SBS - The Best Value in QMS software

NC on API Q2

#1
Hi,
Currently i having some NC raise for the API Q2 and need help to reply to the NC as describe below. We have reply as follow by the auditor come back with the following question
Requirement - MS Standard API Spec Q2 1st Ed

Clause5.1.2b

Description The organization shall determine legal and other applicable requirements.
Product Specification

Clause

Description
Objective Evidence Quality Procedure SP 5.1 Revision 002 Contract Review Checklist QPF 5.1-F 003A Job Nob: S 8571
Nonconformance/Concern Description Legal and Other applicable Requirements are not being documented as being reviewed as part of the Contract review Checklist. In each of the Checklist as presented the Item No 6 Legal and Other applicable items is marked as NO.

Root Cause Analysis

Personnel was under the impression that Contract Review Checklist items are to be checked only upon customer's request for Job No: S8571.

Correction
Contract Review Checklist for Job No: S8571 was updated accordingly.

Corrective Action(s)
Some jobs were sampled to check if contract review checklists were correctly completed and it was found to be done correctly.

API response

Please explain the control you have in place and/or how you have improved the related process to eliminate the cause and to prevent recurrence of the issue.


Anyone can please assist how to reply to the API? Thanks!
 
Elsmar Forum Sponsor

Tagin

Trusted Information Resource
#2
If they accept your root cause "Personnel was under the impression that...", then they are asking for some change(s) that will eliminate that root cause, and/or that will add a control to prevent that root cause from resulting in a recurrence.

So, possible change examples might include:
  • (root cause) Adding a requirement to the process for mandatory training on the checklist for relevant personnel, with specific emphasis on completing "Legal and Other applicable Requirements"
  • (root cause) Adding explanatory language to the checklist form stating how it is required to fill out that checklist section
  • (control) Adding a process step for someone to review & approve the completed checklist with a signature, where the review includes making sure that that "Legal and Other applicable Requirements" is filled out properly.
 

lanley liao

Involved In Discussions
#5
Hi, In fact. The API hopes that you can find out the gap in your management system. the key point for solving this problem is to modify your documented procedures related to contract review. you shall take into consideration three aspects: planning——implement——check.
In planning, you know whether have corresponding rules for this contract control. if yes, then these rules whether with operability; if no, then modified these rules and organized training. In an implementation, some rules we have prepared and employees are not aware of these rules or not understand, then you can organize training for these employees. if they know these rules, not abide by one to do some work. then you need to analyze this reason from four aspects: accountability whether it is clear? capability whether it is enough? sources whether it is sufficient? the extent of implement whether it is enough? In the end, you can know the reason from checking control requirements. The supervise of work is not done well. and i hope it can help you.
 
