SBS - The Best Value in QMS software

How Can I Document Rejections?

NikkiQSM

Quite Involved in Discussions
#1
Hello All -

Here is my current process for documenting rejections:

I log all the information into a list in an excel spreadsheet.
Then I complete an NCMR document which holds all same information.

I am wondering if an NCMR document is even really needed?

This is different from a CAR.

The NCMR document is purely to record the rejection of a product and what we did for disposition.

If all the information is covered in my log - do I really need to complete an NCMR document as well. I find this incredibly redundent and a waste of my time.

Thanks in advance,
Nikki
 
Elsmar Forum Sponsor

Michael_M

Trusted Information Resource
#2
Re: How Can I Document Rejections

Would it be possible to use a database instead?

The database would act as both NCMR and your Excel listing, especially since both have the exact same information. I personally try to avoid using Excel for records due to the fact that I want to keep all records forever (I'm bad).



If your Excel and the NCMR have the same information, I would look to reduce the NCMR document. However, and you probably know this, you need to make sure your not violating your own company policies/procedure doing so. If you change and one of the procedures references the NCMR document, you will need to change the procedure.
 

NikkiQSM

Quite Involved in Discussions
#3
Re: How Can I Document Rejections

Would it be possible to use a database instead?

The database would act as both NCMR and your Excel listing, especially since both have the exact same information. I personally try to avoid using Excel for records due to the fact that I want to keep all records forever (I'm bad).



If your Excel and the NCMR have the same information, I would look to reduce the NCMR document. However, and you probably know this, you need to make sure your not violating your own company policies/procedure doing so. If you change and one of the procedures references the NCMR document, you will need to change the procedure.
Thanks Michael!

Yes I am aware I would have to update our procedure (which would be my job anyways :) )

I also do not like Excel - but right now its what our system uses and has used for the last 15 years. We are moving forward with an ERP system, but that is over a year away and I am not sure how my documents are going to fit in with it right now.

So for the time being - I am trying to reduce the amount of work that I find to be unnecessary.
 
P

PaulJSmith

#4
Re: How Can I Document Rejections

I agree that a database might be the way to go. However, don't be fooled; a database is really just a spreadsheet with a pretty face. The form view, though, could be your replacement for your existing NCMR form, provided the database is accessible to all who will need to use it.
 
S

Shaheen Alam

#5
Re: How Can I Document Rejections

As long as you have CAR, you can use that for recording rejection. Creating separate NCMR can be avoided.
 
P

PaulJSmith

#6
Re: How Can I Document Rejections

As long as you have CAR, you can use that for recording rejection. Creating separate NCMR can be avoided.
Do you really want to go through a complete CA process for every rejection?

... and welcome to The Cove, Shaheen!
 
Last edited by a moderator:

NikkiQSM

Quite Involved in Discussions
#7
Re: How Can I Document Rejections

Do you really want to go through a complete CA process for every rejection?

... and welcome to The Cove, Shaheen!
My answer is no.. and honestly - we do not issue a CAR for every rejection.

If we see a trend of similar rejections, or if a rejection is due to someone doing something against procedure - then yes we open one.

But no, we do not issue a CAR with every rejection.
 
Thread starter Similar threads Forum Replies Date
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 11
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 7
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
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

Similar threads

Top Bottom