Need HELP with Internal Audit Program ISO 13485.2003

love02eat

Involved In Discussions
#1
I am trying to figure out the finding to give our audit. Last year 2017 in May we had our surveillance audit. We had a few findings. 1 was our internal audit program.
CB/Statement of Nonconformance: Type: Minor - Internal auditing is not fully effective in that not all elements of the QMS were audited as required.

Company Response: Action Plan: Review Internal Audit program to determine ways to ensure complete, accurate, and timely planning will align and meet ISO Standard 13485:2003 and "company" Quality Management System. The process of resolving the audit finding ranges from revising the internal audit program, create and revise procedures and forms, and conduct a re-training on using Visual Quality module (Audit Manager).

All the items above where completed. But our QA manager never assigned anyone to assign audits and so forth. I had taken it upon myself in sept to start assigning the audits since I designed the program to be in compliance but so much time passed that I only was able to assign 6 audits and as of Jan 16th they are not completed. Our auditors range from managers to employees that already wear multiple hats and then the end of year had us all busy. So my question is Do I create a CAR as a Major finding since we didn't complete the interval audits as planned even though the program change took place in the middle of the year June). Or do I not nag the employees to complete the audits and take a complete loss and use them for the 2018 schedule? I do not know how to address this our surveillance aduit will be in april to start to see our changes to move forward to ISO1345:2016. Our manager doesn't know what we should do ughhhh. please advise any input is welcomed
 
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GStough

Staff member
Super Moderator
#2
Maybe a direct approach would be best, and skip revising the whole IA program, retraining, etc. Take a closer look at the audit schedule and see if there are any areas on the schedule that don't really need to be. Go through the standard and make sure that all processes/elements are on the schedule, even if you have to combine some of them into one audit (i.e. 6.3 and 6.4 are sometimes combined into one audit). You may be wasting precious time and resources by auditing something that doesn't necessarily need it.

Whichever option you choose, at some point, this could become a major nonconformance at either the internal or external level. If I were in your shoes, I would issue the CAR so the process owner(s) could begin working on the root cause and corrective action BEFORE your registrar returns for the next audit. If s/he sees the same issue again, you should expect a major NC for it.

Just my :2cents:....I hope it helps. :cool:

I am trying to figure out the finding to give our audit. Last year 2017 in May we had our surveillance audit. We had a few findings. 1 was our internal audit program.
CB/Statement of Nonconformance: Type: Minor - Internal auditing is not fully effective in that not all elements of the QMS were audited as required.

Company Response: Action Plan: Review Internal Audit program to determine ways to ensure complete, accurate, and timely planning will align and meet ISO Standard 13485:2003 and "company" Quality Management System. The process of resolving the audit finding ranges from revising the internal audit program, create and revise procedures and forms, and conduct a re-training on using Visual Quality module (Audit Manager).

All the items above where completed. But our QA manager never assigned anyone to assign audits and so forth. I had taken it upon myself in sept to start assigning the audits since I designed the program to be in compliance but so much time passed that I only was able to assign 6 audits and as of Jan 16th they are not completed. Our auditors range from managers to employees that already wear multiple hats and then the end of year had us all busy. So my question is Do I create a CAR as a Major finding since we didn't complete the interval audits as planned even though the program change took place in the middle of the year June). Or do I not nag the employees to complete the audits and take a complete loss and use them for the 2018 schedule? I do not know how to address this our surveillance aduit will be in april to start to see our changes to move forward to ISO1345:2016. Our manager doesn't know what we should do ughhhh. please advise any input is welcomed
 

Golfman25

Trusted Information Resource
#3
I am trying to figure out the finding to give our audit. Last year 2017 in May we had our surveillance audit. We had a few findings. 1 was our internal audit program.
CB/Statement of Nonconformance: Type: Minor - Internal auditing is not fully effective in that not all elements of the QMS were audited as required.

Company Response: Action Plan: Review Internal Audit program to determine ways to ensure complete, accurate, and timely planning will align and meet ISO Standard 13485:2003 and "company" Quality Management System. The process of resolving the audit finding ranges from revising the internal audit program, create and revise procedures and forms, and conduct a re-training on using Visual Quality module (Audit Manager).

All the items above where completed. But our QA manager never assigned anyone to assign audits and so forth. I had taken it upon myself in sept to start assigning the audits since I designed the program to be in compliance but so much time passed that I only was able to assign 6 audits and as of Jan 16th they are not completed. Our auditors range from managers to employees that already wear multiple hats and then the end of year had us all busy. So my question is Do I create a CAR as a Major finding since we didn't complete the interval audits as planned even though the program change took place in the middle of the year June). Or do I not nag the employees to complete the audits and take a complete loss and use them for the 2018 schedule? I do not know how to address this our surveillance aduit will be in april to start to see our changes to move forward to ISO1345:2016. Our manager doesn't know what we should do ughhhh. please advise any input is welcomed
Sounds to me like your system was revised in or about June 2017. Which means, to me, you have until June 2018 for a 1 year period. Thus, I would get on your auditors to "get em done" so you can evaluate before you surveillance. I would start a new schedule after May. Whatever you do, make sure your audit schedules are flexible because regular business gets in the way. Good luck.
 

love02eat

Involved In Discussions
#4
So would I make our CAR a Major since we had a finding against our OLD internal audit program. The problem was that I revised it to become more efficient and compliant. The NB said the program should work well my boss never assigned anyone the responsibilities to take it on after the changes. Our year to year base is Jan to Dec. right or do I change it when the program changed?
 
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