Last edited:
Thread starter Similar threads Forum Replies Date
lanley liao How to understand and master the requirements of each section in API monogram product. Oil and Gas Industry Standards and Regulations 5
Thee Bouyyy Internal NCR - API Q1 5.4.2b - API 16C Clause 4.1.3 Internal Auditing 9
lanley liao How to understand correctly the section of 5.11 MOC in API Spec Q1? Oil and Gas Industry Standards and Regulations 3
A API Monogram audit review process Oil and Gas Industry Standards and Regulations 4
lanley liao Are there guidelines for application of all API monogrammal product? Oil and Gas Industry Standards and Regulations 2
U API License Agreements Oil and Gas Industry Standards and Regulations 2
U API Spec Q1 - 5.6.1.2 C (3) - Design software Oil and Gas Industry Standards and Regulations 3
R American Petroleum Institute - Becoming an API Auditor Professional Certifications and Degrees 2
B There is an estimated date of release of API Q1 10th edition? Oil and Gas Industry Standards and Regulations 9
lanley liao How to correctly understand the bullet list d) of 6.3 Analysis of Data for API Spec Q1 Oil and Gas Industry Standards and Regulations 7
A API Spec Q1 Purchasing Process - Supplier Reevaluation based on Supplier Risks 5.6.1.4 Oil and Gas Industry Standards and Regulations 17
lanley liao How to keep the manufacturing capability under the API monogram Oil and Gas Industry Standards and Regulations 6
lanley liao How to understand this bulleted list from API 600 Oil and Gas Industry Standards and Regulations 0
lanley liao The validity of API Spec Q1 certificate Oil and Gas Industry Standards and Regulations 2
R [ASK] API Q1 Ninth Edition, Section 5.4.5 Oil and Gas Industry Standards and Regulations 4
A Design and development procedure for API Spec Q2 Oil and Gas Industry Standards and Regulations 6
S API Spec.Q1 Standards Version in Purchasing Information Oil and Gas Industry Standards and Regulations 1
S API Spec. Q1 clause 5.6.1.2 On site evaluation Oil and Gas Industry Standards and Regulations 10
S API spec Q1 9th edition - Castings & Forgings Oil and Gas Industry Standards and Regulations 4
N API spec Q1 9th edition Oil and Gas Industry Standards and Regulations 2
H Updating Quality Manual to API Q1 Service Industry Specific Topics 6
lanley liao How to understand the term 3.1.21 'Servicing' and the clause 5.7.1.2 'Servicing' of API Spec Q1? Oil and Gas Industry Standards and Regulations 19
M API 4F/7K/8C Design Package Validation Oil and Gas Industry Standards and Regulations 2
F Who can sit in/perform an API audit? Oil and Gas Industry Standards and Regulations 2
A Does anyone have a checklist of API Spec 650 13th Edition? Oil and Gas Industry Standards and Regulations 0
M API Spec. Q1, 8th Ed. Section 7.5.2 vs. Q1, 9th Ed. Section 5.7.1.5 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 0
N Audit non-compliance API Q1 - Use of External Documents 4.4.4 in Product Realization Oil and Gas Industry Standards and Regulations 8
P Does anyone have a API Q1 Documentation Package? Quality Management System (QMS) Manuals 1
N Audit non-compliance - API Spec Q1 9th Ed 5.6.1.2 b Oil and Gas Industry Standards and Regulations 16
D API 6A Certification Question Oil and Gas Industry Standards and Regulations 4
C New to Site - Request Help with API Q2 Implementation Oil and Gas Industry Standards and Regulations 9
A API Spec Q1 9th Edition # Re-audit - Disputing with API AARs Oil and Gas Industry Standards and Regulations 1
T API Q1 - Will I be able to maintain Q1 if I have products that fall under 6A Oil and Gas Industry Standards and Regulations 5
R Process control documents - Context of API Spec Q1, Clause 5.7.1.3 Other ISO and International Standards and European Regulations 0
P API monogram mark requirements Oil and Gas Industry Standards and Regulations 1
W Does anyone have an API Q2 checklist for internal auditing? Oil and Gas Industry Standards and Regulations 1
K 820.200 Servicing Procedure - Our system (because there is an API involved) is classified as Class 3 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
B API Q1 5.7.1.5 Process Validation - Machining, heat treating, Manganese Phosphate and Zinc Plating Manufacturing and Related Processes 2
K Supplier re-evaluation (API Q1) Manufacturing and Related Processes 9
F List of approved API manufacturers or Formulations manufacturers US Food and Drug Administration (FDA) 0
G Start and main steps of API Q1 Certification Process Various Other Specifications, Standards, and related Requirements 5
S Internal Auditing for API Spec Q1 - auditor qualification requirements Oil and Gas Industry Standards and Regulations 6
S Can we integrate both ISO 9001:2015 and API Q1 Management System Standards Quality Management System (QMS) Manuals 11
S API Spec Q1 - How to define Management Representative competency for QMS Oil and Gas Industry Standards and Regulations 12
R Interesting Discussion API Spec Q1 Addendum 2 Oil and Gas Industry Standards and Regulations 0
F API Spec Q1 Scope - Limiting the scope of certification Oil and Gas Industry Standards and Regulations 3
F API Spec Q1 9th Edition Surveillance Audit - Questions about internal audits. Oil and Gas Industry Standards and Regulations 22
A API Q1 9th ed Addendum 2 - Vendor Assessment for critical products Oil and Gas Industry Standards and Regulations 18
D API 6A Chokes - PR1 / PR2 Tests Oil and Gas Industry Standards and Regulations 12
A API Spec Q1 9th Edition - 12 month Internal Audit Schedule Audit Nonconformance Oil and Gas Industry Standards and Regulations 10

Similar threads

Top Bottom