Change Control - How low do you go before making official changes?

M

mikedavies1

#1
After a recent customer concern, I have the 'pleasure' of re-writing our change control procedures, as part of the corrective actions.
I work in the automotive industry and plan to use the 4M system (Man Machine, Method & Material).
My question is at what point is a 'change' significant enough to required to be recorded. Any opinions/ advice would be greatly appreciated.


Thanks
Mike
 
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Raffy

Quite Involved in Discussions
#2
Hi mike,
In our end, if its immediate, we have to implement it. In our end, we generate a change notice plus the document (hard copy) and have it routed to all department managers to review and approved the said changes, if there are concern, it is immediately address and re-approved again to the department managers previously approved the change notice. Within the next 24 hours, if there were no other concerned that must be addressed on the said document, it will be released on the effective date of implementation.
Hope this helps.
Best regards,
raffy :cool:
 

SteelMaiden

Super Moderator
Super Moderator
#3
Typos - eh, not so much. Changes to what or how you do something? Except where you are trialing a new process (which should have its own documentation, imho) you should change your documentation so that it is available at the time of implementation of the change. So, if you want to start the change tomorrow morning, depending upon how nimble your document control and change notification system is, you need to let people know what the new process is before they can follow it.
 

Ajit Basrur

Staff member
Admin
#4
Agree with Steel. Minor - dont worry but for major ones, change procedure. The definitions for minor and major would be -

Minor changes - Those changes that do not affect the content of quality of the action being prescribed in the document, such as typographical or grammatical changes, template formatting or small changes within the document.

Major changes - Those changes which affect the content of quality of the action being prescribed in the document, such as updated technology resulting in change of procedure or multiple changes within the document.

I am attaching a procedure from Food and Drug Administration on document changes. This may not be 100 % suited for your area but take the sections that fit your organization.
 

Attachments

P

Pogi_

#5
... at what point is a 'change' significant enough to required to be recorded...
Quote from Ajit's reply about "minor change" definition - this is basically in another term - "clerical correction".

Then the major change definition in my opinion basically falls into the document change bucket instead of the definition of change required to be recorded.

4Ms and E is a good approach however this is better for problem solving as in fishbone analysis diagram rather than categorization of change for your purpose. I would recommend looking into the JESD 46 guideline since it provides good example on what type of change is significant enough to be recorded, monitored and followed through. It also gives the more automotive industry accepted definition of a minor and major change. Simple and direct definition as qouted below:

"a) major change: a change that may affect the form, fit, or function of the product or adversely affect the quality or reliability of the product
b) minor change: a change that does not affect the form, fit, function, quality, or reliability of​
the product."....

Token of advise, do not confuse the documentation change with product / process change - your documentation change is the effect/result of your product / process change. They are connected but are 2 different species.... :)

I hope this helps!!
 
M

mikedavies1

#6
Thanks for your responses.

I think I need to give more information on what happened.

Our customer reported a defect and wanted to know the risk, when we investigated the concern, there were 3 factors involved ( New batch of material, new operator and machine had just been changed over to run the product). Each of these changes is recorded in different places and has always been considered as part of the process. Because we were unable to identify the root cause and calculate the possible number of products at risk. The Customer has insisted on the introduction of change control system with traceability to identify products affected by a change.
Basically I need advise on how to define 'process variables' and when these are considered a 'change' which requires being recorded and being traced

Thanks

Mike
 

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#7
Mike,

In part, the response is relative to the level of concern inherent to the product you produce. That being said, the aim should always be to develop product with the highest quality and safety in mind given the circumstances.

Essentially, your problem relates to some basic fundamentals and components within your QMS. To begin with, a comprehensive understanding of the Product Specifications need to be understood, especially in relationship to how the Process Specification is developed. The design of the manufacturing process (including the equipment) is rooted in these documents. Traditional Process Flow Diagrams, Process FMEAs and Control Planning are essential to designing the process capable of producing product to established specifications consistently. These steps not only identify the risk areas in the process being designed, but provide the input needed to design it out of the process (to a lesser or greater extent). Once the process is designed, it needs to be qualified for use. This includes the qualification of the machinery and equipment used in the process, automated processes, and the software needed to run process. These are typically performed before the execution of the process validation, especially when the complexity of the manufacturing process rises. Once the process validation is successfully executed and the process released, the process is frozen. Changes made here to the process, the equipment (including software), or the documentation used to support the process must be reviewed under change control. More on that in a minute.

During your pilot builds using your validated process, you can begin to more critically understand the controls that you have set in place as well as understanding the product yields that you are to expect. These details provide you with input into addressing your customer’s question regarding the level of exposure. In the medical device world, you are expected to ship 100% conforming product even if your process only yields 80% (a scrap rate of 20%). Exposure should be eliminated, but that of course is in a perfect world. The FDA and other international governments mandate emphasis on the level of rigor in your manufacturing process and the verification and acceptance activities. In other genres, there are different agencies and mandates (sometime those only set by your organization), so be familiar with these requirements.

Regarding change control/document control, the definitions given by our colleagues adequately cover the range of complexity for minor to major changes and I’ve nothing more to add here. However, the process for establishing the level of significance is an interesting one, especially with regard the creation of objective evidence for later. What I’ve found is that regardless if they are minor or major changes, flowing these all through your change/document control process is the easiest and most consistent thing to do. Too often folks think something is less significant than it really is and use the ‘least burdensome route’ to only put the business in an awkward position come audit time (this can also have regulatory consequences if you are in a regulated industry). To avoid the creation of a change order for minor issues (e.g. clerical errors), your program and procedures must be thorough and verified (I would also suggest, validated for their intended uses). This is an area that shouldn’t be glossed over: just too important in my opinion. And if traceability and point of introduction (for the change) are important to you (or your customers), this process and the records that it produces provides you important refuge.

