Notified Body CE Project Manager - Worst job ever?

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RobertvanBoxtel

Involved In Discussions
#4
Hi Sam, interesting that you find this "review".

The next line of thought is not directed at you, but at all of us in the QA/RA business.
Experiences with all NB's show that the workload is through the roof. Increased scrutiny of their Competent Authorities (competent by definition..., not hindered by any knowledge on how industry really works), Impact of the joint audits as part of the Dali plan (ancient history - o, no, only 6-7 years ago) --> less NB's, increase qualification requirements, etc etc.

We can all go on and fill in more details here...

As industry, we can also take another point of view and need to realize that we do need their services. How can we ensure that the reduced resources they (NB's) have available, are used more effectively?

Ok, I will give a potential answer: By implementing processes that result in demonstrably compliant dossiers and QMS's. And make that not only the QA/RA responsibility, but the complete company. Don't sent in dossiers that still require addition information or take the approach "let's give it a shot". That's waisting time.

"But management wants us to submit, because we (= Sales/marketing) have already announced this product is almost CE certified". Don't tell me you never heard that before...

If you show your NB that you stick to their timelines, they will stick to yours. And yes, right now, communications can be improved. But not only from the side of NB's...

Easy said, I know, when you have at least found a Notified Body. There still are some accepting clients. Put in the effort to find them. An email to the [email protected] will typically not result in any response.

Concluding, all, stay positive, explain to management why more time is needed and continue to work your magic. Internally and towards NB's.

Regardless of how they can be a pain in the A.S.S., we need them. Hopefully they need us too...
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#5
Until the trend of commoditizing conformity assessment services is reversed, it will always be an uphill battle for CAB's (Conformity Assessment Bodies) to be able to attract high caliber talent in enough quantity to deal with the timeliness and service level expectations of all stakeholders involved.

Let's keep in mind that, to a great extent, the current crunch is due to a perceived lack of confidence by some key stakeholders.

Until CAB's understand their "product" should be CONFIDENCE and not certificates, and be prepared to develop business models that attract and retain the type of talent they need, in a profitable way, this challenge will remain and a lot of pain and angst will be a constant.
 

Randy

Super Moderator
#6
Well totally not my experience, but then I was in a different cost center. Yeah we had long hours that exceeded the 8 hours that could be logged per audit day (totally BS and unrealistic in some cases but those are the rules), but health and alcohol issues are individual choices so the folks going in probably had sorry health patterns to begin with.

Pay? I started very high 5 figure in 2004 and when I quit being a full-timer I was in the mid 6's (still low 6's as a part time contracted person)

I don't know what the educational expectations are but the company in question had me trained up to audit and teach - AS9100, AS9110, BSI 16001, OHSAS 18001, RCMS & RC14001, ISO 50001, ISO 22000, and GHG Verification along with some others.

I don't know the writer of the article but from my perspective they probably never had any honest adversity in their past to deal with, as for me, if they ain't shooting at me, it's all good.
 

somashekar

Staff member
Super Moderator
#7
Its same for all Notified Bodies, however its actually their own mistake. They had given lots of bad companies CE mark... Now they are trying to clean their mess.
As long as the scheme is NOT based on TRUST and relies on a mark by an other contractual body (the NB), disaster is eminent.
The more you tighten the noose around the contractual body, the more difficult the customer feels, still missing the TRUST in the complete process.
There were a lot of takers for the "CE for sale" around the globe, just because it was offered. The contractual body was never accountable but only responsible. The customer shifted the accountability to the NB without understanding the scheme in total.
Disaster....
EU will never learn the FDA way.
 
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