Gap Analysis

• Internal audit
• Bring in Consultants
• Wait for IMB
Gap Analysis
Tissue, March 2007 1

Gap Analysis
• Define the requirements from the standard
• Train staff in auditing techniques
• Measure systems not people
Tissue, March 2007 2

Gap Analysis
• Create a relaxed environment
• Auditors and auditees must work together to
solve problems
• Do not waste time attributing blame
Tissue, March 2007 3

Gap Analysis
Benefit of Internal Audit
• An effective internal audit programme allows
the organisation to measure itself against the
standard
• Promotes an awareness of Quality Management
Systems among all staff
• Weaknesses are corrected before problems arise
• It brings a culture of continuous improvement
to an organisation
Tissue, March 2007 4

Gap Analysis
Carry out gap analysis using:-
• Vertical audit checklist
• Gap analysis template
• Develop corrective action against each gap
• Assign responsibility and close out date
Tissue, March 2007 5

Gap Analysis Tissue March 07
Horizontal Audit Checklist
Gap Analysis
Section
Activity
Outputs to meet Requirement
Compliance
4.0 Organisation and Management
4.1 Responsible Person - Qualifications
- Trained deputy
- Job descriptions
4.2 Organisational Chart - Agreed and in the Quality Manual
Yes
No
4.3 Medical Practitioner/ Clinical Director - Named
- Deputy
4.4 Quality Management System - Quality Manual
- Quality Policy done and in the
Quality Manual
4.5 Risk Management - Identify and document risks
4.6 Service Level Agreement - Service Level Agreement
4.7 Release of Tissue/ Cells - SOP verifying specifications are met
4.8 Cessation of Activity - SOP describing what would happen
and where tissue would go.
4.9 Identification of Tissue - SOP showing identification of tissue
at all stages
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Gap Analysis Tissue March 07
Horizontal Audit Checklist
Gap Analysis
Section
Activity
Outputs to meet Requirement
Compliance
5.0 Personnel
5.1 Resources - Statement in the Quality Manual
- SOP on competency
Yes
No
5.2 Job Descriptions - In place for all
5.3 Training - SOP on training
- Training records
- Continuing Professional Education
(CPE)
Page 2 of 15

Gap Analysis Tissue March 07
Horizontal Audit Checklist
Gap Analysis
Section
Activity
Outputs to meet Requirement
Compliance
6.0 Equipment and Material Requirements
6.1 Commitment to Quality and Safety - Statement in your Quality Manual.
Yes
No
Responsibility for equipment operation, maintenance, cleaning and
validation.
- Equipment procedures and job
description clearly define
responsibility for equipment.
6.2 Asset register. - Detailed asset register (hardcopy or
safety copy.
Calibration programmes in place for equipment measuring variable
parameters.
Methods for validating equipment including software (retrospective/
prospective).
Schedules and defined programmes of work set out for equipment
preventative maintenance.
- Calibration SOP’s and calibration
records.
- SOP controlling validation approval.
- PM schedules and records/ checklists
in support of work done.
Continuous environmental monitoring systems in place i.e. temperature,
particulate method and pressure. These systems must control, monitor
and record data.
- Procedures controlling environmental
monitoring
- Continuous monitoring systems in
place
- Data
Availability of manufacturers instructions. - Equipment manuals
Page 3 of 15

Gap Analysis Tissue March 07
Horizontal Audit Checklist
Gap Analysis
Section
Activity
Outputs to meet Requirement
Compliance
6.0 Equipment and Material Requirements
Change Control system must verify impact of equipment change. - Change Control records
Yes
No
Must have a standardised approach to ensuring quality records relevant to
equipment are collected and readily accessible.
- Equipment file
Equipment validation matrix documented. - Updated equipment validation matrix
6.3 Must have approved plans in place for each equipment type and software
applications. These plans include:-
- User Requirement Specification (URS)
- Installation Qualification protocol (IQ)
- Operation Qualification Protocol (OQ)
- Performance Qualification (PQ)
- URS, IQ, OQ and PQ protocols
Must have validation data to prove that the equipment was validated. - Validation data
The validation data must be reviewed and the suitability of the equipment - Executive summary statement
authorized.
6.4 Programmes must be in place for the routine maintenance of equipment. - Maintenance records and procedure
Programmes must be in place for the routine cleaning of equipment. - Procedure(s) and cleaning records
Programmes must be in place for the routine disinfection and sanitisation - Procedures and records
of equipment.
Procedures must be in place for the routine operation of equipment. - Procedures
Page 4 of 15

