7.5.2 Validation of processes - Special Processes - Transportation Service Industry

[C Emmons]

I dont know why but this particular clause is really hanging me up. Everyone I have talked to relates this clause to "speical processes" such as the weld that can be tested without destroying the part. I am in a service industry - transportation.
I am trying to determine if I can make this clause applicable?? The ONLY scenario I can come with is if we have a new pc of equipment (tractor, trailer) dlvd and it needs to be used to service a customer prior to going through the inspection process - we have measures in place to flag, alert, and make sure that it goes through the required processes at a latter date? Am I way off base? Any idea? So far the only permissible exclusion I plan to claim is Design and development...this may turn out to be another but I want to keep them to a minimum

 

[Jimmy]

Although it doesnt' say it, I believe you will find your registrar will expect that this validation process should happen prior to using the piece of equipment. You validate because you cannot predict if it will work until it is too late.

Sounds as if you do have a method of verifying by subsequent monitoring and measuring - but are using before you are finished? This would be more applicable to 8.2.4 , dealing with concessions.

Be careful also, because design applies to service too. This is something I am struggling with myself.

Good Luck

 

[C Emmons]

Design in service? How are you coming up with that one? We have undergone regular audits to the 1994 version - our most recent one in July...The auditor and I talked alot about our transition and persmissible exclusions (not consulting - value added audit) I went so far as to pose the following: We have an MIS department who designs all of of programs for our system - no use of canned programs - Are we design responsbile? Answer: no -

I guess I am just not understanding 7.5.2!

 

[Jimmy]

I had a misunderstanding regarding some comments made during our last (value added audit)

I did get some clarification from our registrar just now. I will be excluding design!

Sorry for the confusion.

 

[JHuber]

I don't know if this will help you or not. We are a small manufacturing company for the automotive and have upgraded our Quality System to ISO9000:2000, and TS16949.

7.5.2 Validation of Processes for Production & Service Provision
(Also TS-16949 7.5.2.1)

Validation of processes are to occur on production, service, & special processes. (equipment, personnel qualifications, exisiting records.) Special processes are defined as those processes where results and outputs cannot be verified through subsequent inspection & testing (e.g. welding, soldering, brazing, plating, painting, etc.). It also includes processes where deficiencies develop only after installation and/or use. Validation activities on special processes are suppose to be adequate (you define) and appropriate in nature to demonstrate the ability of the processes to achieve desired results. We define our validation activities in our system as our Process Control Procedure, Inspection Procedures and Control Plans.

My thoughts on this is that they took Design Validation 4.4.8 in older version of ISO and moved it to 7.5.2 because it fit better here as flow?

 

[C Emmons]

That helps thank you - I finally checked with my maintenance shop (after hearing the welding example) - We sometimes need to weld an ICC Bumper on the back of a trailer if it cracks..so...
that could be the activity in my operation that addresses this requirement?

 

[JHuber]

Does the weld that maintenance do have inpact on the service you provide your customer? What is it that you provide you sell to the end user?

Based on the little I know of your service you are providing, I would say yes. You are correct.

EX: our process we perform butt or lap welds. This is on the product. This is something we have validated in our control plans and weld instructions on customer products.

But our Maintenance department also does some spot welding and things of that nature unrelated to product, equipment. General stuff. We do not address this as a special process.

 

[C Emmons]

My business is trucking - so I would say maintenance or repair on our equipment definitely can have an impact on our service. If we get shut down at the scales with a customers freight on our trailer - and can't deliver it due to an equipment problem... I just cant think of another place to apply this clause..

 

[JHuber]

I have a friend who is a consultant for a few trucking firms in the Ohio area. Getting them ready for ISO. I do some work for her on the side...........but mostly with her clients that are manufacturing related. I will drop her an email and give her a call to see if she has any thoughts or what she does w/her clients. Perhaps this may clarify for you.

 

[C Emmons]

Ok - I am back on this 7.5.2 Validation of Processes....(Special processes again) As I reminder - I work in the transportation industry - trucking..all service. Consider this scenario:

We deliver a shipment - the customer signs our receipt that the shipment was received in good order. 24 hours later we get a call that when they opened the carton they discoverd hidden damage to the product (happens all the time). We have a process in place to deal with "Concealed Damage Claims" when this happens we generally send a 3rd party inspection company to the customers location to perform an inspection of the product and the packaging and based on the evidence supplied by the inspection company we can agree to pay 1/3.

Would that be applicable as a "special process" under 7.5.2?