8 replies to this topic

[Atopicasso]

Hello,

 

Happy Monday! I'm currently reviewing the NCR and CAPA forms. Both seem quite similar as they both involve identifying the root cause and implementing preventive actions.

 

I'm contemplating a change to the form, removing the specific sections related to root cause and preventive action. Instead, I propose keeping only the description of the non-conformance, immediate action taken, and corrective action. For more critical issues, I'll utilize the CAPA form.

 

Let me know your thoughts on this. The NCR SOP doesn't explicitly mention preventive action, focusing more on corrective action.

 

Thanks!

[SmileSarah72]

Hello!

 

Do you have a definition of what circumstance would require an NCR but not a CAPA? This would be important to make clear so that it isn't based on a persons own judgement/ how busy they are.

 

I would suggest merging them, and having a question (based on your answer to the question above) that determines whether the preventive action section needs to be completed or if "N/A" would be an acceptable answer. As it seems like the main issue is the need to complete a lot of the same information on 2 separate forms.

 

 

In any case, I usually prefer including at least root cause (usually fishbone and/or 5WHY) whenever possible as well. Just because it helps me to more easily identify a quick-win opportunity in the event of common re-occurring causes. As individual NC's, they may not make sense to create a full CAPA, but sometimes many minor NC points may have similar root causes and therefore a preventive action plan would be worth exploring (80% of problems are linked to 20% of causes).

I also find it helpful in making a case to leadership team when I am pushing for something that they challenge the need for. If I have the problems the lack of the process or resource has caused readily available, it makes arguing the impact easier. Particularly things that can be difficult to get their buy-in for (for me it has been the need for a change-management process, and issues with our food safety culture), that I find having the list of associated problems readily available really helps with. (Which I wouldn't have if I hadn't taken the time to really think about root cause). But this may be specific to my current job.

 

Not sure if that makes sense. 

 

 

Thank you

[Atopicasso]

Hello!

 

Do you have a definition of what circumstance would require an NCR but not a CAPA? This would be important to make clear so that it isn't based on a persons own judgement/ how busy they are.

 

I would suggest merging them, and having a question (based on your answer to the question above) that determines whether the preventive action section needs to be completed or if "N/A" would be an acceptable answer. As it seems like the main issue is the need to complete a lot of the same information on 2 separate forms.

 

 

In any case, I usually prefer including at least root cause (usually fishbone and/or 5WHY) whenever possible as well. Just because it helps me to more easily identify a quick-win opportunity in the event of common re-occurring causes. As individual NC's, they may not make sense to create a full CAPA, but sometimes many minor NC points may have similar root causes and therefore a preventive action plan would be worth exploring (80% of problems are linked to 20% of causes).

I also find it helpful in making a case to leadership team when I am pushing for something that they challenge the need for. If I have the problems the lack of the process or resource has caused readily available, it makes arguing the impact easier. Particularly things that can be difficult to get their buy-in for (for me it has been the need for a change-management process, and issues with our food safety culture), that I find having the list of associated problems readily available really helps with. (Which I wouldn't have if I hadn't taken the time to really think about root cause). But this may be specific to my current job.

 

Not sure if that makes sense. 

 

 

Thank you

Thank you for your response. I completely agree in defining when an NCR or CAPA is required. I also appreciate your suggestion to merge them and introduce a question to determine the necessity of a preventive action plan.

To address this, I'm considering changing the title of the form to "NCR/CAPA Form." For the preventive action section, I'll include a specific question: "Does the identified non-conformance involve a significant issue requiring a preventive action plan beyond the immediate corrective action taken? (Yes/No)"

What are you thoughts?

Edited by Atopicasso, 15 January 2024 - 09:32 PM.

[Tony-C]

Hi Atopicasso,

 

 

Welcome to the IFSQN forums.

 

I wouldn’t get too hung up on this as long as you are investigating and taking the necessary action and recording both.

 

As I think you are indicating, you could use your NCR form to log non-conformances and record corrections.

From SQF Guidance: Corrections typically are completed when the deviation is identified.

 

You could then use your CAPA form for non-conformances that require corrective actions and potential non-conformances that require preventative actions.

From SQF Guidance: Corrective and preventative actions are developed from the results of a root cause analysis.

 

Kind regards,

 

Tony

 

[MOHAMMED ZAMEERUDDIN]

Root cause analysis is a must.

[dianafernandesv]

Hello everyone!!

 

I have a lot of difficulties in my current job with "complaints". There are a large number of situations reported due to price errors when invoicing, logistical failures due to item changes, salespeople making mistakes when placing orders because they select the wrong item, etc.

 

All of this goes towards issuing a credit to the customer. There are few complaints due to product quality failure, that is, something that I should take into consideration, in my opinion. Therefore, I have many difficulties in defining cause analysis and corrective actions for these small failures described above.

 

What do you suggest? Describe all these failures in the complaints management document? Or just consider situations of non-compliance and actual customer complaints for products outside of specifications for analysis?

 

Furthermore, all these failures are forwarded to the quality department, which is completely overwhelmed to resolve all these issues.

[MOHAMMED ZAMEERUDDIN]

Define the root causes of these issues and identify the appropriate corrective actions to prevent them from occurring in the future. It is important to consider all aspects of customer feedback.

[Tony-C]

Hello everyone!!

 

I have a lot of difficulties in my current job with "complaints". There are a large number of situations reported due to price errors when invoicing, logistical failures due to item changes, salespeople making mistakes when placing orders because they select the wrong item, etc.

 

All of this goes towards issuing a credit to the customer. There are few complaints due to product quality failure, that is, something that I should take into consideration, in my opinion. Therefore, I have many difficulties in defining cause analysis and corrective actions for these small failures described above.

 

What do you suggest? Describe all these failures in the complaints management document? Or just consider situations of non-compliance and actual customer complaints for products outside of specifications for analysis?

 

Furthermore, all these failures are forwarded to the quality department, which is completely overwhelmed to resolve all these issues.

 

Hi Diana,

 

I would be amending your complaint procedure so that when complaints are received they are categorized then allocated and dealt with by the relevant department who should record, investigate, respond and analyze complaint trends etc. Your department should be responsible for dealing with food safety & quality complaints. You may also want to report total complaints and associated actions/trends for management review.

 

Kind regards,

 

Tony

[kfromNE]

Hello everyone!!

 

I have a lot of difficulties in my current job with "complaints". There are a large number of situations reported due to price errors when invoicing, logistical failures due to item changes, salespeople making mistakes when placing orders because they select the wrong item, etc.

 

All of this goes towards issuing a credit to the customer. There are few complaints due to product quality failure, that is, something that I should take into consideration, in my opinion. Therefore, I have many difficulties in defining cause analysis and corrective actions for these small failures described above.

 

What do you suggest? Describe all these failures in the complaints management document? Or just consider situations of non-compliance and actual customer complaints for products outside of specifications for analysis?

 

Furthermore, all these failures are forwarded to the quality department, which is completely overwhelmed to resolve all these issues.

 

Do what Tony-C said. Have a form to document the complaints then assign accordingly to the different departments. 

I would also do a monthly trending by the type of complaint received.