Is there an FDA requirement for a Supplier Audit Schedule

[Bunny]

Is there an FDA requirement for a medical device manufacturer to have a supplier audit schedule in place? If yes, please point me to the requirement.

 

[mdurivage]

Re: Supplier Audit Schedule

There is not a direct requirement, but it does demonstrate that there is a plan. Additionally, it would be difficult to explain to an inspector/auditor that you do not have an audit schedule in place.

 

[Bunny]

Re: Supplier Audit Schedule

Having annual supplier assessment programs are not enough.

 

[mdurivage]

Re: Supplier Audit Schedule

If you have an annual supplier assessment program in place, the assessment process should/could lead to the development of a supplier audit schedule.

 

[Bunny]

Re: Supplier Audit Schedule

What would occur in the event that many of the suppliers are not audited as indicated by the schedule? I foresee that resource constraints would not allow some audits to take place. Would that cause a problem with the investigator?

 

[mdurivage]

Re: Supplier Audit Schedule

Lack of resources is not an acceptable excuse and should never be verbalized to an inspector. If you use a risk based approached and use supplier quality metrics to review/grade your suppliers as a method to develop you audit schedule you should be fine. If you miss an audit due to a scheduling conflict (on your end or the suppliers) document the reason and reschedule.

 

[Bunny]

Re: Supplier Audit Schedule

OK, thanks.

 

[SuperGirl]

Re: Supplier Audit Schedule

I don't be believe you have to audit all your suppliers in the sense of "Hey, we're here to audit you". Do you inspect parts or what ever the suppiler supply as is arrives? If so, are you not doing a sort of "audit" of the suppiler that way?

 

[Bunny]

Parts inspection is just that - parts inspection. It is not a supplier audit.

 

[SuperGirl]

Not necessarily, Section 820.50 (Purchasing controls) states

Each manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.

(a)Evaluation of suppliers, contractors, and consultants. Each manufacturer shall establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants. Each manufacturer shall:

(1) Evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements. The evaluation shall be documented.

(2) Define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results.

(3) Establish and maintain records of acceptable suppliers, contractors, and consultants

So, you set up your inspection to ensure the supplier is supplying the correct parts and you have defined this to be the extent of your controls (and can justify based on risk), that is all you have to do.

We have many suppliers that we do not “audit”, but we evaluate and have controls set up to satisfy the requirement. It's all about making the system work for your company.