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MODULE 6 Analysis, Corrections, and Release

MODULE 6 Analysis, Corrections, and Release. 15November2013. Module Objective. After completing this module, the student will be able to complete acceptance and release responsibilities for supplier’s products/services. LESSON 1 Calibration Systems. 15November2013. Lesson Introduction.

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MODULE 6 Analysis, Corrections, and Release

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  1. MODULE 6Analysis, Corrections, and Release 15November2013

  2. Module Objective After completing this module, the student will be able to complete acceptance and release responsibilities for supplier’s products/services.

  3. LESSON 1Calibration Systems 15November2013

  4. Lesson Introduction Given the current U.S. metrology and calibration standards, International Organization for Standardization (ISO) quality assurance requirements, and Military Standards (MIL-STD), students will be able to identify calibration requirements susceptible to Government Contract Quality Assurance (GCQA) oversight.

  5. Lesson Objectives Upon completion of this lesson, you should be able to: • Distinguish between standard inspection requirements and higher-level Quality Management System (QMS) requirements regarding calibration. • Identify United States (U.S.) National Standards for calibration. • Evaluate supplier operations to identify measuring and test equipment that may require calibration controls. • Determine the type of surveillance method for a supplier’s calibration system based on contractual quality and technical requirements and associated risks.

  6. Lesson Topics This lesson covers the following topics: • Calibration Requirements • Calibration Standards • ANSI/NCSL Z540.3-2006 Requirements • Surveillance Methods and Calibration Nuances

  7. WIIFM? Ensuring that high quality equipment/products are delivered to the military requires attention to detail and measuring and test equipment (M&TE) that is calibrated and recalibrated on a regular basis. Adequate calibration controls provide a basis of confidence that conformance decisions using that equipment are accurate. Photo by Matthew Montgomery

  8. Calibration Requirements Lesson Topics: Calibration Requirements Calibration Standards ANSI/NCSL Z540.3-2006 Requirements Surveillance Methods and Calibration Nuances

  9. Topic 1: Calibration Requirements • Higher-level calibration requirements • ISO standard • American National Standards Institute (ANSI) standard • Defense Contract Management Agency (DCMA) responsibilities • System audit • Process review • Product examination

  10. Higher-Level Calibration Requirements

  11. Agency Responsibilities

  12. Question and Answer Which specific FAR clause defines higher-level calibration requirements? • FAR 52.246-2 • FAR 52.246-11 • Both A and B • There is no specific FAR clause

  13. Calibration Standards Lesson Topics: Calibration Requirements Calibration Standards ANSI/NCSL Z540.3-2006 Requirements Surveillance Methods and Calibration Nuances

  14. Topic 2: Calibration Standards • U.S. National Standards for calibration • Other standards • Calibration obligations within contract

  15. U.S. National Calibration Standards • ANSI/NCSL Z540.3-2006, Requirements for the calibration of measuring and test equipment • Technical requirements for a calibration system • ANSI/ISO/IEC 17025:2005, General requirements for the competence of testing and calibration laboratories • Laboratory competency demonstration requirements

  16. Other Standards MIL-STD-45662A Calibration Systems Requirements ISO 10012-1 Quality Assurance Requirements for Measuring Equipment, Part 1: Metrological Confirmation System for Measuring Equipment ANSI/NCSL Z540.1-1994 (R2002) Calibration Laboratories and Measuring and Test Equipment – General Requirements

  17. Quality Standards for Measuring and Test Equipment • MIL-Q-9858 • MIL-I-45208 • ISO9001, 9002, and 9003 • AS9100 U.S. Navy photo by Mass Communications Specialist 3rd Class Brent Thacker

  18. Contractual Calibration Obligations Within a Contract (1 of 3) • MIL-Q-9858 and MIL-I-45208 • Brought in MIL-STD-45662 (“higher-level” calibration system requirements) as part of the Quality Program/Inspection System • ISO9001/AS9100 Quality Management Systems • Do not automatically invoke higher-level calibration requirements

  19. Contractual Calibration Obligations Within a Contract (2 of 3) • ISO10012 or ANSI/NCSL Z540.3-2006 • Industry calibration system requirements must be called out separately in the contract to be invoked • Appropriate for complex/critical systems/items including Critical Safety Items (CSIs)/Mission Critical Items (MCIs) 2. SPECIFICATIONS, STANDARDS Reference Documents: American Society of Mechanical Engineers (ASME) B46.1, Surface Texture ASME Y14.5M, Dimensioning and Tolerancing ANSI/NCSL Z540.1, “Calibration Laboratories and Measuring and Test Equipment – General Requirements”