I would also like to point out that Maiden’s comment regarding the trial of a new or modified process is very important, especially if you are entering temporary changes to a validated process (remember that validated=frozen). This occasionally happens during engineering studies where the manufacturing process is temporarily descended upon for experimental builds. These events should have their own documentation and more than likely, its own established process that governs the steps of these intrusions. The bottom line in all of this is in the level of control established in the production and support processes. The more thoughtful and more controlled, the fewer events/issue you are likely to have.

Regarding your immediate problem, production records must include the appropriate information regarding material changes (new batches), associates involved in the manufacturing process, and equipment changes. These are input requirements from your customer (and there may be more), so you need to establish how these are captured (single place/multiple places). The Process Flow Diagram should indicate these points and provide you traceability to where records can be found. However, it appears that you need to establish a control number (batch, lot, serial number range, etc.) at tactical points in the operation to provide you with the traceability you need within your own product runs. These need to be set at the business level (what exposure or risk the company is willing to bear) but also mindful to the other business requirements from your customers. You might be willing to bear more risk than your customer is willing too, so the least common denominator falls to the most risk adverse customer. The business needs to plan around this or establish some other mitigation (e.g. contract negotiation) to offset the liability. You’ll need to discuss this with the business folks going forward. For now, look for things that might establish the bookends around the suspect production, being as generous as you can. Work back towards the center as new information comes to light (move the bookends in towards each other). The game now is containment and appeasement with the customer. Do a good job there so you don’t lose them. Keep searching for the root cause as this will undoubtedly move the bookends in and allow you to properly address the issues. Good luck with your efforts!!

Regards,

Kevin
 
S

sixsigmais

#8
Our customer reported a defect and wanted to know the risk, when we investigated the concern, there were 3 factors involved ( New batch of material, new operator and machine had just been changed over to run the product). Each of these changes is recorded in different places and has always been considered as part of the process. Because we were unable to identify the root cause and calculate the possible number of products at risk. The Customer has insisted on the introduction of change control system with traceability to identify products affected by a change.
Basically I need advise on how to define 'process variables' and when these are considered a 'change' which requires being recorded and being traced
"process variable" are those changing that might affect your product quality or saying might be the rootcause of "defect". Whatever "variable" might affect the stabality of the quality should be recorded and traced.
 
P

Pogi_

#9
Thanks for your responses.

Our customer reported a defect and wanted to know the risk, when we investigated the concern, there were 3 factors involved ( New batch of material, new operator and machine had just been changed over to run the product). Each of these changes is recorded in different places and has always been considered as part of the process.
This made more sense. In the assumption of the following:
1. New batch of material - kept in the qualification and reliability testing records, PCN and PPAP update.
2. new operator - training and certification records
3. machine had just been changed over to run the product - process certification records, PCP and PPAP plus WI updates.
(Take note that all automotive customers requires at least 90days of PCN maturity and approval before you can migrate they will scrutinize you if you dont and they will pursue more if you get to have a problem, which i think is your current case)
4. Your product has the traceabilty marked on its surface or has a serial number traceable to lot codes and date codes

If you have done all of the 4 items above and I'm your customer, I can breath....if not, I'll charge you like a raging bull everytime and its going to mark every time i hit you (metaphoric, but you know my point "wink "wink)

Because we were unable to identify the root cause and calculate the possible number of products at risk.
Im not doubting you engineers' problem solving ability however if you are using an 8D format approach, shouldnt you be doing the containment and risk analysis first then you go to root cause analysis, correction and prevention? What I would do is give them a PPM value for potential risk then I can narrow it down to process specific PPM and threat identification. Then I'll do my is-isnot, fishbone, why-why and FTA. (in your case you did not find any RC)

If you cannot find the root cause and you have exhausted your resource in finding it, you may want to use the phrase "guilty until proven innocent". Go the other way around and find information that will justify that the cause of the problem is not within you boundaries. I could have closed the issue at this point by NFF! - this is a long and time consuming process without clear conclusion but sometimes if your lucky you get good lessons learned.

So i guess the customer just asked for CI (continuous Improvement) which is the "change control system with traceability to identify products affected by a change"

Basically I need advise on how to define 'process variables' and when these are considered a 'change' which requires being recorded and being traced
I suggest you go back to the basics; 1 use JEDEC if your customers agrees to it; 2 get a list of notifiable change from your customer and make it an official boundary for change notice and approval.

Usually they are: manufacturing site, bill of material, process steps (ommision or addition to that effect), dimensions, appearance, function, reliability and/or capability at time 0.

For the system, use the information above as a base line. Modify your product process change procedure to include QA element to the cross-functional review then use your traceability process to ensure that the change cut-off date marked into it. The ECN date of implementation and your product router or process travel cards should be able to pinpoint what were the products processed using the change. If you can integrate this into a single system - great! But seriously all you have to do (or should have done) is to show that you are in control over the change process.

Some companies do send first 3 lot informations together with the shipping documents once the change have been implemented, and I assume that your customer didn't know that you changed something reason why they are running after you.

While your at it, seems to me that you need to review your Product Process Change Notification guidelines as well. Look at it this way, if im giving you an apple all the time for your apple pie and your apple pie is making your children happy, what do you think will happen if i give you a pear tomorrow for your apple pie without telling you before hand?

I hope this helps.
 
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