10881 - Procedures c.f Work Instructions q Procedure how a...

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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 q Lists documents current versions dates authorised q Multiple lists? Approaches to Document Control q Documents 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.

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