ISO 9001 Clause 7.5.2 Validation of Processes - How to comply?

[Jandro]

Okay, so I've read many of the threads (debates ) about this clause. A lot of them are about what is or isn't a special process (so as to exclude or not exclude). Not what I'm looking for.

What I do need: Help grasping a tangible way to fulfill this requirement. A real world example would help me a lot. My company takes sheet steel and cuts it to various widths and lengths (an oversimplification) and redistributes the processes sheets or coils.

Please help me by using a real world example on how 7.5.2 gets fulfilled. Feel free to use my process / product (or not).

Thanks so much ahead of time. This forum has been a big help for a long time. So much so that I never post because the search function has helped tremendously.

 

[mdurivage]

Re: 7.5.2 Validation of Processes - How to do this?

"7.5.2 Validation of processes for production and service provision
The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement and, as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered."​

First are you 100% verifying the finished product cut size? If not I would run a validation that tests the systems ability. I would cut something at or just below the smallest size, at or above the largest size, and something in the middle to demonstrate the process is in control and stable.​

Hope this helps!​

 

[Jandro]

Re: 7.5.2 Validation of Processes - How to do this?

We perform three main inspections: Setup, In Process, and Final. These inspections measure the dimensions we cut the material to, but as a sample. There is no (reasonable) way for us to measure every dimension of every piece.

When an inspection fails we segregate the material until (later) it is determined whether it can be re-purposed (reworked or another application available) or not.

When you say a validation that tests the systems ability do you mean something like an xbar R chart? We have performed PPAPs for those customers that require it, but not sure if you meant that? Sorry for the confusion on my end and THANKS so much for your reply!

 

[somashekar]

Re: 7.5.2 Validation of Processes - How to do this?

Hi Jandro.
Welcome to the COVE and thanks for your encouraging first post...
What you can cut, you can measure, and you will take all the care to set your machine and cut within your required tolerance and periodically verify what you cut.
Take for example the plating process. This process is different than cutting in sense you cannot test the thickness and adhesion to the sheet at all places and on all sheets. Any defect in plating will not show up also until the sheet is put to use or later after certain time elapses. There are things to control in the plating process, and things to control in the sheet pre cleaning and preparation process. How much these have to be controlled within (Ex: current / bath concentration / time / anything else) to get the desired plating requirement ?
When you have this optimum set up parameters after you do some of your trials and apply learning from past experience, you are validating.

 

[Big Jim]

Re: 7.5.2 Validation of Processes - How to do this?

It does not appear that what you do includes any special processes so you have nothing to validate.

If you were to include welding, plating, and/or heat treating with what you either do or what you sublet, then you would have special processes that require validation.

 

[lyang]

Re: 7.5.2 Validation of Processes - How to do this?

If you define your process A, B, C, and what's critical to A, B, C then we can help more. Special process that requires validation is defined within the following documents:

www(dot)fda(dot)gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070336.pdf

www(dot)imdrf(dot)org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-10-2004-qms-process-guidance-04010.pdf

Basically, any processes that does not make sense to 100% verify, should be validated. Hence, a lot of company perform process validation & capability studies in order to perform sampling in a more meaningful way.

 

[Jandro]

Re: 7.5.2 Validation of Processes - How to do this?

Thanks everyone for responding!

(EDIT found the thank you buttons!)

I'm worried this will boil over into a "what should / should not be validated" discussion. My question is really (probably laughable to you guys) "How to validate a process / product?" or "What are some typical methods for validating a process or product?"

 

[somashekar]

Re: 7.5.2 Validation of Processes - How to do this?

Thanks everyone for responding!

(EDIT found the thank you buttons!)

I'm worried this will boil over into a "what should / should not be validated" discussion. My question is really (probably laughable to you guys) "How to validate a process / product?" or "What are some typical methods for validating a process or product?"

There are many things that are person controlled, like hammering a nail, driving a screw, chiseling wood ...and so on. These are skill with tools, and operator competency and his qualification are the controls.
There are other things that a machine tool does, like turning a steel rod, milling a shape on a block, and so on. The controls are direct and are manual on the machine tool or are numerical controlled. Apart from operator qualification the machine capability comes into play, and includes machine proper installation and commissioning, calibration and correct tooling.
There are other things like plating, cement manufacture, sterilization, many adhesive processes, chemical processes, where controls are indirect (like pressure, temperature, speed, concentration, current, voltage..etc) and are set to optimum levels to get the desired output. Including operator qualification, this exercise also captures the equipment installation and commissioning and can also include calibration. We could call this as process validation.

 

[Jandro]

Re: 7.5.2 Validation of Processes - How to do this?

Okay, thanks again everyone. I've found some resources online now that I have limited my question to "what is validation?"

 

[Big Jim]

Re: 7.5.2 Validation of Processes - How to do this?

To some extent, the answer is given in the standard.

a) defined criteria for review and approval of the processes,
b) approval of equipment and qualification of personnel,
c) use of specific methods and procedures . . .

A method of validating welding is to certify the welders so b is the method.

Soldering is often validated by certifying the technician and following guidance from one of the IPC manuals.

Plating and heat treating are often validated by following specific specifications (for plating, tank chemistry, time in tank, rectifier settings, tank temperature) (for heat treat, temperature of oven, length of time in oven, and how quenched).

If you have a special process, you need to figure out how you can tell with a high degree of certenty that the product is viable.

Puzzle your way through determining how a fire sprinlkler company can ensure that their sprinklers will work in a fire without destroying them during testing, and you should begin to see what needs to be done to set up a good validation program.