Gap Analysis Tissue March 07
Horizontal Audit Checklist
Gap Analysis
Section
Activity
Outputs to meet Requirement
Compliance
6.0 Equipment and Material Requirements
Yes
No
In the event of equipment failure, there must be defined back up/
contingency methods in place. These contingency methods must be
tested.
6.6 A master list of specifications for critical materials/ reagents should be in
place.
- Procedures
- Records of testing
- Master list
Detailed documented specifications for the listed critical materials/ - Detailed documented specifications
reagents must be in place.
under Document Control
Documented incoming inspection processes to verify critical materials/ - Records of incoming inspection
reagents meet requirements as specified are required.
Status labelling of critical materials/ reagents is required. - Labels on critical materials/ reagents
Page 5 of 15

Gap Analysis Tissue March 07
Horizontal Audit Checklist
Gap Analysis
Section
Activity
Outputs to meet Requirement
Compliance
7.0 Facilities/ Premises
7.1 Description/ Suitability - Statement in the Quality Manual
Yes
No
7.2 Air Quality - Statement of grade in the Quality
Manual.
- SOP on how to verify and monitor
7.3 Grade A - Grade A with background
- Grade D
7.4 Exclusions - Justify in the Quality Manual
7.5 Quality and Safety - Specify environment in the Quality
Manual
- SOP on entry, gowning, hygiene
7.6 Storage - SOP defining storage conditions
7.7 Critical Parameters - SOP on monitoring and recording
temperature, humidity, air quality
7.8 Storage/ Segregation - Statement in the Quality Manual
- Verify by internal audits.
7.9 Access/ Cleaning/ Maintenance/ Waste Disposal - SOP on each
- Verify by internal audits
Page 6 of 15

Gap Analysis Tissue March 07
Horizontal Audit Checklist
Gap Analysis
Section
Activity
Outputs to meet Requirement
Compliance
8.0 Documentation and Records
8.1 Controlled Documentation System - SOP
- Master register of controlled
documents
- Records of document review,
document circulation and document
revision history.
8.2 Traceability (of critical processes) - Legible completed records in forms,
which are attached to the relevant
procedures.
8.3 Change Management System - SOP
- Completed change control forms
- Register with current status of change
control requests
- Minutes of meetings documenting
review of change requests
8.4 Document Control Procedure (Refer to 8.1) - Refer to 8.1
8.5 Accuracy and Reliability of Results - Statement in Quality Manual defining
organizational policy on data entry.
- Process flow documentation
identifying critical control points.
8.6 Collection of Quality Records - Procedure (SOP)
- List of authorized signatures/ initials
- Validation plans and records to verity
data transfer processes
Yes
No
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Gap Analysis Tissue March 07
Horizontal Audit Checklist
Gap Analysis
Section
Activity
Outputs to meet Requirement
Compliance
8.0 Documentation and Records
8.7 Retention of Quality Records - Quality Manual defines retention
times
- Procedure controlling retention,
storage, security and maintenance of
quality records.
- Service Level Agreement for external
contracted document storage
8.8 Access and Confidentiality - Policy statement in the Quality
Manual.
- User enrolment procedure and
records.
- Job contracts (signed) with
confidentiality clause.
Yes
No
Page 8 of 15

Gap Analysis Tissue March 07
Horizontal Audit Checklist
Gap Analysis
Section
Activity
Outputs to meet Requirement
Compliance
9.0 Quality Review
9.1 Audit System - SOP on audits
- Trained auditor
- Document findings
9.2 Deviations - SOP: Non conforming tissue
- Preventative action
- Reconciliation of above
9.3 Corrective Action - Statement in the Quality Manual
- SOP
- Verify by audit
9.4 Management Review - Statement in the Quality Manual
- Annual Management Review
Meeting
- Above SOP’s
Yes
No
Page 9 of 15

Gap Analysis Tissue March 07
Horizontal Audit Checklist
Gap Analysis
Section
Activity
Outputs to meet Requirement
Compliance
10.0 Tissue and Cell Procurement Requirements
10.1 Service Level Agreements - Service Level Agreements in place
and signed by both parties
Yes
No
10.2 Training of Procurement Personnel - An approved training plan approved
by the Tissue Establishment and
referenced in the Service Level
Agreement
10.3 Procurement Activities are Documented - Master list of procurement procedures
- Process flow identifying critical
control points
- SOPs implemented
10.4 Records to Verify the Procurement Activity - Quality records, forms
Page 10 of 15

