Document levels and approval requirements for lower level documents like work instructions, forms etc.

Elsmar Forum Sponsor

CCaantley

Involved In Discussions
#13
No, you don't need to FIX everything. But a document with a signature and a date doesn't necessarily make it controlled. Your company probably has more to its document control process than just those two items. Before trying to fix a process, best to determine if it is indeed broken.
Our work instructions and forms are stored on a server with who approved and revision date in the footer when printed out. Other items that are for informative purposes (for example: what oil goes in this reservoir) just gets a signature and date, but is not stored on the server. Our ISO trainer(?) told us that was what we needed to do, so if an auditor saw signage like in the example, they would know it was approved. If this is incorrect in any way, I'd appreciate your input.
 

Ninja

Looking for Reality
Staff member
Super Moderator
#14
I guess a bit of this goes into semantics...

"Approved" is not explicitly required, though it is hard to avoid if "control" is established...and there is no good reason to avoid "approved", and many good reasons to ensure it.
If a person makes revB available, and prohibits access to revA...I suppose that constitutes "approval" of revB.
A signature is not particularly required...but again that's down in the weeds and there are pretty good reasons to have a sig of some sort.

I would expect an auditor to look for evidence that revA is not being used, and that some control mechanism was in place to manage/prohibit the use of outdated WI/Proc/Specs. That (to me) is the purpose of control in this area (including posted instructions and lookup sheets).
 

RoxaneB

Super Moderator
Super Moderator
#15
Our work instructions and forms are stored on a server with who approved and revision date in the footer when printed out. Other items that are for informative purposes (for example: what oil goes in this reservoir) just gets a signature and date, but is not stored on the server. Our ISO trainer(?) told us that was what we needed to do, so if an auditor saw signage like in the example, they would know it was approved. If this is incorrect in any way, I'd appreciate your input.
I don't believe that I've every heard or seen informative signage with signatures and dates. If it's really just an FYI type of message, I see little value in chasing someone down for a signature. Besides, what's to stop me from signing and dating it...and what makes my signature less important/relevant than someone else's?

As for items on your server, how do you know that they are approved? These are the ones where some from of documented authorization and approval would come in handy. It doesn't need to be a signature in the traditional sense. Many document control software systems, for example, allow for e-signatures. By entering a password, the approving individual is able to communicate that s/he approves the document (or rejects it). And then as long as only the most recent versions of these approved documents are made accessible to the appropriate stakeholders (i.e., the now obsolete documents removed from use/circulation/accessibility), you're creating a document control process.
 
#16
Our ISO trainer(?) told us that was what we needed to do, so if an auditor saw signage like in the example, they would know it was approved. If this is incorrect in any way, I'd appreciate your input.
Oh yes! Your ISO "trainer" is biased towards doing things to make (ineffective) auditors happy, not doing what ISO actually requires. No documents need signatures or dates, to be approved and controlled, effectively...
 

CCaantley

Involved In Discussions
#17
Oh yes! Your ISO "trainer" is biased towards doing things to make (ineffective) auditors happy, not doing what ISO actually requires. No documents need signatures or dates, to be approved and controlled, effectively...
Well, that's irritating :blowup:
 

Al Rosen

Staff member
Super Moderator
#18
Oh yes! Your ISO "trainer" is biased towards doing things to make (ineffective) auditors happy, not doing what ISO actually requires. No documents need signatures or dates, to be approved and controlled, effectively...
I once had an auditor issue a NC for signatures where, according to the standard, none were required. I called the CB and asked that he never return.
 

John Broomfield

Staff member
Super Moderator
#19
Your forms, instructions and other lower level docs probably belong to a parent procedure in most cases.

Supporting docs are usually reviewed and approved or reapproved together for use and improvement.

But no signature or date is reqd.

Upping the revision from draft (letter) to the next issue (number) may be enough provided earlier versions cannot be used.
 
Thread starter Similar threads Forum Replies Date
A Confused about Document Levels and Quality Manual ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
D Skipping Document Revision Levels Document Control Systems, Procedures, Forms and Templates 20
W Controlled Documents - Trying to differentiate document control levels Document Control Systems, Procedures, Forms and Templates 5
A Classifying Documents for Different Document Levels ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Definition Document Levels - Definition of what Level 1, 2, 3 documents are Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 4
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) 3
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 4
shimonv Document Control Procedure Header Content Document Control Systems, Procedures, Forms and Templates 3
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 14
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
B Document Approval Matrix Benchmarking Document Control Systems, Procedures, Forms and Templates 3
J Document Approval Signature Order Document Control Systems, Procedures, Forms and Templates 10
L How to add exemption or statement to control of document procedure? ISO 13485:2016 - Medical Device Quality Management Systems 5
M What is the proper way to document measurements Measurement Uncertainty (MU) 1
P Equipment 21 CFR 820.70(g) - User Requirements Document for Off the shelf equipment 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
B Do IFU designs have to be document controlled under ISO 13485? Document Control Systems, Procedures, Forms and Templates 2
C Certificate of Conformance Form - COC for each customer a controlled document? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A Document "Correspondence IATF 16949 vs ISO13485" available? IATF 16949 - Automotive Quality Systems Standard 0
R Document Retention - Discard hard-copies after scanning? ISO 13485:2016 - Medical Device Quality Management Systems 2
P Mylar plot suppliers in accordance with D6-51991 document AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
A Document Change Notice vs complete System re-write Manufacturing and Related Processes 4
Q Document approval through SharePoint (without signature) Records and Data - Quality, Legal and Other Evidence 4
S What is considered a "core algorithm"? (From an FDA guidance document) Medical Information Technology, Medical Software and Health Informatics 4
U Document Approval - Software company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
O Please, help with document on ISO/ TS 17758 and (IDF 87: 1979). Thank you. Manufacturing and Related Processes 1
K Proper document of SMPS used in infant warmer for IEC 60601-1 testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
I Nitpicking on document released dates ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
I Document Control on Log Files ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q Refusal to Document Complaints Customer Complaints 39
Q Tracking Procedure Revisions (Document Control) Document Control Systems, Procedures, Forms and Templates 9
C Document Control Stamps - Does anyone still stamp their documents? Document Control Systems, Procedures, Forms and Templates 24
I Master Document Access - ISO 9001:2015 clause 7.5.3 Document Control Systems, Procedures, Forms and Templates 5
I Can a document (form) approval record be separate? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
I Control of Documentation Distribution - Document Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T Advice needed - Environmental MS - unwritten but customer requests policy document ISO 14001:2015 Specific Discussions 5
T Control of downloaded document copies by employees Document Control Systems, Procedures, Forms and Templates 3
T Document control ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
I Is highlighting on a printed document considered a change? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
C QMS Document Management Software Recommendations Quality Assurance and Compliance Software Tools and Solutions 14
E Part 11 Compliance, Excel living documents (i.e. document master list, equipment list, approved supplier list) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
Sidney Vianna Informational New IAQG Document - AS9100 Clarifications of Intent AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
S How to determine & document Organizational Knowledge of a company Document Control Systems, Procedures, Forms and Templates 4
D Are medical device companies required to document every change made to their website? Document Control Systems, Procedures, Forms and Templates 2

Similar threads

Top Bottom