Documents and Records - Difference between and How to control Documents and Records?

[dv8shane]

In Reply to Parent Post by Jason PCSwitches

"non-critical". Most regulations relate to record retention, not amendments. As long as you define your parameters and have records to justify any amendments you are compliant.

I have a customer that is an AS9100 registered FAA DOT approved manufacturer of Avionics. From what I have read in their documentation they are required to keep the original build sheet drawings etc, and not alter it once the unit has been completed and shipped as part of traceability requirements imposed by regulatory authorities. This is an example of how outside regulatory and legal authorities can and do define control of records that are industry specific.

Shane

[Jason PCSwitches]

In Reply to Parent Post by dv8shane

I have a customer that is an AS9100 registered FAA DOT approved manufacturer of Avionics. From what I have read in their documentation they are required to keep the original build sheet drawings etc, and not alter it once the unit has been completed and shipped as part of traceability requirements imposed by regulatory authorities. This is an example of how outside regulatory and legal authorities can and do define control of records that are industry specific.

Shane

Exactly, the point is that you CAN make changes as long as you follow protocol. There is a difference between drawings and measurement/production records. While in context they are the same drawings are specifying the requirements of the product. Your production documents describe how you get there. You may find that the order of processes is not in order, or could be compiled to be more efficient, so you make changes. That work order/traveler is a record is it not? If I change the configuration of the product that is much different than changing my planning or inspection techniques.

[Thoops76]

Hi all, just a quick question with regards to documentation. If a training checklist that is used to ensure an employee is competent at completing tasks is uncontrolled i.e. open for possible editing. Can this be highlighted as a possible non conformance?

[JaneB]

In Reply to Parent Post by Thoops76

Hi all, just a quick question with regards to documentation. If a training checklist that is used to ensure an employee is competent at completing tasks is uncontrolled i.e. open for possible editing. Can this be highlighted as a possible non conformance?

Let's turn that question around - if anyone can edit it and change what is on the checklist, how well do you think that would that work? "Hmm, don't think I agree with these competencies, so I'll just delete them/change them. They really oughta add in these ones, so I'll do it"... etc.
(Not at all well in other words).
So what is the justification for not controlling it?

[John Broomfield]

In Reply to Parent Post by Thoops76

Hi all, just a quick question with regards to documentation. If a training checklist that is used to ensure an employee is competent at completing tasks is uncontrolled i.e. open for possible editing. Can this be highlighted as a possible non conformance?

Thoops,

Your supervisors use this form to assess the competence of the people working for them - is this right? If so the supervisors could be authorized (provided they are competent) to adjust the competencies required of each of their employees according to the jobs they are expected to do well.

Some organizations call such checklists Personal Development Plans which, in larger organizations, tend to be generic for each job title but allow for editable additions for each holder of the job. The generic checklist would not be editable.

If you are concerned about unauthorized changes why not provide fillable PDF forms?

Please also remember that competence is delivered by more processes than training. Many organizations waste money training people who will never be compentent. So recruiting the people with the required attributes is important too.

John

[Thoops76]

Hi, thanks for your feedback. The training checklists are used by experienced employees to sign off peers to carry out tasks. During an internal audit it was found that some of the training checklists where uncontrolled I.e. Open for editing to all employees who have access to where the document is electronically stored.
Uncontrolled documents that have had non conformances logged against them in the past due to those documents being open to editing have been sop's that have documented how people carry out tasks. My question is would a checklist also fall under this category?

[JaneB]

In Reply to Parent Post by Thoops76

My question is would a checklist also fall under this category?

Yes
It would.

[FMS-Steve]

Monitoring Measuring Quality Records, how can we measure control of records/documents