SBS - The Best Value in QMS software

How to Handle 'Scrap and Replace' of Non-Conforming Products

R

ritammy

#1
First let me say we are a ISO 13485 certified medical device company.

I was wondering how others handle simple "scrap and replace" of non-conforming parts during the assembly process. As of this time our procedure reads that every reject needs a In-Process non-conforming items form attached in which I need to disposition as scrap and replace and sign off on and determine if a formal NCR needs to be created. These instances are generall for 1-4 pieces of low dollar components.

My question is if simply recording the scrap and replace on the DHR is sufficient or do these actions require official sign off of the action of scrap and replace. Wondering if I can modify the procedure to just record simple scrap and replaced on the DHR and cut out the extra work of filling out forms and having to approve them every time.

Thanks!!
Tammy
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
Re: How to Handle Scrap and Replace of Non-Conforming Products

A Quick Bump!

Can someone help Tammy?

Thank you very much!!

Stijloor.
 
M

MIREGMGR

#3
Re: How to Handle Scrap and Replace of Non-Conforming Products

If we had your circumstance, we'd be asking other questions than how to scrap and replace parts with less documentation.

How do non-conforming parts get as far as your assembly process without being detected? If you have an acceptance or incoming inspection process, why doesn't it work? Do you know with certainty that the inspection process you're in effect doing at assembly is detecting all of the non-conforming parts before they go into your product? Is your product safe and effective even if assembled with a non-conforming part, so that the part in fact is non-critical...or if the opposite is the case, what steps are supposed to be in place to manage the critical part that aren't working? Is the part specification faulty, or the part production process out of control? When did you last review the qualification of the vendor? How long has this been going on, and what comments were made during your most recent NB surveillance audit? Do you also market in the US?
 

somashekar

Staff member
Super Moderator
#4
Re: How to Handle Scrap and Replace of Non-Conforming Products

My question is if simply recording the scrap and replace on the DHR is sufficient or do these actions require official sign off of the action of scrap and replace. Wondering if I can modify the procedure to just record simple scrap and replaced on the DHR and cut out the extra work of filling out forms and having to approve them every time.
There are few things in your system. One is the handling of NC parts, and if you have the responsibility and authority to take a replace decision you can do that and the product release will anyway have the approval on the DHR after all required testing. You identify the part suitably such that it goes through the NC analysis process, and does not get back into the assembly with an unknown status.
The other is the NC part analysis, which after is either decided as scrap or re-workable or use as is with a deviation approval, where for all these, specific competency and authorization are essential.
You can work around your procedure with these in mind.
Depending on the significance this can lead to internal corrective actions or supplier corrective actions.
 
Last edited:
S

ssz102

#5
Re: How to Handle Scrap and Replace of Non-Conforming Products

does your company have a non-conforming product procedure documents?
if have, you can handle it in according with document
 
R

ritammy

#6
OK, I need to give a bit of clarification. We are a contract manufacturer. The "scrap and replace" parts in question are sent in directly from our customer as previously inspected and accepted by them. During incoming inspection we just check for overall condition using a C=0 sampling plan.

The parts in question are caps and hubs and what not that are being cracked now and again when the assembly process of wires are inserted. During the assembly process we frequently get pieces that crack during assembly for whatever reason. Other instances are film that is cut. If during the cut process a problem with the cut is notated (i.e, frayed edge, uneven cut) it is rejected. Any of these occurances, as examples, an In-Process NCR is filled out by the operator, noted on the DHR and presented to the Quality Manager (me) to be reviewed for a disposition. In both of these cases, detailed previous, I evaluated and sign off on a disposition of "scrap and replace" this disposition is documented on the DHR and the operator moves on.

I recently updated the In-Process NCR procedure to detail that all rejects must be documented on the DHR and include an In-Process NCR. Apparently a lot of these instances had been not documented as they are now coming to me for a million and one little things to sign off on, which is becoming a bit crazy. I was just wondering how I can draw the line of simple scrap and replace like when you got the film and it gets a frayed edge and needs replacing or a .01 cap gets cracked and needs to be replaced. I know ... how can you differentiate between the .01 cap and the 100 dollar knife?!?

I was wondering if there was anything I might write into the procedure that allows simple scrap and replace to be only documented on the DHR. Any input would be greatly appreciated.

ssz102: Yes we do have a Non-Conforming procedure - I wrote it. I think I may have written a bit stringent.

