Document Control Audit points

January 19, 2014 · by · in audit checklist points for document controls, document control audit checklist points, Document Control Audit points

Document Control Audit points

Document Control Audit points

  • Are there quality policy & quality (company level, department objective) documented?

  • Quality manuals are available?

  • Operational procedures are documented?

  • Whether electronic documents, soft copies of documents are properly stored? Frequently backup are maintained?

  • Is the Quality manual & Quality procedures are addressing all relevant requirements and clauses as per quality standards?

  • Are the product / process / concern drawings, defined / required specification, work instructions, manuals, work / job orders, control plans, form / formats are controlled?

  • How to interactions & sequence between the processes of quality system is documented?  Is there process map, flow charts (Diagram) are designed, documented & controlled?

  • All the documents should be approved as directed by manuals, is there evidence? All the processes are reviewed & updated? After update re-approved?

  • All the documents having a revision levels?

  • What measures are implemented to ensure that relevant and current documents are available at points of use?

  • All document having unique identification numbers?

  • List of external origin are records? Records are evident?

  • When obsolete documents are retained, is it for a specific, stated reason? Are obsolete documents clearly marked to distinguish them from current revisions?

  • What other measures are implemented to prevent unintended use of obsolete documents?

  • Are the records sufficient to demonstrate product and process conformity, and the conformity and effectiveness of the quality management system and its implementation?

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