<strong>in</strong>ed program on<br />
<strong>in</strong>com<strong>in</strong>g material <strong>in</strong>spection is <strong>in</strong> place. Monthly supplier<br />
assessments <strong>in</strong> place <strong>to</strong> ensure supplier <strong>in</strong>tegrity.<br />
Refer :<br />
(i) Program on <strong>in</strong>com<strong>in</strong>g material<br />
Inspection :<br />
(ii) External labora<strong>to</strong>ry analysis<br />
All the raw materials and <strong>in</strong>gredients are <strong>be</strong><strong>in</strong>g tested and<br />
accepted only they are found satisfac<strong>to</strong>ry.<br />
Refer : Incom<strong>in</strong>g material Inspection Report<br />
3.3.3 S<strong>to</strong>ck rotation All raw materials and <strong>in</strong>gredients received are la<strong>be</strong>led with<br />
lot num<strong>be</strong>rs and a first <strong>in</strong> first out system is followed for the<br />
rotation.<br />
3.4 Packag<strong>in</strong>g<br />
3.4.1 Design and materials Not Applicable <strong>be</strong>cause packag<strong>in</strong>g operation is not <strong>in</strong> the<br />
system.<br />
3.4.2 "Food grade" materials and gases Not Applicable <strong>be</strong>cause packag<strong>in</strong>g operation is not <strong>in</strong> the<br />
system.<br />
3.4.3 Reusable packag<strong>in</strong>g Not Applicable <strong>be</strong>cause packag<strong>in</strong>g operation is not <strong>in</strong> the<br />
system.<br />
3.5 Water<br />
3.5.1 Water <strong>in</strong> contact with food Water is purified with RO/ U V water purification system, and<br />
then used <strong>in</strong> the production.<br />
Refer : In house Water Analysis Report<br />
3.5.2 Reuse of re-circulated, treated water Not applicable, <strong>be</strong>cause re-circulated water is not <strong>in</strong> use.<br />
3.5.3 Reuse of re-circulated, non - treated Not applicable, <strong>be</strong>cause re-circulated water is not <strong>in</strong> use.<br />
water<br />
3.5.4 As an <strong>in</strong>gredient (Potable water) Refer : In house water analysis report<br />
3.5.5 Ice and steam In house analysis report<br />
3.6 Management and supervision<br />
3.6.1 Type of control and supervision Well – def<strong>in</strong>ed organization structure is <strong>in</strong> place. Roles and<br />
responsibilities of each and every associate are def<strong>in</strong>ed.<br />
Refer: Organization Chart and Roles & Responsibilities.<br />
3.6.2 Knowledge required All the managerial and supervisory staff is tra<strong>in</strong>ed and aware<br />
of food safety and hygiene.<br />
3.7 Documentation and records<br />
3.7.1 Reta<strong>in</strong> records One- year period; after which on revision further retention<br />
will <strong>be</strong> decided.
3.7.2 Effectiveness and credibility Documents are ma<strong>in</strong>ta<strong>in</strong>ed & verified regularly by<br />
appo<strong>in</strong>tments at various sections of operation.<br />
3.8 Recall procedures<br />
3.8.1 Effective procedures A well def<strong>in</strong>ed Product Recall Program is <strong>in</strong> place.<br />
Refer :<br />
SOP on Product Recall, Trac<strong>in</strong>g & track<strong>in</strong>g, Destroy<strong>in</strong>g.<br />
Disposal/ Reprocess<strong>in</strong>g<br />
3.8.2 Trac<strong>in</strong>g and track<strong>in</strong>g Where a product has <strong>be</strong>en withdrawn <strong>be</strong>cause of an<br />
immediate health hazard, other products which are produced<br />
under similar conditions, and may need <strong>to</strong> <strong>be</strong> withdrawn. The<br />
need for public warn<strong>in</strong>gs shall <strong>be</strong> considered.<br />
Refer :<br />
SOP on Product Recall, Trac<strong>in</strong>g & track<strong>in</strong>g, Destroy<strong>in</strong>g.<br />
Disposal/ Reprocess<strong>in</strong>g<br />
3.8.3 Destroy or reprocess Recalled products shall <strong>be</strong> held under supervision until they<br />
are destroyed/ disposed off<br />
Refer:<br />
SOP on Product Recall, Trac<strong>in</strong>g & track<strong>in</strong>g, Destroy<strong>in</strong>g.<br />
Disposal/ Reprocess<strong>in</strong>g<br />
4 Establishments: Ma<strong>in</strong>tenance and Sanitation<br />
4.1 Ma<strong>in</strong>tenance and clean<strong>in</strong>g<br />
4.1.1 General Equipment ma<strong>in</strong>tenance and clean<strong>in</strong>g procedures.<br />
Refer:<br />
Check list on subject<br />
4.1.2 Clean<strong>in</strong>g procedures and methods Well def<strong>in</strong>ed<br />
Refer:<br />
Check list on subject<br />
4.2 Clean<strong>in</strong>g programmes<br />
4.2.1 Specifications Responsibility for Areas, Items of equipment, Utensils,<br />
Conta<strong>in</strong>ers, Method and frequency of clean<strong>in</strong>g, moni<strong>to</strong>r<strong>in</strong>g<br />
arrangements etc are <strong>to</strong> <strong>be</strong> well def<strong>in</strong>ed<br />
4.2.2 Moni<strong>to</strong>r<strong>in</strong>g and verification Equipment clean<strong>in</strong>g program- frequency , area, responsibility<br />
Refer : check list for supervisors<br />
4.3 Pest control<br />
4.3.1 General (i)GHP<br />
Refer : Stand<strong>in</strong>g orders on subject<br />
(ii)Effective Pest control<br />
Refer: pest control programme.<br />
4.3.2 Prevent<strong>in</strong>g access (i) No w<strong>in</strong>dowpanes <strong>in</strong> the production area.<br />
(ii) Proper air curta<strong>in</strong>s and facilities are provided <strong>to</strong> prevent<br />
access of pest <strong>in</strong> production area.<br />
(iii) Security person will take care of animals not <strong>to</strong> enter.<br />
4.3.3 Harborage and <strong>in</strong>festation (i) Air tight S.S conta<strong>in</strong>ers are provided <strong>to</strong> s<strong>to</strong>re the food<br />
items.<br />
(ii) Pest free walk <strong>in</strong> cooler & refrigera<strong>to</strong>r are there for<br />
s<strong>to</strong>r<strong>in</strong>g food stuff & raw materials<br />
(iii) Good house keep<strong>in</strong>g practices <strong>in</strong> place.<br />
4.3.4 Moni<strong>to</strong>r<strong>in</strong>g and detection Pest control activity records are available<br />
Refer :<br />
Program on Pest Control:
4.3.5 Eradication Use of Non residual chemical Process areas excluded from use<br />
