Question 1 - Nitpicking on Document Approval - can a document approval record be separate?

ISO_Man

Involved In Discussions
#1
I have a form to approve. The first 2 pages is the business content - what the form is really for -- the 3rd page is just the approval, revision history, approval signature, etc. The creator of the form wants to be able to print pages 1 and 2 of the approved form for daily use but not waste the 3rd page by printing it every time.

I know that ISO doesn't specify EXACTLY how to do this, but can I have a form that's approved and the approval record is not part of that document? If an auditor picks up the form and it's page 1 of 3 and 2 of 3, the first question is going to be "where's page 3?"

Can I have a separate approval record for each form?
 
Elsmar Forum Sponsor

blackholequasar

Involved In Discussions
#2
I have worked with companies that have something called a DCN/DCR - a document change notification/document change record. A separate document captures the revision history of the document and a log (record) keeps track of changes. In the company I work at currently, I hyperlink this DCN document in the footer of the document for anyone who may want to see the full revision history with signatures. (This is also maintained in a document master binder)

Some older documents have revision changes well into the double digits and it would take up pages of the document. It just seemed to be very cluttered. The DCN serves as record.
 

RoxaneB

Super Moderator
Super Moderator
#3
Since ISO doesn't tell you how to do something, it's up to your organization to create a management system that works for (i.e., adds value to) the organization.

Does having that 3rd page add any value? If Page 3 goes missing, what is the impact to the process?

My own take is that the approval for forms (re: template for what will eventually become a record) doesn't belong on the form itself. Your doc control system should be robust enough to handle this approach.
 

John C. Abnet

Teacher, sensei, kennari
#4
Can I have a separate approval record for each form?
Good day @ISO_Man
I'll answer your question with another question. Why change anything? As long as you can show evidence that the current level document (i assume you keep the " master" as a digital document), is the same level as the document in use, then there is no problem.

Specific to your question of "can I have a separate approval record"? The answer is yes, of course.

One method I have used is as follows...
- A log (data base in some cases) assigns a sequential "serial number" for identifying all change point control (e.g. CP-0001, CP-0002, CP-0003, etc..etc..)
- The log (data base in some cases) simply identifies the following by the assigned serial number.. ..
a) The document number impacted by a given change point control serial number (e.g. CP-0022)
b) WHY the change is desired
c) WHAT changed
d) WHO approved the change
e) WHEN (date of change implementation)

The change point control serial number (e.g. CP-0022) is listed on the document (generally a field on the front/first page).

Now when a document is used, it is clear to see the most recent CPC serial number (instead of rev level) listed on the document. To understand if that is the most recent version and the WHY-WHAT-WHO-WHEN associated with the change (i.e. change history) simply look up CP-0022 in the log (data base in some cases).


Regardless of your approach, don't overthink it. As long as you can show evidence that the relevant information on the document in use is consistent with the intent (current "revision" level), then you have ensured the correct document is being used (and, by the way, satisfy the requirements of the standard).

Hope this helps.
Be well.
 

outdoorsNW

Involved In Discussions
#7
Many places have the document approvals on a separate form, and the actual document or form only has a revision number or date to be used to connect to the approvals. As long as you have good doc control practices so only the current version is accessible and in use, you will not have audit problems.

With printed forms the biggest problem is people printing out a large amount and using outdated revisions.
 
