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:

  • Processes
  • 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:

IATF 16949 Checklist

AS9100 Checklist

ISO 9001 Checklist

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Interaction of Process Maps – The Process Approach

Woman drawing flowchart, business process concept

By Jim Lee, President simpleQuE

Companies typically have some type of flow diagram showing their interaction of processes. This is the most common method to demonstrate compliance with the process requirements in ISO 9001:2015 clause 4.4 or ISO 9001:2008 clause 4.1.  The new standard emphasizes the need to determine inputs and outputs, along with the sequence and interaction of these processes.

For larger companies with multiple sites and headquarters, or parent companies whether domestic or international, a new complexity arises.  Registrars are targeting more detail on the linkages, interactions and inputs from sister sites and parent companies, even though those locations may be out of the certification scope.  For automotive (TS and IATF 16949) it is not permitted to exclude any related support function no matter where it is performed, remote or on-site.  The process map must clearly indicate these interactions.

For ISO 9001 and AS standards we are observing more emphasis by certification body auditors to scrutinize the interaction of process maps to ensure there is adequate clarity of the linkages and interactions, including headquarters that might be out of the certification scope. We are sharing this information as we see more creeping of scope from other standards, and the interpretations of related risks associated with process interactions between sister sites and headquarters.  It makes sense since they can be a source of past and current problems due to a quality system breakdown between these sites.

Clients are addressing this by showing the related bodies on their interaction of process maps, and using color coding or symbols with legends to show what is out of the certification scope and what is in. This is part of a company’s context.  Consider a situation where ABC Company has a Japanese parent company that is outside its certification scope, but interaction with the parent company can have a significant impact on its core processes in ABC’s interaction of process map.  Some companies treat these interactions through the purchasing process, and that is explained as part of their company’s context.

While process mapping is often the first step to process improvement, make sure you are also looking at the bigger picture to understand what influences process performance.  For more information about implementing or improving your quality management system, contact simpleQuE.