Process Documentation is extremely generic

[Donna H]

I audited an area which i feel the documentation are extremely generic, barely define “what” is to be done, and do not address “how”. I ask the group audited Consideration should be given to reviewing the contents of these procedures to ensure that they either reflect how the activities are to be performed, or at least properly reference any on-line databases or tools to be used to complete the related processes.
The response proved back to me was " TS16949 spec where it defines what we have to do"
Since TS is very vague on what is required in documentating the process how so I respond to this

[Stijloor]

Originally Posted by Donna H

I audited an area which i feel the documentation are extremely generic, barely define “what” is to be done, and do not address “how”. I ask the group audited Consideration should be given to reviewing the contents of these procedures to ensure that they either reflect how the activities are to be performed, or at least properly reference any on-line databases or tools to be used to complete the related processes.
The response proved back to me was " TS16949 spec where it defines what we have to do"
Since TS is very vague on what is required in documentating the process how so I respond to this

Is there objective evidence that the "limited" documentation had an effect on process and quality performance? Have you verified that the employees understood the details of their job in a consistent manner? You have to be able to provide evidence that the documentation is not effective. If so, you write a nonconformity report.

Stijloor.

[Jason PCSwitches]

Originally Posted by Stijloor

Is there objective evidence that the "limited" documentation had an effect on process and quality performance? Have you verified that the employees understood the details of their job in a consistent manner? You have to be able to provide evidence that the documentation is not effective. If so, you write a nonconformity report.

Stijloor.

Stijloor is correct. I ran across the same situation when I came aboard my current company, really generic procedures. What you need to do is, as Stijloor suggested, verify if it has any impact on the processes. If you can demonstrate it does, or if there is a variation from the procedure to how they actually do the job, you have a case. Make sure you are objective, paperwork and procedure revisions are not the favorite thing of most production personnel. Good luck

[Citizen Kane]

If you consider them to be too generic, but still they are working as effective and wirght as it should, then there is no problem. But, if I take such documentation, I am able to follow the stemps mentioned and be effective ? If you can prove you cannot be, then they should change.

[John Broomfield]

Originally Posted by Donna H

I audited an area which i feel the documentation are extremely generic, barely define “what” is to be done, and do not address “how”. I ask the group audited Consideration should be given to reviewing the contents of these procedures to ensure that they either reflect how the activities are to be performed, or at least properly reference any on-line databases or tools to be used to complete the related processes.
The response proved back to me was " TS16949 spec where it defines what we have to do"
Since TS is very vague on what is required in documentating the process how so I respond to this

Donna,

For me the key word in your question is "feel".

Agreed, the lack of detail may make you feel uncomfortable.

But you need evidence that the process is not documented sufficient for effective planning, operation or control.

With that evidence you have a 4.2.1d system nonconformity.

But, if you are looking for "how to" detail then should you not have asking for the work instructions per 7.5.1.2?

For which part of this clause (A, B or C below) do your audit notes show that you have evidence of conformity?

1. Documented work instructions for all employees having responsibilities for the operation of processes that impact conformity to product requirements.
   
2. These instructions shall be accessible for use at the work station.
   
3. These instructions shall be derived from sources such as the quality plan, the control plan and the product realization process.

Where you do not may be worthy of further investigation to nail down this nonconformity (if it exists) with evidence.

In writing it up I would avoid the use of any term that expresses an opinion of the auditor such as "I feel", "I believe", " I think".

Note also how the auditor first seeks evidence of conformity and effectiveness.

John