Changes to Control Plans or PFMEA's (Process FMEA)

[5litre]

Is it necesaary for Document Control to keep a record of updates to Control Plans or PFMEA's, or just necessary to up the revision level (date) and issue the new one?

The standard states that you must control documents, but this would be data within the document.

I have not been keeping a Change Record for each part number that gets revised, is this an N/C?

 

[Stijloor]

Re: Changes to CP or PFMEA's

Is it necesaary for Document Control to keep a record of updates to Control Plans or PFMEA's, or just necessary to up the revision level (date) and issue the new one?

The standard states that you must control documents, but this would be data within the document.

I have not been keeping a Change Record for each part number that gets revised, is this an N/C?

This may help:

The AIAG PPAP Manual, Section 6, Page 21 states:

<snip> The organization shall ensure that the appropriate PPAP records from a superseded part PPAP file are included, or referenced in the new part PPAP file.

Stijloor.

 

[5litre]

Re: Changes to CP or PFMEA's

My question would be for rev. changes to a specific part number, not really for a superseded number. We do keep a Document Change Log for changes to documents we use that get revised from time to time.

Thanks

 

[bpritts]

Re: Changes to CP or PFMEA's

I have included control plans in the scope of document control in all of my clients' systems. I suppose you could argue that the changes to the content represent changes to data rather than a document, but data changes must be controlled, too.

Remember the goals of document control and decide for yourself. Documents and/or data which are relied on for product design, manufacturing, inspection or service must be controlled, to ensure that changes are made in an authorized manner, and current information available to all who need it.

Possibly you could use the signatures and dates on the form as evidence of approval, but as noted above you'll also need to ensure that records of implementation and change must be kept, too.

Best regards............Brad

 

[ARTEMIS]

I agree,

If you make any changes to an document that affect the way you perform a tasks in the course of your business that change needs to be controlled.

 

[jerry_Malaysia]

In the place that I work, we control the changes of control plan and FMEA according to document control procedure. We have recorded what are the reason for each change, and attach supporting documents example validation, testing and trial result etc. This is because we need to keep track on why we made the changes and how we made the changes. We may use FMEA as benchmark for similar product development in future, therefore, we would like to have as much information as possible.

 

[jkuil]

Critical is the document change control of any specification

• specification of the product
• specification of how it is being manufactured
• specification of the controls and inspections that ensure product quality

A change record should specify the changes and how they are controlled: the validation of the change and the impact on the risk assessment. It may be necessary to update FMEA's and control plans due to the change. Your change control form should assess and record this need.