API Spec Q1 9th Ed 4.4.2 Non-conformance

QA Manager

On Holiday
Hi Cove Experts,

First of all, thanks @Marc for this awesome platform. I have read the history of Cove. Thanks to all the contributors as well who keep constantly supporting each other by sharing the knowledge.

Coming to the non-conformance, we recently faced the initial audit from API and got one minor non-conformance. I am totally new in this Oil and Gas sector and for QMS work. Our MR stepped back and my boss wants me to complete this task by providing correction, root cause and corrective action. I straight away told him that this is not my cup of tea. He still wants me to complete this task. So here I am.

Clause - 4.4.2
Clause description - All procedures referenced within this document shall be established, documented, implemented and maintained for continued suitability.
Objective evidence - Facility decided to align their quality management system requirements within each section of the quality manual instead of having separated documented procedures. However, while verifying applicable sections on Quality manual for Use of external documents, Risk assessment and management, Analysis of data and validation of process for production and service provision the same were found only comprising the requirement as addressed on the specification.
Nonconformance description - Procedures required by the standard not found established.

Thanks in advance guys.
 

Thee Bouyyy

Multiple Personalities
Our MR stepped back and my boss wants me to complete this task by providing correction, root cause and corrective action. I straight away told him that this is not my cup of tea. He still wants me to complete this task.

This is completely your call/decision to complete this task or not. But I can understand, the pressure on you. On positive side, this will give you new platform to explore your skills.

# Correction #
1. Procedures for use of External documents in product realization (insert procedure number), Risk assessment and management (insert procedure number), Analysis of data (insert procedure number) & Validation of process for production and service provision (insert procedure number) have been transferred to standard operating procedure apart from addressed in quality system manual. Four new Standard Operating Procedure (SOP) were released in system on dated xx.xx.xxxx. Date of completion: xx.xx.xxxx and Date of implementation: xx.xx.xxxx.

2. Existing sections of Quality Manual for Use of External documents, Risk assessment and management, Analysis of data & validation of process for production and service have been revised since separate SOP were released and established as addressed at point number 1. Date of completion: xx.xx.xxxx and Date of implementation: xx.xx.xxxx.

3. CEO (insert the designation of your boss) and senior team member studied quality system manual to make sure that all other departmental SOPs are addressed adequately and separately than written in quality system manual. Date of completion: xx.xx.xxxx and Date of implementation: xx.xx.xxxx.

4. Training on procedures and revised quality manual has been provided to all concerned personnel of facility. Date of completion: xx.xx.xxxx and Date of implementation: xx.xx.xxxx.

5. Effectiveness of imparted training has been evaluated and found effective. Date of completion: xx.xx.xxxx and Date of implementation: xx.xx.xxxx.

# Root Cause #
(Little bit confuse for what to write. Can you tell me the exact scenario why it was actually not addressed in QMS and why it was not available as separate procedure?) - I am trying and thinking on another way to address this.

Top Management wanted to align quality system manual and management related procedure in manual itself, in order to reduce number of SOPs for quality assurance team. Less paper work concept. These procedures were descriptive in the quality manual. Moreover actual work was done as per the API Q1 9th edition requirements. Formats are self-explanatory thereby eliminating the need of a descriptive procedure in the Quality Manual. Records were already shown as objective evidence to auditor. Formats used in processes are in line with API spec Q1 requirements. Personnel’s were already trained to perform activities. However auditor suggested addressing routine working practises as SOP rather than using quality manual section and describing procedures in quality manual.

# Corrective Action #
1. CEO (insert the designation of your boss) and QA Manager revisited complete manual to make sure that any other department procedures are addressed as separate SOP or not?? Respective clauses of API Q1 and working SOP verification was carried out. Date of completion: xx.xx.xxxx and Date of implementation: xx.xx.xxxx.

# Evidences that you have to prepare/submit # (P.S. Just prepare the evidences. Don't upload it on mycert portal as it is minor non conformance)
1. SOP number xxxxxx of Use of External Documents in product realization
2. SOP number xxxxxx of Analysis of data
3. SOP number xxxxxx of Risk assessment and management
4. SOP number xxxxxx of Validation of processes for production and services provision
5. Index of revised quality manual
6. Record for Training for 4 SOPs
7. Effectiveness evaluation record

Hope this will help you to close API non-conformance in line with API Q1 clause 4.4.2. Thanks :)
 

QA Manager

On Holiday
Can you tell me the exact scenario why it was actually not addressed in QMS and why it was not available as separate procedure?

We hired external consultant and he told us that there is no need of separate procedure. He told us that we already addressed the requirements in quality manual itself. My boss agreed with him and here you know the results....

Top Management wanted to align quality system manual and management related procedure in manual itself, in order to reduce number of SOPs for quality assurance team. Less paper work concept. These procedures were descriptive in the quality manual. Moreover actual work was done as per the API Q1 9th edition requirements. Formats are self-explanatory thereby eliminating the need of a descriptive procedure in the Quality Manual. Records were already shown as objective evidence to auditor. Formats used in processes are in line with API spec Q1 requirements. Personnel’s were already trained to perform activities. However auditor suggested addressing routine working practises as SOP rather than using quality manual section and describing procedures in quality manual.

This is perfect. Thanks mate. I will go with this. I will show this to my boss and come back to you.
 

Thee Bouyyy

Multiple Personalities
We hired external consultant and he told us that there is no need of separate procedure. He told us that we already addressed the requirements in quality manual itself. My boss agreed with him and here you know the results....

Yes, agreed with this. As long as you are fulfilling the requirements of clauses you don't need separate procedure.

the same were found only comprising the requirement as addressed on the specification.

In your case auditor found that you are just copy pasted the requirements from standard to your quality manual. That's it.
 

QA Manager

On Holiday
I disagree. Than how can we fulfil the requirement of 4.4.1 c) documented procedure established for the quality management system?
 

Thee Bouyyy

Multiple Personalities
See the Clause 4.4.2, notes 1 & 2, we can address the requirement either in one documented procedure or the same can be satisfied by more than one document. We can develop certain procedures as part of quality manual and balance are in form of SOP. We can treat quality manual section and SOP as working procedure. Nothing wrong in using certain procedure in quality manual and certain procedure as separate SOP.

Quality Manuals can be used in lieu of specific dedicated procedures so long as the relevant requirements are covered.
 

Thee Bouyyy

Multiple Personalities
Also, Why I am so confident about this have another story. In my career, I have always follow the same thing which I said in my above post. Last year one of my client got the non-conformance about this.

Auditor said that, "Facility does not have a procedure but claim that they consider the quality manual section as a procedure."

I challenged to API and here is the API response,

API Spec Q1 9th Ed 4.4.2 Non-conformance
 

lanley liao

Lingli Liao
Hi,I agree with QA Manager and Thee Bouyyy. In fact, A requirement for documented procedures can be satisfied by more than one document or a single document can address the requirements of one or more procedures, which depends on your company's actual condition.
 
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