To write or not to write. That is the question. How many procedures should I write?

[unitedc]

During our last audit it our auditor suggested/requested that we write more Procedures. Our procedures as of now are for the most part department only. My company does contract manufacturing in mostly PC Boards. He suggested we write procedures on things such as out SMT (surface mount) line. I recently wrote a Procedure on shipping.

To my question: Where do you say 'thats enough Procedures'? Should a company have a procedure for everything that has a start and end? I realize we don't need procedures for restroom visits. I think you will get my point so I'll stop there. Thanks all!

[MDQSA]

Our auditor told us that if it's important enough to write down, then it's important enough to put into an actual procedure. He was specifically commenting on guidance documents that we have.
Another point is that if it's for something that needs to be replicated the same way every time, then documenting it is a best practice

[Jim Wynne]

Originally Posted by unitedc

During our last audit it our auditor suggested/requested that we write more Procedures. Our procedures as of now are for the most part department only. My company does contract manufacturing in mostly PC Boards. He suggested we write procedures on things such as out SMT(surface mount) line. I recently wrote a Procedure on shipping.
To my question: Where do you say 'thats enough Procedures'? Should a company have a procedure for everything that has a start and end? I realize we don't need procedures for restroom visits. I think you will get my point so I'll stop there. Thanks all!

Other than the mandatory "big six" documented procedures, you should have as many as you feel you need, and no more than that. Remember that one of the prime purposes of process documentation is establishment of standard methods. In such cases your people may never have a need to read the documents--assuming they've been adequately trained--but when processes are designed, the design and methods should be documented, which obviates relying on tribal knowledge in the future.

[AndyN]

Originally Posted by unitedc

During our last audit it our auditor suggested/requested that we write more Procedures. Our procedures as of now are for the most part department only. My company does contract manufacturing in mostly PC Boards. He suggested we write procedures on things such as out SMT(surface mount) line. I recently wrote a Procedure on shipping.
To my question: Where do you say 'thats enough Procedures'? Should a company have a procedure for everything that has a start and end? I realize we don't need procedures for restroom visits. I think you will get my point so I'll stop there. Thanks all!

Can you give us any more information as to why the auditor was making such a suggestion?

Did they see, for example, a lack of process control or poor product/process performance which might be improved by writing a procedure? Did the auditor detect a lack of consistency in the description (by management and responsible personnel) of the process and its controls, which might also indicate a procedure would be helpful?

If none of these, then your auditor is waaaaaay off in making such comments. Their comfort around more procedures is counter to the revised ISO 9001 requirements (circa 2000) which reduced the reliance on mandatory documented procedures. The auditor has one foot in the past.

I'd suggest that you respectfully ask your CB for an alternate who is a little more 21st century in their understanding of contemporary quality systems and requirements (possibly auditing techniques too)

[somerqc]

Andy,

The auditor may not be in the past. It could simply be that it is a process that the company should have documented is not (i.e. is critical, lack of one has resulted in some near-miss customer issues, etc.).

By all means, I preach the "only document what is necessary to document". I also try to create "multi-purpose" forms as much as possible (thereby less forms, less document control, easier for people to complete).

Just an alternate look at the issue.

Another rule I have recently added - If you are going to write a procedure, make sure that tells someone how to do something! Don't just write a procedure for the sake of having words on a page!!

[db]

This is where 4.2.1 d) comes into play. A procedure is the specified way to carry out a process. My take is that if the absence of a procedure would lead to a deviation, then you need a procedure. If the process is so complex (or the competence of personel is marginal), that the steps used to enact the process needs to be formalized, then formalize them. If folks can follow the process without something in writing, and there is no consequence for deviation, then avoid a documented procedure.

[AndyN]

Hello! Didn't I say that?

Did they see, for example, a lack of process control or poor product/process performance which might be improved by writing a procedure? Did the auditor detect a lack of consistency in the description (by management and responsible personnel) of the process and its controls, which might also indicate a procedure would be helpful?

I thought that encompassed the examples you've given, folks.......

[somerqc]

Mea Culpa....was "keyword" reading.