Effective Documentation and Control Procedures for Laboratory Standards
This document outlines essential procedures and work instructions for maintaining effective documentation in laboratory settings. It explains the purpose, scope, and methods required for proper documentation control as per ISO/IEC 17025 standards. The procedures cover the creation of work instructions detailing specific tasks, document review processes, and record-keeping. It emphasizes the importance of clarity, consistency, and simplicity in documentation, while providing guidelines for effective communication and control of documents to ensure compliance and quality in laboratory practices.
Effective Documentation and Control Procedures for Laboratory Standards
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Presentation Transcript
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
NRL Procedures • Contain sections on: • Purpose of the procedure • Scope • Method • Records • Documents
Work Instructions More detailed explanations of how specific tasks mentioned in the Procedures are carried out.
Work Instructions • Summarise work activities simply as possible • bullet form • flow charts • Numbered sections • for more complex activities • useful for cross reference
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
Internally Generated Supporting Documents • Lists of suppliers • Controlled document master lists • Controlled record master lists
External Documents • Control after arrival • e.g. • Contracts • Standards • Regulations
Document for the Needs of Organisation • Some options: • Combine Quality Manual, Procedures • Different Quality Manuals different sites
Who Should Document ? • Users where possible • expertise • ownership • Writing versus authorisation • Guidelines on style • Quality manager overview
How Much Documentation? ISO/IEC 17025 Section 4.2.1 “…document to the extent necessary to ensure the quality of the test…results.”
What is NOT Required • The name “Quality Manual” • A specific documentation structure • A formal writing style • Documenting everything you do • Irrational changes
Good Reasons to Document • Standardising work • Induction and other training • Instructions • as needed • Defining what is done • responsibility to client
Good Reasons to Document • Meeting requirements of standards • Clarifying what is important • Public relations • where appropriate
Bad Reasons to Document • To satisfy auditors • For the sake of documenting
Results of Bad Documentation • Documentation not useful • Documentation not used • Documentation not updated • Unnecessary non-conformances
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
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)
Document Style? • What is functional? • Can use diagrams, flow charts etc. • Communicate - clarity, simplicity • Effective language • e.g. active rather than passive
Document Style? • Seek to look professional • not necessarily formal • Consistency in style • desirable, not required • Write for results • keep reader in mind
Outline • What is document control? • Document review • Steps in document control & review • Options for document control • Failures of document control • Control of records
Document Control Required: • By ISO 9000 • clause 4.5 • By ISO/IEC 17025 • clause 4.3
What Is Document Control? • System for ensuring: • Only current documents used • Easy review and updating
Why Document Control? • Current documents always available • Nothing but current documents used • What was done is always clear • interpretation of results • relationship with client
Document Control • Unique identification • Approved for use • by authorised personnel • Current versions available • Obsolete versions removed, identified • Master list available
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
Can Use • Headers • Footers • Cover page • Headers for hard copy • footers for electronic
Master Copy of Document • Hard copy - distinguishable • Electronic • Authorised • electronic or by signature
Distribution • Electronic and/or hard copy • Who needs the document? • no less, not much more • Maintain distribution list • quality document
Document Review • Regular review • by same function as approved • Identification of alterations • if possible
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
Controlled Document Master List • Lists • documents • current versions • dates authorised • Multiple lists?
Approaches to Document Control • Documents • hard copy and/or electronic • Control • manual versus electronic • minimise labour • maximise speed, accuracy
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
Failures of Document Control • Photocopies • Notices on walls • if uncontrolled • Handwritten amendments • if unauthorised