of chemicals<br />
Refer :<br />
Program on Pest control;<br />
4.4 Waste management<br />
4.4.1 Removal, s<strong>to</strong>rage Waste is collected <strong>in</strong> bags and immediately shifted <strong>to</strong> garbage<br />
area, which is <strong>be</strong><strong>in</strong>g cleared by MCH every day.<br />
4.4.2 Clean<strong>in</strong>g Clean<strong>in</strong>g is <strong>in</strong> place.<br />
4.5 Sanitation systems<br />
4.5.1 Moni<strong>to</strong>r<strong>in</strong>g Sanitation systems are <strong>in</strong> place.<br />
Refer : Clean<strong>in</strong>g schedules;<br />
Daily check lists of KST Supervisors;<br />
4.5.2 Verification Sanitation systems shall <strong>be</strong> periodically verified by <strong>in</strong>spection<br />
or, where appropriate, by microbiological sampl<strong>in</strong>g of<br />
environment and food contact surfaces and regularly<br />
reviewed and adapted <strong>to</strong> reflect changed circumstances.<br />
Remarks:<br />
Verification by monthly microbiology moni<strong>to</strong>r<strong>in</strong>g. In case of<br />
changes required <strong>in</strong> procedures only division can change<br />
after due validation<br />
Refer : In house lab Reports<br />
Program on microbiological Moni<strong>to</strong>r<strong>in</strong>g<br />
4.5.3 Review Sanitation system shall <strong>be</strong> regularly reviewed and adapted <strong>to</strong><br />
reflect changed circumstances.<br />
GOOD HYGIENE PRACTICES<br />
5 Establishment : personal hygiene<br />
5.1 Health status<br />
5.1.1 Access prevention Regular Medical Check up <strong>to</strong> all the associates and Production<br />
workers <strong>in</strong> twice <strong>in</strong> a year basis. Onsite observation by area<br />
supervisors<br />
Appropriate procedures are <strong>in</strong> place<br />
Refer :<br />
(i) Medical reports<br />
(ii) Informa<strong>to</strong>ry Sign Boards at places of work<br />
(iii) Illness & Injuries Report Register<br />
5.2 Illness and <strong>in</strong>juries<br />
5.2.1 Conditions <strong>to</strong> <strong>be</strong> reported Medical Exam<strong>in</strong>ation reveals any diseases that are exist at<br />
that time. Regular observations by area supervisors will lead<br />
<strong>to</strong> further action required<br />
Refer :<br />
(i) Medical reports<br />
(ii) Informa<strong>to</strong>ry Sign Boards at places of work<br />
(iii) Illness & Injuries Report Register<br />
5.3 Personal cleanl<strong>in</strong>ess<br />
5.3.1 Protective cloth<strong>in</strong>g Protective equipment like shoes, head caps are manda<strong>to</strong>ry<br />
where ever applicable <strong>in</strong>side the Kitchen.<br />
Refer:<br />
Program on personnel hygiene:<br />
5.3.2 Cuts and wounds Area supervisor will act on these issues as and when arises<br />
Refer : program on personnel hygiene:
5.3.3 Wash<strong>in</strong>g hands Wash facilities provided at <strong>to</strong>ilets and at process area<br />
entrance. Procedures <strong>to</strong> clean the hands were provided <strong>in</strong><br />
place.<br />
Refer :<br />
Program on good Manufactur<strong>in</strong>g practices:<br />
5.4 Personal <strong>be</strong>havior<br />
5.4.1 Smok<strong>in</strong>g, eat<strong>in</strong>g, sneez<strong>in</strong>g Smok<strong>in</strong>g , spitt<strong>in</strong>g, chew<strong>in</strong>g & eat<strong>in</strong>g activities are strictly<br />
prohibited <strong>in</strong>side the plant and process areas except<br />
designated areas<br />
Refer :<br />
(i) Program on personnel hygiene / habits<br />
(ii) Program on good Manufactur<strong>in</strong>g practices:<br />
5.4.2 Jewellery Personal work<strong>in</strong>g <strong>in</strong> the process areas are not allowed <strong>to</strong><br />
wear loose jewellery<br />
Refer:<br />
Program on personnel hygiene / habits<br />
5.5 Visi<strong>to</strong>rs<br />
5.5.1 Cleanl<strong>in</strong>ess and <strong>be</strong>havior Visi<strong>to</strong>rs wear caps; sanitize hands and then only lead <strong>to</strong> the<br />
production area.<br />
Refer:<br />
Visi<strong>to</strong>rs policy procedures<br />
6.0 Transportation<br />
6.1 General Closed SS conta<strong>in</strong>ers are <strong>be</strong><strong>in</strong>g used dur<strong>in</strong>g food Serv<strong>in</strong>g &<br />
Food Dispatch/Serv<strong>in</strong>g.<br />
6.2 Requirements Where necessary, conveyances and bulk conta<strong>in</strong>ers shall <strong>be</strong><br />
designed and constructed so that they :<br />
- do not contam<strong>in</strong>ate foods<br />
- can <strong>be</strong> effectively cleaned and, where necessary, dis<strong>in</strong>fected;<br />
- permit effective separation of different foods or foods from<br />
non- food items where necessary dur<strong>in</strong>g transport<br />
(Dispatch/Serv<strong>in</strong>g)<br />
- provide effective protection from contam<strong>in</strong>ation, <strong>in</strong>clud<strong>in</strong>g<br />
dust and fumes ;<br />
- can effectively ma<strong>in</strong>ta<strong>in</strong> the temperature, humidity,<br />
atmosphere and other conditions necessary <strong>to</strong> protect food<br />
from harmful or undesirable microbial growth and<br />
deterioration likely <strong>to</strong> render it unsuitable for consumption;<br />
- allow any necessary temperatures, humidity and other<br />
conditions <strong>to</strong> <strong>be</strong> checked.<br />
6.3 Use and ma<strong>in</strong>tenance Regular clean<strong>in</strong>g of food carry<strong>in</strong>g SS conta<strong>in</strong>ers is <strong>be</strong><strong>in</strong>g done.<br />
7 Product <strong>in</strong>formation and consumer awareness<br />
7.1 Batch identification Not applicable<br />
7.2 Product <strong>in</strong>formation Not applicable<br />
7.3 La<strong>be</strong>l<strong>in</strong>g Not applicable<br />
7.4 Consumer education Be<strong>in</strong>g done as on need basis.<br />
8 Tra<strong>in</strong><strong>in</strong>g<br />
8.1 Awareness and responsibilities Associates are tra<strong>in</strong>ed on food safety and their roles and<br />
responsibilities <strong>in</strong> handl<strong>in</strong>g food products <strong>to</strong> prevent any<br />
contam<strong>in</strong>ation or deterioration.
