SBS - The best value in QMS software

How Do I Handle Customer Engineering Specification Changes?

J

Jgryn

#11
#11
Re: Engineering Specifications

"4.2.3.1 Engineering specifications
The organization shall have a process to assure the timely review, distribution and implementation of all customer
engineering standards/specifications and changes based on customer-required schedule. Timely review should be
as soon as possible, and shall not exceed two working weeks."

I don't think it's possible to misintrepret this. The above lumps engineering standards/specifications and changes together as needing timely review and then further defines timely review as not exceeding two working weeks.

Therefore I still have an issue. Any ideas?

Jen
 
Popular whitepapers from DISCUS
Elsmar Forum Sponsor
S

Satellite

Involved In Discussions
#12
#12
:biglaugh:
Thank you all. This thread was very helpful to my engineering group as they sorted through what was "my opinion" and the facts as presented.

Especially since it so closely matched with our CB's "opinion".
 
S

svance

#13
#13
Our group has a continuing struggle with the timely review but I now we have determined another gap we need to close in connect with this. We are not like Chrysler and do not have an online system which generates our Change Notices to our Vendors (in the past not been a problem). We have in the past used our Purchased drawings and sent them to our Vendors requesting them to sign off but are now being asked for more details than just the drawings.

We are now expanding our business which has given us more Vendors to work with and as most company's have experience now some are overseas.

We have a very good ECR process inhouse and have an access database for tracking which we can modify to track CN's to Vendors but can anyone share how they notify their Vendors of CN's and maybe some actual examples of documents they use?

We are TS16949 certified and I know that this is a gap that needs to be closed soon. Any help would be greatly appreciated.
 
S

sunwen

#14
#14
Re: Engineering Specifications

Satellite said:
I'm looking for ideas to handle customer specification changes.
"... have a process to assure the timely review, distriubtion and implementation of all customer engineering standards/specifications and changes based on customer required schedule".
Its the customer required schedule thats throughing us. In a previous life we were just notified of the specification change and then had to find the standard, what changed and how that impacted our operation. I'm not sure that this is what will be allowed here. :bonk:

Another question that came up is how to track the applicability of the standards to each part produced? Ideas please. :bigwave:
Click to expand...
I think you can treat customer specification change as engineering change.

If your customer wants your following one standard, and you think it is not quite suitable, you can discuss with them or get some suggestion from authority dept or persons.
 
CycleMike

CycleMike

Registered Visitor
#15
#15
Re: Engineering Specifications

Jgryn said:
My problem is not how to handle changes but how to find out about them. There is no subscription service and I'm left with the task of assigning my Product Engineers with reviewing all their applicable customer engineering specifications on a weekly basis. I don't know about your company but my engineers will do this once or twice and never again.

What are other people doing to ensure changes that are not communicated by the customer?
Click to expand...

Our customer representative checks purchase orders, as they arrive, against the current rev. that's in our database. If they don't match and there was no engineering change order given us by the customer, we contact them and let them know. Until it's resolved, we won't run the parts unless we have a written deviation from the customer.
 
D

delorfra

Involved In Discussions
#16
#16
Hello There,

We have written a procedure stating that we only handle standards change analysis during the product development/change stage or if the customer asks for it.

We will never engage in reviewing all the standard updated from all our customers all year round for all the products we manufacture since it would imply hiring tens of people and nagging our customers sending them unasked-for quotations.:bonk:

That's my two cents

François
 
Raffy

Raffy

Quite Involved in Discussions
#17
#17
To everyone,:)
I just want to clarify on Engineering Specifications.
In my understanding Engineering Specifications are the specific requirements that the product is expected to meet. Speaking of requirements, these are limits, e.g. test limit ranges from –5Vdc to +5Vdc. Our procedure states that “If there is no specified customer review schedule, a timely review should be as soon as possible and shall not exceed two (2) working weeks.”
In this regard, I have a concern on the review of engineering specifications: “ Test programs that are being sent to us and the only requirement by our customer is to acknowledge that we received the test programs.”
In this regard, are we satisfying the requirements of Clause 4.2.3.1 Review of Engineering Specifications? Please advice.
1. If yes, can we have a provision that these test programs are not part of the engineering specifications? :confused:
2. If no, it takes time (greater than 2 working weeks) for an engineer to validate the test program that are being sent by the customer.
3. Are we violating the requirements of Clause 4.2.3.1 Review of Engineering Specifications? :(
Thank you very much in advance for the usual kind attention you will give this request.
Best regards,
Raffy:cool:
 
D

Deepa

#18
#18
Hi There,

I'm looking for a procedure or documentation to handle Customer Engineering as we have just started engineering department in our medical device comapny & we dont have any written procedure for the same. Could anyone help me in this regard.

Thank you in advance for your kind help

Regards,
Deepa
 
S

Sam

#19
#19
Raffy said:
To everyone,:)
I just want to clarify on Engineering Specifications.
In my understanding Engineering Specifications are the specific requirements that the product is expected to meet. Speaking of requirements, these are limits, e.g. test limit ranges from –5Vdc to +5Vdc. Our procedure states that “If there is no specified customer review schedule, a timely review should be as soon as possible and shall not exceed two (2) working weeks.”
In this regard, I have a concern on the review of engineering specifications: “ Test programs that are being sent to us and the only requirement by our customer is to acknowledge that we received the test programs.”
In this regard, are we satisfying the requirements of Clause 4.2.3.1 Review of Engineering Specifications? Please advice.
1. If yes, can we have a provision that these test programs are not part of the engineering specifications? :confused:
2. If no, it takes time (greater than 2 working weeks) for an engineer to validate the test program that are being sent by the customer.
3. Are we violating the requirements of Clause 4.2.3.1 Review of Engineering Specifications? :(
Thank you very much in advance for the usual kind attention you will give this request.
Best regards,
Raffy:cool:
Click to expand...
Hi Raffy,
4.2.3.1 states "Timely review asap . . . and shall not exceed two weeks". It does not say who, what, where or how to review. I make the initial review during preparation of the DVP&R. Thereafter I am only concerned with reviewing documents for revision change only. I find that preparing the DVP&R from the customer requirements is the most time consuming. In most cases the customer requirements are wrong, in that the test requirement paragraph(s) that they cite do not match the latest version of the test specification. It usually takes 1 to 5 days to complete the DVP&R. It can take from 1 to 6 weeks to get approval.
 
Raffy

Raffy

Quite Involved in Discussions
#20
#20
Hi Sam,
Thank you.
I agree with you with the requirements of 4.2.3.1 however, in our case what I did to the requirements of 4.2.3.1 is that we create a provision in which the test programs that are being sent to us by the customers and these are backup by our customer that this a normal process from their IT to send all new test program/revised test program to their subcon to ensure that all of them have a common and updated copy of test programs. As their subcon, what they require is to acknowledge the email that they received the program.
Raffy
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
Q How to handle customer request for changing specifications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
D Responsibility of Distributor for Customer Complaints - How should we handle this Customer Complaints 5
K How to Handle an Invalid Customer Complaint? Customer Complaints 24
Y How to handle difficult customer - Improving my communication skill and techniques Service Industry Specific Topics 5
D Internal form we use to handle Customer Complaints - To control or not to control Customer Complaints 6
M How to handle changed Customer Specifications or Requirements IATF 16949 - Automotive Quality Systems Standard 4
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
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
R How to Handle 'Scrap and Replace' of Non-Conforming Products Nonconformance and Corrective Action 9
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

Similar threads

Top Bottom