Document Handling during an Audit

S

sniderdi

#1
The last question I asked went so well, that leads me to my next question. I have been asked to create a Deviation and Customer Complaint procedure, which I have in process right now. The hold up for the powers that be is my tracking spreadsheets I have created. They have been asked in previous client audits of our quality systems to provide and show the client our server and files on the server. I would like to create only one numbering system for both Deviations and Customer Complaints, my office manager is worried if we do that and have gaps in our numbers because we have filtered the spreadsheet by client name, the client will call into question of the numbering gaps. I have tried to assure her that can be explained with client confidentiality and they don't have a right to see those items. Our client specific documents begin with a 2 digit numbering system to indicate which client documents they are. She has suggested I keep a tab for each client that the number begins with their special 2 digit number so their specific Deviations and Customer Complaints remain in chronological order vs having numbering gaps. Any suggestions, opinions, guidance is very much appreciated. I want to make my company happy, my work life as simplified as it can possibly be in the QA/Compliance world and stay within the regulatory guidelines and protecting each client's product/process specific documents. Thank you in advance for your time and assistance.
 
Elsmar Forum Sponsor

Ninja

Looking for Reality
Trusted Information Resource
#2
There is no right answer here, and it looks like you've already considered the pertinent factors (management, client, standard).

FWIW, we would filter by client, and explain the numbering gaps as "we are only showing you those pertaining to you...see what a great job we do for you!"

There will be numbering gaps no matter what you do...search this forum for "numbering gaps" and you'll see a number of threads...all of which end in "what's the big deal...move on".

The CA started by an idiot, and cancelled by you when you saw how idiotic it was....numbering gap.
The PA for janitorial service started by the facility chemist as justification for buying a Rhesus monkey as an 'at work' pet...numbering gap (yes, this happened where I used to work).

Numbering gaps are unavoidable in real life...they just happen.
 

Golfman25

Trusted Information Resource
#3
I think you're on the right track. Make is simple for you. Forget about the customer auditor. Sounds like you're dealing with a doozy. Good luck.

Client confidentiality is a huge deal. We have competitors walk thru our facility and it's a "problem" -- Except for the fact that they have worked for each other. It's kind of funny to see a guy's name on his "competitor's" print.
 
S

sniderdi

#4
That is exactly what has happened in this company. The quality auditor for one plasma center that was harsh with the company I recently gained employment at, is now the quality auditor for another plasma center and is playing the I know you have that document, yeah it is because it was client specific to the previous company. My current employers just created this position that I am in; I am employed because I was QA & Compliance at the pharmaceutical level, so I have worked in strict ISO/FDA/European regulatory. My thing that is different is we are manufacturing, and the only reason they have this kind of regulations and audits is because they are a critical supplier for these plasma centers. I appreciate your insight.
 

Randy

Super Moderator
#5
OK I'll chime it as a person that does nothing but 3rd party audits.... Do whatever works best for you, keep it as simple as possible, but you and only you matter in this (You includes your organization and clients...maintain their confidence/privacy etc.)

As a 3rd party I don't care what you do or how you do it, I really don't. All that matters is that you have a process/method, you use it consistently, it provides the control that's necessary and it fulfills what's set forth in 7.5 for Documentation, anything beyond that is fluff, gravy, icing or maybe wasted effort.
 
S

sniderdi

#6
This is what I have been trying to convey. The procedures I have written are straight forward, so is the tracking system. I am highly organized, once we get out next audit, this company will see this and hopefully be more at ease. They have my manager all kinds of running in circles.
 

dsanabria

Quite Involved in Discussions
#7
OK I'll chime it as a person that does nothing but 3rd party audits.... Do whatever works best for you, keep it as simple as possible, but you and only you matter in this (You includes your organization and clients...maintain their confidence/privacy etc.)

As a 3rd party I don't care what you do or how you do it, I really don't. All that matters is that you have a process/method, you use it consistently, it provides the control that's necessary and it fulfills what's set forth in 7.5 for Documentation, anything beyond that is fluff, gravy, icing or maybe wasted effort.

AMEN - Totally agree - as a third party auditor. We are more interested in the process. it's your process to skip numbering or change your numbering sequence all that matters is that you meet the requirements of the standard. and most of them don't tell you how.
 
