Question about Non-conformances during New Product Introduction

greenlantern

Starting to get Involved
#1
I am working for a small start-up trying to create an ISO 9001 compliant QMS from scratch.

I am currently trying to figure out the NCR/CAPA process and have some questions as it relates to NPI. Currently our company uses Jira to track any bugs that occur during development at the contract manufacturer or supplier site. My question is, whether it is necessary or even useful to open NCR records for every single bug encountered during development.

We already record all failure modes in our process FMEA tables and since they are tracked in Jira as well (unfortunately in uncontrolled software), it seems redundant to open an NCR every single time.

I only see two sections in ISO 9001 regarding documenting failures in design and development:

First 8.3.3 e), which states "The organization shall determine the requirements essential for the specific types of products and services to be designed and developed. The organization shall consider: ... e) potential consequences of failure due to the nature of the products and services."

And second 8.3.4. e) "The organization shall apply controls to the design and development process to ensure that: "... e) any necessary actions are taken on problems determined during the reviews, or verification and validation activities;"

It seems like as long as we document any bugs and corrections that occurred during development they do not necessarily need to be in the NCR process. I understand ISO was written to allow an organization to achieve compliance with some flexibility but it sometimes feels too open to interpretation. Please let me know your thoughts. Thanks
 
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yodon

Staff member
Super Moderator
#2
I've never seen (which doesn't mean it can't be) a company calling issues in development nonconformities (NCs). NCs are typically only opened after transition to manufacturing. Then, they can occur at receiving, during assembly, at final test, after distribution, etc.

Your model of managing issues during development using JIRA is typical. During development, you're under design controls and those changes are managed through 8.3.6.
 

John Broomfield

Staff member
Super Moderator
#3
Once you’ve validated the design of the product you can then learn from controlling product nonconformities, but not before.

Of course, it is better also to validate the design of the production process itself but ISO 9001 does not require this unless the production process is special where product nonconformities may not be detected.
 

qualprod

Trusted Information Resource
#4
Once you’ve validated the design of the product you can then learn from controlling product nonconformities, but not before.

Of course, it is better also to validate the design of the production process itself but ISO 9001 does not require this unless the production process is special where product nonconformities may not be detected.
Why to wait the production/fabrication to apply controls?
8.7 States control of non-conforming outputs .
A bad design, approved drawings, what don't need control? These precious to fabrication?
On the other hand, what about in services?
In a hospital, doctor's decisions, something previous to a surgery or similar situations, will this require control?
Please clear me this point
Thanks
 

Ninja

Looking for Reality
Trusted Information Resource
#5
FWIW, we always left the product and process in "D-status" (covered under Design Control) for the first 5 production lots at a minimum.
We could work out the scale up issues without flooding the CAPA system that way...
The specs were still the specs...but we had freedom to tweak the process into line in scale before production processes were locked down.

HTH
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#6
It seems like as long as we document any bugs and corrections that occurred during development they do not necessarily need to be in the NCR process. I understand ISO was written to allow an organization to achieve compliance with some flexibility but it sometimes feels too open to interpretation. Please let me know your thoughts. Thanks
Your understanding is correct and the actions described are appropriate and commensurate for the NPI stage. No overkill necessary.
 

John Broomfield

Staff member
Super Moderator
#7
Why to wait the production/fabrication to apply controls?
8.7 States control of non-conforming outputs .
A bad design, approved drawings, what don't need control? These precious to fabrication?
On the other hand, what about in services?
In a hospital, doctor's decisions, something previous to a surgery or similar situations, will this require control?
Please clear me this point
Thanks
Bad design of a service or product should be rooted out by validation if not verification of the design. In which case the design would not be approved for use.

Again, service that failed to fulfill requirements would be controlled to limit its impact on the customer after the service design is approved for use. Before then the design is still being validated and the customer should know they are part of the validation process.

Of course, the system, process, service and product may be improved by learning from failures in the design process by the straightforward initiation of the corrective action process.
 

qualprod

Trusted Information Resource
#8
Bad design of a service or product should be rooted out by validation if not verification of the design. In which case the design would not be approved for use.

Again, service that failed to fulfill requirements would be controlled to limit its impact on the customer after the service design is approved for use. Before then the design is still being validated and the customer should know they are part of the validation process.

Of course, the system, process, service and product may be improved by learning from failures in the design process by the straightforward initiation of the corrective action process.
Since non-conformities are non fulfill ment of requirements.
If bad design were found, imagine wrong calculations, wrong specifications, wrong Bill of materials, wrong drawing's in the design process.
Requirements were correct drawings, specifications, bill of materials.
The people in the design process are doing mistakes.
Why no to raise nonconformity reports, before the fabrication?
How to manage these non conformities?
Thanks
 

John Broomfield

Staff member
Super Moderator
#9
Processes are managed by planning, monitoring and correcting inputs and the process itself. Discovering the sort of problems you describe cause the process to be stopped until the plan, inputs and process can be relied upon.

If these incorrect plans, inputs and processes result in nonconforming outputs, these outputs are then controlled to limit the impact on the organization or customer as soon as they are discovered.

Raising NC reports on each design output nonconformity to disposition as: accept, scrap, repair or rework seems wasteful to me. Instead, we’d rather see evidence of work to determine and remove the root causes of such problems so the designs, inputs and process can be relied upon.

If these incorrect designs, inputs and processes result in nonconforming outputs these outputs are then controlled to limit the impact on the organization or customer as soon as they are discovered.

Corrective action to stop recurrence of nonconforming outputs should discover and eliminate the root causes of the nonconformities you describe. It is too late to control a wrong calculation, for example, as nonconforming output.
 

qualprod

Trusted Information Resource
#10
Thanks John , now is clear for me.
Yes I agree, all this stuff be corrected maybe with Corrective actions In design and NCR be raised in production/manufacturing.
could this be real in a company who provide services?
Is it usual in some case (school, hospital) to raise NCR s and apply scrap,repair, rework?
Thanks
 
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