Trusting ISO 13485 Certification of a Supplier... A Sad Story

[MIREGMGR]

As much as we want to trust our government agencies, sometimes they mess up. I seem to recall a case (very fuzzy details) about a company in the southwest USA which fought FDA over some issue and won. Is this the one I'm thinking of? Scott Catron followed it pretty closely.

I have no knowledge of the Utah Medical situation, but I do note that they are PR oriented. They for instance issued this press release in 2010, announcing that they had passed their first FDA QSIT inspection after conclusion of the lawsuit.

On balance, I think I'd rather have an uneventful relationship with FDA, instead of being in court with them.

 

[Reg Morrison]

And who oversees that these audits are doing what you say?

That's a good question and I hope you get an answer.

But, if the audit client (the customer of the audited organization) sees value in the audit findings (positive and negative) and results and keep re-hiring the organization to perform additional 2nd party audits on their behalf, it could be an indication that the auditing organization is doing a good job.

On the other hand, if the audit client outsources these 2nd party audits, simply because they are cheap and "generate a record" of supplier oversight that can be filed and shown to regulatory agencies and external parties, when requested, the audit client will force the auditing supplier to continually "lower their prices", potentially leading to a downward spiral of the qualification and competence of the auditors performing this type of work.

In my opinion, 2nd and 3rd party audits are not mutually exclusive and both can be beneficial.

 

[AndyN]

Agreed, Reg. My only observation is that, from years of being here at the Cove, the 2nd party process (with their auditors) is broken more badly than anyone claims the 3rd party process is...

 

[Wes Bucey]

Agreed, Reg. My only observation is that, from years of being here at the Cove, the 2nd party process (with their auditors) is broken more badly than anyone claims the 3rd party process is...

I don't have my own dog in this fight, but I feel qualified to comment.

First point: Is there anyone who argues that certification/registration (regardless of the registrar identity) is anything more than someone attesting the auditee has met the MINIMUM standards for meeting a Standard?

Second point: Almost every 3rd party auditor says up front they monitor "processes," NOT "products," so customers who require suppliers to get 3rd party audits STILL have no idea whether the products will meet customer requirements even if the supplier is certified/registered.

Third point: There are "some" (very few) non-registrar auditing firms that purport to monitor product quality as well as process quality, but (to my knowledge) no surveys of the clients of such firms exist to assure product quality has improved (at a net savings of cost of audit versus cost of poor quality) to justify hiring such non-registrar auditing firms.

Fourth point: Has anyone knowledge of the REAL reasons organizations hire [what are for all intents and purposes] temporary workers to audit suppliers instead of assigning their own full time staff? (Do such clients really use the data gathered in evaluating a supplier or is it just as Reg Morrison suggests "because they are cheap and "generate a record" of supplier oversight that can be filed and shown to regulatory agencies and external parties"?)

Fifth point: Anecdotally, from my own personal experience and by no means suggesting it is workable for the average customer organization, I have hired "specialists" on an ad hoc basis to investigate and monitor CRUCIAL suppliers once a contract was issued when it was logistically impossible for me or one of my employees competent enough to perform the task to be present during the necessary time window. I consider this a variation of the method the Department of Defense used to monitor defense contractors. These specialists monitored ONLY those aspects of a supplier which directly impinged on products we bought, not their other business. Thus, we scrutinized raw materials (source, analysis, traceability), production methods and control plans, in-process inspection, in-house process for root cause analysis and corrective action if and when a nonconformance was detected.

Stuff like licenses, union contracts, financial stability, etc. were all checked and vetted BEFORE we signed a contract and were not part of the purview of the on-site investigator/monitor (not auditor) and we expected much more than a "snapshot" of this crucial supplier from the specialist. We empowered this specialist to act in our behalf to halt production of our product if, in his opinion, events went beyond parameters we MUTUALLY established with the supplier. Make no mistake, we discussed and negotiated this oversight as part of the contract with the supplier. We never would have thought of arbitrarily imposing it unilaterally.

Where did I get these "specialists?"
Almost all were either independent consultants or retired specialists known personally to me to be qualified for the particular industry they would monitor. Some of the retired ones, in fact, worked ONLY for me, partly as a personal favor and partly for the extra spending money. Another factor was they were headquartered close to the supplier so extra expenses for travel and lodging were minimal. One important attribute was they had no Kwality Kop attitudes - they were introduced to and viewed by suppliers as an important resource to help in resolving issues, not creating issues.

 

[Ronen E]

Second point: Almost every 3rd party auditor says up front they monitor "processes," NOT "products," so customers who require suppliers to get 3rd party audits STILL have no idea whether the products will meet customer requirements even if the supplier is certified/registered.

This "point" undermines the entire concept of QMS standards. The base premise is that adequate QMS will, over time, get requirements defined and products / services aligned with such defined requirements.

In the real world, even sound QMS hardly ever guarantee products will meet 100% customer requirements, but QMS state does give "some idea" about whether or not customer requirements are likely to be met. Actually, IMO a pretty good idea.

