Purchasing Procedure - QSR §820.50 and ISO 9001:1994 Clause 4.6

Hi Marc and Don

I hope you guys remember me. I have been working on patent issues the last 6 months. At last I am back into the Quality world. I have written a purchasing procedure that includes the requirements of QSR (§820.50) and also ISO 9001 (4.6). I have stated in the scope of the procedure the following:

This procedure applies to purchase orders for products, equipment, and services that are part of or incorporated into the final products manufactured by our Company.

The problem is some employees want to include products such as glassware, chemicals, consumables, pens, computers etc that are not incorporated into our final product. I have told them that this is not a requirement according to ISO/QSR, but if they want to integrate such products into the procedure and it is accepted by the management, then it is fine for me. I have told them that I do not want to hear afterwards that the ISO/QSR is a bureaucratic machinery.

Would be happy to get some feedback on this issue

Best Regards

Monica

[Don Winton]

Welcome back.

You are correct in your assertion that including all suppliers would probably be a paperwork nightmare. If you must keep everyone happy, stagger the purchasing requirements based on critical requirements and taylor the requirements accordingly.

For example, items used in final product would be subject to one set of controls (most stringent). Items used in association with but not in final product would be subject to another (less stringent) and finally; items that have nothing to do with final product (least stringent). In my system, I call them stages (Stage I, Stage II, Stage III, etc.).

Of course, this may probably be overkill, but it may keep everyone happy (assuming you cannot persuade them otherwise).

Hi Don,

It is nice to see that you are still active in the forum. I love your system regarding the different stages. However I will try to persuade the employees (after a four week discussion) to exclude the items that have nothing to do with our final product (stage III according to me). I will also ask the management if we really should include such items into the procedure. I know that some companies integrate their own requirements that are not required by the Quality System(s) into their business. They have given this kind of system a special name (I'm not referring to TQM and to be honest it is impossible to translate this word into English) and the employees are aware that they are not only working with the Quality System requirements, but also with the company's requirements. A problem will still remain if we include the items in stage III and that will be the Managers who do not want to approve and review the purchase requisition prior to purchase release. I have a big feeling that this will create a nonconformity against the ISO requirement (4.6.3 the last paragraph) and also the QSR (§ 820.50 which refers to §820.40). Why? Because we will not follow our own procedure. Is it OK to state in the procedure that such items do not require to be approved and reviewed prior to purchase release. If it is OK, then we will bump into a new problem and this will be that anybody can buy very expensive items (stage III) without any approval (I assume that the management will not allow this to happen). In order to solve this problem we could state in the procedure that items less or equal to x dollars do not need to be approved and reviewed prior to purchase release. What do you think about these solutions to the potential problems?

[Don Winton]

<FONT COLOR="#663300"><BLOCKQUOTE>However I will try to persuade the employees (after a four week discussion) to exclude the items that have nothing to do with our final product (stage III according to me). </BLOCKQUOTE></FONT>

Probably a good idea. Simpler is better in most cases.

<FONT COLOR="#663300"><BLOCKQUOTE>I have a big feeling that this will create a nonconformity against the ISO requirement (4.6.3 the last paragraph) and also the QSR (§ 820.50 which refers to §820.40).</BLOCKQUOTE></FONT>

Agreed, that would probably cause a problem. How it would be addressed in the procedures would be most critical. As you stated, leaving them out would probably be better.

<FONT COLOR="#663300"><BLOCKQUOTE>In order to solve this problem we could state in the procedure that items less or equal to x dollars do not need to be approved and reviewed prior to purchase release. What do you think about these solutions to the potential problems?</BLOCKQUOTE></FONT>

As I ststed above, that would work, but it would need to be very specific in nature. Sounds as if you are on the right track. Carry on.