The Elsmar Cove Business Standards Discussion Forums More Free Files Forum Discussion Thread Post Attachments Listing Elsmar Cove Discussion Forums Main Page
Welcome to what was The Original Cayman Cove Forums!
This thread is carried over and continued in the Current Elsmar Cove Forums

Search the Elsmar Cove!

Wooden Line
This is a "Frozen" Legacy Forum.
Most links on this page do NOT work.
Discussions since 2001 are HERE

Owl Line
The New Elsmar Cove Forums   The New Elsmar Cove Forums
  Auditing
  internal quality audit/desk top audit

Post New Topic  Post A Reply
profile | register | preferences | faq | search

UBBFriend: Email This Page to Someone! next newest topic | next oldest topic
Author Topic:   internal quality audit/desk top audit
darwinbb
Forum Contributor

Posts: 10
From:ON, Canada
Registered: Mar 2001

posted 08 June 2001 03:33 PM     Click Here to See the Profile for darwinbb   Click Here to Email darwinbb     Edit/Delete Message   Reply w/Quote
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?

IP: Logged

Al Dyer
Forum Wizard

Posts: 622
From:Lapeer, MI USA
Registered: Oct 2000

posted 11 June 2001 08:10 AM     Click Here to See the Profile for Al Dyer   Click Here to Email Al Dyer     Edit/Delete Message   Reply w/Quote
quote:
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...

IP: Logged

Fire Girl
Forum Contributor

Posts: 41
From:Orillia, Ontario, Canada
Registered: Apr 2001

posted 11 June 2001 10:38 AM     Click Here to See the Profile for Fire Girl   Click Here to Email Fire Girl     Edit/Delete Message   Reply w/Quote
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?

IP: Logged

Al Dyer
Forum Wizard

Posts: 622
From:Lapeer, MI USA
Registered: Oct 2000

posted 11 June 2001 11:35 AM     Click Here to See the Profile for Al Dyer   Click Here to Email Al Dyer     Edit/Delete Message   Reply w/Quote
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...

IP: Logged

energy
Forum Contributor

Posts: 228
From:New Britain, CT
Registered: Nov 2000

posted 11 June 2001 11:38 AM     Click Here to See the Profile for energy   Click Here to Email energy     Edit/Delete Message   Reply w/Quote
quote:
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).]

IP: Logged

Marc Smith
Cheech Wizard

Posts: 4119
From:West Chester, OH, USA
Registered:

posted 11 June 2001 12:00 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
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.

IP: Logged

barb butrym
Forum Contributor

Posts: 637
From:South Central Massachusetts
Registered:

posted 14 June 2001 10:34 AM     Click Here to See the Profile for barb butrym   Click Here to Email barb butrym     Edit/Delete Message   Reply w/Quote
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

IP: Logged

Alf Gulford
Forum Contributor

Posts: 60
From:Portland, OR
Registered: Aug 2000

posted 14 June 2001 03:36 PM     Click Here to See the Profile for Alf Gulford   Click Here to Email Alf Gulford     Edit/Delete Message   Reply w/Quote
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

IP: Logged

ISO GUY
Forum Contributor

Posts: 81
From:Rochester, NY
Registered: Jan 2000

posted 14 June 2001 03:44 PM     Click Here to See the Profile for ISO GUY   Click Here to Email ISO GUY     Edit/Delete Message   Reply w/Quote
quote:
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?

IP: Logged

All times are Eastern Standard Time (USA)

next newest topic | next oldest topic

Administrative Options: Close Topic | Archive/Move | Delete Topic
Post New Topic  Post A Reply Hop to:

Contact Us | The Elsmar Cove Home Page

Your Input Into These Forums Is Appreciated! Thanks!


Main Site Search
Y'All Come Back Now, Ya Hear?
Powered by FreeBSD!Made With A Mac!Powered by Apache!