Sharing key Audit learning across multi-site operations

Govind

Super Moderator
Staff member
Super Moderator
#1
Fellow Quality professionals,

We are exploring the options for sharing key audit learning across sites within our organization.

We are a multi-site facility spread across North America, Asia, Europe and many other locations. We would like to gather the audit findings/ observation from external audits that are out of routine as a learning opportunity for other sites. This is to help other sites to be proactive and prevent such audit conformance before their internal/external audits.

We have already brainstormed internally and have identified few practical options. I would like to know the experience of other corporations in our similar situation. I did a search in COVE and could not find a similar topic discussed in the past. If you find any, please feel free to hyperlink in your reply along with your experience.

Thanks,
Govind.

Note: At this point, I would define out of routine nonconformance as the one raising out of interpretation rather than compliance.
 
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Jim Wynne

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#2
Govind said:
Note: At this point, I would define out of routine nonconformance as the one raising out of interpretation rather than compliance.
Can you explain? How can you have a nonconformance that doesn't emanate from compliance (or noncompliance)?
 

Govind

Super Moderator
Staff member
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#3
Jim Wynne said:
Can you explain? How can you have a nonconformance that doesn't emanate from compliance (or noncompliance)?
Good Point. I rather expected this question.

We are interested learn those that were implemented incorrectly due lack of understanding the interpretation of the standard rather than mere compliance issues.

Example:
We would like to know a finding from a site like “risk assessment not performed when an equipment was found out calibration during the periodic calibration” rather than device XYZ from assembly line 001 was found out of calibration during the audit. The second scenario is not an interpretation issue. It is a lack of compliance issue. It required enforcement and management commitment for ongoing compliance. Earlier one, we found in a specific instance, that the site did not understand that they had to go back and review the risk of the products that were measured using a equipment that may have gone out of calibration during any point of calibration duration.

This is also a compliance issue to your point but rose out of lack of knowledge or interpretation. Some times even the registration auditor interpret something which we may not have come across from our usual understand of the requirement.

Hence we decided to focus on this. However we will also be focusing on the routine ones if they happen frequently.

Regards,
Govind.
 
#4
It will be like playing catch up

because each auditor will have their own 'bias' to finding things like this, Govind. Since these types of findings are very unpredictable, recording and analyzing them is not much use - it's not a process over which there's much 'control'.

I'm not sure that a database is what you need, more like some serious help to develop your knowledge base internally. The findings you indicate are simply things that some external auditors have a bias for. What findings are your internal auditors coming up with? Don't they find similar issues? If not, I'd suggest that the time you are going to invest in the database is better spent on having your internal auditors better qualified........

Andy
 

Caster

An Early Cover
Trusted Information Resource
#5
Really basic idea

Govind said:
Fellow Quality professionals,
Govind said:

We are exploring the options for sharing key audit learning across sites within our organization.

We are a multi-site facility spread across North America, Asia, Europe and many other locations. We would like to gather the audit findings/ observation from external audits that are out of routine as a learning opportunity for other sites. This is to help other sites to be proactive and prevent such audit conformance before their internal/external audits.

We have already brainstormed internally and have identified few practical options. I would like to know the experience of other corporations in our similar situation. I did a search in COVE and could not find a similar topic discussed in the past. If you find any, please feel free to hyperlink in your reply along with your experience. Govind.
quote]

Hi Govind

Rather than implement a possibly expensive solution, why not do a quick pilot first. You may decide that you are not getting useful insight, and it is easier to walk away from a cheap pilot than expensive software that someone had to go to bat for.

Our quality software company does something quick and dirty each year to help them prioritize the next new features. They send an excel spreadsheet of all the years enhancement requests to each key user. We all vote from 1 to 5 (useful, not useful). Then they just average all the votes and do the top x%. I am always amazed to see what other users are focused on, it's like a small peek into their problems.

Nothing fancy, does not take too long.

If I was one of your remote sites, I would love to see ALL the other findings. You can never tell what you might learn. Even if I felt none of it applied to me, I'd have gained much insight into what other auditors are looking at. But most likely I would find all kinds of skeletons in my closet.

Last job we had 3 plants and each of the plant QA managers attended the other plants audits to observe. We always felt "could have been me" for any finding.

Let us know what you decide to do.

I am struggling with lessons learned in Design. It is easier to collect them than to get people to use them. May be the same with audit results.
 
T

tomvehoski

#6
What about just circulating the audit reports among the key individuals (Management Reps?) at each location? An alternative could be a central person reviewing all them and noting any trends. Perhaps if you have an annual conference for all locations you could have each present lessons learned.

I agree that you probably won't have much success trying to set up a database and mine it for this information. Hopefully you don't have a huge pool of findings to catalog
 
S

svance

#7
Audit learning across multi-site operations

Our Third Party auditors post on their audit reports on their website and we have a password that allows us access to all our plants audit reports which does help us to know how the auditors are interpreting the standard and for items that are relevant to all plants.
 

RoxaneB

Super Moderator
Super Moderator
#8
Hi, svance...by your profile, it shows that you've been part of the Cove for a while and have finally come out of lurking to make a post! Congrats! :)

Getting back to the topic, for a truly international group of sites, and assuming that there is some form of company intranet in existence, why not have the reports posted there? An administrator could then develop a summary table with key criteria like areas of findings, clauses, etc. (or whatever is of interest to you) so that people can see similiar issues at other sites. This could prompt a sharing of knowledge when it comes to corrective and preventive actions.
 

Govind

Super Moderator
Staff member
Super Moderator
#9
Thanks and Some more thoughts..

Thanks to all contributors so far. I was waiting to see how this thread evolves.

Your feedback pretty much matches with what we are planning to do. i.e. company intranet (using Share point), periodic discussion on unusual findings. We also have a web based software tool to collect Root causes of all External findings. We plan to Pareto findings across multiple sites to drive systemic actions across organizations.

I agree with Caster’s reply on “I am struggling with lessons learned in Design. It is easier to collect them than to get people to use them. May be the same with audit results.” It is kind of challenging to translate the learning to a different product/process line. However if we can look at it from a system level, you will notice a lot of commonality.

I know registration auditors share the findings from their clients among themselves within their organization and review if they see any trend in nonconformance on certain section of the standard. If you start to see a similar finding coming out all sites from the registrar, you can assume that they have had a meeting earlier. This might be conflicting with the idea that auditors are supposed to look for compliance and not noncompliance. But this also helps for huge organization to drive an organization wide corrective action on Systemic issues.

Registrars should be having huge data base of clients of various industry, size, type and nature of findings. Referring to particular client could be breaching non disclosure agreements; however a generic high level summary of findings without reference to any specific client should be within an acceptable process. I have not come across with registrars that send newsletter on recent audit finding trends, common interpretation issues across their client base, How the findings distribution among total clients on various requirement clauses, etc. This type of proactive information on a quarterly basis from the Registrar can also help their clients get a good grip on the standards and implementations.

Please continue your thoughts.

Thanks,
Govind.
 
K

kei_ko

#10
Govind said:
Your feedback pretty much matches with what we are planning to do. i.e. company intranet (using Share point), periodic discussion on unusual findings. We also have a web based software tool to collect Root causes of all External findings. We plan to Pareto findings across multiple sites to drive systemic actions across organizations.
hi Govind, that sounds exactly like what one of my previous company was doing... however, it was a lot of work (due to the quantity and locations of sites globally) and we lacked proper follow-up (at many of the sites, during the initial period) to get the best value from it. naturally you will need a mature or stable QMS to make it a success :)

by the way, what web based software do your company use?
 
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