Looking for a simple procedure on section 7.5.2 for Validation of Processes

M

MEDQA

I'm looking for an simple procedure that addresses 7.5.2 (ISO 9001:2008)

Also wondering if it is required to have a procedure for this process?

thanks to all..
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
Re: 7.5.2 Validation of Processes Procedure

Good day MEDQA,

ISO 9001:2008 does not require a procedure to accomplish the intent of 7.5.2.

The standard is asking us to confirm that processes (including critical services, not just making stuff) are accomplishing what they set out to do. This "Check" part of Plan-Do-Check-Act can involve a number of activities and may include SPC. For more insights, please feel free to explore the related threads linked at the bottom of this page.
 
M

MEDQA

Re: 7.5.2 Validation of Processes Procedure

Thank you Jennifer. I will check out the links.
I was asked by an auditor (who is preparing to audit us) if we have a procedure for 7.5.2 (which we do not) and I want to be prepared to answer how we address it. What I have learned so far from reviewing the cove is that we address it via controls (Preventive Maint, Tool Life, Inspection Plans, Training, Work Instructions etc.) We also follow processes that have been established by a sister company.

Hopefully I am heading in the right direction.
 

Pancho

wikineer
Super Moderator
As Jennifer said, you shouldn't try to match a procedure to each clause of the standard, particularly for section 7. That section gives you requirements that your product realization processes must meet. Product realization processes are the main "do" bits of your work. If you bake cakes, its the baking process. If you build houses, count design, project management, purchasing, receiving and building itself. Each of these processes needs to meet the requirements in section 7 that may apply.

7.5.1 requires you to produce your product under controlled conditions, including (e), monitoring and measurement to verify product conformity. So your product realization processes will specify inspection or such to make sure the product is conforming. But the outputs of some processes are not readily monitored or measured. Take welding, for example. A weld may look great, but it may still be fragile or weak. A process that outputs such product is called a "special process" in ISO 9000. For those processes there is 7.5.2. It tells you how you should validate your process so that you get conforming product despite not being able to monitor or measure it.

So, for each of your product realization processes, look at its outputs. Can you readily and economically verify their conformity by monitoring and measuring? If so, then do it to meet 7.5.1(e). Else, the process is "special" and, per 7.5.2, you must "establish the [alternate] arrangements" to achieve the desired results.
 

somashekar

Leader
Admin
I'm looking for an simple procedure that addresses 7.5.2 (ISO 9001:2008)

Also wondering if it is required to have a procedure for this process?

thanks to all..
When you understand validation and identify your processes that needs to be validated, you will then have a simple procedure how you will validate each of those processes.
You will look at installation of your process equipment
You will look at operations at various process settings and determine the optimum setting
You will look at measures that assure the required outputs happen at that settings
You will look at performance at these optimum process settings, over determined time and include operator qualification as well.
You will have a record of these.
You will continue processing based on the good results of the validation
 
M

MEDQA

As Jennifer said, you shouldn't try to match a procedure to each clause of the standard, particularly for section 7. That section gives you requirements that your product realization processes must meet. Product realization processes are the main "do" bits of your work. If you bake cakes, its the baking process. If you build houses, count design, project management, purchasing, receiving and building itself. Each of these processes needs to meet the requirements in section 7 that may apply.

7.5.1 requires you to produce your product under controlled conditions, including (e), monitoring and measurement to verify product conformity. So your product realization processes will specify inspection or such to make sure the product is conforming. But the outputs of some processes are not readily monitored or measured. Take welding, for example. A weld may look great, but it may still be fragile or weak. A process that outputs such product is called a "special process" in ISO 9000. For those processes there is 7.5.2. It tells you how you should validate your process so that you get conforming product despite not being able to monitor or measure it.

So, for each of your product realization processes, look at its outputs. Can you readily and economically verify their conformity by monitoring and measuring? If so, then do it to meet 7.5.1(e). Else, the process is "special" and, per 7.5.2, you must "establish the [alternate] arrangements" to achieve the desired results.

thank you for a simple explanation.
 

roneljdsilva

Involved In Discussions
Re: 7.5.2 Validation of Processes Procedure

Hello Jennifer,
I am held up with the same problem as I do not have a specific procedure satisfying the requirements of Clause 7.5.2, however, I have these requirements covered in different subsequent procedures. For example for the qualification of personnel, I have a training and competency procedure or for the qualification of equipment, I have a control of measuring and testing equipment procedure. You catch my drift?
I do not have an explicit procedure for the validation process but am I still good to go?
Thankyou
 

Bev D

Heretical Statistician
Leader
Super Moderator
Are you questioning Vaidation of Product (7.5.1) in general or you specifically asking about the Validation of Processes (7.5.2) aka Special Processes?
 

roneljdsilva

Involved In Discussions
Well Bev,
I am actually trying to conform with API Q1 requirements and I have a clause stating the need for establishing a procedure for control of product and services and another clause for the need for establishing a procedure for the validation of processes. Now under both these clauses are stated requirements similar to that of ISO but I think I cover these requirements in different procedures as I stated in my earlier comment. I just wanted to know if this will suffice?
Thanks
 
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