Internal Auditing Resource Conflict of Interest

D

Dale S

#1
Hello all, I have a question. We are a small company and due to the econonmical times even smaller. We are ISO 13485 certified but are struggling to maintain compliance during internal audits due to conflict of auditing one's own work, plus the unavailability of outsourced audits that are familiar with 13485. I know there were discussions at one time about the MR doing the complete audit, but I don't completely understand how that works. What are the benefits of the MR doing the complete audit and what are the pitfalls. Any help would be appreciated!:thanx:
 
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A

adickerson

#2
I would contact your local ASQ chapter and ask if anyone would be interested in getting audit experience to 13483. I know a lot of quality people are looking to change industries or expand their auditing experience and Medical Device seems more desirable then a lot of the others. Your company may be able to set up a relationship with another company where every 3 months you leave work for two days to go audit someone and then they come to audit you for two days the following month, or something like that.
 
D

Dale S

#3
Thanks, but that will need to be a long term solution for future audits. I was wondering how I can manage short-term since I am limited by resources. As MR I capable of doing the audits, but there will be areas of conflict I will not be able to complete.
 

John Broomfield

Staff member
Super Moderator
#4
Hello all, I have a question. We are a small company and due to the econonmical times even smaller. We are ISO 13485 certified but are struggling to maintain compliance during internal audits due to conflict of auditing one's own work, plus the unavailability of outsourced audits that are familiar with 13485. I know there were discussions at one time about the MR doing the complete audit, but I don't completely understand how that works. What are the benefits of the MR doing the complete audit and what are the pitfalls. Any help would be appreciated!:thanx:
Dale,

Contacting your local ASQ Chapter is an excellent idea provided the volunteer auditors are properly trained to see how well your management system helps you and your colleagues to determine and meet requirements.

Examine evidence of their certified training in ISO 13485 and auditing. Some volunteers may think this a bit cheeky but stick to your guns.

Another option is to search the RABQSA database for certified ISO 13485 auditors based locally.

You could also make contact with another small medical device company (not a competitor) to occasionally exchange internal auditors.

John
 

SteveK

Trusted Information Resource
#5
Hi Dale,

As the MR and Quality Assurance Manager in a small Medical Device company I understand your problems. I trained up a new internal auditor just before the last NB audit – as the previous incumbent left the company! The person who conducted the internal audit is in charge of the production area i.e. he is the Production Manager. The auditor picked up on this i.e. auditing his own work - argued he did the scheduling - i.e. was not 'hands on'. Did not get a NC and surprisingly he just indicated that I could audit his relevant area (i.e. 7.1 Planning of product realisation). I thought I could not do this as I would be auditing my own work since I wrote the Production related SOPs and the Work Instructions etc – but no he was OK on this. So on the internal audit schedule for next year I now have space for input from two auditors!

Hope this helps.

Steve
 

somashekar

Staff member
Super Moderator
#6
Thanks, but that will need to be a long term solution for future audits. I was wondering how I can manage short-term since I am limited by resources. As MR I capable of doing the audits, but there will be areas of conflict I will not be able to complete.
Go ahead and do the internal audits without much worry. About the audit of the MR function in perticular, have an other trained person audit it and assist him where necessary. A purposeful internal audit is more necessary than any thinking about conflict of interests. Being a part of your organization yourself, conflict of interest does not exist in the sense it is used.
Good luck
 
Q

qualitymanager

#7
Hi Dale,

<snip> I thought I could not do this as I would be auditing my own work since I wrote the Production related SOPs and the Work Instructions etc – but no he was OK on this. So on the internal audit schedule for next year I now have space for input from two auditors!

Hope this helps.

Steve
My interpretation of "auditing your own work" in this situation would be you auditing production plans/schedules you created.

If you decided to audit whether the SOPs were developed in accordance with the Document Control procedure then I would say couldn't audit that aspect of Planning (and comply with ISO 9001 8.2.2).
 

Golfman25

Trusted Information Resource
#8
We run into this a lot. You simply need to break the audits into smaller segments and have your auditors "trade off" the parts they can't audit. So an auditor might be able to audit 90% of the requiremen and will have to defer 10% to someone else. Good luck.
 
Q

Quality-Geek

#9
ISO 19011:2008 4d) states "Auditors are independant of the activity being audited and are free from bias and conflict of interest. Auditors maintain an objective state of mind throughout the audit process to ensure that the audit findings and conclusions will be based only on the audit evidence."

The supplemental guidance, S4.3 Use by small organizations, states "These principles apply equally to small organizations as stated. There is no less emphasis on independence, professional care, and evidence-based approach for a single-person operation where audit results directly impact business than for a very large organization. In fact, the smallest organizations are often more sensitive to the need for independence and a factual based approach. For such organizations, it may not be possible for internal auditors to be wholly independent of the activity being audited."

I was taught that being objective and evidence based is a higher priority than being independent of the function being audited. I work for a mid-sized company with several internal auditors, and I still end up completing most of the audits because no one has enough time. Hope this helps.
 
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