Is a PFMEA (Process FMEA) a record or document?

D

darkafar

#1
Because we treat document and record differently, I want to know to which does it belong in your judgement. Anybody's opinion is appreciated.
 
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P

potdar

#2
Re: Is PFMEA a record or document?

Because we treat document and record differently, I want to know to which does it belong in your judgement. Anybody's opinion is appreciated.
Darkafar,

ISO now defines the record to be a 'special type of document'.

Anyway, its speciality is that the record is history, it is a fact, it is dead. Basically, it cannot be modified.

On the other hand, a document is living. It is valid till it gets revised. And it can be revised unlike a record.

The pFMEA will get revised every time the process or even the design is proposed to be changed. And these are expected to be frequent events due to CA, PA and CI.

The pFMEA is a document.
 
V

vanputten

#3
Re: Is PFMEA a record or document?

I think an FMEA is a document. I think a control plan is a document. The peices of paper (or electronic files) that have evidence of performance of the activities listed on the FMEA or control plan are records.

According to ISO 9000:2005, a record is a type of document. So even if one decides the PFMEA is a record, it is still a document too.

Did I correctly answer the question?

Regards,

Dirk
 

Jim Wynne

Staff member
Admin
#4
Re: Is PFMEA a record or document?

Because we treat document and record differently, I want to know to which does it belong in your judgement. Anybody's opinion is appreciated.
The answer is: [C] Neither.

PFMEA is a process. The document that is produced as a result of the process is a record.

Furthermore, I don't understand the reasoning behind differentiating between documents and records. Can anyone name a type of record that can't be (at least logically) accurately characterized as a document?
 
D

Dean Frederickson

#5
Re: Is PFMEA a record or document?

The answer is: [C] Neither.

PFMEA is a process. The document that is produced as a result of the process is a record.

Furthermore, I don't understand the reasoning behind differentiating between documents and records. Can anyone name a type of record that can't be (at least logically) accurately characterized as a document?
What is the Declaration of Independance? A record or a document? The original document is a record that can never be changed, but every time a law pertaining to the Declaration of Independance is changed or a new law added it makes the current Declaration of Independance a record and we have a new Declaration of Independance. Same with the original Bill of Rights as it changes with new laws the old one becomes a record and the new one is a document until the next change. Same as your PFMEA, the 1st one becomes a record when a new revision is released, the current PFMEA is a document until the next rev. change makes it a record.
 
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P

potdar

#6
Re: Is PFMEA a record or document?

What is the Declaration of Independance? A record or a document? The original document is a record that can never be changed, but every time a law pertaining to the Declaration of Independance is changed or a new law added it makes the current Declaration of Independance a record and we have a new Declaration of Independance. Same with the original Bill of Rights as it changes with new laws the old one becomes a record and the new one is a document until the next change. Same as your PFMEA, the 1st one becomes a record when a new revision is released, the current PFMEA is a document until the next rev. change makes it a record.

Exactly. In other words, an obsolete document is history. Its a record.

P.S. This definition comes from ISO 9001:1994. Today, records are considered 'special' documents. So, they are documents.

I propose we limit the discussion to the 'specialness' involved.
 
D

darkafar

#7
Re: Is PFMEA a record or document?

The answer is: [C] Neither.

PFMEA is a process. The document that is produced as a result of the process is a record.

Furthermore, I don't understand the reasoning behind differentiating between documents and records. Can anyone name a type of record that can't be (at least logically) accurately characterized as a document?
By our current procedure, DCC is responsible for registering the current revision of document, and records are preserved by the departments that produce them.

I want to know whether PFMEA is a special type of document (record) or just document because I want to know wether or not the just produced PFMEA should be registered by DCC.
 

Jim Wynne

Staff member
Admin
#8
Re: Is PFMEA a record or document?

By our current procedure, DCC is responsible for registering the current revision of document, and records are preserved by the departments that produce them.

I want to know whether PFMEA is a special type of document (record) or just document because I want to know wether or not the just produced PFMEA should be registered by DCC.
It's a record.
 

Helmut Jilling

Auditor / Consultant
#9
Re: Is PFMEA a record or document?

I think an FMEA is a document. I think a control plan is a document. The peices of paper (or electronic files) that have evidence of performance of the activities listed on the FMEA or control plan are records.

According to ISO 9000:2005, a record is a type of document. So even if one decides the PFMEA is a record, it is still a document too.

Did I correctly answer the question?

Regards,

Dirk

I agree with Dirk. The PFMEA is regarded by most people as a semi-living document, because it is a document that is subject to revision.

Records generally don't get further revision. The version you file in your PPAP submission is a "record" of what that FMEA said at that point in time.

The "process" comment overly complicates it. Writing a work instruction or designing a form is a "process" by that definition they should be records too? Too complicated.

It is a document. It should be controlled. Chnaging a FMEA may necessitate notifying the customer.
 
P

potdar

#10
Re: Is PFMEA a record or document?

By our current procedure, DCC is responsible for registering the current revision of document, and records are preserved by the departments that produce them.

I want to know whether PFMEA is a special type of document (record) or just document because I want to know wether or not the just produced PFMEA should be registered by DCC.
I am not sure of what you mean by DCC. But normally in a manufacturing facility there are multiple agencies controlling the documents. Typically, the QMS related documents (manual, procedures, WI,..) are controlled by the Management Representative, while drawings are controlled by the design office. There is nothing wrong if your PPAP and pFMEA documents are controlled by a different agency. You just have to define who.

As we have been discussing, documents are revisable. Your document control procedure is a document which can be revised. Revise it to suit your needs.:)
 
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