Tra<strong>in</strong><strong>in</strong>g on Food Safety <strong>to</strong> all associates is <strong>be</strong><strong>in</strong>g conducted.<br />
Refer :<br />
Program on Tra<strong>in</strong><strong>in</strong>g:<br />
8.2 Tra<strong>in</strong><strong>in</strong>g programs The tra<strong>in</strong><strong>in</strong>g on FSMS <strong>in</strong>cludes all the requirements<br />
Refer :<br />
Program on Tra<strong>in</strong><strong>in</strong>g<br />
8.3 Instruction and supervision A well – def<strong>in</strong>ed tra<strong>in</strong><strong>in</strong>g program is <strong>in</strong> place and the<br />
effectiveness of the tra<strong>in</strong><strong>in</strong>g is <strong>be</strong><strong>in</strong>g assessed periodically.<br />
Supervisory and Managerial level Staff is aware of FSMS.<br />
Refer :<br />
Program on Tra<strong>in</strong><strong>in</strong>g:<br />
8.4 Refresher tra<strong>in</strong><strong>in</strong>g Tra<strong>in</strong><strong>in</strong>g programs shall <strong>be</strong> rout<strong>in</strong>ely reviewed and updated<br />
where necessary.<br />
Systems shall <strong>be</strong> <strong>in</strong> place <strong>to</strong> ensure that food handlers rema<strong>in</strong><br />
aware of all procedures necessary <strong>to</strong> ma<strong>in</strong>ta<strong>in</strong> the safety and<br />
suitability of food.<br />
Remarks:-<br />
Based on the skill Gap Analysis the associates are evaluated.<br />
Based on the Skill Matrix, the associates <strong>be</strong><strong>in</strong>g provided with<br />
a required awareness/ refreshers tra<strong>in</strong><strong>in</strong>g.<br />
HACCP PLAN:<br />
S<br />
.<br />
N<br />
o<br />
Product<br />
Name<br />
1 Chicken<br />
biryani<br />
Step Hazard Critical limit Moni<strong>to</strong>r<strong>in</strong>g Corrective action<br />
Parameter Value Procedu<br />
re<br />
Freque<br />
ncy<br />
Resp Record Procedure Record<br />
cook<strong>in</strong>g<br />
Micro<br />
biological<br />
; survival<br />
of<br />
pathogeni<br />
c Microorganism<br />
s<br />
Cook<strong>in</strong>g<br />
time,<br />
cook<strong>in</strong>g<br />
temp<br />
M<strong>in</strong> 1<br />
hr,<br />
80 -<br />
100 0 c<br />
Check<strong>in</strong>g<br />
cook<strong>in</strong>g<br />
time<br />
with<br />
s<strong>to</strong>p<br />
watch,<br />
and<br />
tempera<br />
ture<br />
with<br />
digital<br />
thermo<br />
As and<br />
when<br />
cooked<br />
as per<br />
menu<br />
chef<br />
Refer:<br />
Time<br />
and<br />
Temp<br />
of food<br />
items<br />
i)if found<br />
undercooke<br />
d <strong>in</strong>crease<br />
the cook<strong>in</strong>g<br />
time<br />
ii)if found<br />
over<br />
cooked<br />
discard the<br />
item<br />
Time &<br />
Temp<br />
record
meter(S<br />
S Pro<strong>be</strong>)<br />
2 Pla<strong>in</strong><br />
rice<br />
Clean<strong>in</strong>g<br />
of rice<br />
Physical:<br />
presence<br />
of foreign<br />
particles<br />
Extraneou<br />
s matter/<br />
foreign<br />
particles<br />
- i)<strong>in</strong>spect<br />
ion of<br />
s<strong>to</strong>ck<br />
arrived<br />
ii)superv<br />
is<strong>in</strong>g<br />
rice<br />
clean<strong>in</strong>g<br />
As and<br />
when<br />
done<br />
s<strong>to</strong>re man<br />
Refer:<br />
Raw<br />
material<br />
data<br />
sheet<br />
i)Get the<br />
rice<br />
clean<strong>in</strong>g<br />
redone<br />
ii)Return <strong>to</strong><br />
supplier if<br />
foreign<br />
matter is<br />
more<br />
i.Reject<br />
on<br />
record<br />
ii.Vendo<br />
r,<br />
compla<br />
nts<br />
record<br />
7.6. ESTABLISHMENT OF HACCP PLAN<br />
7.6.1 HACCP Plan<br />
• The HACCP plan is documented for each CCP which <strong>in</strong>cludes food safety hazard critical limit<br />
moni<strong>to</strong>r<strong>in</strong>g procedure and corrective actions required with responsibilities and authorities.<br />
Refer HACCP Plan…<br />
7.6.2 Identification of CCP<br />
• For each food hazard that is <strong>to</strong> <strong>be</strong> controlled by HACCP plan CCPs are determ<strong>in</strong>ed by CCP decision<br />
tree. The CCP decision <strong>in</strong>cludes<br />
1. Do preventive measure exist?
2. Is the step specially designed <strong>to</strong> elim<strong>in</strong>ate/reduce the likely occurrence of an acceptable level?<br />
3. Could contam<strong>in</strong>ation with identified hazard(s) occur <strong>in</strong> acces acceptable level(s) or could<br />
<strong>in</strong>crease <strong>to</strong> an unacceptable?<br />
4. Will a subsequent step elim<strong>in</strong>ate identified hazard (s) or reduce likely appearance <strong>to</strong> an<br />
acceptable level?<br />
(Refer: CCP-Decision Tree as Annex 7.6.2 of this Manual on next page)<br />
EXAMPLE OF DECISION TREE TO IDENTIFY CCPS
CCP DECISION WORKSHEET:
S.No Step Type of<br />
Hazard<br />
1 Procurement<br />
Perishable items<br />
Non- perishable<br />
items.<br />
CCP Decision(yes/ No)<br />
1<br />
Do<br />
preventi<br />
ve<br />
measure<br />
exist?<br />
2<br />
Is the step specially<br />
designed <strong>to</strong><br />
elim<strong>in</strong>ate/reduce<br />
the likely<br />
occurrence of an<br />
acceptable level?<br />
3<br />
Could contam<strong>in</strong>ation<br />
with identified<br />
hazard(s) occur <strong>in</strong><br />
acceptable level(s) or<br />
could <strong>in</strong>crease <strong>to</strong> an<br />
unacceptable?<br />
Physical Yes Yes No No<br />
Chemical Yes Yes No No<br />
Biological Yes Yes No No<br />
Physical Yes Yes No No<br />
Chemical Yes Yes No No<br />
4<br />
Will a subsequent<br />
step elim<strong>in</strong>ate<br />
identified hazard (s<br />
or reduce likely<br />
appearance <strong>to</strong> an<br />
acceptable level?<br />
2 S<strong>to</strong>rage a)<br />
S<strong>to</strong>rage of<br />
perishable items<br />
freezer, walk <strong>in</strong><br />
cooler<br />
b) S<strong>to</strong>rage of nonperishable<br />
items <strong>in</strong><br />
dry s<strong>to</strong>rage area.<br />
Biological Yes Yes No No<br />
Physical Yes Yes No No<br />
Chemical Yes Yes No No<br />
Biological Yes Yes No No<br />
Physical Yes Yes No No<br />
Chemical Yes Yes No No<br />
Biological Yes Yes No No<br />
6.3 Determ<strong>in</strong>ation of critical limits for critical control po<strong>in</strong>ts<br />
• XYZ has def<strong>in</strong>ed the critical limit(s), which must <strong>be</strong> met at all times dur<strong>in</strong>g the operation for the<br />
various parameters. Also, normal operational target values have <strong>be</strong>en <strong>in</strong>dicated are the various<br />
parameters, as well as the action limit values which <strong>in</strong>dicate when <strong>in</strong>tervention <strong>in</strong> the operation is<br />
required <strong>in</strong> order <strong>to</strong> cont<strong>in</strong>uously meet the critical limits.
