API Q1 9th edition NCR

MOODY

Registered
#1
Hi Guys,

Kindly, I want your help
API Auditor found 4 NCR but with the same point

1- Facility presented section 3.2 of “Document & Data Control” (Doc#: TG-QMS-P001) rev 00 as the documented procedure for use of external documents in product realization. The method used to identify & incorporate the requirements of external documents into product realization processes was not identified in the procedure.

2- Section 3.1.3 of “Quality Records Control” (Doc#: TG-QMS-P002) Rev 00 requires all quality records to be retained for a minimum period of 5 years. This does not conform to API 6A, 15.1.2 which requires quality control records to be retained for a minimum of 10 years following the date of manufacture.

3- Facility's “Corrective & Preventive Action” Procedure (Doc#: TG-QMS-P005) Rev 00 does not identify the requirement for MOC when corrective or preventive actions require changed controls.

4- Facility has no documented procedure for annual vision examination of inspection personnel. Annual vision examination report was not available for Mostafa Diab (QC Engineer) who is responsible for Visual Examination.

all above NCR's whit the same problem one point missing in procedure.

Kindly help me about the reply ( correction, root cause, corrective action),
with accepted way.

Thank you
 
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yodon

Leader
Super Moderator
#2
Those are rather disparate subjects (control of external docs, record retention, CAPA, competence). Not sure how those could be covered in one point in a procedure.

One common approach to finding root cause is through the "5 Why" process. Why did something happen, why was that allowed, etc. I'm sure you can google or search here in the cove to get more info on that process. Without a LOT more info on your company, I doubt anyone could help much on root cause and corrective action(s).
 

jmech

Trusted Information Resource
#3
I fully agree with Yodon. You need to determine the root cause for each of these NCRs and then determine appropriate corrective actions.

Once you have a draft response to API, feel free to post it here and we may be able to give suggestions.
 

MOODY

Registered
#4
[ Correction ]
• Procedure “TG-QMS-P002 Quality Records Control” was revised (Rev. 01) dated 20/05/2022 the clause no. 3.4.
• system examination for Quality Record Control procedure will be conducted through internal Audit on
departments (HR – Maintenance and Admin) For any occurrences according to:
1. procedure enforcement to all applicable forms.
2.Q1 requirements to Quality Record Control procedure.

[ Root Cause Analysis ]
• There was a haste in procedure implementation due to being committed with other daily tasks.

[ Corrective Action(s) ]
• A part of the daily tasks was handled to the junior employees on 20/05/2022, this in order to save enough time to
make system updates by the QMR.
• system examination for ALL procedures will be conducted through internal audit under the umbrella of API Q1
Last edition and API 6A Last edition to assure efficiency.

[ API Response ]
Please provide further explanation to your root cause. Your analysis doesn't determine “why” your internal procedure is
not meeting the 6A requirement referenced above. Once the root cause is fully determined, please explain the actions
your organization has taken to minimize the likelihood of recurrence.
Additionally, have the given corrective actions been completed? The way they are written implies a future correction
and API does not accept corrective actions that are incomplete. Also, API does not accept attachments as responses.
Please enter your response in the box provided. Attachments will only be reviewed when evidence of corrective action is
required.
 

yodon

Leader
Super Moderator
#5
[ Root Cause Analysis ]
• There was a haste in procedure implementation due to being committed with other daily tasks.
Yup, I probably would agree that this is not a root cause. Things can be done 'hastily' and still be correct. How do you eliminate "hastiness" or ensure sufficient time is available in the future? The statement somewhat implies that:
  • you don't have appropriate management commitment to properly do the job (not allocating necessary resources).
  • the resources used did not have sufficient skills (why was it thought a junior employee would be sufficient)
The intent of finding the root cause(s) is to eliminate them which, presumably, would ensure the problem doesn't recur.

Your 1st corrective action is just background info, not any corrective action. Your 2nd corrective action is pretty good but it sounds like they want something more immediate rather than a scheduled internal audit.
 

Zero_yield

No cost too great...for Quality
#6
In general, it's a good idea to keep digging if the only root cause you've got is human factors. Sometimes, the issue is that a human didn't do their job. More often, there are are deeper problems that interfere with people being able to do their jobs properly. Is there a procedure or standard that guides this process? Was the person responsible trained to that procedure or standard?
 
#8
Be sure to follow the API Audit Response Instructions! Doing so will help answer some Reviewer questions up-front.
You can find the instructions at:
api.org / products-and-services / api-monogram-and-apiqr / resources#tab-program-documents
 
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