Should documents that support the operation of its processes be excluded from control?

Integrator

Registered
How about if it were on a white board?

Another thought is that revision controlled documents need review and approval - who is gonna review and approve schedule changes? Is the manufacturing manager scheduling poorly? In contradiction of established planners schedules? Are their schedules affecting Customer delivery commitments? If so it’s not the document that needs control it’s the manager…
Concerning need for review and approval of changes to schedule I must point out that the data contained in the form (each daily production schedule record) is different day to day. Also, each handwritten daily production schedule record is retained as required by ISO 9001 7.5.3.2 'Documented information retained as evidence of conformity shall be protected from unintended alterations'. My point is that I believe that the form itself, not the data in each daily created record, should be controlled.
 

Integrator

Registered
Where is your evidence that this form is not under control?

Which requirement is not met?

Where is your evidence that this form is not under control?

Which requirement is not met?
As I said, 'the form was filled out by hand by the Manufacturing Manager to communicate production schedules to his staff and resided in his personal folder'.
A document on a personal drive may not be under control. The problem is just that people may leave the company. Refer to ISO 9001 7.5.3.2 For the control of documented information, the organisation shall address the following activities, as applicable: a) distribution, access, retrieval, and use.
I've also seen uncontrolled electronic documents getting lost and the only hardcopy gradually fading into illegibility. Refer to ISO 9001 7.5.3.2 b) storage and preservation, including preservation of legibility.
 

Bev D

Heretical Statistician
Leader
Super Moderator
Concerning need for review and approval of changes to schedule I must point out that the data contained in the form (each daily production schedule record) is different day to day. Also, each handwritten daily production schedule record is retained as required by ISO 9001 7.5.3.2 'Documented information retained as evidence of conformity shall be protected from unintended alterations'. My point is that I believe that the form itself, not the data in each daily created record, should be controlled.
If YOU want to control this form AND you can get others to agree then fine. But there is NO requirement to control this type of form. Period. Fulls stop
 

Jim Wynne

Leader
Admin
My point is that I believe that the form itself, not the data in each daily created record, should be controlled.
Long ago I decided to stop controlling forms, with only a few exceptions here and there. What's important is the contents, not the container. Control the information that needs to be communicated and/or archived. A good example of this strategy may be seen in the AIAG manuals, wherein forms are provided for recording required information, but it's specified that those forms, or "a convenient format" may be used.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
Document controlling forms is only reasonable if changes would potentially remove critical information recorded in there, make the form hard to understand or use, or if customer(s) are concerned about it.

Controlling white boards is nonsense. They, and this manager's schedule are a form of communication.
 

qualitymanagerTT

Involved In Discussions
As I said, 'the form was filled out by hand by the Manufacturing Manager to communicate production schedules to his staff and resided in his personal folder'.
A document on a personal drive may not be under control. The problem is just that people may leave the company. Refer to ISO 9001 7.5.3.2 For the control of documented information, the organisation shall address the following activities, as applicable: a) distribution, access, retrieval, and use.
I've also seen uncontrolled electronic documents getting lost and the only hardcopy gradually fading into illegibility. Refer to ISO 9001 7.5.3.2 b) storage and preservation, including preservation of legibility.

And maybe the manager will "hand it over" to their replacement before leaving the organization, and it will continue to be under their control.

Responding to my question with "maybe" doesn't answer it. While I now have a "maybe" about a requirement not being met, I am not clear on which requirement is actually not being met.

And the other issues you have raised can be considered risks arising from internal issues - why don't you have a system for managing documents when persons leave the company? Why isn't there a system which ensures that there are at least 3 persons who can manage documents in the absence of 1 or 2 of them? Why are there no controls for these electronic documents which got lost? Why are hardcopies allowed to fade into illegibility?
 
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