API Specification Q1 9th Ed. Fundamentals Training Course

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 U Approved Q1 9th Edition Training Course Overview

Posted on Updated on

API-U Specification Q1 9th Edition Training Course Overview for Quality Systems– Fundamentals

Hello Everyone, we are planning to start API Q1 training Seminar in Mumbai, India, Aberdeen, United Kingdom, Poiesti, Romania, Dammam, Saudi Arabia, Rayong, Thailand, Kuala Lampur, Malaysia, Jakarta, Indonesia, Sydney, Australia, Baku, Kuwait, Qatar, Oman, Singapore Location.

API-U Q1 9th Ed. Fundamentals Training Calendar links:

http://goo.gl/jKXU2p

http://goo.gl/R2nXh0

http://goo.gl/tMdJWK

http://goo.gl/B3CR1c

http://goo.gl/r9CWL9

http://goo.gl/lbqUBg

http://goo.gl/25aXz5

http://goo.gl/gMB9cM

Click Here to see PPT: http://www.slideshare.net/API-Training/api-approved-q1-9th-edition-course-overview


Click Here to Watch Video: https://youtu.be/vYbSSciEunY


If anyone interested to attend API-U Training Course.For more information feel free to contact us.


if you have any question you can feel free to email us.


Email: API.Training@Gmail.Com

https://api-training.blogspot.in/

https://apitrainingcourse.wordpress.com/

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