Thread starter Similar threads Forum Replies Date
A Labeling Question (Dietary Supplements/Food) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
T Question for: Cg & Cgk calculation General Measurement Device and Calibration Topics 3
N ASL Question for GitHub ISO 13485:2016 - Medical Device Quality Management Systems 6
hogheavenfarm GDT Flatness measurement question Inspection, Prints (Drawings), Testing, Sampling and Related Topics 10
A Question on ISO 14001:2015 - Are annual audits required? ISO 14001:2015 Specific Discussions 8
dinaroxentool Question about FDA Classification of a Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Another DFAR question 252.225-7009 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 0
T GDT Callout Question Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
F Conflict Mineral Smelter Question RoHS, REACH, ELV, IMDS and Restricted Substances 8
R NRTL - Scope Question - Off-the-Shelf Plug In IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
D API 6A Certification Question Oil and Gas Industry Standards and Regulations 4
dinaroxentool Question about qualification as a medical device or accessory in Europe EU Medical Device Regulations 2
R DHR question: Traceability of components ISO 13485:2016 - Medical Device Quality Management Systems 2
C MDR - Question around software accesories EU Medical Device Regulations 2
Watchcat Authoritative References about the Research Question? Quality Tools, Improvement and Analysis 0
T Question about Quality Department employee position titles Quality Manager and Management Related Issues 7
N Question on creepage/clearance requirements for HF Active Accessories for 2nd edition 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
J Question: How to create an IMDS RoHS, REACH, ELV, IMDS and Restricted Substances 3
K Question on whether IEC 60601-2-62 standard is applied IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
B QMS question in regards to multiple medical devices/products and N/A activities Other Medical Device Related Standards 12
C NB approval - Basic question about Notified Bodies and their role EU Medical Device Regulations 10
G Question about Non-conformances during New Product Introduction Nonconformance and Corrective Action 14
F ISO 13485 8.2.3 Reporting to regulatory authorities: Question regarding a procedure for this clause. ISO 13485:2016 - Medical Device Quality Management Systems 4
O Mitutoyo Digital Caliper to PC USB question General Measurement Device and Calibration Topics 2
R Probability - Need a help to solve the below question Statistical Analysis Tools, Techniques and SPC 5
B Minitab Type 1 Gage Study on True Position Question Measurement Uncertainty (MU) 1
Q Supplier audit question cataloque VDA Standards - Germany's Automotive Standards 0
Ed Panek Inactive key supplier question - We are not actively buying from them ISO 13485:2016 - Medical Device Quality Management Systems 2
T Potential Off-Label Use question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
R Question on determining defective units - I am not recording fixture to part rejected Statistical Analysis Tools, Techniques and SPC 5
Ed Panek Rule 11 Question - CE approvals for software as well as the medical device EU Medical Device Regulations 6
H Question about implications of performing Firmware upgrade via MDDS - Medical Device Data Systems 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
D Company Moving - Relabelling Question Medical Device and FDA Regulations and Standards News 0
Ronen E Tolerance intervals (?) question - Flow Rate Probability Range Statistical Analysis Tools, Techniques and SPC 6
S Conformity Assessment Route question for Class IIa medical device under MDR EU Medical Device Regulations 3
K AS9100D 8.4.1.1 external providers question - Walmart, Home Depot, our lawn care team. etc. AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 20
E Question on GD&T added to print - Positional callout for the small holes Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
J IEC 60601-1, ed 3.1 - Blue icon question IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
A PFMEA English language question IATF 16949 - Automotive Quality Systems Standard 4
D GD&T Drawing Question - I have a drawing and it makes no sense to me whatsoever Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
D Yet another torque question... Assembly processes AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
A A Question about Continual improvement process in AS9100 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 4
S Question about a basic additive variance/tolerance example Quality Tools, Improvement and Analysis 2
M Interview question - IMS (Integrated Management Systems) a necessity or an ISO mistake? ISO 14001:2015 Specific Discussions 10
J Question on very low NDC number with tolerable GRR ratio's Capability, Accuracy and Stability - Processes, Machines, etc. 7
M Medical Devices Sterility - Question from A Regulator Other Medical Device Regulations World-Wide 3
N The question asks about sampling plans and AQL Reliability Analysis - Predictions, Testing and Standards 5
L AS9102 Form 1 Section 13 Detail or Assembly Question AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
D AS9100D implementation question AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 9
O Interview question about IATF 16949 2016 IATF 16949 - Automotive Quality Systems Standard 4
Similar threads


















































Top Bottom