ISO 9001 Survelliance Audit Preparation

[QualMike1]

Good Afternoon,

I am approaching my 2nd surveillance audit with my registrar. However I am in a bit of a troubling situation. We had an employee resign around 6 months ago and I had to absorb those responsibilities in addition to being our site's Management Rep. I have fallen behind on pretty much everything with regard to our QMS. I now have an assistant to aid with my other responsibilities and am actively catching up. Is it better to simply air out the fact that we hit a problem area for a few months and build a corrective action plan to correct the lost time. Or is it acceptable to simply produce the records and back-date them accordingly to where they would/should have been?

 

[AndyN]

Good Afternoon,

I am approaching my 2nd surveillance audit with my registrar. However I am in a bit of a troubling situation. We had an employee resign around 6 months ago and I had to absorb those responsibilities in addition to being our site's Management Rep. I have fallen behind on pretty much everything with regard to our QMS. I now have an assistant to aid with my other responsibilities and am actively catching up. Is it better to simply air out the fact that we hit a problem area for a few months and build a corrective action plan to correct the lost time. Or is it acceptable to simply produce the records and back-date them accordingly to where they would/should have been?

Hello Mike:
How long do you have before the visit? Have you received an audit plan from your auditor. Have you been in touch with the auditor?

 

[QualMike1]

Day 1 is on the 31st of March.
I have a rough agenda but nothing extremely formal. I am basically going through each point he is planning to audit and tidying up the system where I think it needs it. So I have a little less than 3 weeks

 

[Reg Morrison]

Or is it acceptable to simply produce the records and back-date them accordingly to where they would/should have been?

Isn't that cooking the books? Once you feel that you can play loose with records, it is a slippery slope.

 

[QualMike1]

That's why I am inquiring with the forums to see if anyone else has ever run into similar trouble. As far as I can see - it makes sense to simply open an action plan to recover. And a lot of the paper work exists in piles, I simply need to gather and load it into the electronic database we use to show our reports.

 

[Helmut Jilling]

Good Afternoon,

I am approaching my 2nd surveillance audit with my registrar. However I am in a bit of a troubling situation. We had an employee resign around 6 months ago and I had to absorb those responsibilities in addition to being our site's Management Rep. I have fallen behind on pretty much everything with regard to our QMS. I now have an assistant to aid with my other responsibilities and am actively catching up. Is it better to simply air out the fact that we hit a problem area for a few months and build a corrective action plan to correct the lost time. Or is it acceptable to simply produce the records and back-date them accordingly to where they would/should have been?

It is probably too late before your audit...but, it sounds like you need some good training, and reread the standard, and might need a good consultant to put in a rapid corrective action plan...not trying to be pessimistic, but it sounds like you were left with a mess, perhaps you were trying to operate beyond your level of knowledge the last few months, and the company was probably cheating you on needed resources...

 

[Kronos147]

Eric

 

[Randy]

Apparently we have a lack of MAINTAINING the system, because of a lack of RESOURCES, and effective PLANNING

What we seem to have is a people based activity called a QMS instead of an effective processed based QMS

What would happen if you left? Apparently there'd be a non-functioning QMS.

Are we seriously expecting the audit to have a 100% positive outcome by putting a couple short term band-aids on it when there appears to be obvious hemorrhaging going on?


It doesn't matter who the auditor is of who the CB is or even what day of the week or hour of the day it is, the minimum that must absolutely be covered on a Surveillance is clearly defined in ISO 17021 as:

9.3.2 Surveillance audit
9.3.2.1 Surveillance audits are on-site audits, but are not necessarily full system audits, and shall be
planned together with the other surveillance activities so that the certification body can maintain confidence
that the certified management system continues to fulfill requirements between re-certification audits. The
surveillance audit program shall include, at least
a) internal audits and management review,
b) a review of actions taken on non-conformities identified during the previous audit,
c) treatment of complaints,
d) effectiveness of the management system with regard to achieving the certified client's objectives,
e) progress of planned activities aimed at continual improvement,
f) continuing operational control,
g) review of any changes, and
h) use of marks and/or any other reference to certification.

 

[Alpine]

I could never falsify records. It goes against everything I was taught and who I am. My view is that you need to be honest with your CB and if you have a action plan to get things on track again, I feel you will be fine. The consequences of what would happen, should you get caught out, are not worth considering. Most organisations will have hiccups at some point. The most important thing is what they do when they happen.

 

[Helmut Jilling]

I could never falsify records. It goes against everything I was taught and who I am. My view is that you need to be honest with your CB and if you have a action plan to get things on track again, I feel you will be fine. The consequences of what would happen, should you get caught out, are not worth considering. Most organisations will have hiccups at some point. The most important thing is what they do when they happen.

That is the better route to take. If the audits goes very badly, it sometimes helps to use a professional consultant to help your team address how to fast track the corrective actions. Can help jumpstart things back to where they need to be.... Best wishes...