Gap Analysis Tissue March 07
Horizontal Audit Checklist
Gap Analysis
Section
Activity
Outputs to meet Requirement
Compliance
11.0 Reception at Tissue Establishment
11.1 Verification - SOP on incoming inspection
Yes
No
11.2 Quarantine/ Review - SOP on incoming inspection
11.3 Non Conforming Tissue - SOP on non conforming tissue
11.4 Required Data - Statement in Quality Manual
- SOP on incoming inspection
11.5 Reproductive Cells - Statement in Quality Manual
- SOP on incoming inspection
Page 11 of 15

Gap Analysis Tissue March 07
Horizontal Audit Checklist
Gap Analysis
Section
Activity
Outputs to meet Requirement
Compliance
12.0 Tissue and Cells Processing Requirements
12.1 Validation of Critical Processing Activities - Detailed process flow documentation
- List of critical control points
- Matrix for process validation
- Validation plans
12.2 Validation Data in Place for Each Critical Processing Activity - Validation data/ reports
- Executive summary statement
12.3 Process Procedures - Approved SOPs in place
12.4 Process Procedures Strictly Adhered To - Forms and records traceable to the
activity
12.5 Viral Inactivation process - SOPs
- Validation plan
- Validation data
12.6 Management of Change - Change control procedure
- Change control forms
12.7 Requalificaion of processes - QC data, audit reports
- Equipment requalification
12.8 Disposal and Destruction of Tissue and Cells - Procedures, records
- Reconciliation data
Yes
No
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Gap Analysis Tissue March 07
Horizontal Audit Checklist
Gap Analysis
Section
Activity
Outputs to meet Requirement
Compliance
13.0 Storage and Release of Products
13.1 Storage Time - SOP stating maximum storage time
and how this time has been validated.
Yes
No
13.2 Inventory Hold - SOPs on stock control, reconciliation
and release.
13.3 Identification - SOP on identification of released
tissue/ cells, from quarantine, from
discard
13.4 Product Release - SOP on product release including
audit trail
13.5 Assessment Following Change - SOP on change control and assessing
effects of change on tissue
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Gap Analysis Tissue March 07
Horizontal Audit Checklist
Gap Analysis
Section
Activity
Outputs to meet Requirement
Compliance
14.0 Distribution of Tissue and Cells (Requirements)
14.1 Transport Conditions and Requirements - Transport and packaging procedure
Yes
No
14.2 Validation of Transport Containers and Packaging - Validation plan and data
14.3 Service Level Agreement for Transportation - Service level agreement signed by
both parties
14.4 Product Recall Authorisation - Procedure for product recall
14.5 Product Recall Procedural Requirements - Procedure for product recall
- Product recall forms
- Notification of IMB records
- Reconciliation reports
14.6 Product Recall and Investigation for Cause - Look back procedure
14.7 Issuing of Tissue and Cells - Request form
- Release authorization form
- Dispatch notes
14.8 Return of Unused Tissue and Cells - Procedure
- Return notes
- Validation data
Page 14 of 15

Gap Analysis Tissue March 07
Horizontal Audit Checklist
Gap Analysis
Section
Activity
Outputs to meet Requirement
Compliance
15.0 Final Labelling and Distribution
15.1 Primary Container - SOP on labeling
- Prepare label
Yes
No
15.2 Accompanying Documentation - Prepare documentation
15.3 Shipping Container - Prepare label
Page 15 of 15

Internal Quality Audit Schedule (Horizontal)
Year: 2007
Issued by: ______________________
Date: ___________________
HORIZONTAL AUDIT Sections of Quality
ACTIVITIES
Manual
Organization and Management 4.0
Jan. Feb. Mar. April May June July Aug. Sept. Oct. Nov. Dec.
Personnel 5.0
Equipment/ Materials 6.0
Facilities and Premises 7.0
Documentation and Registry 8.0
Quality Review 9.0
Procurement 10.0
Receipt at the Tissue
11.0
Establishment
Processing 12.0
Storage and Release 13.0
Distribution and Recall 14.0
Final Labelling 15.0
CH/QA/SOP/030 Ver. 1 Effective Date: ____/____/____ Att. 6.1
CENTRAL HOSPITAL

