Change Approval Requirements - Does every change need formal customer approval?

Daring D

Starting to get Involved
#1
Good morning!

Albeit checking in frequently for the very useful guidance and trove of expertise on this site, today my very first query. Indulge my naively start with a very general question and allow me to read through your first reactions before eventually switching to a more in depth discussion.

"Does every change need formal customer approval, or is it allowed/common to just inform the customer of implemented changes/upcoming changes?"
 
Elsmar Forum Sponsor

Tagin

Trusted Information Resource
#2
I think its going to depend on the requirements of the individual customer. We have customers that want change notification pushed up the supply chain as much as possible, with notification on any kind of change. These customers usually have a supplier agreement for us to sign which contains these notification requirements. Other customers only want notification if a component change would affect form/fit/function/price.
 

Daring D

Starting to get Involved
#3
I think its going to depend on the requirements of the individual customer. We have customers that want change notification pushed up the supply chain as much as possible, with notification on any kind of change. These customers usually have a supplier agreement for us to sign which contains these notification requirements. Other customers only want notification if a component change would affect form/fit/function/price.
Dear Tagin,

Thanks for your reaction.
To your input, i see no issue in keeping our customers informed about changes, even beyond engineering topics. I believe our change management process is very solid and none of the changes we introduce are unplanned. Everything is consciously worked out and evaluated and tested prior to serial introduction. Even after full serial production we keep studying the effects of the change and move cautiously forward.
What bothers us somewhat is the expectation of a formal customer approval before any change can be introduced. I'm curious if there's actually a clear standard explaining when a notification is sufficient without having to go through the, often unwarranted time consuming, formal customer approval process.
 

Jim Wynne

Leader
Admin
#4
Good morning!

Albeit checking in frequently for the very useful guidance and trove of expertise on this site, today my very first query. Indulge my naively start with a very general question and allow me to read through your first reactions before eventually switching to a more in depth discussion.

"Does every change need formal customer approval, or is it allowed/common to just inform the customer of implemented changes/upcoming changes?"
What kind of changes are you referring to? If it's product changes, who owns the designs? Please be more specific.
 

chris1price

Trusted Information Resource
#5
Very much depends what is in your quality agreement with the customer. It is common to have three levels; customer approval required, customer notification required and no customer notification required. However where you draw the line between these is between you an the customer; and not all customers want the same thing.
 

Tagin

Trusted Information Resource
#6
What bothers us somewhat is the expectation of a formal customer approval before any change can be introduced. I'm curious if there's actually a clear standard explaining when a notification is sufficient without having to go through the, often unwarranted time consuming, formal customer approval process.
There is no standard I am aware of. Instead, as has been mentioned, it is an agreement or understanding between you and your customer.
 

optomist1

A Sea of Statistics
Super Moderator
#7
my two euros here...in the Automotive...now know as Mobility field....most have a requirement contained in their Source Package or Quality Manual (using generic names here as they vary from firm to firm) called a FR or Forever Requirement...some of these same firms have chosen to make this FR part of their Formal (Engineering) Change Notice or Change Request System...regardless of nomenclature, or location, the purpose is to capture changes that do not fall within the definition of their CN or CR system....in relative terms insignificant changes...The Point, its always best to solicit customer input and keep the lines of communication open...in my experience the great suppliers among other things do exactly this...this precludes any "unforeseen surprises" and is keeping with transparency.
 

Jim Wynne

Leader
Admin
#8
Dear Tagin,

Thanks for your reaction.
To your input, i see no issue in keeping our customers informed about changes, even beyond engineering topics. I believe our change management process is very solid and none of the changes we introduce are unplanned. Everything is consciously worked out and evaluated and tested prior to serial introduction. Even after full serial production we keep studying the effects of the change and move cautiously forward.
What bothers us somewhat is the expectation of a formal customer approval before any change can be introduced. I'm curious if there's actually a clear standard explaining when a notification is sufficient without having to go through the, often unwarranted time consuming, formal customer approval process.
Could you please be more specific in telling us more about your situation?
 

Ninja

Looking for Reality
Trusted Information Resource
#9
The Point, its always best to solicit customer input
Strongly disagree.
and keep the lines of communication open...
Strongly agree
in my experience the great suppliers among other things do exactly this...
In my experience, the great suppliers know from the above communication what the customers really care about, and know when it is in everyone's best interest NOT to solicit customer input because it will lead to a rabbit trail for all involved.
I've personally lost an automotive customer for sharing too much (a change to the product they buy).
I didn't lose it for the change...I lost them for being "too high maintenance" for informing them.

this precludes any "unforeseen surprises" and is keeping with transparency.
Completely agreed.

I parse the above only to point out that the boiler-plate statement "always ask" is not a good mantra.
 