• The critical limit(s), action limit(s) and target value for each parameter have <strong>be</strong>en documented <strong>in</strong><br />
the OPRP & HACCP Plan associated with each CCP and or Operational PRP.<br />
• When determ<strong>in</strong><strong>in</strong>g the critical limits and the deduced action limits and target value, the<br />
requirements of the relevant legislation and regulations and/or <strong>in</strong>ternal risk analysis for the safety<br />
of foodstuffs has <strong>be</strong>en considered as requirements. These have <strong>be</strong>en identified / referenced <strong>in</strong> the<br />
HACCP Plan associated with each CCP.<br />
(Refer: HACCP Plan tables)<br />
7.6.4 SYSTEM FOR THE MONITORING OF CCPs<br />
• Moni<strong>to</strong>r<strong>in</strong>g is the scheduled measurement or observation of a CCP relative <strong>to</strong> its critical limit.<br />
• Moni<strong>to</strong>r<strong>in</strong>g details has <strong>be</strong>en elaborated <strong>be</strong>low, through which answer for follow<strong>in</strong>g four questions<br />
are obta<strong>in</strong>ed:<br />
- What is <strong>be</strong><strong>in</strong>g moni<strong>to</strong>red? (say temperature)<br />
- How the moni<strong>to</strong>r<strong>in</strong>g is done? (say digital thermometer with SS pro<strong>be</strong>,<br />
record<strong>in</strong>g thermometer, digital time/temperature data logger or similar device and visual<br />
check on time)
- How often the moni<strong>to</strong>r<strong>in</strong>g is <strong>be</strong><strong>in</strong>g done (frequency)? (<strong>in</strong> case of digital record<strong>in</strong>g- cont<strong>in</strong>uous<br />
moni<strong>to</strong>r<strong>in</strong>g, with visual check at least once <strong>in</strong> cycle/batch but not less than once per day, <strong>in</strong><br />
case of other type of device- visual check at least once <strong>in</strong> cycle/batch but not less than once<br />
per day)<br />
- Who is do<strong>in</strong>g moni<strong>to</strong>r<strong>in</strong>g? (Ex. Chef/Chef/Manager QC /Manager S<strong>to</strong>re)<br />
• Measurement/ observation for each product and for each CCP has <strong>be</strong>en identified and <strong>in</strong>dicated <strong>in</strong><br />
HACCP plan. Records associated with the moni<strong>to</strong>r<strong>in</strong>g have <strong>be</strong>en <strong>in</strong>dicated <strong>in</strong> relevant Column.<br />
• The Moni<strong>to</strong>r<strong>in</strong>g Devices shall <strong>be</strong> identified though the list of Moni<strong>to</strong>r<strong>in</strong>g Devices, The methodology<br />
for calibrat<strong>in</strong>g the moni<strong>to</strong>r<strong>in</strong>g devices shall <strong>be</strong> calibrated<br />
(Refer Records of calibration of Moni<strong>to</strong>r<strong>in</strong>g Devices)<br />
• The results of moni<strong>to</strong>r<strong>in</strong>g process parameters (with the calibrated <strong>in</strong>struments shall <strong>be</strong> recorded)<br />
7.6.5 ACTIONS WHEN MONITORING RESULTS EXCEEDS CRITICAL LIMITS<br />
• For the identified CCPs, it is ensure that Corrective Actions are <strong>in</strong>itiated and implemented <strong>in</strong> case<br />
action limit value or a critical value is exceeded the cause of the deviations shall <strong>be</strong> analyzed and<br />
documented with the justification for the corrective action <strong>in</strong>itiated and responsibilities and<br />
authorities of the personnel <strong>in</strong>volved<br />
• The corrective action may <strong>in</strong>clude:<br />
- With respect <strong>to</strong> the product- temporary hold of the product/batch, blockades <strong>to</strong> product<br />
recall, identification of nonconform<strong>in</strong>g product, rework, disposal/ destruction of<br />
product/batch.<br />
- With respect <strong>to</strong> process- adjust<strong>in</strong>g the process, adjustment/ correction of process conditions.
• Specific corrective actions have <strong>be</strong>en established for each CCP <strong>in</strong> order <strong>to</strong> deal with deviations<br />
when they may occur. The actions taken ensure that the CCP has <strong>be</strong>en brought under control.<br />
(Refer: HACCP Plan tables)<br />
7.7 UPDATING OF THE PRELIMINARY INFORMATION AND DOCUMENTS SPECIFYING THE PRP’S<br />
AND HACCP PLAN)<br />
• The organization has updated the follow<strong>in</strong>g <strong>in</strong>formation:<br />
- Product characteristic<br />
- Intended use<br />
- Flow diagram<br />
- Process steps<br />
- Control measures<br />
• Prior <strong>to</strong> application of HACCP, it has <strong>be</strong>en ensured that:<br />
- The general pr<strong>in</strong>ciples of Food Hygiene as per Codex Standard for the food sec<strong>to</strong>r referred <strong>in</strong> the<br />
scope are <strong>in</strong> place. An audit checklist based on Codex Standard prepared <strong>to</strong> conform <strong>to</strong> food<br />
hygiene, personnel hygiene and good manufactur<strong>in</strong>g practices for the applicable food sec<strong>to</strong>r.<br />
- The compliance of which is <strong>be</strong><strong>in</strong>g ensured dur<strong>in</strong>g <strong>in</strong>ternal audit by the assigned audi<strong>to</strong>r.<br />
Note-Like the products and the process, the PRP is subjected <strong>to</strong> the hazard analysis <strong>in</strong> order <strong>to</strong> identify<br />
potential hazards and <strong>to</strong> decide <strong>in</strong> which way the hazards (risk) need <strong>to</strong> <strong>be</strong> controlled.<br />
• Food Safety Legislation [Prevention of Food Adulteration Act] is implemented.
