Finding Root Cause or Cause of Non Compliance

Greetings all.

Is there anyone can give me examples of root cause for Non-Compliance Findings belows:

1. No validation conducted for critical limits for both CCP 1 (receiving of raw material temperature ≤4°C) and CCP 2 (cold room storage temperature ≤-18°C). and,

2. The establishment did not maintain documented procedures for verification:

 

Greetings all.

 

Is there anyone can give me examples of root cause for Non-Compliance Findings belows:

1. No validation conducted for critical limits for both CCP 1 (receiving of raw material temperature ≤4°C) and CCP 2 (cold room storage temperature ≤-18°C). and,

 

2. The establishment did not maintain documented procedures for verification:

     i. Mock recall not conducted for previous year.
     ii. End products and environment cleanliness (swab test) sampling not conducted as scheduled in year 2020.

 

Regards.

 

Hi John,

I deduce this is related to Malaysian Standard which afaik unfortunately not accessible on line so I have to make some "typical" assumptions.

General - Some context would have assisted to avoid possibly irrelevant suggestions.

(1) No Validation should have been necessary since both items should have been PRPs.

(2) See ^^^ "General"

i - Forgot ? ie Human Error >> Training/Responsibility/Procedure/Policy/HACCP Documentation.

ii - Ditto.

Hi Mr. Charles.

Thank you for your kind assists. It is quite 'typical' sir. Hope, my auditor will accept for 'human error' cause. :')

Hi John,

 

I deduce this is related to Malaysian Standard which afaik unfortunately not accessible on line so I have to make some "typical" assumptions.

 

General - Some context would have assisted to avoid possibly irrelevant suggestions.

 

(1) No Validation should have been necessary since both items should have been PRPs.

 

(2) See ^^^ "General"

 

i - Forgot ? ie Human Error >> Training/Responsibility/Procedure/Policy/HACCP Documentation.

ii - Ditto.

Hi John, 

Both issues seem to point to a lack of scheduling.

If "No validation conducted for critical limits for both CCP"....You can use 5 whys as a simple method to get to the root cause. 1. Why was no validation conducted?  Using Charles C example.....because the person assigned forgot to do it. 2. Why did the person forget to do it .........Because there was no prescribed schedule and there was no means of following up to confirm it was done. 3. Why was there no prescribed schedule for CCP validations? Because the Validation Procedure did not include the requirement.  The corrective action must then be consistent with the root cause.

Corrective action based on the root cause examples above: The Validation Procedure was revised to state that validation of CCPs must be done annually according to the Validation Schedule; A validation schedule was developed with prescibed dates set up with electronic reminders in "----QA calendar"; Internal audit of the Validation Program will include checking/confirming that validations were completed as scheduled.