Inquiry about the number of changes in a document

#1
Hi all, :)

I work for a Pharmaceutical company and in our last audit we had that comment in the inspection report

* Number of changes in the documents after which reissuing takes place is not determined
just wanted to understand :frust: this item and what it means?

Thank you so much, Love this site,

TarKEpa
 
Elsmar Forum Sponsor

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Re: Inquiry about No. of changes in a document ?

That is a pretty cryptic write up. It seems to me like a document revision control comment.
 

Wes Bucey

Quite Involved in Discussions
#3
Hi all, :)

I work for a Pharmaceutical company and in our last audit we had that comment in the inspection report

Quote:
* Number of changes in the documents after which reissuing takes place is not determined
just wanted to understand :frust: this item and what it means?

Thank you so much, Love this site,

TarKEpa
I would "guess" this auditor was struck by looking at "redlined" documents (documents where changes are added to an existing document and then initialed by approving entities) and wondered [opportunity for improvement] why the changes weren't incorporated into a revised document which was then reissued (a clean document without all the markups.) The comment appears to aim at creating an "organization policy" for maintaining clear documentation.

But why guess? Call or email the auditor who wrote the comment and ask for a clarification. In the future, try to ask such questions at the closing meeting, but do not feel "stupid" if a question arises in interpretation after the auditor has left the building. Auditees cannot be expected to read the mind of an auditor and have every right (even responsibility) to ensure they understand the comment and the basis for the comment (often called the "show me the shall" in referring to a citation against a Standard or a company policy.)
 
Last edited:
#4
I would "guess" this auditor was struck by looking at "redlined" documents (documents where changes are added to an existing document and then initialed by approving entities) and wondered [opportunity for improvement] why the changes weren't incorporated into a revised document which was then reissued (a clean document without all the markups.) The comment appears to aim at creating an "organization policy" for maintaining clear documentation.

hi Mr. Wes

Did it aim at making a "change control table" in all SOPs mentioned in it the No. of changes + the reissued date ?
 

JoCam

Trusted Information Resource
#5
Hi TarKEpa,

I read from this that the Auditor is stating that the changes made to documents and presented to document control for up-issue are not highlighted. For example, insertions in green and strike through of omissions. These changes need to be highlighted to assist approvers of the amended documents, and ensure full traceability of amendments in the doument history.

I may be wrong, but it is another way of intepreting the statement.

Hope this helps,

Jo
 
M

mzeeshanz

#6
Dear TarKEpa,

IMO, you should consider the best suggestion as made by Wes Bucey (Call or email the auditor who wrote the comment and ask for a clarification.)

The guess of
Wes Bucey is also "well-guessed". If auditor's clarification would be similar to this guess, then you should simply have to add a piece of text in you procedure of document control that describe your procedure of handwritten changes. The text to be added may be like this:

"Handwritten changes followed by review and approval from authorized personnel are allowed. In such cases formal procedure for reissuing is not followed but XYZ (designated personnel) ensures that all distributed copies of particular document are updated accordingly. After NN (number of) changes, particular document is formally reviewed, approved and distributed with new issue number."

Hope it helps.

Regards:
Zeeshan
 

raghu_1968

Involved In Discussions
#7
Dear TarKEpa,

Hope that auditor is looking for the revision history of the document. The revision history shall contain:

1. S.No.
2. Revision number
3. Description of the change (With change control form no.)
4. Effective date of the particular revision.

This revision history should be part of the each procedure.

Regards / Raghu
 
D

DrM2u

#8
TarKEpa,

Follow Wes Bucey's advice: contact your auditor for clarification! As you can see so far, there are many interpretations of the same statement.

I am going to assume that you are following ISO 13485, being a pharmaceutical organization. If that is the case, there is no requirement in the standard to determine the "number of changes in the documents after which reissuing takes place [...]" (see clause 4.3 for requirements). Therefore the auditor' comment cannot be more that an opportunity for improvement for your procedure and/or document control process. At this point you can ignore it (if the system is suitable and compliant) or take action (if you see the opportunity as well). Whatever you decide to do, and at the risk of repeating myslef, contact your auditor for clarification first!!!
 
