Hi Beat Schlumpf, 

Subject: Batch Record Review, Deviations and Change Control, CAPA Corrective and Preventive Action, Deviation & Document Transfer

Any advice as the Pharma company is going through "SHUTDOWN", they are closing the site. What are the most important things one have to take into considerations primarily?
Would appreciate greatly if you could have some lines. Any link, document or knowledge would be highly appreciable.  Thanks in advance

Best regards to you

Saima 

 

Thank you Saima for your request.
Unfortunately I have no additional information.

Beste regards
Beat

 

Hi Beat,

In response to your question, I offer the following:

"ISO makes standards and does not get involved in the certification business." This is the "standard" response to your question. 

I agree that there should be rotation of auditors because after the same auditor continually performs audits on the same auditee, the auditor will become overly familiar to the Management System that he/she audits and most likely will not be able to add much value to the organization audited, or worse, act more as a "consultant."  Also too much familiarity between the auditor and auditee and their Management System may cause a less effective audit result.

Also, to my knowledge the IAF has not imposed any specific rules or restrictions either. 

Regards,
john F. Mascaro, Fellow
ASQ Audit Division
Vice Chair - Technology
 

Thank you very much John for your reply.

Beat
 

You are right, but I would like to point out that the standard that specifies the rules for the work of certifying bodies ISO 17021-1: 2015 and the series of standards that indicate the competence of auditors (ISO  TS 17021-2 up to 10), provide enough basis for regulating these issues as well. It is still important to note that the need for ongoing learning for auditors is a condition and that many changes to the composition of assessment teams can be expected in this regard. As a leading tutor in IRCA and PECB courses for lead auditors with experience of running more than 300 those courses, I point out that this situation is always addressed during the class. If the assessment situation is correct, if the auditors  and the certification bodies, through their training, ensure the achievement of the audit goals, and goals changes in each audit from stage 1 and stage 2, annually surveillance 1 and 2 and recertifications, then this issue is not essential to evaluate the validity and usefulness of certificates in the market.
It is really the responsibility of the certification bodies to take care of these ethical and coral elements of auditing and composition of the aufit teams. What the mantioned standards requires, and why it is not in practice, may be to ask the accreditation bodies and the policies of the certification bodies themselves. In the end, the market knows who is who. If a certified organisation only wants a picture on the wall, not the real improvements to their management systems with standard implementaions, which they basically are used for, then they don't care who audit  them, and are more likely to rejoice the witness by the known autiror, as you declare.
Personally, I think that if the auditgs practices continue with bad tendencies, the certification bodies, or at least some, cut the branch they are sitting on and that will be very vengeful to them, anytime.
 Vladimir Simic

Beat Schlumpf:
In Switzerland,   companies conducting audits use the same auditors for years in the same companies. It is a win-win situation for the certification company (for example same routine over years = less expenses) and for the Company itself (same auditor = high fulfilment rate)

According to my understanding the auditors should be independent and a rotation system should be in place.

The Swiss State Secretariat for Economic Affairs, SECO (accreditation body) confirms that only in EN 9104:2013 / EN 9100, EN9110 and EN 9120, certification companies are obliged under chapter 8.3.8 to change auditors after 2 consecutively  certification cycles.
 
For ISO 9001, there is no obligation to change an auditor after he or she has conducted the audit in the same company 2 or more times.
 
The negative impact in terms of quality is obvious.
 
The question for me is why ISO has not stipulated rotation rules for auditors in ISO 9001?
 
Any clue?