Internal Quality Audit - Desk Top Audit First?

[darwinbb]

internal quality audit/desk top audit

Greetings..

I am in the process of doing Internal Quality Audit in our facility..is it also necessary to do a desk top audit before the registration audit comes along?

 

[Al Dyer]

Originally posted by darwinbb:
Greetings..

I am in the process of doing Internal Quality Audit in our facility..is it also necessary to do a desk top audit before the registration audit comes along?

I have not come across a registrar that doesn't require a desk/document audit. At the least I would consider it critical in ensuring that your documentation covers all the requirements of whatever standard or specification you are using.

ASD...

 

[Fire Girl]

I agree with our good friend Al. It has been my experience that the registrar will ask to do a desk top audit before they will even schedule you an audit! The company I am with now, I sent them a copy of our Policy/Procedure manual. They rejected the procedure manual the first time. I fixed it sent it back- all clear, and booked myself an audit. They come prepared with their checklists based on your manual.

Pretty common experience, Al?

 

[Al Dyer]

Fire Girl:


That's been my experience over the years. Our current registrar has forwarded a copy of their desk audit so we will be one step ahead of the game.

ASD...

 

[energy]

Originally posted by darwinbb:
Greetings..
is it also necessary to do a desk top audit before the registration audit comes along?

Darwin,
Are you asking if YOU should do a desk top audit prior to the registration audit coming along? If not,I agree with Fire Girl that Registrars and most Customers will ask to see the QP Manual prior to auditing you. They have to start somewhere. That could be considered their desktop audit.
If the question is whether you do a desktop audit or not, I understand that in the normal auditing process, the desk top audit is a necessity. The rule of thumb that we have been taught is: For every hour of audit, you should do 2 hours of desk top auditing. It allows to you define the scope of the audit and keep you focused. I guess I don't really understand the question.

P.S. Firegirl 6/8/@ 2:28PM
6/8/@ 3:44PM
6/11/@9:30AM
6/11/@10:00AM
energy


[This message has been edited by energy (edited 11 June 2001).]

 

[Marc]

I think this is being over- analyzed. A desktop audit is just that - at a desk. It can be a compliance audit - such as a comparison of the quality manual to the standard. A systems and/or process audit can also be done that way - partially. You ask for paperwork but don't go out to where the work takes place. A desk audit is, more than anything, a verification audit.

Where you actually visit the place where the work is being done is the 'standard'. That is a validation audit - Show Me.

Registrars typically do a document review - a compliance audit - at their office. Typicaly charge ranges from US$700 to US$1700. It typically addresses the quality manual, but good registrars also want supporting level 2's. Again - this is a verification audit. And a 'desk' audit.

Next comes the pre-assessment. Different registrars handle this differently, but the gist is they come in and at least review documentation and discuss systems with managers. Often eveidence is brought to them. This is also verification but borders on validation (show me some evidence). However, some registrars actually do go out on the floor and do some minimal validation checks.

We all know what the registration audit is about. Validation. Direct observation of the systems working.

 

[barb butrym]

it seems we are back to semantics once again (my favorite thing!!!!!)
what is a desk audit, one done at a desk obviously ...... LOL

But to me it is part of the prepration for the audit as well..the plan, putting the scope on paper, checklist prep, familiarization with the system and department and the requirements (scope?), understanding the who why and how of what you will be looking at, time schedule insight, efficiency tool...UMMMMMMMMMMMMM how many more ways can I say the same thing with slight variations???????????????

The registrars need to know that the system , on paper, meets the standard.....as in when the standard says "thou shall" you say "We do" and check for that before they come in,,,why? So as not to waste time if there is a gaping hole, or an element is missing from your system. And for many of the same reasons stated in my triad above.

Should you do one before being audited? Well, it is my belief that when you are to be audited, you need to go anywhere they plan to and be one step ahead.... just as good practice, But that is just my humble opinion and certainly not a requiremnet

 

[Alf Gulford]

Sometimes I'll schedule 'desktop' audits so we can really focus on the procedures and forms themselves. When we're visiting areas and interviewing people there are so many things to try to keep in mind and anticipate (especially since we incorporate FDA regulations into the audits) that it's real easy to miss details. By doing a desktop audit in a (kind of) quiet place without (many) interruptions, it's much easier to make sure everything's in place.

Alf

 

[Aaron Lupo]

Originally posted by darwinbb:
Greetings..

I am in the process of doing Internal Quality Audit in our facility..is it also necessary to do a desk top audit before the registration audit comes along?

Maybe I am wrong but I think he is asking does his company have to do a "desk audit" before the registrar comes in. IMHO I would say not you dont have to, if your IA system is doing what it is intended to do your system should be in good shape, in otherwords there should be no glaring problems. Am I off the mark on this one?