Unformatted text preview: Procedures c.f. Work Instructions
q Procedure - how a general function is performed
e.g. internal audits q Work Instruction - specific detail of how a single activity is performed
e.g. a laboratory method NRL Procedures
q Contain sections on:
1. Purpose of the procedure 2. Scope 3. Method 4. Records 5. Documents Work Instructions
More detailed explanations of how specific tasks mentioned in the Procedures are carried out. Work Instructions
q Summarise work activities simply as possible
bullet form flow charts q Numbered sections
for more complex activities useful for cross reference Numbering Documents - NRL
q Procedures, e.g. P-EV-0602
Evaluations - reserve 0601-0700 q Work Instructions, e.g. WI-EV-0602/3
Relates to P-EV-0602 q Forms, e.g. FM-EV-0609
Relates generally to Evaluations Internally Generated Supporting Documents
q q q Lists of suppliers Controlled document master lists Controlled record master lists External Documents
q Control after arrival e.g. Contracts Standards Regulations Document for the Needs of Organisation
q Some options:
Combine Quality Manual, Procedures Different Quality Manuals different sites Who Should Document ?
q Users where possible
expertise ownership Writing versus authorisation q Guidelines on style q Quality manager overview
q 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
q q q q q The name "Quality Manual" A specific documentation structure A formal writing style Documenting everything you do Irrational changes Good Reasons to Document
q q q Standardising work Induction and other training Instructions
as needed q Defining what is done
responsibility to client Good Reasons to Document
q q q Meeting requirements of standards Clarifying what is important Public relations
where appropriate Bad Reasons to Document q q To satisfy auditors For the sake of documenting Results of Bad Documentation
q q q q Documentation not useful Documentation not used Documentation not updated Unnecessary non-conformances Some General Points
q q q 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 q Some General Points
q Use existing documents and systems wherever possible and appropriate No need to use numbers in standard(s)
can cross-reference standards q q No need to use jargon of standard(s) Document Style?
q q q q What is functional? Can use diagrams, flow charts etc. Communicate - clarity, simplicity Effective language
e.g. active rather than passive Document Style?
q Seek to look professional
not necessarily formal q Consistency in style
desirable, not required q Write for results
keep reader in mind Document Control Outline
q q q q q q 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:
q By ISO 9000
clause 4.5 q By ISO/IEC 17025
clause 4.3 What Is Document Control?
q System for ensuring: Only current documents used Easy review and updating Why Document Control?
q q q Current documents always available Nothing but current documents used What was done is always clear
interpretation of results relationship with client Document Control
q q Unique identification Approved for use by authorised personnel q q q Current versions available Obsolete versions removed, identified Master list available Required in a Document
q q q q Identify document uniquely Identify revision number and/or date Number pages Show end of document e.g. "Page 4 of 7" q Show who authorised Can Use
Headers q Footers q Cover page q Headers for hard copy
q footers for electronic Master Copy of Document
q Hard copy - distinguishable Electronic Authorised
electronic or by signature q q Distribution
q q Electronic and/or hard copy Who needs the document?
no less, not much more q Maintain distribution list
quality document Document Review
q Regular review
by same function as approved q Identification of alterations
if possible Steps in Document Control
q q q q q q 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
documents current versions dates authorised q Multiple lists? Approaches to Document Control
hard copy and/or electronic q Control
manual versus electronic minimise labour maximise speed, accuracy Document Control
q q q q 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
q q Photocopies Notices on walls
if uncontrolled q Handwritten amendments
if unauthorised ...
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This note was uploaded on 02/23/2012 for the course PHARM 290 taught by Professor Staff during the Fall '10 term at Rutgers.
- Fall '10