Validation of processes for production & service provision - Service industry

B

Bernie - 2011

Hi,
Our company is a service company supplying professional services to clients at our client sites. We are currently implementing ISO9001. I am struggling with the interperation of "validation of processes for production and service provision" - 7.5.2. We use the clients procedures and equipment to provide the service. How can we validate our service?
All help appreciated!
B
 
Colin

Colin

Quite Involved in Discussions
Re: Service industry - Validation of processes for production & service provision

Bernie, welcome to the Cove.

Clause 7.5.2 refers to a situation where you cannot verify the outcome of a process by the usual monitoring and measuring techniques that we normally use. e.g. if you were making matches, you can't prove that they will work without striking them - that makes them hard to sell :lol:

What the clause requires is that you prevent problems as much as you can by ensuring that the process is appropriate and that the people are competent and that you provide any necessary instructions - all of which is designed to reduce the risk of the process going wrong.

It could well be that your organisation could exclude this clause as not being applicable to the work you conduct.
 
Q

qualitymanager

Bernie said:
Hi,
Our company is a service company supplying professional services to clients at our client sites. We are currently implementing ISO9001. I am struggling with the interperation of "validation of processes for production and service provision" - 7.5.2. We use the clients procedures and equipment to provide the service. How can we validate our service?
All help appreciated!
B
Click to expand...

See if you can get your hands on a copy of ISO 9001:1994 and look at clause 4.9 Process Control where it talks about special processes (at least, I hope that's the clause it's mentioned in), and requirements for "control" aka validation (again, my memory may not be 100%).

If that's not viable, some other poster will be able to direct you to more recent material.
 
J

JaneB

qualitymanager said:
See if you can get your hands on a copy of ISO 9001:1994 and look at clause 4.9 Process Control where it talks about special processes (at least, I hope that's the clause it's mentioned in), and requirements for "control" aka validation (again, my memory may not be 100%).

If that's not viable, some other poster will be able to direct you to more recent material.
Click to expand...

Huh?? I completely disagree with this advice!! I can think of few things more likely to be confusing and less likely to be helpful than this suggestion!
 
J

JaneB

Bernie said:
Hi,
Our company is a service company supplying professional services to clients at our client sites. We are currently implementing ISO9001. I am struggling with the interperation of "validation of processes for production and service provision" - 7.5.2. We use the clients procedures and equipment to provide the service. How can we validate our service?
All help appreciated!
B
Click to expand...

Bernie, this frequently can't be done in a service environment. Can you tell us what kind of professional services you supply (roughly), so there's a more helpful context here?
1. Don't confuse process with procedure - you appear to be using them almost interchangeably.

2. You refer to using the clients' procedures - don't you have any of your own?

3. What processes do you have (when you deliver/provide your services)?
 
B

Bernie - 2011

Hello,

Thank you for your help. Ironically we provide validation services to regulated industeries. Therefore we don't use our own procedures to perfrom the actual work - we use the clients procedures.

We have our own procedures too - mainly those required by ISO. Our process maps are quiet detailed so we didn't write procedures where thesere was sufficient info in the process map.

The processes we have to deliver service include sales (where we document client requirements) through to processes ensuring people we send to client sites have the necessary skill level for the job. And then processes around the after sales service to ensure we are perfroming to our targets, training & development etc.

Bernie
 
F

FDAINFO

ISO:1994 is probably a good place to start. If you are referring to the new FDA General Principles for Process validation, ISPE had a good webinar a few weeks ago and we wrote on it.
Email me and I can send you the article
Ken Reid
 
N

neelu

Bernie said:
Hello,

Thank you for your help. Ironically we provide validation services to regulated industeries. Therefore we don't use our own procedures to perfrom the actual work - we use the clients procedures.

We have our own procedures too - mainly those required by ISO. Our process maps are quiet detailed so we didn't write procedures where thesere was sufficient info in the process map.

The processes we have to deliver service include sales (where we document client requirements) through to processes ensuring people we send to client sites have the necessary skill level for the job. And then processes around the after sales service to ensure we are perfroming to our targets, training & development etc.

Bernie
Click to expand...
In third paragraph of your mail, you have mentioned that you are ensuring skilled employees do the assigned job. That means you are already carrying out an activity that may be part of the set of requirements necessary to validate the type of service you provide. Intent of the clause is to ensure that you visualize the type of service jobs you will be providing to your customers and then you take advance action to see that your service men are skilled, have necessary equipment and have necessary soft skills to deal with customers at site(these are only representative)-ultimately to ensure that your customers are always happy. Reason for this is due to the fact that it may not be possible for your customers to assess the quality of the service that your people have provided immediately on completion of service. Clause 7.5.2 requires that you will identify such validation requirements(like the three mentioned above) in advance; see that these requirements are fulfilled; and review them at specified intervals. Some orgs. also mention that this review will also be done when some nonconformities are observed either by your org. or customer(complaint).
 
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