posted 10 October 1998 09:01 AM               

>From: wmalmborg
>
> ISO 9001 states "Quality planning is to be CONSISTENT with all other
> requirements of a supplier's quality system." Any comments on how to do
> this or what criteria is used to audit this area.
>
> Walter F. Malmborg, Jr.
> Software Quality Engineer
> Team Member, ISO Coordination Group
> Brown International Corporation
> 256-705-1234
> 256-705-1299 fax

--------------------

I have always interpreted this to be an indication that quality planning does not have to be a separate activity, but can be a part of other quality system activities, for example design and process control. How it is performed depends upon (is consistent with) the nature of your business. Here are two examples.

First, a company builds products to a customer's prints: many defense contractors fall into such a class. Each contract is a separate "program". [Marc note: I used to write QAPPs (QAPP = Quality Assurance Program Plan)] In this case, the company might well perform quality planning, and generate a unique quality plan, for each contract.

Second, a company offers its own lines of products for sale. Customers can order certain standard or custom modifications to the products in the line. This company may only engage in separate quality planning activities when a new line is developed. The review of any modifications or customization will take place during the proposal stage, and they will consider what, if any, changes are necessary to their exisiting quality system, capabilities, etc, during pre-contract review, early design planning or process control planning.

In both extremes, quality planning is done, but it might take on a different appearance. e.g., There is a process control quality planning checklist at our site. Going through such a checklist is a form of quality planning.

posted 10 October 1998 09:43 AM               

From: Len Litvan
Subject: Re: Q: 4.2.3 Consistency/Malmborg/Litvan

wmalmborg wrote:

> ISO 9001 states "Quality planning is to be CONSISTENT with all other
> requirements of a supplier's quality system." Any comments on how to do
> this or what criteria is used to audit this area.
- - - - - - - - - - - - - - - - - - - - - - - - -
Here are two views:

First, the focus of quality planning should reflect the focus in executive management's policy for quality (sometimes called a quality policy statement). And that focus should also extend throughout the quality manual, work instructions, training, auditing, etc. For example, if executive management's focus is on productivity improvement through quality activities, the quality system (and planning) would be different from a company emphasizing rapid product/service development and introduction.

Second, the assignment of responsibility, authority and interrelationships defined in quality planning activities should not conflict with those elsewhere in system documentation. An example--if a company developed a "responsibility matrix" to define who does the activities 4.2 a) through h) as appropriate but then in procedures elsewhere define someone else as responsible, there is a problem. If 4.2 says the softrware engineer updates quality control, inspection and testing techniques and 4.11 assigns that responsibility to the quality manager, there is inconsistency.

Just some examples.

Regards,