Small changes on Design Outputs

[Uriel Alejandro]

Hello everybody,

I'm dealing with some situation that I would like to have some opinions, to be sure I'm doing right.

Situation: There are simple changes (not affecting part features or functionality) and it was set out the possibility to omit EC process in these cases. These cases are, for example:

1) Due to a slip, the engineer did not include some dimensions in the drawing and need to be added.
2) Included other dimensions complicated to meet during manufacturing and that were not necessary for the product and need to be deleted.

Please see my assumptions below

Assumption 1
Design and development features are captured in the outputs (typically drawings, CAD?s, specifications, etc.), which need to be:

? reviewed and verified against requirements (7.3.4 and 7.3.5).
? validated for capability of meeting the requirements for the specified application or intended use (7.3.6).

Records of all this must be maintained.

Assumption 2
I assume that it is not possible to omit EC process since the standard says that ?changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered (7.3.7).?

Basically 7.3.7 asks to go back to 7.3.4, 7.3.5 and 7.3.6 regardless of the nature of the change. If the output was modified, it shall go through this control.

It makes sense for me because I would have to verify that this simple change was correctly performed and no other important features were affected by mistake during the change.

So, my assumptions are correct or it's possible to omit the EC process for this type of changes?

Thank you in advance for your help

 

[kgott]

Hello everybody,

I'm dealing with some situation that I would like to have some opinions, to be sure I'm doing right.

Situation: There are simple changes (not affecting part features or functionality) and it was set out the possibility to omit EC process in these cases. These cases are, for example:

1) Due to a slip, the engineer did not include some dimensions in the drawing and need to be added.
2) Included other dimensions complicated to meet during manufacturing and that were not necessary for the product and need to be deleted.

Please see my assumptions below

Assumption 1
Design and development features are captured in the outputs (typically drawings, CAD?s, specifications, etc.), which need to be:

? reviewed and verified against requirements (7.3.4 and 7.3.5).
? validated for capability of meeting the requirements for the specified application or intended use (7.3.6).

Records of all this must be maintained.

Assumption 2
I assume that it is not possible to omit EC process since the standard says that ?changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered (7.3.7).?

Basically 7.3.7 asks to go back to 7.3.4, 7.3.5 and 7.3.6 regardless of the nature of the change. If the output was modified, it shall go through this control.

It makes sense for me because I would have to verify that this simple change was correctly performed and no other important features were affected by mistake during the change.

So, my assumptions are correct or it's possible to omit the EC process for this type of changes?

Thank you in advance for your help

This may be an unconvenentional view but the management system belongs to management. If this was just a one off occurance I would run it past the main person and get their agreement that its a very minor change and will not affect the integrity of the finished product.

I would also get it reviewed and approved by someone who knows what the story is or by a person having knowledge of the imapct of the changes by getting them to review it and put their initials along side the change.

Depending on why you might want to go down this path, but I have known this to take place to prevent $t of k's costs being incured and customer delivery being delayed.

Sometimes things happen in the real world. However, having said all this I would be very reluctant to see this become commonplace and I'd be keeping a close eye on it because the more it happened the more it would appear to me that things are breaking down

 

[SmallBizDave]

Under your description of Assumption 2 your quote from the standard includes the words "as appropriate". The standard leaves you the option to define what review, verification and validation is appropriate to your business.

I've seen several systems that allow for minor changes to be made with a reduced approval cycle, sometimes just the document control person and the drawing owner verbally agree to the change. This type of thing is typically limited to things like typos, note changes that don't affect the part or process and other administrative changes. Usually this is captured under a change type called Administrative or Class 3 (Class 1 and 2 being Major and Minor changes that do affect the product).

That said, changing dimensions on a drawing would normally be at least a Class 2 change, with a full approval cycle required. If the changes really don't affect form/fit/function this situation could fall into a Class 3 category and you could make it without approvals if your system is written to allow that.

 

[somashekar]

Situation: There are simple changes (not affecting part features or functionality) and it was set out the possibility to omit EC process in these cases. These cases are, for example:

1) Due to a slip, the engineer did not include some dimensions in the drawing and need to be added.
2) Included other dimensions complicated to meet during manufacturing and that were not necessary for the product and need to be deleted.

When you call them simple changes and slip of engineer and that it is not affecting part features or functionality, why are you pressing to make the changes now when detected ?
Perhaps these can be noted and corrected when a real change needs to be made.

By not correcting are any users put to difficulty, or a specification is effected ?

