The Cove Business Standards Discussion Forums
Corrective Actions Root Causes from Surveillance Audit Findings
UL - Underwriters Laboratories - Health Sciences
Corrective Actions Root Causes from Surveillance Audit Findings
Corrective Actions Root Causes from Surveillance Audit Findings
Corrective Actions Root Causes from Surveillance Audit Findings
Corrective Actions Root Causes from Surveillance Audit Findings
Corrective Actions Root Causes from Surveillance Audit Findings
Corrective Actions Root Causes from Surveillance Audit Findings
Corrective Actions Root Causes from Surveillance Audit Findings
Corrective Actions Root Causes from Surveillance Audit Findings
Corrective Actions Root Causes from Surveillance Audit Findings
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

Corrective Actions Root Causes from Surveillance Audit Findings


Monitor the Elsmar Forum
Sponsor Links




Courtesy Quick Links


Links Elsmar Cove visitors will find useful in the quest for knowledge and support:

Jennifer Kirley's
Conway Business Services


Howard's
International Quality Services


Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum


Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining


Ajit Basrur
Claritas Consulting, LLC



International Standards Bodies - World Wide Standards Bodies

AIAG - Automotive Industry Action Group

ASQ - American Society for Quality

International Organization for Standardization - ISO Standards and Information

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology


Some Related Topic Tags
audit nonconformances and findings, corrective action (ca), iso 13485 - medical device qms, root cause failure analysis
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 24th May 2013, 03:03 PM
ehoqa

 
 
Total Posts: 28
Please Help! Corrective Actions Root Causes from Surveillance Audit Findings

Hi Cove members!

I hope someone has some insight on how to determine the root cause and corrective action for some minor findings from our ISO 13485 surveillance audit. We are a small medical device company and ISO 13485 is pretty new to us, as we just started a couple of years ago. I don't expect anyone to answer these for me but I hope to be guided though this by objective readers

1. One of the nonconformities was written up against Sec. 4.1. which states that outsourced processes must be controlled and identified within the QMS. While it was found that our outsourced processes are controlled, they are not identified.

It was mentioned that the fix can be as simple as marking the outsourced processes on our approved vendor list. Great!

Now I'm stuck on figuring out the root cause and corrective action. We have an approved vendor list, but we didn't know we had to explicitly identify which ones are outsourced. Why not? Because no one here (me) is an expert at this, though we were trained to this standard to understand the basics. I don't want to say it's a training deficiency because even with further training on ISO 13485, I don't see how the issue of not being aware all the details will be resolved.


2. The second nonconformity is against 8.2.2 where it states that internal audit follow-up activities shall include verification and reporting verification results. The reason for this nonconformity is that this requirement isn't addressed in our procedure. I tried to fight this one because the auditor didn't have evidence that this requirement was not being performed (we use CAR forms with a verification section), but the auditor said it needs to be addressed in the procedure.

I'm better at determining the root cause for repeating/systemic process issues. However, I'm at a lost when it comes to things like needing to explicitly identify outsourced services or something is missing from the procedure.

Thanks for any help in advance!

Sponsored Links
  Post Number #2  
Old 24th May 2013, 03:57 PM
insect warfare's Avatar
insect warfare

 
 
Total Posts: 539
Re: Corrective Actions Root Causes from Surveillance Audit Findings

Outsourced processes can also be identified through the use of a process map. If an overall process map already exists within your organization, then you could simply identify them there - the added benefit is you can show how they interact with your internal processes and have a good reference document as a plus. But keep in mind that the word "identified" in this context does not necessarily mean "documented", so if you were able to adequately explain to your auditor what those outsourced processes were without having them documented per se, this still counts as "identified" and IMO maybe should have only been raised as an OFI (opportunity for improvement) and not a NC.

As for your 8.2.2 dilemma, what does your corrective/preventive action procedure state in regards to how internal audit findings are followed up on and verification recorded? The reason I ask is that even though your internal audit procedure may not state the requirements explicitly, your CAPA procedure may already contain this information, which still satisfies the requirement. If not, your auditor may have a case here, but still should be an easy remedy.

Brian
  Post Number #3  
Old 24th May 2013, 04:30 PM
ehoqa

 
 
Total Posts: 28
Re: Corrective Actions Root Causes from Surveillance Audit Findings

Thanks, Brian. I think both have easy remedies/corrections, but that's just it. I'm wondering how to dig deeper to the root cause in these cases.
  Post Number #4  
Old 24th May 2013, 04:38 PM
insect warfare's Avatar
insect warfare

 
 
Total Posts: 539
Re: Corrective Actions Root Causes from Surveillance Audit Findings

Quote:
In Reply to Parent Post by ehoqa View Post

I'm wondering how to dig deeper to the root cause in these cases.
This would be a good place to start:

5-Whys
Fishbone Analysis

No affiliation with the website BTW....

Brian
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > >

Bookmarks



Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Emoticons are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
Need examples of Preventive and Corrective Actions (Need to correct audit findings) Lorenzo36 Preventive Action and Continuous Improvement 19 24th August 2016 03:42 AM
On Time Delivery - Non conformance? Root Causes, Corrective Actions Sardokar ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10 11th March 2011 03:26 AM
Corrective Actions - Getting to the True Root Cause Willyboy Problem Solving, Root Cause Fault and Failure Analysis 12 17th September 2009 10:46 AM
New Nonconformance Findings During Corrective Actions Falken ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5 9th November 2007 08:36 PM
2nd TS16949 surveillance audit - 0 findings ralphsulser IATF 16949 - Automotive Quality Systems Standard 2 18th May 2006 08:32 PM



The time now is 02:41 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.



Misc. Internal Links


NOTE: This forum uses "Cookies"