ISO CL 5.4.2 Quality Management System Planning

[JIT]

Could someone help me in preparing this planning document? During the certification audit, what evidence auditor will look for with respect to this clause?

How Quality System planning differs from Planning of Product realization-Cl. 7.1? I have already prepared the product realization planning document in the form of flow chart. But I am confused with Quality system planning document.

I would appreciate, if someone e-mail me a sample Quality plan document.

Thanks in advance,

Jit Gupta

 

[db]

Quality Planning vs. quality planning

When discussing quality planning there are two views that must be considered. Product Realization planning deals with the product and product specifications/customer requirements. You must also consider the bigger picture things. Going back to 4.1 and the list of things there can help. Also, global quality objectives, such as 100% on-time delivery, zero defects and 100% customer delight should also be considered in quality planning.

In other words, think globally; those items that affect the QMS, or customer relations that are not tied to a specific product. Also think specifically; those items that are product-related.

IMNSHO

Hope that helps

 

[JIT]

Thanks Dave for your quick reply. My basic question is that whether Quality system planning will be a single document that auditor wants to see during audit. I have prepared the product relaization planning document in the form of flow chart. What should I do for Quality System planning? You have mentioned about clause 4.1 which has global requirments. I have addressed all requirements, a) to f) in the Quality Manual. Is it sufficient to satisfy the clause 5.4.2? Or, I have to prepare a separate document for it?

Thanks,

Jit

 

[HFowler]

JIT,

I took this from BVQI's ISO 9001:2000 Interpretations.

Regarding sub-clause 5.4.2 Quality Planning

Auditors have to use their judgement in evaluating the entire collected audit evidence in order to assess effectiveness of planning activities. Evidence of effective planning may include, any plans, documented or not, management review minutes, memos, internal communication. The auditor may also satisfy
him/herself that planning was done, by interviewing the personnel involved in establishing or achieving specific quality objectives.

Planning includes:

All those planning activities undertaken to establish the QMS in accordance with clause 4.1

The existence of effective, documented and implemented QMS provides collective evidence demonstrating that these planning activities have been performed effectively.

Deficiencies in the quality system may indicate that these planning activities were not quite effective.

Auditors are recommended to attribute such QMS deficiencies to relevant clause, requirements of which were contravened, rather than to clause 5.4.2.

Another aspect of quality management planning is that planning undertaken in order to achieve any quality objectives established by an organization from time to time.

The evidence of effective planning may include:
- any programs or plans, documented or not
- minutes of meetings
- memos
- internal communication

Where there is lack of documented evidence an auditor may satisfy him/herself that the planning was done by interviewing the personnel at those levels and functions involved in achieving particular objectives.

Another methodology allowing assessment of effective planning involves review of the progress in implementation of such plans aimed at adhering to individual objectives.

Best Regards,
Hank Fowler

 

[JIT]

HFowler,

I think I am you are in same wavelength in this regard. It is a global requirement and has to satisfy globally. Someone informs me that I have to prepare some kind of planning chart such as APQP etc. We are not a QS 9000 certified company.

Thanks,

Jit

 

[HFowler]

JIT,

An APQP Chart is not required. This requirement was a direct carry-over from ISO 9001:1994. If you read 4.2.3 in the old standard it has a lot more detail that might make it clearer.

Good Luck,
Hank Fowler