What is a controlled document?

Question - what types of documents need to be controlled?

Our QM says that all documents used in manufacturing areas need to be controlled, I disagree.
I cannot see why locally prodcued documents e.g. data collection forms used by improvement teams ; process set-up time / cycle time monitoring forms.

I can't find any reference within QS9000 to these types of documents requiring issue control ; I can do without yet more documents to be responsible for!

[Marc]

Q Manual
Level II's
Control plans, FMEAs and other process related documents, for starters. Documents of external origin can be tricky.

There is no requirement for centralized control. Local control is perfectly acceptable.

[barb butrym]

I like the rule ,...ok, so if the information in this is wrong or inconsistent...what gets affected...and is that critical? if it matters then it needs some sort of control....The level is dependant on criticality and origin.

[David Mullins]

I ask "do current or new people need to refer to this information to do the job correctly (quality/cost/time)?"

If the answer is YES, because people don't have the required skills or knowledge, the you need a controlled document.

If the answer is NO, and people (including new starters) have the skills and knowledge, then no document is required.

BEWARE, if the answer is NO, and people don't have the skills and knowledge, as well as a standardized methodology, then they do need a controlled document, and they are either fooling themselves, attempting to fool you, or both!

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