API Q1 standard 9th edition - Summary of changes

[유문종]

API Q1 standard 9th edition now released from API. 

This new standard shall be in effective from June 1 2014. Instead of 8 chapters and one Annexure of 8th edition now it is 6 chapters and 3 annexures. 

There are new requirements in the form of Risk assessment and Management, Contingency Plan, Preventive Maintenance, Management of change, Product quality if specified by the contract etc.

The facts

• Approximately 93 additional requirements were added in the new revision
• Legal is mentioned 19 times instead of 1 in 8^th edition
• Documented Procedures 27 instead of 13 earlier
• 228 shall clauses instead of 213 from 8^th edition
  

The task

• Quality manual to be revised by addressing each requirement of this specification
• Almost all the procedures shall be affected by this change
• New forms shall be in place to address the changes
• The workforce must be trained with the new requirement

Summary of changes briefed below

Clause no	New requirements from 9nth Edition
4.1.5.1 b	Data analysis result communicated within the organization
4.1.5.2 d	Quality plans and changes
4.2.3.c	MR to Initiate actions to minimize nonconformance
4.3.2.2	Records of Competency Determination
4.3.2.3 b	Ensure that customer specified training and/or customer-provided training when required. Is included in the training program
4.4.1 b 3	Identification of processes requiring validation
4.4.1 e	Legal and other applicable requirements
4.4.2	Procedures in place of control features
4.4.3 d	Procedures, work instruction and forms controlled
5.2.c	Address legal requirement
5.2 d	Address contingencies based on risk assessment
5.2 g	Address management of change
5.2	Planning output updated with changes
5.3	Risk assessment and Management
5.4.6	Completed designs approved after validation
5.5	Contingency Planning
5.6.1.1 a	Purchasing Determine Criticality
5.6.1.1 c	Type and extend of control over supplier based on criticality
5.6.1.1.e	Maintain list of approved supplier and supplier scope
5.6.1.2	Criteria for initial eval‎uation of critical suppliers
5.6.1.2 b	Assessment by first article inspection, or how identifying product conforms to legal or contractual requirements
5.7.1.1 c	Ensure design requirements and related  changes are satisfied where applicable
5.7.1.1 f	Process control documents
5.7.1.2 d	Ensure identification and traceability maintained
5.7.1.4	Maintain evidence of capability to meet product requirements
5.7.2	Product quality plan
5.7.6.2	Use of designated store area, assessment of stock at specified intervals and records of assessment maintained
5.7.7.3	Final inspection based on plan or procedures to validate and document results
5.7.8	Preventive Maintenance
5.11	Management of Change
6.2.1	Customer satisfaction records maintained
6.2.2.1	Onsite outsourced activities subject to internal audits
6.2.2.2	QMS Processes audited  before claiming conformance to this specification
6.3	Analysis of data shall consider information on nonconformities and on objectives
6.5.2	Management review minutes inputs to include process performance, result of risk assessment and supplier performance analysis
4.4.2	Procedures in place of control features
4.4.3 d	Procedures, work instruction and forms controlled
4.5	Reports including outsourced activities provide evidence of conformity
5.4	Controls for other organization design locations impacting design
5.4.3 d	Design & Dev output Critical products or components
5.6.1.3	Initial supplier eval‎uation noncritical purchases meeting the requirement 5.6.1.2 or other requirements