Validation of Processes - What is meant by 7.5.6 (a) - Defined Criteria for Review

[Philip B]

I'm just writing a validation procedure. Fairly straightforward but I'm not entirely clear what is meant by 7.5.6 (a) defined criteria for review and approval of the processes?

Is this review and approval prior to or after validation?

Thanks

 

[somashekar]

Re: Validation of Processes - What is meant by 7.5.6 (a) defined criteria for review.

Philip.

Before you get on with the procedure, understanding the requirement of validation must be good with everyone across the team.
This review and approve is not about any document.

Its about your process criteria that you are up with validating. May be Temperature, Pressure, RPM, Voltage, Time, Hardness, ....

 

[Philip B]

Re: Validation of Processes - What is meant by 7.5.6 (a) defined criteria for review.

Philip.

Before you get on with the procedure, understanding the requirement of validation must be good with everyone across the team.
This review and approve is not about any document.

Its about your process criteria that you are up with validating. May be Temperature, Pressure, RPM, Voltage, Time, Hardness, ....

Thanks Somashekar; so, for example, in the case of packaging validation, the validation approach that we are taking (seal strength testing, ageing testing, transit testing etc) needs to be reviewed and approved before we begin actual validation?

 

[shimonv]

Re: Validation of Processes - What is meant by 7.5.6 (a) - Defined Criteria for Revie

Hi Philip,
The criteria for review and approval of the processes needs to be defined prior to the execution of the protocol.
Otherwise it would be like shooting the arrow and then marking the target...

Cheers,
Shimon

 

[Philip B]

Re: Validation of Processes - What is meant by 7.5.6 (a) - Defined Criteria for Revie

Hi Philip,
The criteria for review and approval of the processes needs to be defined prior to the execution of the protocol.
Otherwise it would be like shooting the arrow and then marking the target...

Cheers,
Shimon

Thanks Shimon, but is the standard talking about the process itself (how we package devices) or the validation process (how we validate the packaging process)?

 

[shimonv]

Re: Validation of Processes - What is meant by 7.5.6 (a) - Defined Criteria for Revie

The ISO 13485 standard describes the high level processes in a quality management system (the what..). It does not go into the details of implementation.

There are other standards that discuss specific processes in greater details. For example, ISO 14971 has a lot of information about the risk management process.

To my knowledge there is not standard that speaks on how to package a device or how to validate the packaging. But there are standards for testing packaging integrity. Your process should be robust enough so you can pass these tests successfully and consistently.

That standards are, for the most part, guidelines. It is up to you to do the implementation (the how...), and if you have a good example it makes it much easier.

Shimon

"Good artists copy, great artists steal." - Pablo Picasso

 

[kreid]

Re: Validation of Processes - What is meant by 7.5.6 (a) - Defined Criteria for Revie

The standard is talking about validating the (packaging) process and the process you use for that validation.

So you have to approve the validation protocol before using it and then validate the processes by using the protocol.

If that makes sense?!

 

[Philip B]

Re: Validation of Processes - What is meant by 7.5.6 (a) - Defined Criteria for Revie

The standard is talking about validating the (packaging) process and the process you use for that validation.

So you have to approve the validation protocol before using it and then validate the processes by using the protocol.

If that makes sense?!

Thanks Kreid, that makes perfect sense and is what we do anyway thankfully!