Daring D

Starting to get Involved
#10
Jim, as direct answers to some of your questions:
We produce a socket outlet with USB charging ports. we own the designs and development. Our OEM customers are buying a finished product on which we only adapt laser printing marking and colors of external visible parts according to their wish. The change we want to introduce is a shift form half automated to full automated injection moulding for one of the plastic parts.
I believe however, Correct me if I'm wrong, the answer to my question has been given: there's no international standard prescribing the change request/notification rules. It is a customer contract requirement and/or gentlemen's agreement based practice.
 
Thread starter Similar threads Forum Replies Date
D Document Change Approval ISO 13485:2016 - Medical Device Quality Management Systems 6
P Notified Body Approval of Change EU Medical Device Regulations 2
N China - Start manufacturing before change approval? China Medical Device Regulations 3
R PMA (Parts Manufacturing Approval) Supplement - Labeling Software Change 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S Design Change Drawing Reviews and Customer Approval Process Document Control Systems, Procedures, Forms and Templates 5
M Change Control Form - Approval process for cross departmental communication ISO 13485:2016 - Medical Device Quality Management Systems 4
R MDD Approval Route by Change of Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4
0 Complaints time series significant change Customer Complaints 38
N Malaysia Shelf Life Change Other Medical Device Regulations World-Wide 2
P Self Certified Class 1 MDR 2017/745 Design Change CE Marking (Conformité Européene) / CB Scheme 2
O Article 120 - significant change interpretation EU Medical Device Regulations 4
V Would the customer drawing change necessitate re-PPAP of the Product? APQP and PPAP 3
S Do we have to create a new PPAP to our customer if our Sub Contractor had to change? APQP and PPAP 10
M PMA submission change Medical Device and FDA Regulations and Standards News 0
U Change to the manufacturing Date for a device in the field US Medical Device Regulations 0
F Change in address for critical supplier - does NB need to be informed? CE Marking (Conformité Européene) / CB Scheme 19
K Change in address on ERLM US FDA: Implications to import US Medical Device Regulations 0
N Change our Registrar? Pros and Cons ? Registrars and Notified Bodies 5
F Using non-randomized clinical study for change in existing 510(k) device? US Food and Drug Administration (FDA) 1
FuzzyD ISO 13485 change in process ISO 13485:2016 - Medical Device Quality Management Systems 3
R IVD Label Change China Medical Device Regulations 1
Judy Abbott Change of PVC stabilizer Japan Medical Device Regulations 6
R IVD Label Change Requirements Other Medical Device Regulations World-Wide 0
M EE's - Laptops/Printer Change and Emissions Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
mtmt70a Change\ my MTBF Prediction SW Tool from the RELEX tool with yearly Lic. access Telecordia database to another solution. Recommendations? Reliability Analysis - Predictions, Testing and Standards 0
S Can a product option change the product class? CE Marking (Conformité Européene) / CB Scheme 2
M Regulatory Change assessment US Food and Drug Administration (FDA) 3
G Software change management Design and Development of Products and Processes 3
J Changes to OS - Significant change under MDR EU Medical Device Regulations 8
A If document coding is change will there be a revision Document Control Systems, Procedures, Forms and Templates 1
G Change Control for Test Samples Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
Z Change color or shape of individual data point in control chart Using Minitab Software 6
J Medical Device Component Change - Testing, Sampling Criteria ISO 14971 - Medical Device Risk Management 3
S When to change the status of a GTIN from "Premarket" to "In Use" ? US Medical Device Regulations 2
Y Is there any EU Significant change guidance issued? EU Medical Device Regulations 5
B How to change hour format to text but not changing the number ? Excel .xls Spreadsheet Templates and Tools 1
N API Q1, Management of Change & Document Change Request Oil and Gas Industry Standards and Regulations 4
adir88 Substantial Change to QMS (Annex IX, Chapter I) EU Medical Device Regulations 0
A Eudamed actor registrations if you change AR for MDR product EU Medical Device Regulations 0
C Change Management Process ISO 14971 - Medical Device Risk Management 8
S ISO13485:2016 7.3.9 design and development change ISO 13485:2016 - Medical Device Quality Management Systems 3
N Change Control for processes & products Manufacturing and Related Processes 7
Quality Specialist Change Control Numbering system Document Control Systems, Procedures, Forms and Templates 7
D Laboratories listed in the Declaration of Conformity change Canada Medical Device Regulations 1
M Change control on Tracking Sheet ISO 13485:2016 - Medical Device Quality Management Systems 11
D EU MDR - Change of device name (legacy device) EU Medical Device Regulations 17
L Change Log in (controlled) Forms? (ISO 9001:2015) Document Control Systems, Procedures, Forms and Templates 6
H Control of Change i.e. process and WI IATF 16949 - Automotive Quality Systems Standard 9
dgrainger Informational MHRA's Software and AI as a Medical Device Change Programme UK Medical Device Regulations 0
K Is implementing Electronic Signatures a Significant Change to the QMS? ISO 13485:2016 - Medical Device Quality Management Systems 10

Similar threads

Top Bottom