Can the Registrar add an Observer without client approval?

[SGquality]

We have an ISO 13485 audit next Tuesday. The audit plan was provided earlier but just this morning, they emailed a new audit plan and added an "Observer".

I know this is wrong and observers cannot be added without the approval of my organization as a client.

Am I correct? Are there are any requirements on how observers can be added to the audit?

 

[Sidney Vianna]

You should clarify who this person is and their role. Normally an observer is an auditor in training and s/he observes the audit team in action to get acquainted with the protocols. In principle, the registrant can refuse the observer participation in the audit, but few organizations object to that.

 

[Randy]

You should also check your contract, if it's an accreditation body observer like an ANAB witness auditor and you refuse your certification could be at risk.

 

[Ed Panek]

I have had observers on my audit however I request they don't interject commentary or feedback on items. 4 eyes are better than 2 and I would be apprehensive if the auditors were each asking questions.

 

[Sidney Vianna]

That’s why I mentioned the need to clarify this individual role in the audit. When I was involved in CB operations, the OJT for auditors required a minimum of 3 observation audits; the first one was a passive, voyeuristic role, not able to ask questions, nor interject in the audit progress at all. The second observation audit demanded some small active participation as an auditor, just to get their feet wet and under close monitoring of the audit team leader or assignee. The third observation audit required the individual to perform significant active auditing, still under close monitoring.

We never sprung this type of surprise onto the auditees and an observer presence and participation in the audit was always communicated and approved with the client beforehand. In this day and age of COVID-19, anyone can be an infection vector and you want to minimize potential exposure.

 

[Chrisx]

When I worked for a notified body, it was a constant issue that auditees did not want to participate in a witness audit. They do not want the additional scrutiny of another regulatory agency at the audit, even if they are not to participate in the audit. Also, auditors sometimes behave differently during witness audits. This should not be the case, but unfortunately does happen.

In the end, the notified body has no choice. They must allow for witness audits. It is also no different for registrars. IMO, industry needs to accept that this is the reality of regulated industry. There is always going to be an organization that regulates the notified bodies. If you want to be certified by accredited organizations, then you have to accept someone has to audit the auditors. The only alternative is certificates from agencies with no accreditation and no oversite. Is that really in the best interests of the industry?