Does anyone know if ISO publishes audit findings/results much like the FDA

[Sandra Gauvin]

Randy,
I work in the biotech industry and we constantly monitor inspection citings by the FDA (known as 483's) to see what the current trends are and to make sure that we are not vulnerable to the same citings. Each auditor (whether it's ISO or FDA) has a somewhat different interpretation, so this gives a company the opportunity to see the different interpretations and trends, and to learn from them....I was just wondering if ISO shares the same information so that companies can be proactive.

Thanks,
Sandra

 

[Sandra Gauvin]

Re: Publication of Audit Findings by ISO

Sandra - the 'ISO Folks' are only responsible for the standards documents, not certification - where (most) audit findings would be generated. Indeed, implementing ISO really doesn't have to result in certification, if it's used as (originally) intended.

CB's have in the past compiled lists of trends from audit findings but I can tell you that they really weren't much use - most of them came from 'document control' or calibration - because these are easy targets............

Andy,
Thanks for the information. It just seems like this information should be published at least to all ISO members (showing the actual findings without revealing the company's identify)....even if each registrar published their findings so that the companies that they audit can use this information to see how that particular registrar interpreted some of the clauses and what trends they are noticing....it seems like a lost opportunity on the registrars part to partner with their clients.

Thanks,
Sandra

 

[Paul Simpson]

Re: Publication of Audit Findings by ISO

Andy,
Thanks for the information. It just seems like this information should be published at least to all ISO members (showing the actual findings without revealing the company's identify)....even if each registrar published their findings so that the companies that they audit can use this information to see how that particular registrar interpreted some of the clauses and what trends they are noticing....it seems like a lost opportunity on the registrars part to partner with their clients.

Thanks,
Sandra

Interesting idea, Sandra. I personally don't see the value - except perhaps to show how many auditors stay in the 'comfort zone' of document control and how few understand process management - I'll leave it to the other covers to fill in the clause numbers.

I'm not sure also of the 'proactivity' - IMHO again you would get registered organizations following trends and fine tuning areas of the system that don't need work while neglecting areas where problems really exist. Dr Deming would be spinning in his grave.

 

[Sandra Gauvin]

Paul,
It's just a way of making sure that you don't fall prey to some of the same pitfalls that other companies do. I realize that if you follow ISO requirements, then in theory you shouldn't have to worry about this...but reality doesn't always mimic theory.

Take care,
Sandra

 

[AndyN]

Paul,
It's just a way of making sure that you don't fall prey to some of the same pitfalls that other companies do. I realize that if you follow ISO requirements, then in theory you shouldn't have to worry about this...but reality doesn't always mimic theory.

Take care,
Sandra

Sandra, it's a nice idea, but I have to agree with Paul. The data is too auditor specific to be of real use. It's been known for a long time (since the first analysis was published by CB's) that document control is almost 80% of the findings! As a result, have people become better at document control? No, not at all! I'd like to see some real data for use by companies, but - alas and alack - it just isn't the sort of process you can trust - too many variables at play.

I do, however, agree that CB's should offer more than just a bunch of 'honey-do's' at the end of their audits.......