Incomplete Unannounced Audit - No Active Production at the time

[Mor628]

Hi all,

Has anyone experienced the following scenario with unannounced audits?

We recently had our NB send 2 auditors to audit our OEM. Upon arrival at the manufacturing site, the auditors were told that the production of they device they intend to audit was already at the end stage (printing and packaging).

Because of this, they decided not to conduct the audit, had a brief look around the site and left.

Our NB then called and told us that they will need to re-audit the facility during active production of the medical device because the audit could not be completed, and the we will have to bear the cost.

This seems utterly ridiculous to us, because they could have at the very least checked on the documentation of the current production.

Any thoughts?

 

[paulag]

Re: Incomplete Unannounced Audit

Hi all,

Has anyone experienced the following scenario with unannounced audits?

We recently had our NB send 2 auditors to audit our OEM. Upon arrival at the manufacturing site, the auditors were told that the production of they device they intend to audit was already at the end stage (printing and packaging).

Because of this, they decided not to conduct the audit, had a brief look around the site and left.

Our NB then called and told us that they will need to re-audit the facility during active production of the medical device because the audit could not be completed, and the we will have to bear the cost.

This seems utterly ridiculous to us, because they could have at the very least checked on the documentation of the current production.

Any thoughts?

Hi,

A German notified Body said in an article that manufacturers where supposed to inform them about production stop times of their medical devices . Not sure though if the Regulation says so, or only that specific NB?!

 

[Mor628]

Re: Incomplete Unannounced Audit

When we filled out the questionnaire, we were told to specify the exact address of the manufacturing sites and working/shift hours. And production only occurs when there are orders, therefore there isn't a specific timeline we could give them, nor did they ask before heading over.

 

[Edward Reesor]

Re: Incomplete Unannounced Audit

From the TUV website on Unannounced Audits FAQ:
"Does the manufacturer need to inform TÜV SÜD of OEM shutdowns?

No. To date, there has been no official requirement established for the manufacturer to provide this information.

During routine audits, auditors would routinely assess which of the manufacturer’s OEM might be good options for unannounced audits and may ask for the shutdown information for those particular suppliers."

Reading the legislation on Unannounced Audits, at the end in Annex III, on the very last page of the document it states, "The contractual arrangements should foresee that the manufacturers continuously inform the notified bodies on the periods when devices falling under the notified bodies’ certificates will not be manufactured. The contractual arrangements should authorise the notified bodies to end the contract as soon as their permanent unannounced access to the premises of the manufacturer or its critical subcontractors or crucial suppliers is no longer assured."

From reading the above, I would suggest you see what your contract states. I believe ours states that we inform when the company and/or manufacturing plant has operating hours or is closed for vacation, holidays, etc. I will now have to re-read the contract to see if it includes when manufacturing actually takes place.

Thanks for the heads up.

 

[Ronen E]

Re: Incomplete Unannounced Audit

Hi,

A German notified Body said in an article that manufacturers where supposed to inform them about production stop times of their medical devices . Not sure though if the Regulation says so, or only that specific NB?!

It's definitely not in the regulation, which is very short and general regarding unannounced audits.

 

[Sidney Vianna]

Re: Incomplete Unannounced Audit

Reading the legislation on Unannounced Audits, at the end in Annex III, on the very last page of the document it states, "The contractual arrangements should foresee that the manufacturers continuously inform the notified bodies on the periods when devices falling under the notified bodies’ certificates will not be manufactured. The contractual arrangements should authorise the notified bodies to end the contract as soon as their permanent unannounced access to the premises of the manufacturer or its critical subcontractors or crucial suppliers is no longer assured."

It's definitely not in the regulation, which is very short and general regarding unannounced audits.

I am not fully versed in the regulatory regime for this, but as stated by Edward Reesor, the text comes from an ADOPTED recommendation. So, are adopted recommendations, mandatory legal requirements? In my experience dealing with Accreditation Bodies, if CB's disregard their "suggested practices" as the text contains terms such as "should" rather than "shall", as recommendations are supposed to be phrased, they must be prepared to defend their positions, if they don't adhere to the guidance, at the risk of being written up, during oversight audits.

 

[Ronen E]

Re: Incomplete Unannounced Audit

I am not fully versed in the regulatory regime for this, but as stated by Edward Reesor, the text comes from an ADOPTED recommendation. So, are adopted recommendations, mandatory legal requirements? In my experience dealing with Accreditation Bodies, if CB's disregard their "suggested practices" as the text contains terms such as "should" rather than "shall", as recommendations are supposed to be phrased, they must be prepared to defend their positions, if they don't adhere to the guidance, at the risk of being written up, during oversight audits.

