API Q1 Consulting | API Spec Q1 9th Edition

API Q1 adds Risk management to 9th Edition

Posted on Updated on

API Q1 adds Risk management to 9th Edition

API Q1 9th Edition adds a  new clause on Risk Assessment and Management. It is positioned in the standard clause 5.3 under “product realization”. It has an important bearing throughout the standard and cross-references to Risk Assessment have been made directly and indirectly by other requirements of API Q1  9th Edition.

So what is Expected  by  this new clause of Risk Assessment and Management :

1 ) The organization is expected to maintain a documented procedure

2) The procedure should identify the techniques (tools)  and the process of application of these chosen tools through the stages of identification till risk mitigation.

3) The standard adds a NOTE mentioning considerations of Severity, detectability, and probability  of risk

4) Risk assessment has to be carried out for (a) Product Quality (b) Product Delivery

5) Records for Risk Assessment should be kept handy

So  How are the other clauses of API Q1 9th Edition  linked to this clause

  • Risk assessment is a input to the contingency planning ( 5.5)
  • Risk Assessment is actively linked to corrective(6.4.2) and preventive action( 6.4.3)
  • Risk Assessment is indirectly referenced in planning (5.2)
  • As an input to Design and Development ( 5.4.2)
  • Preventive maintenance (5.7.8)
  • Management of Change (5.11)
  • Management Review( 6.5.1)

Although  PQP, Product release, and  Initial Supplier Evaluation – Critical Purchases – may not  appear to refer to risk analysis and management, however in practice it is always required to consult as you prepare or review these

If you are Interested, Please fill out the Enquiry form below:

API Q1 Internal Auditing Service

Posted on Updated on


we offer internal auditing service to companies who are either planning to take API monogram or Q1 or Q2 certification or just wish to improve the depth of Internal Audit.

Our Expert acts as an Anchor for the Internal Audit and does a thorough Internal audit by:

– Reviewing your internal team of Auditors qualifications.( offsite)
–  Reviewing the audit plan ( offsite)
– Reviewing the audit checklist developed by the Internal auditor ( offsite)
– Conducting the Internal Audit with the team as per the audit plan  ( onsite)
– Recording of Nonconformities against API specs/Q1/Q2( onsite )
-Reviewing the Root cause and Corrective Action 


Benefits of this service for organizations

  • The trainee auditors learn Auditing skills
  • The Trainee auditors learn objective evidence collection and how to write a non conformity
  • The Program Manager learns how to plan
  • The Internal Auditors learn how to make checklists
  • The Audited learns how to do a Root cause analysis
  • The Program Manager learns when to accept a corrective action




API Spec Q1 9th Edition 4 Days Training Course, API Specification Q1 9th Ed. Practitioner Course

Posted on Updated on

API Specification Q1 9th Ed. Fundamentals Training Course

We are Providing API Spec edition 4 Days Training Course for Quality Management System Requirements for Manufacturing Organizations for the Petroleum and Natural Gas Industry Q1, 9th

API Specification Q1 9th Edition Practitioner four days Training Course for manufacturing companies seeking Q1 certification or Q1 refresher training.

API Auditor Certification Programs:

  1. API Spec Q1 Lead Auditor 4 days Training Course
  2. API Spec Q1 Internal Auditor days Training Course

API Q1 Course locations:

Mumbai, India, Qatar, Kuwait, Saudi Arabia, Oman, Baku, Malaysia, Indonesia, Singapore

The 4-day API Spec Q1. Practitioner course provides an extended look into Spec. Q1. This is a 1.5-day extension to the Q1 Fundamentals Training course. Participants gain all information covered in the Fundamental Training Course, and in addition, gain a greater understanding of these four topic areas:

  • Checkmark Risk Assessment & Management
  • Checkmark Contingency Planning
  • Checkmark Management of Change
  • Checkmark API Monogram Program

This course is ideal for those companies pursuing API Q1 certification.

If you’re interested in becoming an API Q1 lead auditor, Attend our API Lead Auditor training Seminar. API Spec Q1 9th Edition Training Specification for Quality Systems– Fundamentals & Practitioner

For More information, Please Fill out the Enquiry form below: