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Task Group 8 Update January 23, 2014 Kim Wiita

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Page 1: January 23, 2014 Kim Wiita. Activities Completed Task Group has met 3 times since the Summer 2013 meeting: August 26, 2013 October 8, 2013 November 11,

Task Group 8 UpdateJanuary 23, 2014

Kim Wiita

Page 2: January 23, 2014 Kim Wiita. Activities Completed Task Group has met 3 times since the Summer 2013 meeting: August 26, 2013 October 8, 2013 November 11,

Activities Completed Task Group has met 3 times since the Summer 2013 meeting:

August 26, 2013 October 8, 2013 November 11, 2013

In July, 2013, API sent out a communication to API Spec Q1 users and auditors, at the request of the Task Group, seeking feedback on concerns or questions that they wanted to see addressed in the Guidance Document.

At the August meeting, we reviewed the responses which mostly asked for interpretation. The Task Group decided that its charge was not to issue interpretations.

Page 3: January 23, 2014 Kim Wiita. Activities Completed Task Group has met 3 times since the Summer 2013 meeting: August 26, 2013 October 8, 2013 November 11,

Activities Completed General Direction:

Focus on intent of clause(s) and changes from 8th edition Avoid interpretations Identify relationships between sections where they exist Do not re-state the requirements of Q1 9th edition No new requirements

Decided to issue the document as a Technical Report.

Agreed on a method to begin drafting the Guidance Document. For each Section in API Spec Q1, we will document: Intent of the Section, and Changes from the previous edition

 

Page 4: January 23, 2014 Kim Wiita. Activities Completed Task Group has met 3 times since the Summer 2013 meeting: August 26, 2013 October 8, 2013 November 11,

Activities Completed Using the agreed upon format, the Task Group has drafted and

reviewed the following sections: Scope 4.1 Quality Management System Requirements 4.2 Management Responsibility 4.3 Organization Capability 4.4 Documentation Requirements 4.5 Control of Records 5.1 Contract Review 5.2 Planning 5.3 Risk Assessment and Management 5.4 Design and Development  5.5 Contingency Planning 5.6 Purchasing

Page 5: January 23, 2014 Kim Wiita. Activities Completed Task Group has met 3 times since the Summer 2013 meeting: August 26, 2013 October 8, 2013 November 11,

Next Steps The remaining sections need to be reviewed:

5.7 Production and Servicing Provision 5.8 Control of Testing, Measuring, & Monitoring Equipment 5.9 Product Release 5.10 Control of Nonconforming Product 5.11 Management of Change (still needs to be drafted) 6.1 & 6.2 Monitoring, Measuring, & Improving 6.3 Analysis of Data 6.4 Improvement 6.5 Management Review

Discuss any actions needed with respect to color-coded version of Spec Q1 which was sent out to the Task Group for review on December 17, 2013

Next Task Group 8 meeting tentatively planned for early February (2/4 – 5 or Feb. 5 – 6)