Product/Process Qualification Plan

[Jimmy Olson]

Hello Everybody.

We are currently in the process of opening a manufacturing facility in Mexico and I have been asked to supply information or guidelines for a qualification plan. We have some information (mainly based on FDA qualification framework) but managment wants something simple and easy to comprehend. So I figured who better to ask

If anybody has anything in 'laymen' terms or knows of a good resource I would appreciate it. Sorry that I'm not being more specific in what I'm looking for, but management isn't really being specific either I figured I will get some things together to show them and hopefully get a better idea of what they are looking for. Thanks

[Al Rosen]

Originally Posted by Richard Olson

Hello Everybody.

We are currently in the process of opening a manufacturing facility in Mexico and I have been asked to supply information or guidelines for a qualification plan. We have some information (mainly based on FDA qualification framework) but managment wants something simple and easy to comprehend. So I figured who better to ask

If anybody has anything in 'laymen' terms or knows of a good resource I would appreciate it. Sorry that I'm not being more specific in what I'm looking for, but management isn't really being specific either I figured I will get some things together to show them and hopefully get a better idea of what they are looking for. Thanks

Hi Richard:

Are you qualifying a process or a product? What are the specifications or requirements you need to meet? A qualification plan should show that you are able to meet the specs or requirements. If you you have a product spec, the plan should show conformance to each spec requirement. If you have a process, you would show that you can perform to geach process spec. I don't know if this is any help? If you do a google search on "qualification test plan" you will find examples.

[Jimmy Olson]

Hi Al,

In a nutshell, they want me to come up with a qualification plan for the whole factory. I tried telling them that we just need to follow the ISO requirements and our own quality system, but was told that's not enough. I think they are confused about what they want, and I'm confused by proxy.

Basically we are setting up a facilitiy from scratch and they want a qualification plan that shows the steps and requirements for setting it up. As far as I can tell I think they are expecting some sort of checklist that they can hand off to someone in Mexico. I mentioned product qualification, equipment qualification, etc., but they want something that covers the whole thing (again, back to ISO requirements). I was hoping that maybe someone has experienced a similar situation and might have ideas.

I apologize for confusing everyone, but I need to stop writing now before I get too frustrated over the whole thing.

[Cari Spears]

Holey Mackerel!! That's some task you've been given! I wish I could offer some suggestion - but I think I agree with you that the ISO standard and the QMS are indeed what they are kinda asking for.

[Wes Bucey]

Originally Posted by Richard Olson

Hi Al,

In a nutshell, they want me to come up with a qualification plan for the whole factory. I tried telling them that we just need to follow the ISO requirements and our own quality system, but was told that's not enough. I think they are confused about what they want, and I'm confused by proxy.

Basically we are setting up a facilitiy from scratch and they want a qualification plan that shows the steps and requirements for setting it up. As far as I can tell I think they are expecting some sort of checklist that they can hand off to someone in Mexico. I mentioned product qualification, equipment qualification, etc., but they want something that covers the whole thing (again, back to ISO requirements). I was hoping that maybe someone has experienced a similar situation and might have ideas.

I apologize for confusing everyone, but I need to stop writing now before I get too frustrated over the whole thing.

I note your company is in the business of creating "turn key" manufacturing facilities for other companies.

1. What is the basic checklist you work with?
2. How many facilities have you [either the organization and/or you, personally]set up before?
3. Has your organization ever set up facilities outside the USA before?
4. Is the primary problem related to the type of facility or to the location?

With some answers to these basic questions, you may be able to get more pertinent input from The Cove members.

I note your organization was registered to the 1994 version of ISO. Have you updated to 2000?

[Jimmy Olson]

Hi Wes,

Not entirely sure where you got the information, but it's not accurate.

We are a contract manufacturer of circuit board assemblies and currently only have the one facility (located outside of Seattle). We have also been registered to 9001:2000 since October of 2002.

[Wes Bucey]

Originally Posted by Richard Olson

Hi Wes,

Not entirely sure where you got the information, but it's not accurate.

We are a contract manufacturer of circuit board assemblies and currently only have the one facility (located outside of Seattle). We have also been registered to 9001:2000 since October of 2002.

Your organization's web site says:
"A Focus on Partnerships

When you work with Applied Technical Services, you really work with us. Emphasizing working partnerships with our customers and OEMs enables us to be more responsive and flexible while delivering a higher quality product at a very competitive cost.

We provide turnkey and consignment manufacturing solutions and both SMT and Thru-hole PCB assembly and test services. You’ll find we offer the skills and expertise of a much larger contract manufacturer, but with the flexibility and service they simply can’t deliver.

Above all we are devoted to quality and we are proud of our quality system which is ISO 9002 certified."

"Turn key" has meaning to me of setting up independent facility for new owner who literally "turns key" to begin operation in new facility.

I based my thought about '94 vs. 2000 on statement "ISO 9002 certified"

What about answers to remaining 2 questions:

1. What is the basic checklist you work with? (for taking on any new product line)
2. Is the primary problem related to the type of facility or to the location?