Year: 2007
Internal Quality Audit Schedule (Vertical)
Jan. Feb. March April May June July Aug. Sept. Oct. Nov. Dec.
√ √ √ √
Approved By: ____________________________ Date: _____/_____/_____
Quality Assurance Manager
Note: Two complete batch records are selected at random and are followed through from donor assessment to final implantation of the
processed cells.
CH/QA/SOP/030 Ver. 1 Effective Date: ____/____/____ Att. 6.1
CENTRAL HOSPITAL

CH/QA/SOP/030 Ver. 1 Effective Date: ____/____/_____ Att. 6.2
CENTRAL HOSPITAL
Checklist for Vertical Audit (Fertility Clinic)
Audit No.: ______________
Date: ____/____/____
Auditor: ________________
Tissue/ Cell ID No.: _________ Type of Tissue/ Cell:________ Date Released: ____________
Tissue/ Cell ID No.: _________ Type of Tissue/ Cell:________ Date Released: ____________
Audit Checklist
Activity
Complies Y/N
Evidence of Compliance/ Non
Compliance
1. Review the donor assessment documentation
including diagnosis and plan of action.
2. Review the contract with the contracted
laboratories for Endocrinology and Virology
markers and their recent performance in EQA
schemes.
3. Review the detailed questionnaire for
appropriateness relevant to best practice
requirements.
4. Review IQC and EQA data for the period semen
analysis was performed on the male donors.
5. Review the equipment file including PM
schedules and calibration for the scanning
equipment.
6. Verify based on objective evidence, that where
further testing or surgery in advance or part of the
treatment process was performed that the outcome is
clearly documented.
7. Review the consent process for the agreed plan
of action and where deviation occurs in treatment
verify that this deviation was consented.
8. For the defined treatment plan, review the
donation records.
9. Review the air velocity readings of the Class I
Cabinets. Review PM visit data, including DOP test
results.
10. Review temperature monitoring data on 2
selected incubators for the date(s) of processing.
11. Review the labelling of documentation,
specimens and cells at all stages of the process.
(Availability of barcode)
12. Review data to support the selection of embryos
for transfer. (batch release)
13. Review and perform as appropriate a stock
reconciliation. Actual versus documented
inventory.
14. For frozen embryos, review the freeze curve
and ensure the control rate freezing is as per
specification.
CH/QA/SOP/030 Ver. 1 Effective Date: ____/_____/_____ Att. 6.3
CENTRAL HOSPITAL

Audit Checklist
15. Review storage of liquid N 2 including
alarm systems.
- Review the thawing record.
16. Select 3 standard operating procedures at
random and review for document control
requirements.
17. Review gowning up procedures and entry
and exit procedures for product, patient and
personnel.
18. Review security procedures for
compliance. (Product, patient, staff,
engineers and visitors)
19. Review the outcome (current status)
20. Review training records of personnel for
activities performed.
- Review external training records.
21. Review validation data for a selected
process and/ or piece of equipment.
22. Review calibration data for 3 selected
pieces of equipment.
23. Check that selected equipment has an
asset ID number and is on the asset register.
Activity
Complies Y/N
Evidence of Compliance/ Non
Compliance
For each item on the checklist reviewed, refer to the relevant procedure.
Audited by: ________________________
Date: ____/____/____
CH/QA/SOP/030 Ver. 1 Effective Date: ____/_____/_____ Att. 6.3
CENTRAL HOSPITAL

Workshop Exercise 4 Service Level Agreement
Clause 1
Parties to this Agreement
Clause 2
Duration and Renewal of the Agreement
Clause 3
Objectives of the Agreement
Clause 4
Testing
Clause 5
Results Reporting
Clause 6
Turnaround Time
Page 1 of 3

Workshop Exercise 4 Service Level Agreement
Clause 7
Out of hours Service
Clause 8
Confidentiality
Clause 9
Charges
Clause 10
Agreement Co-ordinators
Clause 11
Performance
Clause 12
Reciprocal Indemnity
Page 2 of 3

Workshop Exercise 4 Service Level Agreement
Signed on behalf of: Date: ____/____/____
Signed on behalf of:
Date: ____/____/____
Attachment 1: Schedule A - List of Tests Referred
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
Page 3 of 3

Gap Analysis Tissue March 07
Gap analysis
Section
Activity
Outputs to meet Requirement
Compliance
Yes
No
.
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Gap Analysis Tissue March 07
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