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
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