Design and Development Planning - Controlled Document?

[w_grunfeld]

I have reread 7.3.1 Planning in the 2008 version as well, and it says nothing about having to have a plan as a controlled document or record.The only hint that it should be documented at all is "Planning output shall be updated , as appropriate, as the design and development progresses" at the end of the section.
Nevertheless the registrar and many second party auditors keep writing up the lack of a controlled record.
Does anyone else have this problem?

 

[qusys]

Re: Design and Development Planning- Controlled doc?

I have reread 7.3.1 Planning in the 2008 version as well, and it says nothing about having to have a plan as a controlled document or record.The only hint that it should be documented at all is "Planning output shall be updated , as appropriate, as the design and development progresses" at the end of the section.
Nevertheless the registrar and many second party auditors keep writing up the lack of a controlled record.
Does anyone else have this problem?

They are right.
The records and the document for Design and Development planning shall fall under the scope of 4.2.3 ( Control of Documents) and 4.2.4 ( Control of records). You as organization shall define what documentation to retain and for how long, also aiming at satisfying eventual Customer requirement as well as legal and cogent issues.
hope this helps

 

[Randy]

Re: Design and Development Planning- Controlled doc?

They are right because 7.3.1 is a general requirments description clause for D&D that is expanded into greater detail from 7.3.2 to 7.3.7, most of which specifically require the generation of a record.

As with 4.1, 7.3.1 cannot be met without successful fulfillment of 7.3.2 - 7.3.7 except for where exclusions can be justified.

 

[harry]

Read the APG Guidance on: Auditing the Design & Development Process

 

[w_grunfeld]

Thanks for the attachement. I have read it but did not find auditing that the plan must be a CONTROLLED document or record

 

[w_grunfeld]

Re: Design and Development Planning- Controlled doc?

They are right because 7.3.1 is a general requirments description clause for D&D that is expanded into greater detail from 7.3.2 to 7.3.7, most of which specifically require the generation of a record.

As with 4.1, 7.3.1 cannot be met without successful fulfillment of 7.3.2 - 7.3.7 except for where exclusions can be justified.

Randy,
I have no issue with that, 7.3.2-7.3.7 specifically reference 4.2.4 while 7.3.1 does not.
I am speaking of D&D planning which is documented in an excel workbook with the development phases, all milestones, resources , etc. is kept updated as the design develops, except is not in a CONTROLLED DOCUMENT format (revision lettter, signatures, description of changes)
My point is that it is impractical to place such a record under formal revision control.

 

[qusys]

Re: Design and Development Planning- Controlled doc?

Randy,
I have no issue with that, 7.3.2-7.3.7 specifically reference 4.2.4 while 7.3.1 does not.
I am speaking of D&D planning which is documented in an excel workbook with the development phases, all milestones, resources , etc. is kept updated as the design develops, except is not in a CONTROLLED DOCUMENT format (revision lettter, signatures, description of changes)
My point is that it is impractical to place such a record under formal revision control.

Did you define it as a quality documentation and record in your procedures??

I do not know if you apply APQP but I think it is important to give a correct control to these documents. Probably you should have in place a Document Mgmt and Record in electronic shape that manage all these things ( workflow, approval, record retention, versioning etc.)

 

[Howard Atkins]

I have reread 7.3.1 Planning in the 2008 version as well, and it says nothing about having to have a plan as a controlled document or record.The only hint that it should be documented at all is "Planning output shall be updated , as appropriate, as the design and development progresses" at the end of the section.
Nevertheless the registrar and many second party auditors keep writing up the lack of a controlled record.
Does anyone else have this problem?

Have you asked the auditors. They must provide the reference!!!!! If they are the S*I then they probably do not know
The finding of a 3rd party audit MUST refer to the shall in the standard in the NC statement otherwise you cannot reply.

2nd party auditors can ask for what they want and are not bound by the standard.

 

[somashekar]

I have reread 7.3.1 Planning in the 2008 version as well, and it says nothing about having to have a plan as a controlled document or record.The only hint that it should be documented at all is "Planning output shall be updated , as appropriate, as the design and development progresses" at the end of the section.
Nevertheless the registrar and many second party auditors keep writing up the lack of a controlled record.
Does anyone else have this problem?

For a design plan xxx do you have a plan 1 (dated) as was made in the first instance and then plan 2 (dated) when changes to plan was done as design progressed ? Do you have several such plans further like plan 3, plan 4 etc etc until the design cycle per the plan was completely executed / currently at a specific stage ?
Is this plan in control of the head of design function ?
Perhaps this is what the auditor was keen to see .....

 

[w_grunfeld]

Howard,
You are absolutely correct both as regards your presumption and your comment....