Do I need to break out 4.2.3 and 4.2.4 Documents and records into two documented procedures or can I have one? Please offer your opinion on either side.

Thanks Kevin

Do I need to break out 4.2.3 and 4.2.4 Documents and records into two documented procedures or can I have one? Please offer your opinion on either side.

Thanks Kevin

There is no requirement for separate documents. So long as control of documents and control of records are both addressed, you can do it in a single document if you want to.

I can't comment about ISO/TS 16949 but certainly it is OK in ISO 9001. However, I find there is a lot of confusion over what is a document and what is a record so I tend to keep them separate to help differentiate between them.

I see no advantage to combining them, but do see disadvantages:

- as Colpart said, it may just confuse people as to the difference between a document and a record

- it will just make the procedure longer, and if you want people to read it, that's not good

- documents tend to be controlled by a relatively small number of people/departments, while records are usually managed by almost all departments

Do I need to break out 4.2.3 and 4.2.4 Documents and records into two documented procedures or can I have one? Please offer your opinion on either side.

Thanks Kevin

Kevin,

My opinion is I have no opinion :D !

I say that because since there is no requirement for seperate procedures - do what works for you. Size and complexity of your system will really dictate what you will need.

JMHO

Kevin,

I say that because since there is no requirement for seperate procedures - do what works for you.

Absolutely true, BUT ....

I see no advantage to combining them, but do see disadvantages:

- as Colpart said, it may just confuse people as to the difference between a document and a record

this is not good. If people find it difficult to differentaite between a document and a record, there is something drastically wrong with training. :cool:

Do I need to break out 4.2.3 and 4.2.4 Documents and records into two documented procedures or can I have one? Please offer your opinion on either side.As far as the std is concerned you can deal with this as you please, but you also asked for our opinions: Mine is to keep them separate. It is often easier to keep small and to the point written procedures updated.

/Claes

As far as the std is concerned you can deal with this as you please, but you also asked for our opinions: Mine is to keep them separate. It is often easier to keep small and to the point written procedures updated.

/Claes

Claes,

I agree. I have always had them as seperate procedures, but I can envision situations where it might work to have them as one. So much is dependent on the enviroment. A very small company with 10 employees could very easily have them contained in one procedure, in fact, I would find that to be ideal. But a company my size (150 ppl), 2 procedures are definitely needed.

Do I need to break out 4.2.3 and 4.2.4 Documents and records into two documented procedures or can I have one? Please offer your opinion on either side.

Thanks Kevin


Answer to question....You can have one procedure if you determine it will effectively meet your needs. It's all about effectiveness and not numbers.

My opinion? Personally, I don't care either way. As an auditor, I don't care either way as long as everything is effectively controlled.

Keep it as simple as possible. Simple to understand, simple to use.