MIREGMGR: Is your product safe and effective even if assembled with a non-conforming part? Our product would not be assembled with a non-conforming part. We have many in-process inspections and final inspections. Operators are trained to inspect as they go on top of that. We have never had any complaints on the product line in question in regards to the scrap and replace issue. The customer cuts corners where they can and some of the insignificant parts are purchased in China and are a bit inferior I believe. However, it is what it is - they are inspected and accepted the pieces. They are aware of the scraps and replaces and are ok with us weeding through the non-conformities (which we charge for). ... the part in fact is non-critical...or if the opposite is the case, what steps are supposed to be in place to manage the critical part that aren't working. I think this is key to distinguish non critical and critical parts and write into a procedure how to handle these somehow.?!?

Thanks to all for their input.

Thanks!
Tammy
 

normzone

Trusted Information Resource
#7
We build computers and have similar challenges - gaskets that get damaged, delicate cable connectors that break. As I see it, the challenge is to have a system that allows for the routine disposal of low cost / high failure materials yet sounds the alarm when issues that need to or can be corrected surface.

Our first level of filter is cost. Set a threshold of $5, $20 or whatever works for you and allow scrapping of those items with logging to permit review periodically. Train your personel to recognize the difference between acceptable anomalies and occasions to ask for input.

Unrealistic expectations of process capability is common in my environment. You may need to back up your decisions with some data, hence logging and review.
 
S

ssz102

#8
We build computers and have similar challenges - gaskets that get damaged, delicate cable connectors that break. As I see it, the challenge is to have a system that allows for the routine disposal of low cost / high failure materials yet sounds the alarm when issues that need to or can be corrected surface.

Our first level of filter is cost. Set a threshold of $5, $20 or whatever works for you and allow scrapping of those items with logging to permit review periodically. Train your personel to recognize the difference between acceptable anomalies and occasions to ask for input.

Unrealistic expectations of process capability is common in my environment. You may need to back up your decisions with some data, hence logging and review.
haha, you are in Circuit Assembly?
 
S

ssz102

#9
OK, I need to give a bit of clarification. We are a contract manufacturer. The "scrap and replace" parts in question are sent in directly from our customer as previously inspected and accepted by them. During incoming inspection we just check for overall condition using a C=0 sampling plan.

The parts in question are caps and hubs and what not that are being cracked now and again when the assembly process of wires are inserted. During the assembly process we frequently get pieces that crack during assembly for whatever reason. Other instances are film that is cut. If during the cut process a problem with the cut is notated (i.e, frayed edge, uneven cut) it is rejected. Any of these occurances, as examples, an In-Process NCR is filled out by the operator, noted on the DHR and presented to the Quality Manager (me) to be reviewed for a disposition. In both of these cases, detailed previous, I evaluated and sign off on a disposition of "scrap and replace" this disposition is documented on the DHR and the operator moves on.

I recently updated the In-Process NCR procedure to detail that all rejects must be documented on the DHR and include an In-Process NCR. Apparently a lot of these instances had been not documented as they are now coming to me for a million and one little things to sign off on, which is becoming a bit crazy. I was just wondering how I can draw the line of simple scrap and replace like when you got the film and it gets a frayed edge and needs replacing or a .01 cap gets cracked and needs to be replaced. I know ... how can you differentiate between the .01 cap and the 100 dollar knife?!?

I was wondering if there was anything I might write into the procedure that allows simple scrap and replace to be only documented on the DHR. Any input would be greatly appreciated.

ssz102: Yes we do have a Non-Conforming procedure - I wrote it. I think I may have written a bit stringent.

MIREGMGR: Is your product safe and effective even if assembled with a non-conforming part? Our product would not be assembled with a non-conforming part. We have many in-process inspections and final inspections. Operators are trained to inspect as they go on top of that. We have never had any complaints on the product line in question in regards to the scrap and replace issue. The customer cuts corners where they can and some of the insignificant parts are purchased in China and are a bit inferior I believe. However, it is what it is - they are inspected and accepted the pieces. They are aware of the scraps and replaces and are ok with us weeding through the non-conformities (which we charge for). ... the part in fact is non-critical...or if the opposite is the case, what steps are supposed to be in place to manage the critical part that aren't working. I think this is key to distinguish non critical and critical parts and write into a procedure how to handle these somehow.?!?

Thanks to all for their input.

