Questions for Auditing Utilizing a Process Approach
Whether facing a surveillance audit from a certification body or preparing for an internal audit – knowing what you face and being prepared puts you a step ahead. Review this checklist which covers the majority of the QMS requirements.
1) Who or what are the:
- Process Owner
- Personnel Interviewed
- Documentation Reviewed
- Records Sighted
2) What are the resources needed for the process?
3) Are these resources appropriate?
4) Are authorities and responsibilities for required resources defined, documented and known
throughout the organization?
5) Are these persons competent?
6) Are competency criteria defined? What are these criteria? How is competency evaluated,
approved and monitored, and by which method(s)?
8) Are these methods effective? – refer to outputs
9) Are the resources adequate? Which are they?
10) Are records available and appropriately maintained?
11) What are the inputs to this process?
12) Are these inputs documented and reviewed by competent persons?
13) Is a description of the processes available and documented?
14) Are these descriptions controlled? – Verify the effectiveness of the organization’s
documented information control procedure.
15) Who are the “customers” (internal and external) of the processes?
What are the requirements of these customers?
17) What are the characteristics of the intended results of the process?
18) What are the characteristics of the unintended results of the process?
19) Are correction and corrective action applied as appropriate?
20) What are the criteria for monitoring, measurement and analysis?
21) How are these criteria incorporated into the planning of the processes?
22) Are the business performance issues taken into proper account?
23) What methods are used for data gathering?
24) What records are kept and how these are maintained?
25) What are the communication channels?
26) How is external and internal information about the process provided?
What are the outputs of the process? – Identify outputs.
28) Do these outputs provide evidence of effective implementation of the process?
29) How is process performance monitored?
30) Are appropriate controls defined?
31) What measurements are applied?
32) How is the gathered information analyzed?
33) How are the results of the analysis taken into account?
34) How is feedback obtained?
35) What data is collected?
36) Is the issue of improvement of the processes properly addressed? How?
What are the results?
Source: Eagle Certification Group – 2017 Annual Bootcamp/Conference
SimpleQuE offers free sample manufacturing process audit checklists for AS9100, ISO 9001 and IATF 16949 which can be used as an example to examine a company’s key manufacturing process and prepare your company for the highest quality internal auditing possible.
Links to Sample Manufacturing Process Audit Checklists:
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