Control of Documents and Records

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Control of Documents and Records

• 4.3 Document Control
• 4.13 Quality and Technical Records

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• ISO 15189 Requirements for Document Control (4.3)
• ISO 15189 Requirements for Quality and Technical
  Records (4.13)
• Templates for Meeting Requirements of 4.3 and 4.13

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Requirements for Document Control

• 1. - Requirement for procedure to control
• documents that define the Quality
• Management System.
• - Documents defining the Quality
• Management System can be internal/ external
  and are called controlled documents.
• - Internal (e.g. SOPs
• - External (standards, regulations)

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Requirements for Document Control

• 2. - The retention period for controlled
  documents must be approved by the Laboratory
  Director.
• - Controlled documents can be hardcopy/
• softcopy.
• 3. Must define the document types and make
• up the Quality Management System.
• e.g. A document may be in hardcopy or electronic
  format and may consist of any instruction or
  information including .

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Requirements for Document Control

• 4. Changes to controlled documents must be
• controlled-
• - Identify change
• - Review change
• - Authorise change
• 5. Procedure must define and control-
• - The review and authorisation of
• Quality Management System documents
• prior to issue to Laboratory personnel.

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Requirements for Document Control

• 5. - A master list of controlled documents
  which identifies-
• Document name
• Document number
• Version
• Effective date
• - A document review history and distribution
  listing for each identified controlled document.

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Requirements for Document Control

• 5. - Removal of obsolete versions of
• controlled documents from point of use.
• - The regular review of controlled
• documents and their revision if required.
• - The labelling of superceded master
• documents so as to identify them as separate
  from the current version.
• - The circumstances if any that allow hand
  amendments to be made including the review and
  authorisation processes.

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Requirements for Document Control

• 5. - Procedures must define and control-
• Changes to electronic documents e.g. report
  formats, parameterisation, calculations etc.
• 6. Controlled documents must be uniquely
  identified-
• - Title of document
• - Number of document including version
• - Page number
• - Name of reviewer/ authoriser
• - Source
• - Changes made from last version

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Requirements for Quality and Technical Records

• Quality and technical records
• - A quality record provides objective
  evidence

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Requirements for Quality and Technical Records

• Require procedure to control Quality Records
• Identification of quality records
• Collection of quality records
• Access to quality records (security)
• Storage of quality records (environment)
• Maintenance of quality records (pest control and
  archiving)
• Safe disposal (authorisation/ shredding)
• A defined retention time for each record type

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Requirements for Quality and Technical Records -
Identification
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Requirements for Quality and Technical Records

• Collection of Quality Records
• Must be legible
• Must be completed by trained/ authorised
  personnel
• Must be readily retrievable
• Must be collected in a certain manner
• Records may be stored on any appropriate medium
  i.e. electronic, hardcopy, CD, microfilm

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Requirements for Quality and Technical Records

• Storage of quality records - current records
  - old records
• Onsite/ off site (usually warehouse)
• Facility used must-
• - be suitable and prevent damage,
  deterioration, loss or unauthorised access
• Facilities should be alarmed with sensors (fire/
  smoke detection)
• Facilities for key documents should have fire
  proof vaults e.g. for validation documents

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Requirements for Quality and Technical Records

• Water fire retarded systems are destructive, gas
  retardant systems are acceptable.
• Retention times
• - Must have documented retention times for each
  record type (days permanently)

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Templates for Meeting Requirements of 4.3 and 4.13

• What procedures/ manuals do we need to
• meet requirements of 4.3 Document Control
• and 4.13 Quality and Technical Records?
• - Quality Manual
• - Procedures
• The number of procedures is totally up to you
• 1 or more.

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Templates for Meeting Requirements of 4.3 and 4.13

• Templates are provided-
• Template 1 Document Numbering System (4.3)
• Template 2 Preparation, Style and Format of
• Standard Operating Procedures (4.3)
• Template 3 Operation of a Controlled
• Document System (4.3)
• Template 4 Completion and Retention of
• Quality Records (4.13)
• Template 5 Procedure for the Control of
• Quality and Technical Records (4.13)

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Templates for Meeting Requirements of 4.3 and 4.13

• Document Numbering System (Template 1)
• Unique Numbering System (made up of
• composite parts) location/ area of application/
• document type/ number and version.
• Attach forms to a procedure (link)
• Facility for expansion
• Allocation of document numbers, who?
• Large documents (break up in sections)
• A master list of documents.

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Templates for Meeting Requirements of 4.3 and 4.13

• Preparation, Style and Format of Standard
• Operating Procedures (Template 2)
• Fresh fish for sale (short sentences)
• Black and white instructions
• Method Q-Pulse/ Microsoft Word
• Secure access/ password control
• Who writes the SOPs? (training)
• Consistent headings

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Templates for Meeting Requirements of 4.3 and 4.13

• Preparation, Style and Format of Standard
• Operating Procedures (Template 2)
• Who, where, how, what, when, why?
• Test method procedures and the role and control
  of product inserts
• Critical steps/ checks/ corrective actions
• Link change control to the procedure

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Requirements of Document Control

• Operation of a Controlled Document
• System (Template 3)
• Why? Prevent inadvertent use of obsolete
• Documents
• Official, master, information, uncontrolled
• documents
• Define process for issue, review, revision,
• distribution and disposal of controlled
• documents.
• Write, review, authorise (who?)
• Record on the first page

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Requirements of Document Control

• Operation of a Controlled Document
• System (Template 3)
• Role of Document Controller
• Type and make corrections
• Information copies for training in advance
• Maintain document review history
• Distribute copies and record
• Withdraw obsolete version and destroy
• Control current master and obsolete master
  documents

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Requirements of Document Control

• Operation of a Controlled Document
• System (Template 3)
• Role of Document Controller
• Master list of documents
• Document Index
• Ensure current version of forms are in place
• Do not copy copies
• Assign document number
• Control documents of external origin
• Documentation control stamps

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Requirements of Document Control

• Operation of a Controlled Document
• System (Template 3)
• Training record for procedures
• Uncontrolled documents in the laboratory (common
  failings)
• Laminating key sections of procedures
• All documents do not have to be under document
  control
• Use of books of forms (pre-printed)

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Requirements of Document Control

• Completion of Controlled Documents
• (Template 4)
• Traceability to the person who completed the
• record
• Authorised signature and initials of personnel
• Indelible ink
• Concurrent completion of records with task

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Requirements of Document Control

• Completion of Controlled Documents
• (Template 4)
• Rubber stamps/ ditto marks
• Avoid transcription
• Correction fluid
• Correcting errors.

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Requirements of Document Control

• Procedure for Control of Quality/ Technical
• Records (Template 5)
• Master list of record types with retention
  periods
• Consult with Hospital policy on retention of
  records
• Meet INAB standards
• Meet legal requirements (EU Directive)
• Control of disposal
• Approval by the Laboratory Director