Implement FAI process in my Incoming (Receiving) Inspection Procedure

[Pierrot]

Hello everyone,

I'm really not familiar with Elsmar yet (I'm new here ), so I don't know if I have this question posted in the right spot...I hope so!

So, I'd like to implement a FAI process in my incoming inspection procedure and I'd like to be helped here. We're certified ISO 9001+13485 and we work in a medical field (implantable or not) with mechanical parts (titanium) and/or electronics modules.

My queries are:
- On which kind of articles shall we apply the FAI process: for all parts (including basic components as metallic frames, resistors, capacitors…) or only for the manufactured parts?
- What is the best frequency: shall we apply the FAI process only when we receive the first delivery or shall we do this process on the three first deliveries? On prototypes or on validated parts by our R&D?
- Do you agree with me if I say: the supplier, upon our request, shall send us a complete FAI report? That means we "just" validate this report and perform in parallel a 100% mechanical measurement on one part?
- Who is in charge to ask a FAI report to the supplier : QA department, purchasing departement, R&D department?

Thank you for your help on these many questions. I’m a bit lost…

Have a good end of day,
Pierre

 

[Stijloor]

Hello everyone,

I'm really not familiar with Elsmar yet (I'm new here ), so I don't know if I have this question posted in the right spot...I hope so!

So, I'd like to implement a FAI process in my incoming inspection procedure and I'd like to be helped here. We're certified ISO 9001+13485 and we work in a medical field (implantable or not) with mechanical parts (titanium) and/or electronics modules.

My queries are:
- On which kind of articles shall we apply the FAI process: for all parts (including basic components as metallic frames, resistors, capacitors…) or only for the manufactured parts?
- What is the best frequency: shall we apply the FAI process only when we receive the first delivery or shall we do this process on the three first deliveries? On prototypes or on validated parts by our R&D?
- Do you agree with me if I say: the supplier, upon our request, shall send us a complete FAI report? That means we "just" validate this report and perform in parallel a 100% mechanical measurement on one part?
- Who is in charge to ask a FAI report to the supplier : QA department, purchasing departement, R&D department?

Thank you for your help on these many questions. I’m a bit lost…

Have a good end of day,
Pierre

Can anybody help?

Thanks!

Stijloor.

 

[gholland]

- On which kind of articles shall we apply the FAI process: for all parts (including basic components as metallic frames, resistors, capacitors…) or only for the manufactured parts?

For 'off the shelf' parts you should be able to obtain a spec sheet and get a certification from the supplier that the parts meet the specification. For manufactured parts you would do a FAI and ongoing incoming inspection.

- What is the best frequency: shall we apply the FAI process only when we receive the first delivery or shall we do this process on the three first deliveries? On prototypes or on validated parts by our R&D?

If you do a FAI you would do it on parts that are from the Production process. In other words you can use 'pre Production' parts as long as they use the same control plans and processes they will use when supplying you production parts. R/D and prototype parts typically don't get FAI'd unless your R/D team wants them inspected.

- Do you agree with me if I say: the supplier, upon our request, shall send us a complete FAI report? That means we "just" validate this report and perform in parallel a 100% mechanical measurement on one part?

This would work for suppliers that demonstrate high capability and a excellent process controls. If a supplier demonstrates CpK >1.33 on your inspection points and has process controls in place you are confident in this would work. If they cannot demonstrate such controls or capability you would want to use something like the c=0 inspection methods for lot acceptance.


- Who is in charge to ask a FAI report to the supplier : QA department, purchasing departement, R&D department?

They way it works in our organization is Quality requests it through the purchasing department.

 

[Pierrot]

Many thanks for all your help.

 

[Kira_n]

Hi,

Is it common to use FAI in the medical field or is there another standard procedure?

Regards,
Kira

 

[chris1price]

Hi

There isnt a standard procedure used within the medical device industry. Whether you sample one batch or three is largely up to you and your perceived risk. Ideally you should pass the work back to the subcontractor, however they don't always have the equipment or expertise to work with your requirments. Even the terminology differs between companies, some call it an FAI or FAIR others refer to an ISIR. It frequently depends on past experience and training.

Chris

 

[Pierrot]

Hi Kira,
Initially, the FAI requirement comes from the US standard SAE AS 9100 (Quality Management Systems - Requirements for aviation, space and defence organizations).
But more and more of our medical customers are sensitive to this specific requirement even if it's not included in our used standards (9001 and 13485). This is also not required by the CFR 21 (FDA) part 820 (QSR).

I think implementing a FAI process (or similar which could be adapted to your job and your customers requirements) in the receiving activities for the medical devices is really appreciated by the customers. It will be able to improve your quality level and make the suppliers aware of their responsabilities.

Pierre