Procedure for Control and Maintain of Records in each Design Stage

[mondie]

Hi alll,

I need some advice and help here.

I am asked to create a procedure to describe the records to keep at each design stages (plan--> input--> output-->.. etc) for Tool design.

Anyone has any idea how can I put them together? Anyone can send me a sample of such procedure or piece of advice?

Thank you !

 

[bio_subbu]

Re: Procedure for control and maintain of records in each design stages

Hi Welcome to the Cove!!

Please refer following Elsmar and Clinivation resource links

Design Control file attachments

Clinivation

Regards
S. Subramaniam

 

[mondie]

Hi!

Thank you for your inputs.

Can I just check with you, are there such procedure that describe only the quality records specifically for each design stage? And also describe how you control the records?

And do you have any idea how can I validate the records before filing?


Thank you!!!

 

[JaneB]

Mondie,

I'd rarely want to see a stand alone procedure focussed just on records, because records are an output of a process, and perhaps the procedure/s supporting that process.

Rather than a 'procedure' you could perhaps do this by having some kind of matrix:

Design stage: you must know what the stages are in your design process
Records output (list here whatever the record/s output )
Then for each record:
Responsibility & storage (ie, who makes sure they exist, where are they stored and in what format?)

As to how you would 'validate' them - what do you mean by validate? Do you mean make sure we have all the records, or do you mean check every piece of data on them is accurate?

 

[mondie]

Hi JaneB,

Thank you for your useful inputs.

I am actually trying to apply the ISO 13485 /FDA design Control clause to ''tool design'' . I have read some on the design control clause but that applies to ''product design'', but if its for tool design, any advice on that?

And for the validate of records, if I were to validate the records to ensure that the records that are required are there. I just require a checklist will do?

If I were to validate the records according to accuracy, how can I do that? The records may include drawings etc.

As a quality standpoint, if to validate records before filing to the design history file, what are the methods?

Thanks !!

 

[JaneB]

My advice was general. I'm not familiar with the detail of the Standard nor the requirements, so I'll leave it to someone else who is!

 

[sagai]

Welcome!

Can we know a bit more about the Tool?

Is it a finished medical device? Which market is it distributed to?

br
Sz.

 

[mondie]

hi!

Its producing mold for medical customers....

I need to come out with a quality system to control the tool design stage from the beginning till it's transferred to the manufacturing.

 

[sagai]

I am asking it, in order to avoid the implementation of unnecessary control into your QMS.
What are the regulatory environment of this product? Is there any regulatory requirement to comply with?

br
Sz.