It needs more deeper analysis. As a system driven organization EC process must be applied.

 

[dsanabria]

Hello everybody,

I'm dealing with some situation that I would like to have some opinions, to be sure I'm doing right.

Situation: There are simple changes (not affecting part features or functionality) and it was set out the possibility to omit EC process in these cases. These cases are, for example:

1) Due to a slip, the engineer did not include some dimensions in the drawing and need to be added.
2) Included other dimensions complicated to meet during manufacturing and that were not necessary for the product and need to be deleted.

Please see my assumptions below

Assumption 1
Design and development features are captured in the outputs (typically drawings, CAD?s, specifications, etc.), which need to be:

? reviewed and verified against requirements (7.3.4 and 7.3.5).
? validated for capability of meeting the requirements for the specified application or intended use (7.3.6).

Records of all this must be maintained.

Assumption 2
I assume that it is not possible to omit EC process since the standard says that ?changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered (7.3.7).?

Basically 7.3.7 asks to go back to 7.3.4, 7.3.5 and 7.3.6 regardless of the nature of the change. If the output was modified, it shall go through this control.

It makes sense for me because I would have to verify that this simple change was correctly performed and no other important features were affected by mistake during the change.

So, my assumptions are correct or it's possible to omit the EC process for this type of changes?

Thank you in advance for your help

Quick question.

1. Is this product in production?

2. Was a First Article Inspection Report Done?

3. When does the discrepancy noted.


This is the reason - for historical purpose that EC are done and another FAIR done. I have seen that while trying to fix something small, something big was accidentally omitted.

 

[Chennaiite]

I agree with SmallBizDave. Understandably not all Engineering Changes will have to undergo same level of review, verification, Validation, Approval, etc and therefore changes like these which are typically typos can undergo only limited review and approval. Having said that, sometimes typos can influence change of material planning, sourcing, manufacturing process, cost of the product, etc which have to be given due importance. It's definetly not going to be one-size-fits-all approach.

 

[Uriel Alejandro]

Quick question.

1. Is this product in production?

2. Was a First Article Inspection Report Done?

3. When does the discrepancy noted.


This is the reason - for historical purpose that EC are done and another FAIR done. I have seen that while trying to fix something small, something big was accidentally omitted.

1. Yes, the item it's in production.
2. No, the FAI report it's not done yet, the tool still in production.
3. The discrepancy was noted when the manufacturing engineer was creating the operation sheets before start production.

That's why it was considered to as small change, correct it on drawing took two minutes for design engineer.

 

[Uriel Alejandro]

When you call them simple changes and slip of engineer and that it is not affecting part features or functionality, why are you pressing to make the changes now when detected ?
Perhaps these can be noted and corrected when a real change needs to be made.

By not correcting are any users put to difficulty, or a specification is effected ?

It needs more deeper analysis. As a system driven organization EC process must be applied.

well, by not correcting it, the only affected would be production people they need the dimension to machine but certainly it wouldn't result on nonconforming product it would only delay a bit the production until clarify the situation.

But I see where are you trying to explain me and I'm agree. The EC process shall not be omitted but shall be simpler

 

[Fa Pa]

Hi, I'm sorry to bug in like this but I figured my question is related to this scenario. Same situation as expressed above. Question is, under a FDA regulated company, operating under medical devices, CFR 820, how do I know that a small change in design, perhaps a temporary change in design, requires risk analysis and validation/verification? Sometimes my boss passes by and tells everyone in manufacturing that we will no longer use spring washers but star washers (just an example). Does that require risk analysis/validation? How about if it's a temporary change? Thank you in advance for your help !!

 

[somashekar]

Hi, I'm sorry to bug in like this but I figured my question is related to this scenario. Same situation as expressed above. Question is, under a FDA regulated company, operating under medical devices, CFR 820, how do I know that a small change in design, perhaps a temporary change in design, requires risk analysis and validation/verification? Sometimes my boss passes by and tells everyone in manufacturing that we will no longer use spring washers but star washers (just an example). Does that require risk analysis/validation? How about if it's a temporary change? Thank you in advance for your help !!

Hi Fa Pa, Welcome to the Cove.
What ever be the suggested change, when you analyse it technically to understand the prospects and consequences of that change, you are simply doing a risk analysis. When you try to get answers to your prospects and consequences by doing certain tests / checks systematically you are into verification / validation.
Instead of asking "How do I know" for small change or temporary change, ask yourself "Do I know how"
The answers you get or fetch is risk analysis...