• The FS Team Mem<strong>be</strong>rs have <strong>be</strong>en tra<strong>in</strong>ed on the steps, pr<strong>in</strong>ciples and application of HACCP and<br />
Food Hygiene. Tra<strong>in</strong><strong>in</strong>g has also <strong>be</strong>en provided <strong>to</strong> personnel at various levels on pr<strong>in</strong>ciples of<br />
ma<strong>in</strong>ta<strong>in</strong><strong>in</strong>g cleanl<strong>in</strong>ess and hygiene and this is an on-go<strong>in</strong>g activity. As an aid <strong>in</strong> develop<strong>in</strong>g specific<br />
tra<strong>in</strong><strong>in</strong>g, work <strong>in</strong>struction and procedures have <strong>be</strong>en prepared.<br />
• XYZ’s Food Safety team updates the <strong>in</strong>formation of the PRP, Operational PRP’s and HACCP Plan<br />
whenever new products are <strong>in</strong>troduced or any new equipment are <strong>in</strong>stalled or any change of<br />
control measures or process flow or any change <strong>in</strong> <strong>in</strong>tended use would <strong>be</strong> required<br />
7.8. VERIFICATION PLANNING<br />
• The ma<strong>in</strong> function of verification is <strong>to</strong> determ<strong>in</strong>e compliance with the specification of the FS System<br />
and <strong>to</strong> confirm that the FS System is work<strong>in</strong>g effectively through the application of audit<strong>in</strong>g,<br />
procedures and tests <strong>in</strong>clud<strong>in</strong>g random sampl<strong>in</strong>g and analysis. The frequency of verification activity<br />
which <strong>in</strong>ter-alia <strong>in</strong>clude the follow<strong>in</strong>g should <strong>be</strong> sufficient <strong>to</strong> confirm that the FS System is work<strong>in</strong>g<br />
effectively:<br />
- review of the FS System and its records,<br />
- review of non-conformities and product disposition, and<br />
- Confirmation that CCPs are <strong>kept</strong> under control.<br />
• Verification of CCP Moni<strong>to</strong>r<strong>in</strong>g - In-charge quality assurance reviews the performance of CCP<br />
operation with respect <strong>to</strong> the follow<strong>in</strong>g:<br />
- Critical Control Limits- This review is <strong>to</strong> ensure that the records are complete and <strong>to</strong> verify that<br />
the documented values are with<strong>in</strong> the critical limits. This review is done at regular <strong>in</strong>tervals, for<br />
each product and is submitted on prescri<strong>be</strong>d format. This report is reviewed by FS Team Leader.<br />
- Conduct<strong>in</strong>g Test/Analysis- This is <strong>to</strong> verify that the results of test or analysis corroborate the<br />
purpose or <strong>in</strong>tent of the CCP’s. This verification is done at regular <strong>in</strong>tervals specified <strong>in</strong> for each<br />
product and records ma<strong>in</strong>ta<strong>in</strong>ed.<br />
VERIFICATION LOG FOR CRITICAL CONTROL POINTS<br />
Date/Time Product CCP No. Observation/measurements Comments Signature
• On Go<strong>in</strong>g Verification <strong>to</strong> Show Compliance with Plan<br />
• FS Team reviews the performance of operation of FS System on quarterly basis. This review<br />
<strong>in</strong>cludes verification of follow<strong>in</strong>g records <strong>to</strong> ensure that FS System is <strong>in</strong> place and work<strong>in</strong>g<br />
satisfac<strong>to</strong>rily:<br />
- Moni<strong>to</strong>r<strong>in</strong>g activities have <strong>be</strong>en performed at the locations specified <strong>in</strong> the HACCP plan<br />
- Moni<strong>to</strong>r<strong>in</strong>g activities have <strong>be</strong>en performed at the frequencies specified <strong>in</strong> the HACCP plan<br />
- Corrective actions have <strong>be</strong>en taken whenever moni<strong>to</strong>r<strong>in</strong>g <strong>in</strong>dicated deviation from critical<br />
limits and also tak<strong>in</strong>g <strong>in</strong><strong>to</strong> consideration <strong>in</strong>ternal and external audit results<br />
- Equipment has <strong>be</strong>en calibrated at the frequencies specified <strong>in</strong> the <strong>in</strong> quality system<br />
procedures<br />
- Confirmation that CCPs are <strong>kept</strong> under control.<br />
- Review of Consumer Compla<strong>in</strong>ts that have relevance <strong>to</strong> the performance of FS System<br />
- Review of Sanitation Records and GMP<br />
- Review of the result of periodic <strong>in</strong>-process and f<strong>in</strong>al product test<strong>in</strong>g.<br />
Comprehensive Food Safety System Verification (Reassessment)<br />
• This verification answers the questions, whether Food Safety plan is controll<strong>in</strong>g hazards? and is the<br />
Food Safety Plan still controll<strong>in</strong>g hazards? It is a thorough review of hazard analysis <strong>to</strong> address<br />
specific hazards <strong>to</strong> determ<strong>in</strong>e if they are controlled. A reassessment of the adequacy of the plan is<br />
done on any changes that could affect the hazard analysis or alter the plan <strong>in</strong> any way such as raw<br />
materials, source of raw materials, product formulation, process<strong>in</strong>g methods or system, <strong>in</strong>tended<br />
use or consumers of the product, product distribution system etc, or at least annually.<br />
Audits<br />
• In addition, <strong>in</strong>ternal audits (Refer: FSMS Manual Doc.No.XYZ./FSMSV-8.4.1) and external audits also<br />
provide feed back on effective implementation of the system and provide evidence for verification.
Documentation and Records<br />
• The Food Safety Team has established an efficient documentation and record keep<strong>in</strong>g the relevant<br />
FS System Procedures have <strong>be</strong>en ma<strong>in</strong>ta<strong>in</strong>ed separately. Records are <strong>kept</strong> from all areas, which<br />
are critical <strong>to</strong> product safety <strong>to</strong> demonstrate that the Food Safety system is <strong>in</strong> compliance with the<br />
documented system, some of them are <strong>in</strong>dicated <strong>be</strong>low:<br />
• Food Safety Team Meet<strong>in</strong>g records<br />
Non conform<strong>in</strong>g product record,<br />
Traceability record,<br />
CCP Moni<strong>to</strong>r<strong>in</strong>g Records,<br />
CCP verification records,<br />
Corrective Action records if any,<br />
Hygiene Audit record<br />
Control Measures Record (Time & temp)<br />
Agenda & m<strong>in</strong>utes of Management Review<br />
Tra<strong>in</strong><strong>in</strong>g & Evaluation of Tra<strong>in</strong><strong>in</strong>g records,<br />
Audit records,<br />
Record of Daily check lists<br />
Water Analysis record<br />
Pest Control records<br />
