CONTROL OF QUALITY RECORDS: a major task for quality system development.. Ask the following questions, preferably at contract stage:
Which documents are critical for the quality system and must be controlled? (contract to delivery stage)
Who will control the MASTER DOCUMENT LIST (one authorised person)?
How will authorised persons access the List?
Who will have “read only” access?
Who will have authorised access for review, revision? (usually the Quality Management Representative (QMR)
Have the documents been subjected to the severest scrutiny before issue? e.g.,
- verification of content
- identity of reader (who needs to know)?
- logical sequence of processes with the reader in mind (policies, procedures, working instructions, forms)
- grammar, spelling, vocabulary
Where do the documents begin to appear in the design and production process?
Are user documents included (customer, regulatory bodies, other interested parties)?
What is the distribution? (Please, no uncontrolled copies!)?
What are the intra- and interdepartmental connections for each document, with authority for receipt and distribution?
Are other interested parties involved?
Where will hard copy documents be kept (secure from damage or other deterioration)
Who will be in charge of the documents at point of use?
Has documentation development been included in the quality plan?
See also Documentation Requirements section in the Quality System Internal Audit Checklist available FREE from this web site.