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
E Do anyone have document of automotive production risk and control of risk? Lean in Manufacturing and Service Industries 1
Q Document representation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J Document Control of Online Management Software ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
W Document control Document Control Systems, Procedures, Forms and Templates 10
D Increasing efficiency - Capt. Proj. Document Review Matrix Document Control Systems, Procedures, Forms and Templates 4
A ISO 9001:2015 8.5.6 and 7.5.3 Document Control Questions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
qualprod Sheets into a spreadsheet document control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
J Document Changes that don't have to be approved Document Control Systems, Procedures, Forms and Templates 11
D Electronic Document Management System ISO 13485:2016 - Medical Device Quality Management Systems 16
M Document Control - Applying Suitable Identification to Obsolete Documents ISO 13485:2016 - Medical Device Quality Management Systems 5
D Document Control Question involving DocuSign US Food and Drug Administration (FDA) 6
M Document Control ISO and FDA ISO 13485:2016 - Medical Device Quality Management Systems 7
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 1
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 1
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 4
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 14
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 4
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

Similar threads

Top Bottom