Preventive Ma<strong>in</strong>tenance record<br />
Clean<strong>in</strong>g schedules<br />
Staff medical reports,<br />
In house lab analysis reports,<br />
Record of Calibration of measur<strong>in</strong>g and test<strong>in</strong>g equipments
7.9 Traceability system<br />
• The product identification and traceability is required <strong>be</strong>cause of one or more of the follow<strong>in</strong>g<br />
reasons:<br />
- Status of the food products at all stages of manufactur<strong>in</strong>g<br />
- Contractual requirement, where<strong>in</strong> the food product is marked by a specific mark or<br />
code for subsequent verification by the cus<strong>to</strong>mer<br />
- Intended use of application<br />
• Food product identification starts with the receipt of the raw materials / <strong>in</strong>gredients and ends with<br />
the delivery and serv<strong>in</strong>g of the food product, clear<strong>in</strong>g of the used crockery, housekeep<strong>in</strong>g of the<br />
place and disposal of the left-over food. The identification and traceability helps <strong>in</strong> effective s<strong>to</strong>ck<br />
rotation and ensures product recall, if called for.<br />
The organization has established a traceability system that enables the identification of product lots and<br />
their relation <strong>to</strong> raw material, process<strong>in</strong>g and delivery record for identify<strong>in</strong>g <strong>in</strong>com<strong>in</strong>g material for the<br />
immediate suppliers. Traceability record shall <strong>be</strong> ma<strong>in</strong>ta<strong>in</strong>ed for a def<strong>in</strong>ite period for system assessment<br />
<strong>to</strong> enable the handl<strong>in</strong>g of potentially unsafe product. Record shall <strong>be</strong> <strong>in</strong> accordance with the statu<strong>to</strong>ry and<br />
regula<strong>to</strong>ry requirements<br />
7.10 CONTROL OF NON-CONFORMING PRODUCT
• Products not conform<strong>in</strong>g <strong>to</strong> the requirements are identified and prevented from un<strong>in</strong>tended use or<br />
delivery.<br />
• Control exercised along with the def<strong>in</strong>ed responsibility for handl<strong>in</strong>g the non-conform<strong>in</strong>g product is<br />
descri<strong>be</strong>d <strong>in</strong> procedure for Non Conform<strong>in</strong>g product.<br />
7.10.1 Corrections<br />
The follow<strong>in</strong>g methods are employed if any non-conformity is detected<br />
- Action <strong>to</strong> elim<strong>in</strong>ate the detected non conformities<br />
- Authorize its use, release under concession by relevant authority<br />
- Preclude its orig<strong>in</strong>al use.<br />
• Records of nonconformities subsequent corrective actions taken are ma<strong>in</strong>ta<strong>in</strong>ed.<br />
7.10.2 Corrective action<br />
• It <strong>in</strong>cludes:<br />
- Necessary corrective actions are taken up by the respective chefs <strong>to</strong> prevent recurrence of<br />
nonconformities noticed.<br />
- Corrective actions are carried out as per procedure for corrective and preventive action which<br />
<strong>in</strong>cludes:<br />
- Review<strong>in</strong>g non-conformities, <strong>in</strong>clud<strong>in</strong>g cus<strong>to</strong>mer compla<strong>in</strong>ts<br />
- Determ<strong>in</strong><strong>in</strong>g the causes of nonconformities<br />
- Evaluat<strong>in</strong>g the need for action <strong>to</strong> ensure that nonconformities do not re occur<br />
- Determ<strong>in</strong><strong>in</strong>g and implement<strong>in</strong>g action needed<br />
- Records of the results of action taken<br />
- Review<strong>in</strong>g corrective action taken<br />
• For each critical control po<strong>in</strong>t, <strong>in</strong> the associated OPRP & HACCP Plan, XYZ has documented (or<br />
referenced) the corrective actions <strong>to</strong> <strong>be</strong> taken if an action limit value or critical limit is exceeded.<br />
The procedure <strong>in</strong>cludes the process <strong>to</strong> <strong>in</strong>vestigate the cause of the deviation.<br />
• The Food Safety Team is considered as Emergency Team for respond<strong>in</strong>g <strong>to</strong> critical limit<br />
deviations. The team evaluates the causes of deviation and decides which additional preventive<br />
actions are <strong>to</strong> <strong>be</strong> taken.
7.10.3 Handl<strong>in</strong>g of potentially unsafe products<br />
7.10.3.1 General<br />
• XYZ has also established arrangements that provide for recall of the products from the<br />
market place and/or from end consumers. Proper product identification and a “trac<strong>in</strong>g and<br />
track<strong>in</strong>g” system are operational. These are detailed <strong>in</strong> the Handl<strong>in</strong>g of Potentially Unsafe<br />
Products Procedure.<br />
7.10.3.2 Evaluation for release<br />
• All corrective actions taken, the causes and consequences, and the <strong>in</strong>dividuals <strong>in</strong>volved <strong>in</strong> the<br />
corrective action are recorded. The effectiveness of the corrective action (for both process<br />
and product) is evaluated.<br />
7.10.3.3 Disposition of non conform<strong>in</strong>g product<br />
• Any product result<strong>in</strong>g from the process <strong>while</strong> the critical limit has <strong>be</strong>en exceeded is treated<br />
as non -conform<strong>in</strong>g product. The corrective actions with respect <strong>to</strong> product might <strong>in</strong>clude:<br />
− Actions rang<strong>in</strong>g from raw material <strong>to</strong> product / batch / lot recall.<br />
− Identification of the non-conform<strong>in</strong>g products / batches / lots.<br />
− Disposal / destruction of the product / batch / lot.<br />
7.10.3.4 Withdrawals<br />
• XYZ has established a procedure for withdrawal of end product which have <strong>be</strong>en identified<br />
as unsafe<br />
• The withdrawal activity <strong>in</strong> XYZ is <strong>in</strong>itiated by FST Leader.<br />
8 VALIDATIONS, VERIFICATION & IMPROVEMENT OF THE FOOD SAFETY MANAGEMENT SYSTEM<br />
8.1 General<br />
• Validation is done <strong>to</strong> ensure that the hazards orig<strong>in</strong>ally identified are complete and correct and that<br />
the hazards are effectively controlled<br />
• Necessary validations of control measures are planned and implemented <strong>to</strong>:<br />
- Demonstrate conformity of the product <strong>to</strong> the specified requirements<br />
- Ensure conformity <strong>to</strong> Food Safety Management System<br />
- Cont<strong>in</strong>ually improve effectiveness of Food Safety Management System<br />
• Food Safety Team shall plan and implement the processes needed <strong>to</strong> validate control measures,<br />
comb<strong>in</strong>ations and verify and improve the system.
