I've lurked on the forum for quite awhile and gone through the forum threads several times. I haven't seen this issue discussed and am really in a jam. Help, help, help.

I recently took a supplier quality position with a well-established medical device company. The position is a direct report to the purchasing buyer (?) not the quality director, materials director, or engineering. The purchasing buyer has no interest in or understanding of the FDA, ISO, CMDR or MDD/AIMD requirements for control of purchasing functions within a medical device company. :mg: Oh-kay...

The previous individual in the position I took had begun developing metrics for monitoring and evaluation of suppliers, but became frustrated and left the company. The metrics were not consistently assessed, nor were they implemented for all suppliers. Most of the metrics are macros in Excel that are either broken or not available (were stored on the C drive and wiped off the harddrive before I started). He had developed a scorecarding system including receipts review, failure/ faulty delivery review, top spend, and sole sources. Probably would have been a great system. But I can't make it work and no one else in my department has the expertise.

My questions to the body of knowledge that is the Cove:

Who does your supplier quality rep. report to?
What should I do for metrics? And how?

Any info/ help/ would be appreciated!

I've lurked on the forum for quite awhile and gone through the forum threads several times. I haven't seen this issue discussed and am really in a jam. Help, help, help.

I recently took a supplier quality position with a well-established medical device company. The position is a direct report to the purchasing buyer (?) not the quality director, materials director, or engineering. The purchasing buyer has no interest in or understanding of the FDA, ISO, CMDR or MDD/AIMD requirements for control of purchasing functions within a medical device company. :mg: Oh-kay...

The previous individual in the position I took had begun developing metrics for monitoring and evaluation of suppliers, but became frustrated and left the company. The metrics were not consistently assessed, nor were they implemented for all suppliers. Most of the metrics are macros in Excel that are either broken or not available (were stored on the C drive and wiped off the harddrive before I started). He had developed a scorecarding system including receipts review, failure/ faulty delivery review, top spend, and sole sources. Probably would have been a great system. But I can't make it work and no one else in my department has the expertise.

My questions to the body of knowledge that is the Cove:

Who does your supplier quality rep. report to?
What should I do for metrics? And how?

Any info/ help/ would be appreciated!Excuse me for saying this, but it seems the entrenched powers that be have relegated you to a position similar to what we called an "expediter" back in the 60's and 70's.

In many organizations today, the goal is for SQA (supplier quality analyst/auditor) to be an arm of BOTH the Quality and Purchasing departments. The SQA (in an ideal world) is the eyes and ears of the organization in approval of new supplier candidates, checking on QMS researching "buzz" and rumors about quality of products, service, and responsiveness to inquiries.

He maintains the track record of each supplier under his scope for on-time delivery, quality (at incoming inspection, at supplier inspection, on the production line, etc.) and time and completeness of resolution of any "issues" which may arise. (there are off-the-shelf software programs that make this easy for multiple suppliers and product lines.)The SQA "hammer" is always the implied threat of having Purchasing pull the plug on continuing business for "cause." The SQA relies on Quality and Production to tell him how well the supplier performs for data to enter in his charts. Typically, the SQA is the public face of the customer for most suppliers, so the position requires a certain political sophistication in walking the line between keeping suppliers working as partners and cracking the whip when suppliers have systemic failures.

Who does your supplier quality rep. report to?
What should I do for metrics? And how?

The first question is mostly irrelevant to your predicament unless you think you can change the reporting structure. Your boss needs someone who will support his or her priorities, regardless of how misbegotten those priorities might be. It's not unusual for lazy people to talk out of both sides of their mouths. You might hear quality-related platitudes being regurgitated (Zero defects! We're a customer-centered organization!) while the the person ralphing them has no idea what he or she is talking about, or how to accomplish it, and wants nothing to do with anyone who does. Trying to lead such a person out of the wilderness is probably what caused your predecessor to jump ship, and unless you feel that you're equal to the task yourself, you're probably shoveling poop against the tide.

As for the second question, you need to sit down with your boss and try to get a clear understanding of what he/she considers important, and the best way to measure it. It's not going to help if you count things that your boss thinks don't need to be counted, regardless of how much sense your proposed metrics might make. You're working in a tightly regulated industry, and if the boss doesn't understand the basic requirements, then your first priority is trying to make him understand them, and what you feel you need to be counting in order to satisfy regulations. You need to do the best job you can of collecting and parsing the data, and making sure that the people who need to know see the results. What they do with it is, ultimately, their business.

Thanks, Jim and Wes. I learn everyday here.

1. Is this an FDA regulated industry, and have you already received approvals on something? Then, chances are, there has been some form of supplier audits prepared previously.

2. Do you have an approved vendor list? That may be a good start. If you don't have one, I would think that would be a great start. If you have one, you need to compare it to the suppliers you are already using.

These medical devices-is there any design control/design review at your organization? Maybe there is something there to help you.

I'm just kinda brainstorming here to see if there is something you could start off with.

Thanks to you all for your replies!

Mr. Bucey - Your post definitely calmed my raging spirits, thanks for putting it all in perspective. I'd never heard the term "expediter" in this context.

Mr. Wynne - I may be able to change things quite a bit because there have been multiple internal and 3rd party audit findings about the supplier qualty program failing to keep adequate records, address the requirements of the standards, and oversight of the program. There is a CAPA open to address the failings of the program. Plus, I have some buy-in within the company at a higher level. Unfortunately the mgr doesn't know enough or care enough to ralph out the cliches. I am working to get him up to speed, but now just tell him, "because the FDA won't let us sell stuff if we don't do this". And all he cares about for metrics are receiving inspection non-conformances, because we need things (read: tolerances/accuracy/precision) the supplier can't provide (then why are they the preferred supplier?).

BradM - The program is in place, it just hasn't been maintained for a long time. Everything (supplier info including approved and qualified vendors) is current now. I'm traveling a lot to make up the audits that need to be done. I did find a contact within the company to help me sort out the existing metrics, so I am hopeful on that one. The design controls program idea was a good one.

Once again, thank you all very much for your input!