One of my first jobs on a contract is to review documents currently in use in the quality system. Documentation is often the weakest link in the quality system chain and can be a major nonconformance in the certification audit.
In my experience the assessors could regard the following as non-conformances:
- no central record (Master Document List, Document Index, company intranet access)
- no issue or revision status
- poorly located (e.g., not available at point of use)
The assessors will use the documents as part of their certification audit. For Qualidoc clients they have the Quality Policy Manual (Management Responsibility and Authority), Quality Assurance Procedures manual (how the policies are implemented) and the Quality System Internal Audit Checklist. The assessors have often asked me to provide the client’s Quality Policy Manual (which I help to prepare) before their site visit.
During the audit, they might overlook one or two instances where documents are not signed or procedures not followed, but if they find more than one or two they might regard this as a trend. In these technology times they will be looking for computer systems that give them the evidence they require.
Non-conforming trends mean that the assessors will stay on your premises much longer while they dig around for more evidence. If they find trends which have a critical effect on the quality system they will issue a major non-conformance which has to be corrected before you can be recommended for certification. Who wants to drag through all that again? Better to get it right the first time.
A good QAM will ensure that working instructions and procedures are available at point of use, are legible, in current revision status and accurately reflect what is needed to do the job. Having them in the right place at the right time will not do any good if they can’t be read because they’ve been eaten by rats or covered in flood water or dust. (And yes I have seen this in my consulting career).
Paper records are still an important part of many business environments and should not be neglected in the haste to automate document and process flow. .An automated system is not the starting point; you need a stable quality system to make intelligent assessments of the need for automation.