Concerning procedures within Quality Manual

[itsbiodiversity]

I would love some of your thoughts. In my previous life I had a million procedures outside of the Quality Manual based on 17025 "shall have a procedure etc."; however, I realized that many of those external procedures would fit nicely within the QM itself.

With that said - is there any point in actually assigning a procedure (Such as Quality Procedure 01) to a procedure within the document?

My preference would be to maintain 17025 numbering and just say something along the lines of "the following is the procedure for (example) Internal Audits" and then go in to detail.

My reasoning is the internal audit procedure, for example, will probably not change as it is an annual deal that either results in action or does not.

Looking forward to your thoughts on this technicality.

 

[Jen Kirley]

I'm not sure I understand you correctly, but I see no problem with a procedure's sending users to another procedure that was made for a different standard. It is much better to simplify, as there is risk in making the same controls in more than one place.

 

[Marc]

<snip> My preference would be to maintain 17025 numbering and just say something along the lines of "the following is the procedure for (example) Internal Audits" and then go in to detail. <snip>

I would avoid any document numbering/ID using a standard, as it may change in the future. Devise a numbering/ID system that is right for your company.

 

[somashekar]

I would love some of your thoughts. In my previous life I had a million procedures outside of the Quality Manual based on 17025 "shall have a procedure etc."; however, I realized that many of those external procedures would fit nicely within the QM itself.

With that said - is there any point in actually assigning a procedure (Such as Quality Procedure 01) to a procedure within the document?

My preference would be to maintain 17025 numbering and just say something along the lines of "the following is the procedure for (example) Internal Audits" and then go in to detail.

My reasoning is the internal audit procedure, for example, will probably not change as it is an annual deal that either results in action or does not.

Looking forward to your thoughts on this technicality.

Please use the standard and do not lean on to the standard by quoting it across procedures. Your procedures must be useful to you. Devise your own simple numbering system which can be extended in future when a need arises.
The purpose of the manual and the procedures are different and hence its good to keep them different. Just make them for the sake of your organization and your people who use them.

 

[dwperron]

I have to agree with Somashekar.

When I have seen a quality manual written to mimic a quality standard (9001 or 17025) I get the impression that the organization is just trying to meet audit requirements - and it is easier to perform an audit with that format.

In reality, I have never seen an organization that runs its business that way. You should create a quality manual based on your operations, not on the numbering system of a standard. This document can be a useful tool.

 

[locutus]

+1 to somashekar and dwperron. Now and in the near future, your QMS needs to reflect how you do business, not a regurgitation of the standard - already see Registrars challenging companies that take that approach.

 

[itsbiodiversity]

I appreciate the replies.

I want to be clear - the procedures within the Quality Manual would be specific to our business practices, not a regurgitation of the standard. The procedures would be in the appropriate location within the standard.

For example, the procedure for assuring the quality of calibration results would be located in section 5.9 of 17025 quality manual. While some verbiage would be directly from 17025 - our procedure would be right beneath the "regurgitation" and directly reflect our practices.

Of course, as some of you mentioned, I am trying to make an audit go as smoothly as possible from a "paperwork" or review perspective. I am NOT trying to regurgitate the standard and call it our procedure.

I am very much appreciative of the replies.

With this being stated - would you still maintain the procedures outside of the QM? And if they are maintained within the QM it seems the consensus here is to assign a numbering value to the procedure (For example 5.9 assuring quality of calibration results (QUALITY PROCEDURE XX)?
Once again - I look forward to your replies.

 

[howste]

As with anything document related, you should first consider the users. What format will give them the information they need as quickly as possible so they can get back to doing their work. If it's easier for them to find everything in one massive document then do it. If it's easier for them to find it in shorter, more focused documents, then do it. I would say that if you do decide to go for everything in the manual then make sure you have an easy-to-read table of contents or index to link them to the content they're looking for.

 

[itsbiodiversity]

As with anything document related, you should first consider the users. What format will give them the information they need as quickly as possible so they can get back to doing their work. If it's easier for them to find everything in one massive document then do it. If it's easier for them to find it in shorter, more focused documents, then do it. I would say that if you do decide to go for everything in the manual then make sure you have an easy-to-read table of contents or index to link them to the content they're looking for.

With CONTROL+F functionality it has become very simple to search through a long document.

I also have been in touch with registrars concerning this issue and from what I gather it is completely up to the laboratory how to organize and if it makes sense to combine to one document with very few outside quality procedures that is just fine.

Thank you for chiming in.

 

[Hershal]

The true key is the need. Most quality procedures can in fact be contained in the QM. However, technical procedures such as equipment operation and so forth should be independent. Where there is an accepted Standard (e.g., ATSM), refer to it, and include detail only as needed to complete the requirements.