Internal Quality Audit Checklist

How to use this checklist: adapt every line to your own procedures before first use, and add process-specific questions from recent nonconformances, complaints, and the previous audit. For each item, record objective evidence (document numbers, record dates, what was observed), not just a check mark. Verdict codes: C = conforming, NC = nonconformity (classify major/minor), OFI = opportunity for improvement.

Audit header

Audit date / number
Process / area audited
Auditor(s)
Auditee(s) / process owner
Reference documents (procedures, standard clauses)
Previous audit findings reviewed? (Y/N)

1. Process definition and documents

Question	Evidence examined	C / NC / OFI	Notes
Is there a current, approved procedure or work instruction for this process, available at the point of use?
Does the documented version match what operators actually do? (Watch the work.)
Are obsolete documents removed from the floor?
Are process changes controlled and communicated (change record, training on revisions)?

2. Competence and training

Question	Evidence examined	C / NC / OFI	Notes
Are training/competence records current for the people performing this process today?
Can operators explain what they do when something goes wrong (nonconforming product, equipment fault)?
Are new or temporary workers covered by the same competence requirements?

3. Equipment, measurement, and calibration

Question	Evidence examined	C / NC / OFI	Notes
Are measurement devices used in this process identified and within calibration?
What happens when a device is found out of calibration? Is impact on past product assessed?
Is equipment maintained per schedule, with records?

4. Process control and records

Question	Evidence examined	C / NC / OFI	Notes
Trace one recent order/batch end to end: are all required checks recorded, signed, and complete?
Are in-process checks performed at the defined frequency (sample actual records against the requirement)?
Are records legible, retrievable, and retained per the retention requirement?
Where identification/traceability is required, can this product be traced to material lots and process records?

5. Nonconforming product

Question	Evidence examined	C / NC / OFI	Notes
Is nonconforming product identified and segregated so it cannot be used unintentionally?
Are dispositions (use-as-is, rework, scrap, return) made by authorized people and recorded?
Sample recent NCRs: were corrections completed and, where warranted, root cause pursued?

6. Corrective action and improvement

Question	Evidence examined	C / NC / OFI	Notes
Sample open CAPAs touching this process: on time, root cause credible, actions implemented?
Sample closed CAPAs: was effectiveness verified with evidence before closure?
Were findings from the previous audit of this area closed, and did the fixes hold?

7. Closing summary

Total findings: major / minor / OFI
Findings requiring CAPA
Agreed owners and due dates
Follow-up verification date
Auditor signature / date
Process owner signature / date