8.2 Validation of The Control Measures Comb<strong>in</strong>ations<br />
• Validation is activity prior <strong>to</strong> authoriz<strong>in</strong>g HACCP Plan. For this, organization has constituted a<br />
Validation team compris<strong>in</strong>g of follow<strong>in</strong>g:<br />
• It is the responsibility of the validation team <strong>to</strong> review that effectiveness after support<strong>in</strong>g evidence<br />
used <strong>in</strong> the HACCP study i.e., control measures, moni<strong>to</strong>r<strong>in</strong>g system for PRP , OPRP and CCP &<br />
corrective actions taken for any deviations<br />
a) Initial Validation<br />
• The HACCP Plan prepared by the FS Team has <strong>be</strong>en validated for its adequacy and completeness by<br />
the validation team. Validation has <strong>be</strong>en performed on the basis of the quantifiable and objective<br />
his<strong>to</strong>rical results from on-l<strong>in</strong>e quality control moni<strong>to</strong>r<strong>in</strong>g, end product test<strong>in</strong>g, and cus<strong>to</strong>mer<br />
compla<strong>in</strong>ts and by demonstrat<strong>in</strong>g that:<br />
- the established list of potential hazards is based on sound scientific data and has <strong>in</strong>cluded all<br />
hazards,<br />
- questions used <strong>to</strong> assess the significance are answered us<strong>in</strong>g sound scientific and technical<br />
knowledge,<br />
- the control measures(general and specific) are appropriate <strong>to</strong> control the hazards,<br />
- fluctuations of the control parameters(equivalent <strong>to</strong> process criterion) with<strong>in</strong> the def<strong>in</strong>ed critical<br />
limits will not affect the safety of the product,<br />
- parameters and methods used <strong>to</strong> moni<strong>to</strong>r the control measures are appropriate,<br />
- corrective actions are appropriate and will prevent the release of unsafe products and provide<br />
evidence that the situation can <strong>be</strong> corrected immediately<br />
Note- Food bus<strong>in</strong>ess opera<strong>to</strong>rs produced safe food for many years <strong>be</strong>fore the <strong>in</strong>troduction of the HACCP<br />
system. Therefore, his<strong>to</strong>rical results from on-l<strong>in</strong>e Quality Control moni<strong>to</strong>r<strong>in</strong>g, end product test<strong>in</strong>g,<br />
cus<strong>to</strong>mer or consumer compla<strong>in</strong>ts are used as evidence when validat<strong>in</strong>g HACCP plans. It is important <strong>to</strong><br />
note that the data must <strong>be</strong> quantifiable and objective if it is <strong>to</strong> <strong>be</strong> useful.<br />
b) On go<strong>in</strong>g validation<br />
• Critical Control limits are validated once <strong>in</strong> a quarter <strong>to</strong> confirm whether they are still valid. If not<br />
provid<strong>in</strong>g the degree of confidence envisaged, new limits are established. The FS system is also<br />
validated by the team whenever:<br />
- CCP,s are changed/modified,<br />
- Process changes takes place affect<strong>in</strong>g food safety,<br />
- Equipment changes/replacement occur affect<strong>in</strong>g food safety,<br />
- Major system failures occur<br />
• Validation of the CCP
PRODUCT<br />
CCP NO<br />
CCP<br />
CRITICAL LIMIT<br />
CCP OBJECTIVE<br />
MONTH & YEAR OF REVIEW<br />
MONITORING RECRD<br />
CORECTIVE ACTION IF ANY<br />
TEST STATUS<br />
MAINTENANCE STATUS<br />
CALIBRATION STATUS<br />
COMPLAINT IF ANY<br />
VERIFICATION STATUS<br />
REMARKS IF ANY<br />
8. VALIDATIONS, VERIFICATION AND IMPROVEMENT OF FSMS<br />
8.1 General<br />
• Necessary validations of control measures are planned and implemented <strong>to</strong>:<br />
- Demonstrate conformity of the product <strong>to</strong> the specified requirements<br />
- Ensure conformity <strong>to</strong> Food Safety Management System<br />
- Cont<strong>in</strong>ually improve effectiveness of Food Safety Management System<br />
8.2 Validation of control measure comb<strong>in</strong>ations<br />
• The objective of validation is <strong>to</strong> ensure that the hazards orig<strong>in</strong>ally identified by the Food Safety<br />
Team are complete and correct and that they will <strong>be</strong> effectively controlled under the proposed plan.<br />
• To meet the objectives of validation, the effectiveness of the support<strong>in</strong>g evidence used <strong>in</strong> the HACCP<br />
study as well as the general and specific control measures, the moni<strong>to</strong>r<strong>in</strong>g system and the corrective<br />
actions have <strong>be</strong>en reviewed.
• Each time XYZ operation changes <strong>in</strong> a manner that could adversely affect food safety the<br />
correspond<strong>in</strong>g OPRP & HACCP Plan/s is/are updated.<br />
• Validation is performed by the Validation Team’s <strong>in</strong>dependent review of the follow<strong>in</strong>g:<br />
−<br />
−<br />
−<br />
−<br />
−<br />
The established list of potential hazards is based on sound scientific data and has <strong>in</strong>cluded all<br />
hazards.<br />
The questions used <strong>to</strong> assess the significance are answered us<strong>in</strong>g sound scientific and technical<br />
knowledge.<br />
The control measures (OPRP’s & CCP’s) are appropriate <strong>to</strong> control the hazards, i.e. <strong>to</strong> prevent<br />
or elim<strong>in</strong>ate, <strong>to</strong> reduce or ma<strong>in</strong>ta<strong>in</strong> at an acceptable level<br />
Fluctuations <strong>be</strong>tween target values and action limits will not affect the safety of the product.<br />
The parameters and methods used <strong>to</strong> moni<strong>to</strong>r the control measures are appropriate<br />
• XYZ have produced safe food <strong>in</strong> their earlier assignments. Therefore, his<strong>to</strong>rical results from on-l<strong>in</strong>e<br />
quality control moni<strong>to</strong>r<strong>in</strong>g, end product test<strong>in</strong>g, and cus<strong>to</strong>mer or consumer compla<strong>in</strong>ts have <strong>be</strong>en<br />
used as evidence when validat<strong>in</strong>g OPRP & HACCP Plans.<br />
8.3 CONTROL OF MONITORING AND MEASURING<br />
• XYZ demonstrates the :<br />
- Conformity of the food product<br />
- Conformity of FSMS<br />
- Cont<strong>in</strong>ual Improvement of the effectiveness of the FSMS<br />
• XYZ has established and ma<strong>in</strong>ta<strong>in</strong>ed a moni<strong>to</strong>r<strong>in</strong>g (and/or measur<strong>in</strong>g, as appropriate) system for<br />
effective and efficient control of the Critical Control Po<strong>in</strong>ts.<br />
• The moni<strong>to</strong>r<strong>in</strong>g and measur<strong>in</strong>g system is def<strong>in</strong>ed <strong>in</strong> the OPRP & HACCP Plan associated with each<br />
CCP, and <strong>in</strong>cludes all planned measurements, observations and analysis of the control parameters<br />
determ<strong>in</strong><strong>in</strong>g that the CCP is under control.<br />
• The Plan associated with each CCP documents (or references) the follow<strong>in</strong>g <strong>aspects</strong>:<br />
− The development of the moni<strong>to</strong>r<strong>in</strong>g system.<br />
− The identification of moni<strong>to</strong>r<strong>in</strong>g (measur<strong>in</strong>g) devices.<br />
− The methodology of measurement and/or the <strong>in</strong>structions for measur<strong>in</strong>g and record<strong>in</strong>g of<br />
measurements.<br />
• The method for establish<strong>in</strong>g the reliability of the measurements and/or the equipment (calibration).<br />
• Where measurements and product tests by subcontrac<strong>to</strong>rs are used as a means of moni<strong>to</strong>r<strong>in</strong>g /<br />
measur<strong>in</strong>g, these are generally done from recognized labora<strong>to</strong>ries.
