integrating quality management system requirements into the sabs ...

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integrating quality management system requirements into the sabs ...

INTEGRATING QUALITY

MANAGEMENT SYSTEM

REQUIREMENTS INTO THE SABS

PERSONNEL DOSIMETRY COMPUTER

SYSTEMS

JUNE 2007


ABOUT THE SABS

1. SOUTH AFRICAN BUREAU OF STANDARDS (SABS)

• Established in 1945 to assist South African industry with standardization

• Publication and maintenance of standards and specifications

• Regulating compulsory specifications and legal metrology

• Providing accredited system and product certification services, e.g. ISO9000,

ISO14000

• Provision of conformity testing services for a wide variety of products, with

main focus areas Food&Health, Mining&Minerals, Transportation,

Mechanical&Materials, Electrotechnical, Chemical and Services

• Most of the laboratories and tests are ISO/IEC 17025 accredited

2. RADIATION PROTECTION SERVICE

• Monitoring approximately 17 000 radiation workers

• Using Panasonic dosimetry equipment

• ISO/IEC 17025 accredited


OVERVIEW OF PRESENTATION

This presentation will give examples where

workflow control and quality system

requirements have been integrated and

computerized

in such a way that control was improved

and workflow simplified

with built-in proof of compliance to quality

system requirements


BACKGROUND

1. ERRORS

• During 2005 we experienced a number of work stoppages as a

result of staff not following workflow steps

• Often the person responsible was not identifiable and did not

come forward

• The work systems picked up the errors and still ensured

quality of results, but did not prevent rework and time loss

• Work flow processes had many steps and had to be followed

carefully

2. CONSEQUENCES

• Delays

• Extra resources (mainly time of specialists) to unblock

stoppages

• Lack of personal ownership of work (frustration)

• Rework


DECISIONS: TOWARDS A SOLUTION

• Identify all problems and frustrations staff experience with

work flow processes, as well as ideas for improvement

(problem/idea list)

• Analyze, prioritize and address ALL problems

• Simplify and automate work flow processes as far as possible

• Evaluate impact of all items of problem/idea list on other work

processes

• Reduce paper records

• Ensure continued full compliance to ISO/IEC 17025 and build

proof of compliance into automated systems

• Use the opportunity to systematically upgrade/replace old

1994 vintage computer system

• Do not only fix problems, but change systems to prevent

problems from happening again


DECISIONS: TOWARDS A SOLUTION (picture)

Frustrations

Problems

Ideas

Get info

Analyze

These are the rules:

ISO 17025 compliance

Reduce paper

Replace old computer system

Robust (foolproof)

Simplify

Automate

Decide what

to do

Implement


CONTINUOUS IMPROVEMENT

Collection of facts

Implement

changes

Analyze, identify

solutions and

prioritize


PILOT STUDY: DOSIMETER ISSUE AND PACKAGING

• Old workflow:

17 steps, of which 5 were inefficient back and forth conversions

between computer systems

Traceability to responsible persons through additional paper

records

• New workflow:

12 steps

new, re-designed computer interface

equipment time saving of approximately 1.5 hours per 500 badges

decrease of approximately 1.5 hours per batch of 500 badges in

issue process time because of equipment time saving

built-in traceability to responsible persons (electronic, no paper)

because ideas and problems from other work areas had been

identified prior to the implementation, the new system

incorporated changes that were beneficial to those areas as well

immediate reduction in workflow stoppages and rework


PILOT STUDY: DOSIMETER ISSUE AND PACKAGING

• Responsible persons can be traced back to individual badges

as well as issue groups

• Process control – next issue batch cannot be started unless

all steps have been checked off


CHANGING THE DOSE PROCESSING PROCESS

OLD SYSTEM

• Paper based records (store rooms full of them)

