Supplier Audit Form for Purchasing Controls

[medguy123]

I have viewed numerous supplier auditing forms online which seem impractical... requesting org charts, employee shift schedules, etc. We are a small company, and need an audit form which our vendors will actually complete and meets CFR requirements. Any suggestions?

Thanks!

 

[Ronen E]

I have viewed numerous supplier auditing forms online which seem impractical... requesting org charts, employee shift schedules, etc. We are a small company, and need an audit form which our vendors will actually complete and meets CFR requirements. Any suggestions?

Thanks!

Hi,

21 CFR 820 doesn't specify the supplier evaluation requirements. It's up to you to set and document them:

Subpart E--Purchasing Controls

Sec. 820.50 Purchasing controls.
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.

(b)Purchasing data. Each manufacturer shall establish and maintain data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services. Purchasing documents shall include, where possible, an agreement that the suppliers, contractors, and consultants agree to notify the manufacturer of changes in the product or service so that manufacturers may determine whether the changes may affect the quality of a finished device. Purchasing data shall be approved in accordance with 820.40.

If you'd like that, I can prepare a supplier questionnaire for you.

Cheers,
Ronen.

 

[AMIT BALLAL]

Define minimum things you want your supplier's quality management to have in place / maintain.

These can include (but not limited to):
Receiving, Inprocess, final inspection. Process qualification , actions on rework / rejections (Corrections at-least), fixture validation, calibration, etc.

You know your suppliers best, so best person to define those points is you & no one else.

Minimum & easy the points are, you will be able to monitor QMS of your suppliers & may provide help for their QMS development. Otherwise you will end up raising & closing the NCs only, regardless of what you need.

You can also prepare a time-based plan about what will be your next scope once the points defined in your supplier audit check-sheet are achieved & maintained (Sustained).


Thanks,
Amit