• The results of the moni<strong>to</strong>r<strong>in</strong>g are documented by means of records (as <strong>in</strong>dicated <strong>in</strong> the Plan) and the<br />
practices are descri<strong>be</strong>d <strong>in</strong> process control plans (as referenced <strong>in</strong> the Plan).<br />
• The records <strong>in</strong>clude:<br />
− Moni<strong>to</strong>r<strong>in</strong>g Reports (dated and signed)<br />
− Records of Deviations which have occurred (action limits and critical limits) and corrective<br />
actions taken are available.<br />
8.4. FSMS VERIFICATION<br />
• XYZ has established and implemented procedures for the verification of the Food Safety<br />
Management System. The ma<strong>in</strong> purpose of verification is <strong>to</strong> determ<strong>in</strong>e compliance with the<br />
specifications of the Food Safety Management System and <strong>to</strong> confirm that the system based on ISO<br />
22000:2005 standard is work<strong>in</strong>g effectively through the application of (audit<strong>in</strong>g) methods,<br />
procedures, tests (<strong>in</strong>clud<strong>in</strong>g random sampl<strong>in</strong>g and analysis) and other evaluation, <strong>in</strong> addition <strong>to</strong><br />
moni<strong>to</strong>r<strong>in</strong>g.<br />
8.4.1 Internal audit:<br />
• Internal audits are conducted based on the schedule drawn up <strong>to</strong> determ<strong>in</strong>e whether the Food<br />
Safety Management System<br />
- Conforms <strong>to</strong> the planned arrangements for meet<strong>in</strong>g the product realization, ISO<br />
22000:2005 and Food Safety Management System requirements.<br />
- Is effectively implemented and ma<strong>in</strong>ta<strong>in</strong>ed<br />
• XYZ has def<strong>in</strong>ed an <strong>in</strong>ternal audit program, tak<strong>in</strong>g <strong>in</strong><strong>to</strong> consideration the status and importance of<br />
the processes and areas <strong>to</strong> <strong>be</strong> audited, as well as the results of previous audits. The audit criteria,<br />
scope, frequency and methods are def<strong>in</strong>ed generally <strong>in</strong> the Internal Food Safety Audits<br />
• Selection of audi<strong>to</strong>rs and the conduct of audits are done <strong>in</strong> such a way as <strong>to</strong> ensure objectivity and<br />
impartiality of the audit process. Audi<strong>to</strong>rs do not audit their own work.<br />
8.4.1.2 Internal Audits are planned tak<strong>in</strong>g <strong>in</strong><strong>to</strong> consideration the importance of the processes and<br />
activity <strong>be</strong><strong>in</strong>g audited and results of the previous audits.<br />
8.4.1.3 Scope, audit criteria, frequency and methods of audit<strong>in</strong>g are def<strong>in</strong>ed <strong>in</strong> procedure for <strong>in</strong>ternal<br />
food safety audits.
8.4.1.4 This procedure also identifies the responsibility and requirements for plann<strong>in</strong>g and<br />
conduct<strong>in</strong>g audits, for report<strong>in</strong>g the results and ma<strong>in</strong>ta<strong>in</strong><strong>in</strong>g the records.<br />
8.4.1.5 Tra<strong>in</strong>ed personnel <strong>to</strong> ensure objectivity and impartiality conduct <strong>in</strong>ternal audits.<br />
8.4.1.6 The personnel responsible for the area audited identify and implement the necessary<br />
corrective actions <strong>to</strong> elim<strong>in</strong>ate the recurrence of the reported nonconformance. The corrective<br />
actions taken up by the auditee are verified and the verification is recorded.<br />
• XYZ determ<strong>in</strong>es whether the FSMS:<br />
- Conforms with the planned arrangements:<br />
- With the “Requirements for an ISO 22000-based Food Safety System” and<br />
- With the requirements established by XYZ itself, and reflected <strong>in</strong> the current food safety<br />
system.<br />
- Is effectively implemented and ma<strong>in</strong>ta<strong>in</strong>ed.<br />
• Verification <strong>aspects</strong> are covered under the Internal Food Safety Audits. The Internal Audit<br />
Procedure descri<strong>be</strong>s the <strong>in</strong>ternal audit and verification methodologies which are carried out as per<br />
the Verification plan at XYZ, <strong>to</strong>gether with the responsibilities and requirements for plann<strong>in</strong>g and<br />
conduct<strong>in</strong>g audits, for report<strong>in</strong>g results and ma<strong>in</strong>ta<strong>in</strong><strong>in</strong>g records.<br />
8.4.2 Evaluation of <strong>in</strong>dividual verification results.<br />
• Each department compiles data <strong>to</strong> demonstrate the suitability and effectiveness of Food Safety<br />
Management System and identifies improvements for effectiveness of Food Safety Management<br />
System <strong>in</strong> respect of operation of each department.<br />
• The data <strong>in</strong>cludes <strong>in</strong>formation generated through measurements and moni<strong>to</strong>r<strong>in</strong>g and other relevant<br />
sources. This <strong>in</strong>cludes moni<strong>to</strong>r<strong>in</strong>g and review of the objectives at the department level and also<br />
<strong>in</strong>cludes<br />
a. Exist<strong>in</strong>g procedures and communication channels<br />
b. HACCP plan , OPRP’s and hazard analysis conclusions<br />
c. The PRP’s<br />
d. The tra<strong>in</strong><strong>in</strong>g plan and tra<strong>in</strong><strong>in</strong>g effectiveness of food handlers
8.4.3 Analysis of results of verification activities<br />
• The analysis of data by Food safety team <strong>in</strong>clud<strong>in</strong>g <strong>in</strong>ternal and external audits provides<br />
<strong>in</strong>formation relat<strong>in</strong>g <strong>to</strong><br />
- Cus<strong>to</strong>mer satisfaction<br />
- Product conformity<br />
- Characteristics and trends of processes and products <strong>in</strong>clud<strong>in</strong>g opportunity for preventive<br />
action<br />
- Suppliers<br />
• The analysis is carried out<br />
a. To confirm overall performance of FSMS as per the established requirements by the<br />
organization<br />
b. To update or improve the FSMS<br />
c. To identify trends with a higher degree of <strong>in</strong>cidence for potentially unsafe products<br />
d. To upgrade and plan <strong>in</strong>ternal audit program as per the status and importance of FSMS<br />
e. To provide evidence for any corrective action as per FSMS that have <strong>be</strong>en taken are effective<br />
• The results of analysis and the result<strong>in</strong>g activities are recorded<br />
• Record are ma<strong>in</strong>ta<strong>in</strong>ed<br />
8.5 IMPROVEMENT
8.5.1 Cont<strong>in</strong>ual Improvement:<br />
• Based on the analysis of data and results of audit, areas need<strong>in</strong>g improvement are identified <strong>to</strong> <strong>in</strong>itiate<br />
necessary corrective and preventive actions.<br />
• Where appropriate, the relevant Food Safety Objectives and Food Safety Policy are revised and<br />
reviewed <strong>in</strong> meet<strong>in</strong>gs <strong>to</strong> focus on improvement<br />
• XYZ cont<strong>in</strong>ually improves the effectiveness of the Food Safety Management Systems through the<br />
use of :<br />
- Evaluation of <strong>in</strong>dividual verification results<br />
- Validation of control measure comb<strong>in</strong>ation<br />
- Food Safety Policy<br />
- Food Safety Objectives<br />
- Internal Audits<br />
- Analysis of Data<br />
- Corrective Actions<br />
- Preventive Actions<br />
- Management Reviews<br />
- FSMS Updat<strong>in</strong>g<br />
8.5.2 UPDATING OF FSMS<br />
• XYZ ensures that FSMS is cont<strong>in</strong>uously updated by evaluation and updat<strong>in</strong>g activities like<br />
a. Inputs from communication, <strong>in</strong>formation with reference <strong>to</strong> FSMS<br />
b. Input from <strong>in</strong>formation concern<strong>in</strong>g the suitability, adequacy and effectiveness of the<br />
FSMS and Statu<strong>to</strong>ry and regula<strong>to</strong>ry bodies<br />
c. Outputs from verification activities and management review.<br />
d. Output from management review meet<strong>in</strong>gs<br />
• Records of these activities are reported as an <strong>in</strong>put <strong>to</strong> the management review.