• Batch processing directed by proceduralized paper

checklist

• Whole batch held back if supervisor action required

• Constant back and forth between computer screen and

paper printouts during processing

• Staff intermittently not following procedural steps

correctly

• Staff tended to do everything on auto pilot, then return

to checklist to sign off every step

• Intermittent missing signatures for some of the steps


CHANGING THE DOSE PROCESSING PROCESS

OLD SYSTEM WORK REPORT

Actions taken

according to the

flags on the right

Actions /

observations

recorded on the

printout

After changes on

computer, reprint

of work report as

proof of change


CHANGING THE DOSE PROCESSING PROCESS

OLD SYSTEM PROCEDURALIZED PAPER CHECKLIST

Carry out

each step

Each step

describes

what to do

Sign off

each step

when

complete


CHANGING THE DOSE PROCESSING PROCESS

NEW SYSTEM

• On-screen system – no writing on paper records

• On-screen proceduralized checklist

• If all checks not ticked, cannot close off batch

• Certain conditions will completely block closing off – requires

supervisor clearance

• Specific badges can be put on hold for later supervisor action,

letting rest of batch go through in the meantime

• Later retrieval of records linked to badge number

• Average time for batch of 500 reduced by 20 minutes

• A number of automations in information lookup and

verification added

• With a few further changes, the few remaining paper record

pages can also be changed to electronic format

• Major reduction in “I forgots” and other processing errors


CHANGING THE DOSE PROCESSING PROCESS

NEW SYSTEM

Click on filter

item or button

to display

relevant

badges and

instructions

for handling

Tick off the

step when

done

Notes,

comments

etc, onscreen


SCHEDULED ACTIVITIES

1. INTERNAL AUDIT FINDINGS

• During 2006, number of internal findings

• Root cause for most: scheduling of activities

2. EXAMPLES OF ACTIVITIES REQUIRING SCHEDULING

• Internal audits

• Maintenance

• Review of quality control data for trends

• Review of quality system documentation

• Review of training

• QC / QA periodic actions

3. SOLUTION

• Compiled complete list of all items in quality system

requiring scheduling

• Created computer database application for centralized

review and control


SCHEDULED ACTIVITIES

If item overdue,

flag appears

Items can be

linked to

electronic

calendar

History of

changes for

future review

of compliance

to schedule

Printable list of

overdue items


EQUIPMENT RECORDS

For us, electronic equipment records are easier to maintain

Centralized control of scheduled activities is also easier with

electronic records


READER STATUS

Reader status

previously

indicated on

front panel of

readers with

coloured notices

Intermittent “I

forgots” by staff

Now reader

authorization

set up centrally

and enforced by

new reader

control program


CONSUMABLES

1. STOCK LEVEL CONTROL OF CRITICAL CONSUMABLES

WAS COMPUTERIZED

• Each consumable was allocated to a specific responsible

person

• Every person taking a consumable item must update the stock

register (click on item, click on “Take an item”)

• If minimum level breached, warning is displayed to order more

• Monthly stock-taking is done to validate the stock register

• History of changes is kept – able to track usage rate

• Person taking an item is logged


ELECTRONIC DOCUMENTATION SYSTEM

1. HISTORY

• Paper work instructions and procedures were replaced

by electronic windows help files during 1996

• During 2006 the system was upgraded to change from

help files to PDF files and expanded to include all

quality system documents

2. ADVANTAGES

• No unauthorized changes (e.g. scribbled notes)

• Easy update (done on only one copy and available

immediately to everyone)

• Easy availability over a wide physical area


ELECTRONIC DOCUMENTATION SYSTEM

• Documents are opened with double-click

• Makes use of PDF, MS Word document and MS Word template

files (other types can also be added)

• Document register is a simple text file that can be maintained

simply and easily by not-so-computer-literates

• To create PDF files is very easy nowadays, with a number of

free PDF creating programs available on the internet


CONCLUSION

• Examples of a few important and some not so important

changes were presented

• The value of examples is often more in what can be done

rather than the specifics

• The overall impact of incorporating quality system

requirements into a broader management system was

significant:

Major decrease in system stoppages

Sustained decreased turnaround times

Major decrease in errors

Major decrease in “I forgots”

Time for other things

• Continuous improvement is by nature a continuous process,

so the work has not been completed


Du Toit Volschenk

Radiation Protection Service

South African Bureau of Standards

Private Bag X191

Pretoria

0001

South Africa

dutoit@sabs.co.za

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