Thread starter Similar threads Forum Replies Date
B AOS Assembly Operations Sheet Inquiry Manufacturing and Related Processes 0
Nikki9154 MDSAP inquiry for China Contract Manufacturers ISO 13485:2016 - Medical Device Quality Management Systems 4
I Food Contact Materials Declaration of Compliance Inquiry - (EC) 1935/2004 Food Safety - ISO 22000, HACCP (21 CFR 120) 4
B Inquiry for Class II medical device licence amendment application Canada Medical Device Regulations 1
D Inquiry about QC Testing (In Line Sampling) Reliability Analysis - Predictions, Testing and Standards 13
R Customer Complaint/Nonconforming Product Inquiry ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
B Inquiry about MEDDEV 2.12/2 rev2 - PMCF studies EU Medical Device Regulations 3
B Inquiry about Canadian Medical Device Licence with different Establishment Other Medical Device Related Standards 1
B Inquiry about IEC 60601-2-10:2012 & IEC 60601-1-11:2010 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
N NIST Special Publications and Technical Notes inquiry General Measurement Device and Calibration Topics 4
S Site Master File inquiry - Distribution in India EU Medical Device Regulations 6
R Six Sigma / DPMO Related Inquiry - A 6 Sigma related Statistical Sampling question Six Sigma 2
L Customer Inquiry - Graph showing the expansion of oil (mm) at different temperatures Service Industry Specific Topics 5
R Inquiry for License needed when not releasing your self? Pharmaceutical Products Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
Kales Veggie Shop Floor Real Time SPC Inquiry Statistical Analysis Tools, Techniques and SPC 15
B Partial Joint (Hip Prosthesis) Replacement Class inquiry EU Medical Device Regulations 3
K Inquiry on kinds of document a customer is requiring us to submit? Quality Tools, Improvement and Analysis 2
Marc FDA begins inquiry on Guidant defibrillator flaw World News 1
D Control Number for Class III and IV devices Canada Medical Device Regulations 0
K How to handle GTINs for different configurations of one device with one part number? Other Medical Device Related Standards 0
K How can Acceptance Number and Reject Number be larger than Sample Size on Z1.4 Table? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
D Determining the the maximum number of reprocessing cycles of attachments CE Marking (Conformité Européene) / CB Scheme 2
K Why 'FD&C act section number' and 'section number' in the title of the act are different? US Food and Drug Administration (FDA) 1
A Risk Number for each software requirement IEC 62304 - Medical Device Software Life Cycle Processes 7
K Adding the Notified Body Number CE Marking (Conformité Européene) / CB Scheme 2
C Quantifying risk in choosing the number of parts, operators and replicates in a GR&R Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
Jane's Like-for-like critical raw material change qualification - type of testing/ number of lots required ISO 13485:2016 - Medical Device Quality Management Systems 4
Q LOT or Serial Number Symbol not used when the information is contained in the UDI? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Proud Liberal Power Query to combine multiple tables of unequal number of columns Statistical Analysis Tools, Techniques and SPC 1
Q How is Medical Device Number (MDL) assigned to companies? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
D How to get EUDAMED Single Registration Number (SRN) EU Medical Device Regulations 17
M Informational US FDA – Modifications to the List of Recognized Standards, Recognition List Number: 052 Medical Device and FDA Regulations and Standards News 0
M Nonconformity for missing form number on the job description document Nonconformance and Corrective Action 1
I Number of decimals in equation calculated by MiniTab Using Minitab Software 0
F 2017/745 Article 31 Single Registration Number Medical Device and FDA Regulations and Standards News 5
Z Do we still have to put UDI if we have DI and lot number seperately on our product ? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
Z Two Payment Identification Number (PIN) for the same order in DFUF website 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Ed Panek GTIN (Global Trade Item Number) for non CE Mark Other Medical Device Related Standards 4
A The latest revision number and changes in automotive core tools IATF 16949 - Automotive Quality Systems Standard 1
G Belgium - How do I get an enterprise CBE Number Other Medical Device Regulations World-Wide 0
M Document Control - Revision Number in Document Names Document Control Systems, Procedures, Forms and Templates 4
M Informational USFDA – FDA Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 051 Medical Device and FDA Regulations and Standards News 0
S How to number and control translated SOPs - Three languages Document Control Systems, Procedures, Forms and Templates 4
qualprod Calculate number of people in processes, considering cycle time/takt time = quantity of people Lean in Manufacturing and Service Industries 9
A Doubt on multiple inspection carrying out for same balloon number during Stage Inspection and Final Inspection? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
K Relabeling or Not Relabeling - Adding our internal Part Number barcode label 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
lilybef Number of lots required for stability testing of a Class II device in the 510(k) Qualification and Validation (including 21 CFR Part 11) 3
J DoE - Number of runs in Plackett-Burman (Minitab) Using Minitab Software 2
G Heat Number on CofC - Stainless steel tube Manufacturing and Related Processes 2
M Determining number of employees within the "Scope" of the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9

Similar threads

Top Bottom