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 8th edition
- Documented Procedures 27 instead of 13 earlier
- 228 shall clauses instead of 213 from 8th 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 |
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