ISO 13485 Supplier Monitoring Minimum Requirements

[andesite]

Hi,

I was wondering if anyone would be able to help. I've just become involved with supplier monitoring for a 13485 compliant company for the first time. The system in place was not being used as people found it too difficult to get the information from various departments due to the time it was taking to gather the info. I'm looking to strip the system back to the most basic requirements possible as we need to be doing something instead of avoiding it.

We've started just trending the number of SCARs raised against each supplier every month, eventually we'll be looking to use PPM instead but this is step one. What are the other things which have to be considered as the most basic supplier monitoring system? We do perform initial supplier surveys/audits and hold the ISO certs, but the standard seems to imply we need to do more than just the number of SCARS and the preliminary steps. There are lots of great spreadsheets for scoring on here, but ideally we'd like to avoid aspects such as deliveries etc as we want the most basic system possible for the time being, until it is being used routinely and then we can develop it.

Any guidance would be much appreciated as I don't want to get pinged on an audit for not having an adequate system in place (or an adequate system that isn't being used...).

Thanks a lot =)

[SteveK]

Taking about going back to basics, in the first instance what do your procedures say?

Clause 7.4.1 “The organisation shall establish documented procedures to ensure that purchased product conforms to specified purchase requirements.”

You can obviously modify these to reflect what you actually do, but you will certainly be ‘pinged’ in an audit if you are not following written procedures.

I hope this is relevant!

Steve

[somashekar]

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In Reply to Parent Post by andesite

Hi,

I was wondering if anyone would be able to help. I've just become involved with supplier monitoring for a 13485 compliant company for the first time. The system in place was not being used as people found it too difficult to get the information from various departments due to the time it was taking to gather the info. I'm looking to strip the system back to the most basic requirements possible as we need to be doing something instead of avoiding it.

We've started just trending the number of SCARs raised against each supplier every month, eventually we'll be looking to use PPM instead but this is step one. What are the other things which have to be considered as the most basic supplier monitoring system? We do perform initial supplier surveys/audits and hold the ISO certs, but the standard seems to imply we need to do more than just the number of SCARS and the preliminary steps. There are lots of great spreadsheets for scoring on here, but ideally we'd like to avoid aspects such as deliveries etc as we want the most basic system possible for the time being, until it is being used routinely and then we can develop it.

Any guidance would be much appreciated as I don't want to get pinged on an audit for not having an adequate system in place (or an adequate system that isn't being used...).

Thanks a lot =)

You have two things up to be done, and both are simple.
1) Supplier re-evaluation
2) Control over out-sourced process

For the first, records of supplies having met your requirement regularly does a big help. In case of corrective actions requested from suppliers, your assessment of his good and sound corrective action, followed by its effectiveness monitoring over various supplies will do.
Other things like periodic supplier audit, third party test lab use for verification, and such other can support if you have included them into your supplier re-evaluation methods. Supplier rating score in terms of performance (Typically weighted score of Quality, Delivery, Pricing) is also practiced by several organization and if this is scientifically done it can be useful and meet the requirement of supplier monitoring. However this is not a requirement within the ISO13485 / ISO9001.

For the other, we have adopted an Input >> Output approach with such suppliers.
We state what inputs we provide for the out-sourced process and what specific activities must be performed by the supplier in order to process our job (Ex, Process Validation, Calibration, Deployment of well trained personnel, .. etc etc) and along with the processed part delivery the other outputs like records of product release, Batch process control records, trace-ability records are also sought. We also do have some periodic controls like, the valid QMS certification, Third party test report of some process consumables quality that are critical to our product, and more.

For both you need to define the requirement based on this:
The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product.

Which goes to say that you must not copycat your same control across all your suppliers and purchased products blindly without applying the risk based reasoning.

[Deep Krothapalli]

Clause 7.4.1 “The organisation shall establish documented procedures to ensure that purchased product conforms to specified purchase requirements.”

Also- consider performing part qualifications (supplier process qualification, beyond first article) prior to bringing each part into your system.