How to document use of wrong engineering drawing

L

lostmanager

#1
We have a job that engineering put the wrong print out on the floor and resulted in the part being non conforming. The part was made to print but now has to scrapped due to an error on the drawing. How do I document issues such as these? Is this an NCR or ECR? I wouldn't think NCR because of a drawing error. I know we need a correct print and now new material to replace the scrapped part. I will issue a CAR but what else?
 
Elsmar Forum Sponsor

Ajit Basrur

Staff member
Admin
#2
Re: How to document use of wrong engineering drawing ?

We have a job that engineering put the wrong print out on the floor and resulted in the part being non conforming. The part was made to print but now has to scrapped due to an error on the drawing. How do I document issues such as these? Is this an NCR or ECR? I wouldn't think NCR because of a drawing error. I know we need a correct print and now new material to replace the scrapped part. I will issue a CAR but what else?
Firstly, sorry to hear the loss of parts ... that would be a huge scrap.

I would still advise use of NCR first. I am unsure of your quality management system but the NCR could lead to an Root Cause Investigation involving CAPA and the Engineering Change Request could be a CA to eliminate the cause of the existing defect while the PA would be to ensure that appropriate review and approval is ensured in future to prevent these issues happen again. You should also be revisiting all currently approved prints to check if there are no errors.

Note: I have moved the thread to an appropriate forum to get more directed responses.
 
#3
Re: How to document use of wrong engineering drawing ?

We have a job that engineering put the wrong print out on the floor and resulted in the part being non conforming. The part was made to print but now has to scrapped due to an error on the drawing. How do I document issues such as these? Is this an NCR or ECR? I wouldn't think NCR because of a drawing error. I know we need a correct print and now new material to replace the scrapped part. I will issue a CAR but what else?
How was it found to be non-conforming? If it was checked to print, it would be good, wouldn't it?
 
L

lostmanager

#4
Re: How to document use of wrong engineering drawing ?

It was found non conforming because when the part was presented to quality for in process inspection, it was found that the part was machined per print but the drawing should have called out a 4" ID bore not to be machined all the way through. The machinist should have caught it but he did what the print stated. The bore is never machined all the way through and now cannot be used.
 
#5
Re: How to document use of wrong engineering drawing ?

It was found non conforming because when the part was presented to quality for in process inspection, it was found that the part was machined per print but the drawing should have called out a 4" ID bore not to be machined all the way through. The machinist should have caught it but he did what the print stated. The bore is never machined all the way through and now cannot be used.
I'm confused! How did someone determine the part was wrong to the drawing? How did a machinist make it to print but not "catch" it was made wrong? :confused:
 
#7
Re: How to document use of wrong engineering drawing ?

Firstly, sorry to hear the loss of parts ... that would be a huge scrap.

I would still advise use of NCR first. I am unsure of your quality management system but the NCR could lead to an Root Cause Investigation involving CAPA and the Engineering Change Request could be a CA to eliminate the cause of the existing defect while the PA would be to ensure that appropriate review and approval is ensured in future to prevent these issues happen again. You should also be revisiting all currently approved prints to check if there are no errors.

Note: I have moved the thread to an appropriate forum to get more directed responses.
No PA - it's a non-conformity, so only corrective action on the design process to stop the feature being missed again...
 
L

lostmanager

#8
Re: How to document use of wrong engineering drawing ?

Sometimes you have to be smarter than the print and say to yourself, do this look right? In this case the machinist wasn't. There has been too many times, when engineering makes a mistake and result in rework. Engineering is disagreeing with me an out an NCR is not needed since the drawing was wrong and only needs an ECr and CAR. In this case when the part is scrapped, how do I document that and get new material to be machined?
 
S

Seizetem

#9
Re: How to document use of wrong engineering drawing ?

Sometimes you have to be smarter than the print and say to yourself, do this look right? In this case the machinist wasn't. There has been too many times, when engineering makes a mistake and result in rework. Engineering is disagreeing with me an out an NCR is not needed since the drawing was wrong and only needs an ECr and CAR. In this case when the part is scrapped, how do I document that and get new material to be machined?


instead of a process that is man-dependent, develop a standardize system..

ensure to review for applicability of every customer requirement, have it registered & controlled..train to all personnel

the best practice..make a fool-proof system.....

for now, you have to back-track if there are any other affected parts for containment and move forward on how to avoid it to re-occurrence.
 

TPMB4

Quite Involved in Discussions
#10
Excuse my slow-witted take on this but I read the original post as saying that the engineering department gave the wrong or incorrect drawing to the operator. This operator made to the drawing which is what he/she is paid to do. Initiative is good but setting up processes so it is not needed is better (error proofing). Is that correct?

Sorry but operators can have initiative, which is to be commended when it happens, but you need to make it so you don't rely on it. The operator makes parts to specification (this case drawing). The issue here is engineering gave out the incorrect or wrong drawing not the operator's fault surely???

Either way you have NC parts, all our customers would write a NCR up straight away and we'd go through the full RCA and reporting process (8D in our case). This then gets everything logged and recorded. Preventative actions made and applied to all other parts that could be affected. If I have read this right, in this case it is something to do with the engineering checking that their drawings are right before issuing them. Some check in place perhaps. I supposed part of containment is to withdraw the drawing, issue the correct one and get the parts made correctly so the customer is only affected as little as possible by this NC.

For my sins I'm heavily involved in the 8D process here and in our case there is a lot of causes that involve documentation, WI, specs, etc. Basically spelling out everything that can go wrong. Operator error rarely washes with our customers, they like a nice, clean systems or process error to be corrected.

Of course I could have read it all wrong but the above is my rather long :2cents:
 
Thread starter Similar threads Forum Replies Date
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) 3
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 4
shimonv Document Control Procedure Header Content Document Control Systems, Procedures, Forms and Templates 3
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 14
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
T Document control ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
I Is highlighting on a printed document considered a change? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
C QMS Document Management Software Recommendations Quality Assurance and Compliance Software Tools and Solutions 14
E Part 11 Compliance, Excel living documents (i.e. document master list, equipment list, approved supplier list) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
Sidney Vianna Informational New IAQG Document - AS9100 Clarifications of Intent AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
S How to determine & document Organizational Knowledge of a company Document Control Systems, Procedures, Forms and Templates 4
D Are medical device companies required to document every change made to their website? Document Control Systems, Procedures, Forms and Templates 2
M Informational IMDRF draft document – Principles and Practices for Medical Device Cybersecurity 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
R Training Matrix for Document revisions ISO 13485:2016 - Medical Device Quality Management Systems 4
S Controlled Document Location Document Control Systems, Procedures, Forms and Templates 3
M Setting deadlines (ex. 45 days) for Document Registration & Review Cycle Document Control Systems, Procedures, Forms and Templates 3

Similar threads

Top Bottom