Thanks!
Tammy
this paragraph is too long, it would be better if you hanlded it previously, such as separate use punctuation or subsection

fistly, you should be definite the grade for non-conformities part, for instance, minor, major and critical etc;

secondly, you should be develop a document that if who is produce these nonconformities parts, what will they get punishment or decrease their performance;

finally, as you who are in charge of quality for all parts of you company, you should be emphasise how to plans for you company goods quality
 
Thread starter Similar threads Forum Replies Date
K Different Indications for Use in Different Countries -- how to handle IFU? Other Medical Device Regulations World-Wide 4
K How to handle GTINs for different configurations of one device with one part number? Other Medical Device Related Standards 0
I How to handle pending FSN when incident happens? EU Medical Device Regulations 1
Jimmy123 Process disturbances and the repair - How do you handle this risk in your company? FMEA and Control Plans 18
GoSpeedRacer How to handle operator involvement in the non conformance ISO 13485:2016 - Medical Device Quality Management Systems 5
A How to Handle Documented Information in an online database for ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
O How will you handle Clause 6.1 - Risks and Opportunities for AS9100 Rev. D Auditors? Risk Management Principles and Generic Guidelines 22
V Systems to Handle Development and Batch Analysis in same Laboratory Qualification and Validation (including 21 CFR Part 11) 3
dubrizo How do you handle damaged IM&TE in your organization? General Measurement Device and Calibration Topics 3
D MDD Classification of Bone Saw Handle ISO 13485:2016 - Medical Device Quality Management Systems 1
1 How to handle Nononformances in Clincal Manufacturing ? Nonconformance and Corrective Action 2
R How do we handle Training during transition and overlap from one system to other ? Training - Internal, External, Online and Distance Learning 4
Q How to handle different voltages for different countries Document Control Systems, Procedures, Forms and Templates 1
A How to handle complaints after end of specified medical device life-time ISO 13485:2016 - Medical Device Quality Management Systems 5
M How does Australia handle products that are EU PPE, but Australia Medical Devices? Other Medical Device Regulations World-Wide 7
C How to handle this Inspection conflict? Second Shift Inspector? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Q How to handle customer request for changing specifications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
T How to handle Demo Units during an ISO 9001 Audit General Auditing Discussions 3
C ISO 9001 Nonconformances an how to handle them ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
D How to handle a blood stained GMP document ? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 6
T How to handle 510(K) submisison in 2014 when the Fees were paid in FY13 ? US Food and Drug Administration (FDA) 3
C How to handle Action Results in a new FMEA Review once we have a new RPN? FMEA and Control Plans 1
Mikishots How to handle CAR (Corrective Action Request) Scope vs. Timely Response Nonconformance and Corrective Action 9
J Quality Procedure to handle some standard Medical Device Processes Document Control Systems, Procedures, Forms and Templates 1
L How to handle a Business Shutdown - Business Dissolution 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D Plan & Procedure to handle a Product that's being Withdrawn from the Market 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
J Can you handle passivated parts without wearing gloves? Manufacturing and Related Processes 5
A How to handle the various Document Revisions Document Control Systems, Procedures, Forms and Templates 2
N How to handle Quality and Safety Deficiencies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
L Client that refuses to help - How to handle ? Misc. Quality Assurance and Business Systems Related Topics 5
C How to handle Outsourcing with Same Site - Separate Cert ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
B How to handle Medical Device Emergency Software Releases Software Quality Assurance 4
B How to handle/follow supervisor and department head with different supervisory style? Quality Manager and Management Related Issues 7
Z If this is a Nonconforming Product (Service) under clause 8.3? How do we handle it? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
D Responsibility of Distributor for Customer Complaints - How should we handle this Customer Complaints 5
B Upper Management makes changes to a report - How do I handle this? Six Sigma 12
J SOP for How to Handle an Investigation wanted Document Control Systems, Procedures, Forms and Templates 1
J AS9100 C - 7.5.1.3 - How do you handle Production Equipment Maintenance? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
J Seeking advice on how to handle a Special Process Nonconformance AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
M How to handle the task of Organizing a Regulatory File Room Document Control Systems, Procedures, Forms and Templates 2
V ISO 26262 - How to handle OEM ASIL A (Automotive Software Integrity Requirements) Other ISO and International Standards and European Regulations 4
M How to handle Rejections of a Internal NCR event Nonconformance and Corrective Action 7
G Manufacturing Process Subcontracted - How do I handle Cl. 7.5? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
P How to handle Out of Tolerance during Calibrations and exceeded Alert Action Limits Quality Manager and Management Related Issues 4
M The importance of Document Control? How do you handle your Document Control? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
R How do you handle 'Contaminated Wood Pallets'? US Food and Drug Administration (FDA) 16
L Quality Objectives - How various device companies handle "Quality Objectives" ISO 13485:2016 - Medical Device Quality Management Systems 9
A How does your registrar handle 2 certificates, one for AS9100 and one for ISO9001? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 18
Le Chiffre Great article on how to handle continuous improvement Quality Manager and Management Related Issues 3
E Validity of ISO 9001:2000 Certificates - How to handle supplier ISO 9001 certificates ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4

Similar threads

Top Bottom