| Documented process for managing calibration / verification records.
Records needed to provide evidence of conformity to internal requirements, legislative and regulatory requirements, and customer-defined requirements
| Statistical studies conducted to analyze the variation present in the results of each type of inspection, measurement, and test equipment system identified in the control plan
Analytical methods and acceptance criteria used must conform to MSA manual
Other methods and acceptance criteria may be used if approved by the customer (Must have records)
| Multidisciplinary approach including risk identification and risk mitigation methods for developing and improving plant, facility, and equipment plans. In designing plant layouts, the organization shall:
Optimize material flow, material handling, and value-added use of floor space including control of nonconforming product, and
Facilitate synchronous material flow, as applicable.
…Manufacturing feasibility assessments shall include capacity planning
Periodic re-evaluation relative to risk, to incorporate any changes made during process approval, control plan maintenance (see Section 220.127.116.11), and verification of job set-ups (see Section 18.104.22.168).
Assessments of manufacturing feasibility and evaluation of capacity planning shall be inputs to management reviews
| Ensure that quality objectives to meet customer requirements are defined for relevant functions, processes, and levels throughout the organization
Results of the interested parties and their relevant requirements review must be considered when the organization establishes its annual (at a minimum) quality objectives and related performance targets (internal and external).
More Articles ...
- S017 - Section 22.214.171.124: Contingency Plans
- S016 - Section 126.96.36.199: Preventive action
- S015 - Section 188.8.131.52: Risk Analysis
- S014 - Section 5.3.2: Responsibility and authority for product requirements and corrective actions
- S013 - Section 5.3.1: Organizational roles, responsibilities, & authorities – supplemental