Validation of Processes - How to meet requirement of TS 16949 para. 7.5.2.1?

Hello folks,

7.5.2.1 is one clause where I have seen maximum number of interpretations.

1st interpretation: This requirement is nothing but PPAP. If we have PPAP for all the processes, then it meets the requirement.

2nd interpretation: This requirement should be read along with 7.3.3.2 whiich says "The manufacturing process design ouput shall be expressed in terms that can be verified against manufacturing process design input requirements and validated".

3rd interpretation: Manufacturing process audit is used to check the effectiveness of any process. So if you find do a manufacturing process audit, your process has been validated.

There are other interpretations. I have given only the most convincing ones.

What are you folks doing? How are you meeting this requirements?

My comments are:-

PPAP In this case, the resulting out-put is ensured/validated to be capable of meeting the requirements. All associated production processes are validated.

7.5.2.1 In this case, the resulting out-put cannot be verified subsquently.So the validation is limited to all associated production processes, personnel..etc. only

In both the cases, production processes are validated. Thus if you have PPAP, you are automatically covering 7.5.2.1

Audit of mfg. process can not be considered as validation of process.

We are going ahead by doing manufacturing process audit to meet this requirement.

I add some more comments:-

In our process the out-put is validated at every stage including final products for specified requirements.We also do not have "service provision". However we have added the following in our quality manual to meet the requirements of 7.5.2/7.5.2.1.,

Validation applies to all processes in our business process including those which can not be verified by monitoring and measurement. This ensures that the processes have the ability to meet planned results. Validation is done by defining:
(i). Criteria for review and approval of processes, equipments and
qualification of personnel.
(ii). Use of appropriate procedures / work instructions.
(iii). Requirement of records.

This way you show records/evidences when it comes to 7.5.2/7.5.2.1

My Interpretation of 7.5.2.1

This is my Interpretation of 7.5.2.1

If the resulting output of the process can be verified in subsequent monitoring or measurement then It is more and more related with Clause No 8.2.3.1, ie concentrate on "Process parameter Optimisation"

A.Vijayakumar

Sambasi said:

Validation applies to all processes in our business process including those which can not be verified by monitoring and measurement. This ensures that the processes have the ability to meet planned results. Validation is done by defining:
(i). Criteria for review and approval of processes, equipments and
qualification of personnel.
(ii). Use of appropriate procedures / work instructions.
(iii). Requirement of records.

Click to expand...

Do you mean to say that you have validated all BUSINESS processes. If so, how did you validate "Internal communication process","contract review process", " Manufacturing process" etc.Since it comes under 7.5, can we not restrict it to manufacturing process. For a manufacturing process itself, we are breaking our heads on how to meet the requirement and also add some value.

Validation 7.5.2.1

Like I posted in another thread some time ago.
The base line of validation is that validation should prove that the process does what it is supposed to do ( that it achieves the planned results ).
IMO This should be in several areas like:

- Quality
- Quantity or capacity
- Availability
- Safety
- Ergonomics
- Environment
- Maintainability
- .....
The first 3 can be done via O.E.E.

Hope this helps.
Best regards and success!!

Antoine

As informed by Mr. Antoine.dias in the previous posting, it is adequate if the process does what it is supposed to do.

I wish to clarify Mr. Andrews' querry regarding "Validation of Internal Communication Process".

If we closedly look into the standard,
-The word "Communicate / Communication" appear in 14 places,
-The word "Inform" appears in 16 places,
-The work "Timely" appears in 8 places.
Translating these requirements into our way of working, I had prepared a matrix for our internal communication process. Pleas see attachment. This forms a part of our procedure for communication.

The same approach applies to other processes when the output can not be validated.

I request your comments on the attachment.

Efficiency and effectiveness measurables are identified for Quality management system processes like internal communication ,which can be used for monitoring and measurement. So IMHO 7.5.2.1 should not be applied to such QMS processes.

Any more interpretations ????? How are TS2 certified companies meeting this requirement.