From the same document:

1. PURPOSE

To facilitate the consistent application of the conformity assessment provisions contained in Directive 90/385/EEC, Directive 93/42/EEC and Directive 98/79/EC, the notified bodies should apply the provisions of this Recommendation when they perform product assessments, quality system assessments and unannounced audits.

By providing general guidelines for such assessments and unannounced audits, this Recommendation should facilitate the work of the notified bodies as well as the Member States’ evaluation thereof. This Recommendation does not create any new rights and obligations. The legal requirements applicable to all types of devices and conformity assessments are set out in the Union legislation on medical devices.

(Emphasis added)

 

[Sidney Vianna]

It seems to me that, during oversight audits of NB's, by DA's or Joint Audits, NB's would have to demonstrate close conformance with such adopted recommendations. The level of prescriptiveness is, obviously, much higher than in the actual regulations, and it is a byproduct of of the fact that not all NB's take their jobs with the same level of seriousness, professionalism and ethics, as I stated in the Independence on Notified Bodies thread.

What many people fail to understand is the fact that some Conformity Assessment Bodies don't think long term, don't understand the need to provide confidence and assurance for their survival and prosperity. They are in the business for short term profits, doing as little as possible in order to maintain their credentials and ride the "low cost approach" to certification. As I have been stating now for 23 years, the trivialization of the certification business puts it's long term survival at risk.

 

[Ronen E]

It seems to me that, during oversight audits of NB's, by DA's or Joint Audits, NB's would have to demonstrate close conformance with such adopted recommendations. The level of prescriptiveness is, obviously, much higher than in the actual regulations, and it is a byproduct of of the fact that not all NB's take their jobs with the same level of seriousness, professionalism and ethics, as I stated in the Independence on Notified Bodies thread.

What many people fail to understand is the fact that some Conformity Assessment Bodies don't think long term, don't understand the need to provide confidence and assurance for their survival and prosperity. They are in the business for short term profits, doing as little as possible in order to maintain their credentials and ride the "low cost approach" to certification. As I have been stating now for 23 years, the trivialization of the certification business puts it's long term survival at risk.

Regardless of whether I agree with you, I think we're straying away from the original topic. To me, the original topic was a NB apparently harassing a Manufacturer on the basis of a Commission Recommendation (that doesn't place additional legal requirements on the Manufacturer) at best, making unreasonable demands that are apparently not even founded on contractual arrangements or previous communication. Why the NB is doing what it's doing in this case is irrelevant to the manufacturer; it can't serve as a justification for unfounded demands. If the NB is at fault with the legislation / guidance / overseeing authority that govern its conduct, it is the NB's responsibility to rectify it without causing its clients undue trouble.

The fact that there are substandard NBs should not justify regulatory creep and unlimited power to other NBs (or even overseeing authorities) to place upon Manufacturers requirements that are not legally well-founded. There are reasons why the Council and the Parliament (not the Commission) issue Directives and Regulations, and why in certain cases the Commission issues Recommendations rather than Decisions. Further, even if a recommendation to have certain contractual arrangements in place is treated as "de-facto regulation", it should not mean an ultimate power to demand what would have been in such contracts where in fact no such arrangements were made. If all this is ignored the entire legislative process's point is missed.

 

[Sidney Vianna]

it is the NB's responsibility to rectify it without causing its clients undue trouble.

If the rectification requires additional oversight of the medical device manufacturer, there is no other way.

The fact that there are substandard NBs should not justify regulatory creep and unlimited power to other NBs (or even overseeing authorities) to place upon Manufacturers requirements that are not legally well-founded.

Again, I clearly see the parallels of what is happening with increasing prescriptiveness of the Notification Body "rules of engagement" and the accredited certification of management system process. When accreditation was developed in the early 90's, we had a very high level set of requirements for CB's: ISO Guide 62 for QMS and ISO Guide 66 for EMS, followed by ISO guides for the Guides 62 and 66, ISO 17021, revised several times, with ever increasing levels of prescriptiveness, IAF Mandatory Documents, Informative Documents, accreditation bodies heads up's, accreditation rules, heavily augmented accreditation requirements for sector specific standards, such as the IAQG 9104-1, -2, -3, IAQG 9101, etc, the IATF Rules for Certification, etc....

If Conformity Assessment Bodies decide to exploit loopholes to make their lives easier, the amount of prescriptiveness imposed onto them will only increase to close such loopholes.

Some of the manufacturers might end up as innocent victims and endure the pain of having to fulfill requirements they were not envisioning, but, at the end of the day, some manufacturers were complicit in demanding easy paths to certification, encouraging CAB's to find the loopholes mentioned above, resulting in higher prescriptiveness and controls for all. Welcome to the wonderful world of "REGULATED INDUSTRY".