Auditing 5.4.2 Quality System Planning



A dumb question if you will.....I'm working on my Audit Checklist for my "first" internal audit on our system since the changes. One particular item in this audit covers 5.4.2. My question.....if you were auditing this what would be some of the things you'd look for? Just curious.

Elsmar Forum Sponsor

Russ Kochis

I feel that the evidence of quality planning is obtained from the audit results of all other elements. 5.4.2 references 4.1 which is essentially a brief summary of the overall ISO 9001 requirements. It also refers to maintaining integrity during change and meeting quality objectives.

The evidence of effective planning is the demonstration of a system that operates effectively in your organizations environment. You indicated that your organization recently underwent change, is there evidence that the change was controlled? Where customer requirements consistently met during the change? Was senior management briefed on the progress and impact of the change? Where system or process failures noted during the change?

Management review is an important record of quality planning. Are the quality objectives reviewed/revised as needed? Are the needs for and results of system change reviewed? Is the overall effectiveness of QMS monitored, measured and reviewed?

What type of planning occurs for corrective and preventive actions and how are they documented? How does your organization plan for new equipment, processes, products, etc?

Are internal audit results reviewed to determine if project or program planning were casual contributors to nonconformances?

This is the method that is used at my organization and it has worked well. I hope this this has helped you a little.

Russ Kochis

M Greenaway

Try looking at how new processes or new products are introduced. This can be difficult for some companies that have a well established process and undertake no product design.

barb butrym

Quite Involved in Discussions
points to look at:

look at how "critical to quality points" are identified and handled

look at how customer requirements from contract review are communicated to the factory and included in the plan (router/ traveler?)

how do you plan for/provide resources to support new processes/materials. how do you identify training needs?

how is a design released to the factory?
I would look into issues such as Customer complaints, late deliveries, product non-conformities, Cost of Quality, Project delays, essentially, all issues which would indicate lack of effective planning.
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