Controlled Documents & Note Making

[Deli88]

Hi Everyone,

I have a quick question on controlled documents in the form of job specifications.

Every job we do have their own spec card with details on how to set up the machines and cut product to size, occasionally or on the first issue of a spec the operator will write notes on the spec, usually this has to do with the fine-tuning product to meet tolerances or increasing yield.

is this acceptable if the notes are incorporated into the spec when it is returned to the office on completion of the job or is this a major no-no?

Any suggestions on how I could do this while conforming to ISO standards would be appreciated

Thanks in advance

 

[Marcelo]

Hum, you know that a specification is a document that contains requirements, right? So a specification would not define how to do stuff, it would contain the expectations.

The document that contains the way to fulfill the requirements is a procedure, or work instruction, or the like.

 

[Deli88]

I didn't come up with the terminology, I just inherited it from my predecessor.

It is essentially a work instruction for individual jobs and does define the finished product dimensions (which are never changed unless through an agreement with the customer) but the means of achieving these specifications may need altering. This is usually required after the first run when the operator notes adjustments are needed to achieve the correct tolerances on the finished product.

 

[Marcelo]

I didn't come up with the terminology, I just inherited it from my predecessor.

No problem, I was just trying to make things clear so we people can better help.

Every job we do have their own spec card with details on how to set up the machines and cut product to size, occasionally or on the first issue of a spec the operator will write notes on the spec, usually this has to do with the fine-tuning product to meet tolerances or increasing yield.

is this acceptable if the notes are incorporated into the spec when it is returned to the office on completion of the job or is this a major no-no?

It is essentially a work instruction for individual jobs and does define the finished product dimensions (which are never changed unless through an agreement with the customer) but the means of achieving these specifications may need altering. This is usually required after the first run when the operator notes adjustments are needed to achieve the correct tolerances on the finished product.

So, whatever the document is (let's use your comment on work instruction) it would be ok to write it and then include it in a revised work instruction if:

- This possibility is included in the document control (procedure)
- The person can do this (responsibility and authority)
- The way it's done is according the document control (the usual way to accept written changes is to have the corrected text have a strikethrough without loosing the original text, and the new text is written near it, and the person signs and dates it - but there can be more ways to do that)

 

[Deli88]

Thanks Marcelo,

I was thinking something along these lines but its always nice to have a second opinion on something like this.