Procedures c.f. Work Instructions

1. Procedures c.f. Work Instructions • Procedure - how a general function is performed • e.g. internal audits • Work Instruction - specific detail of how a single activity is performed • e.g. a laboratory method

2. NRL Procedures • Contain sections on: • Purpose of the procedure • Scope • Method • Records • Documents

3. Work Instructions More detailed explanations of how specific tasks mentioned in the Procedures are carried out.

4. Work Instructions • Summarise work activities simply as possible • bullet form • flow charts • Numbered sections • for more complex activities • useful for cross reference

5. Numbering Documents - NRL • Procedures, e.g. P-EV-0602 • Evaluations - reserve 0601-0700 • Work Instructions, e.g. WI-EV-0602/3 • Relates to P-EV-0602 • Forms, e.g. FM-EV-0609 • Relates generally to Evaluations

6. Internally Generated Supporting Documents • Lists of suppliers • Controlled document master lists • Controlled record master lists

7. External Documents • Control after arrival • e.g. • Contracts • Standards • Regulations

8. Document for the Needs of Organisation • Some options: • Combine Quality Manual, Procedures • Different Quality Manuals different sites

9. Who Should Document ? • Users where possible • expertise • ownership • Writing versus authorisation • Guidelines on style • Quality manager overview

10. How Much Documentation? ISO/IEC 17025 Section 4.2.1 “…document to the extent necessary to ensure the quality of the test…results.”

11. What is NOT Required • The name “Quality Manual” • A specific documentation structure • A formal writing style • Documenting everything you do • Irrational changes

12. Good Reasons to Document • Standardising work • Induction and other training • Instructions • as needed • Defining what is done • responsibility to client

13. Good Reasons to Document • Meeting requirements of standards • Clarifying what is important • Public relations • where appropriate

14. Bad Reasons to Document • To satisfy auditors • For the sake of documenting

15. Results of Bad Documentation • Documentation not useful • Documentation not used • Documentation not updated • Unnecessary non-conformances

16. Some General Points • Change only what is necessary or useful • Names do not matter • Standards adaptable for organisations of different sizes • Fit documentation to organisation • not organisation to documentation

17. Some General Points • Use existing documents and systems wherever possible and appropriate • No need to use numbers in standard(s) • can cross-reference standards • No need to use jargon of standard(s)

18. Document Style? • What is functional? • Can use diagrams, flow charts etc. • Communicate - clarity, simplicity • Effective language • e.g. active rather than passive

19. Document Style? • Seek to look professional • not necessarily formal • Consistency in style • desirable, not required • Write for results • keep reader in mind

20. Document Control

21. Outline • What is document control? • Document review • Steps in document control & review • Options for document control • Failures of document control • Control of records

22. Document Control Required: • By ISO 9000 • clause 4.5 • By ISO/IEC 17025 • clause 4.3

23. What Is Document Control? • System for ensuring: • Only current documents used • Easy review and updating

24. Why Document Control? • Current documents always available • Nothing but current documents used • What was done is always clear • interpretation of results • relationship with client

25. Document Control • Unique identification • Approved for use • by authorised personnel • Current versions available • Obsolete versions removed, identified • Master list available

26. Required in a Document • Identify document uniquely • Identify revision number and/or date • Number pages • Show end of document • e.g. “Page 4 of 7” • Show who authorised

27. Can Use • Headers • Footers • Cover page • Headers for hard copy • footers for electronic

28. Master Copy of Document • Hard copy - distinguishable • Electronic • Authorised • electronic or by signature

29. Distribution • Electronic and/or hard copy • Who needs the document? • no less, not much more • Maintain distribution list • quality document

30. Document Review • Regular review • by same function as approved • Identification of alterations • if possible

31. Steps in Document Control • Request for new or revised document • Document drafted, consultation • Document authorised • Staff notified of change • Old documents replaced by new • Master list of documents updated

32. Controlled Document Master List • Lists • documents • current versions • dates authorised • Multiple lists?

33. Approaches to Document Control • Documents • hard copy and/or electronic • Control • manual versus electronic • minimise labour • maximise speed, accuracy

34. Document Control • Depends on document structure • Small change  change whole document • Or document control on each page? • Possibly control: • Quality Manual in sections • other documents as a whole

35. Failures of Document Control • Photocopies • Notices on walls • if uncontrolled • Handwritten amendments • if unauthorised