Cheers,
Ronen.

 

[Wes Bucey]

This "point" undermines the entire concept of QMS standards. The base premise is that adequate QMS will, over time, get requirements defined and products / services aligned with such defined requirements.

In the real world, even sound QMS hardly ever guarantee products will meet 100% customer requirements, but QMS state does give "some idea" about whether or not customer requirements are likely to be met. Actually, IMO a pretty good idea.

Cheers,
Ronen.

Yep. Second point DOES undermine the concept because "some idea" is NOT assurance. In the ten years and more that I've been reading and contributing to the Cove, we continually see threads pop up where customers and even employees of certified/registered suppliers decry the fact they have a certificate on the wall and yet they ship dreck out the door or, worse, have high internal reject rates.

I recall being a crank here in the Cove about a stainless steel teakettle I bought which looked super slick enough for me to plunk down money to own it only to find out the manufacturer had used a plain steel (1214 - I had it chemically analyzed) bolt to fasten the heat proof knob to the lid. Within 2 weeks in the steam and heat, the bolt had corroded to the point where oxide flakes were dropping into the pot.

Investigation revealed the company manufacturing the tea pot did, indeed, have ISO 9001 registration from a reputable registrar. I, of course, did not pre-condition my purchase on the registration status of the manufacturer, but I presumed the department store chain where I purchased it had done a due diligence of its suppliers. Some chains flex their economic muscle on manufacturers to meet "price points," forcing the manufacturers to seek ways to lower their costs. In the case of the kettle, they may have supplemented their profit by saving a penny or two on the bolt. The department store chain purchasing departments rarely have the level of expertise to ferret out some item like that and, even so, the original PPAP samples may have had stainless steel bolts. Specialists like the kind I hired would never be employed to monitor a commodity item like a teapot and so the scam continued. Most consumers would not have the resources or even think to look for them because of a rusty bolt - they'd just start over. For me, if I buy another stainless steel commodity like the tea pot, I'll examine the components MUCH more closely before purchase and either forego purchase or make preemptive replacements before use, depending on a cost-benefit analysis.

What's the bottom line solution?
Customers must be vigilant. A former President of the USA had a wonderful sound bite:
"Trust, but verify!"

 

[MIREGMGR]

The department store chain purchasing departments rarely have the level of expertise to ferret out some item like that and, even so, the original PPAP samples may have had stainless steel bolts.

True for a narrow-regional store. Not enough power over their suppliers.

Not true for the modern mega retailers: Walmart/Costco/Target and the like, and regional merchandising powerhouses like Meijer in the Midwest or Macy's.

They actually keep track of returns and quality issues. Computerization makes that possible. If they introduce an item and three weeks later they have a ten percent complaint rate, action happens at the supplier end if the supplier wants to do any more business...and with supplier reduction programs, usually the ongoing suppliers very much want to do more business.

That's an example of how bigger customers cause better quality.

 

[Wes Bucey]

Sadly, like most consumers, unless it's a big ticket item like a major appliance or an auto, I didn't complain to the store. That damn teapot cost $25.00. I didn't complain to the store (one of which you named in your list), but neither have I ever bought anything from that store again. Their loss, not mine. My take away was simply that I am a much more circumspect shopper (as OEM customers should be when selecting and continuing to do business with their suppliers.)


This is off topic of ANYTHING to do with medical devices, but I was surprised to learn of an unintended consequence of Honda implementing a special kind of motor mount as a "safety measure" so in collisions, the motor would drop down to the street and not smash into the passenger compartment. The unintended consequence is that these motor mounts are deteriorating badly and a large number require replacement at around the 100,000 mile mark. That's an expensive surprise labor cost for a vehicle that otherwise seems to satisfy owners. So far, Honda (according to internet chatter) is treating these as "expendable" in the same category as brake pads, drive belts, coolant hoses, windshield wipers.

 

[John Broomfield]

The Kitemark is an exception. Conformity assessment of the product and of the system that produced it.

 

[Wes Bucey]

As I wrote (see highlighted word):

"Third point: There are "some" (very few) non-registrar auditing firms that purport to monitor product quality as well as process quality, but (to my knowledge) no surveys of the clients of such firms exist to assure product quality has improved (at a net savings of cost of audit versus cost of poor quality) to justify hiring such non-registrar auditing firms.
​

In regard to Kitemark, is it substantially different from the Good Housekeeping Seal of Approval wherein advertisers had their goods essentially "insured" by the magazine where they placed paid advertisements because the magazine "guaranteed" satisfaction or money back? It still doesn't answer the issue of whether the quality is actually better from a cost standpoint or just a good marketing ploy to allow charging higher prices for the "guaranteed" product? (the higher price essentially an insurance premium for assurance of replacement or money back, but no real guarantee the product will outlast or outperform a competitor at a lower price.)

[color me cynical, to say the least :]