Thread starter Similar threads Forum Replies Date
J Material Handling Plan as Described in v5.5 of the PSO Document - Please critique Customer and Company Specific Requirements 3
J Multilingual Document Control - How are other companies handling control? Document Control Systems, Procedures, Forms and Templates 5
D Document Control Question involving DocuSign US Food and Drug Administration (FDA) 5
M Document Control ISO and FDA ISO 13485:2016 - Medical Device Quality Management Systems 5
D Document Change Approval ISO 13485:2016 - Medical Device Quality Management Systems 6
R Does anyone use iQMS for their ISO based document control? Manufacturing and Related Processes 0
C Document Identification Question ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
B Document retention Policy for Japan's PMDA Japan Medical Device Regulations 1
B Document Retention Policy for NMPA China Medical Device Regulations 0
B Document Retention period for MHRA submission UK Medical Device Regulations 0
A If document coding is change will there be a revision Document Control Systems, Procedures, Forms and Templates 1
S Document numbering question? ISO 13485:2016 - Medical Device Quality Management Systems 7
R Quality policy review document IATF 16949 - Automotive Quality Systems Standard 3
dpenbert AS9100 7.5.3 - Manual Document Control AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
S Software design document NMPA guidance and consultant China Medical Device Regulations 3
qualprod Is it worth to document all the processes? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S Help in document control procedure Document Control Systems, Procedures, Forms and Templates 8
P Which MDCG Document should I use for PMS Plan and PSUR? EU Medical Device Regulations 2
N API Q1, Management of Change & Document Change Request Oil and Gas Industry Standards and Regulations 3
J Project management Document. IATF 16949 - Automotive Quality Systems Standard 4
S Master Document Register Document Control Systems, Procedures, Forms and Templates 3
M Preparing a document for Raw Material of Medical Device EU Medical Device Regulations 1
R Regulations on Controlled Document Size (Paper Size) Document Control Systems, Procedures, Forms and Templates 4
M Document Architecture ISO 13485:2016 - Medical Device Quality Management Systems 8
cgaro62 Using internal audits as part of document reviews Document Control Systems, Procedures, Forms and Templates 21
J Training on the importance of Document Control Document Control Systems, Procedures, Forms and Templates 3
Ed Panek External Standards List - Should this document include previously revised standards? ISO 13485:2016 - Medical Device Quality Management Systems 4
H Document retention period Canada Medical Device Regulations 2
S Document Notes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M ISO 13485 and document control for programs ISO 13485:2016 - Medical Device Quality Management Systems 6
Ed Panek MR Mandate Document EU Medical Device Regulations 1
C Document Index Document Control Systems, Procedures, Forms and Templates 5
K ASME, ANSI, ASTM and similar specifications and their requirements for document control. Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
H If we use agile - do we still need to document TF as a waterfall just for the notified bodies need? IEC 62304 - Medical Device Software Life Cycle Processes 2
Q ISO 9001/IATF 16949 Audit Finding Question - Document Retention IATF 16949 - Automotive Quality Systems Standard 11
B Document Issued with incorrect Document number code Document Control Systems, Procedures, Forms and Templates 3
J Requirement for Signature on Document Document Control Systems, Procedures, Forms and Templates 13
J Document Control Metrics Document Control Systems, Procedures, Forms and Templates 3
A Document Review and Document Approval --- 2 Signatures needed acc. §820.40? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance document to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
I Document Control Software Document Control Systems, Procedures, Forms and Templates 2
K 25-year lifetime of medical device - document storage period EU Medical Device Regulations 1
J UDI - Where to document it? EU Medical Device Regulations 8
T Controlling Expandable Forms in Paper-Based Document Control System Document Control Systems, Procedures, Forms and Templates 10
S Changing revision status of a reviewed document Manufacturing and Related Processes 11
shimonv Document Control Procedure Header Content Document Control Systems, Procedures, Forms and Templates 4
A Document release vs its related training. Which should come first? ISO 13485:2016 - Medical Device Quality Management Systems 18
Q Document ownerships Document Control Systems, Procedures, Forms and Templates 15
E Document Change Request forms (or no forms)? ISO 13485:2016 - Medical Device Quality Management Systems 9
O Any info on release date of FDA “Computer Software Assurance for Manufacturing and Quality System Software” document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0

Similar threads

Top Bottom