  20. Contractual Calibration Obligations Within a Contract (3 of 3) A third-party certification to ISO9001/AS9100 DOES NOTinclude a certification to ISO10012 or ANSI/NCSL Z540.3-2006

  21. Question and Answer What are the primary U.S. national calibration standards? • MIL-STD-45662A • ANSI/NCSL Z540.3 -2006 • ANSI/ISO/IEC 17025:2005 • Both B and C

  22. ANSI/NCSL Z540.3-2006 Requirements Lesson Topics: Calibration Requirements Calibration Standards ANSI/NCSL Z540.3-2006 Requirements Surveillance Methods and Calibration Nuances

  23. Topic 3: ANSI/NCSL Z540.3-2006 Requirements ANSI/NCSL Z540.3-2006 prescribes requirements for a calibration system to control the accuracy of the measuring and test equipment used to ensure that products and services comply with prescribed requirements.

  24. ANSI/NCSL Z540.3-2006 - Section 4 • General Requirements • 4.1 Calibration System Objectives • 4.2 Quality Objectives • 4.3.2 Competence and Training • 4.5 Shipping and Handling

  25. 4.1 Calibration System Objectives Highlights • The organization shall: • Establish, implement, and maintain documented procedures for shipping, receiving, transporting, storing, and dispatching measuring and test. • Include all measuring and test equipment (M&TE) in the calibration system that have an influence on the quality of the organization’s products.

  26. 4.2 Quality Objectives Highlights The organization shall: Define and establish measurable quality objectives for the calibration system and its components.

  27. 4.3.2 Competency and Training Highlights • The organization shall: • Ensure personnel are competent and have demonstrated the ability to perform assigned tasks. • Evaluate the effectiveness of training. • Provide training as needed. • Maintain records of training.

  28. 4.5 Shipping and Handling Highlights • The organization shall: • Establish, implement and maintain documented procedures for: • Shipping, • Receiving, • Transporting, • Storing, and • dispatching measuring and test equipment (M&TE).

  29. ANSI/NCSL Z540.3-2006 - Section 5 • Calibration System Implementation • 5.1 Calibration Requirements • 5.2.1 Identification • 5.2.3 Nonconforming Measuring and Test Equipment • 5.3 Calibration of Measuring and Test Equipment • 5.3.3.2 Measurement Traceability • 5.3.4 Calibration Equipment • 5.3.6 Influence Factors and Conditions • 5.3.9 Calibration Records • 5.4 Calibration Intervals • 5.4.1 Measuring and Test Equipment Calibration Intervals • 5.5 Outside Suppliers

  30. 5.1 Calibration Requirements Highlights The organization shall: Include all measuring and test equipment (M&TE) in the calibration system that has an influence on the quality of the organization’s products.

  31. 5.2.1 Identification Highlights • Measuring and test equipment (M&TE) included in the calibration system shall be: • Clearly identified and distinguishable from other equipment. • Have a calibration status that is evident to the user.

  32. 5.2.3 Nonconforming Measuring and Test Equipment Highlights M&TE suspected or known to be nonconforming shall be removed from service and identified by prominent labeling or marking.

  33. 5.3 Calibration of Measuring and Test Equipment Highlights All measuring and test equipment included in the calibration system, shall be calibrated prior to use and recalibrated at predetermined intervals.

  34. 5.3.3.2 Measurement Traceability Highlights The results of calibration or measurement shall be traceable through a controlled, unbroken chain of competent calibrations to and through the National Institute of Standards and Technology (NIST) to the International System of Units (SI) of measurement.

  35. 5.3.4 Calibration Equipment Highlights If outside equipment needs to be used, the calibration-servicing component shall assure that all applicable ANSI/NCSL Z540.3-2006 requirements are met.

  36. 5.3.6 Influence Factors and Conditions Highlights All factors and conditions of the calibration area that adversely influence calibration results shall be defined, monitored, recorded, and mitigated.

  37. 5.3.9 Calibration Records Highlights • Records shall: • Contain specific information. • Be sufficient to demonstrate whether measuring and test equipment have satisfied specified performance requirements. • Be sufficient to demonstrate the traceability of measurements and to reproduce the calibration results.

  38. 5.4 Calibration Intervals Highlights • Records shall: • Shall be established for M&TE included in the calibration system. • Shall have documented procedures for establishing and adjusting intervals and process controls. • Calibration data shall be: • Regularly monitored. • Intervals shall be adjusted to maintain measurement performance requirements.

  39. 5.4.1 Measuring and Test Equipment Calibration Intervals Highlights A mandatory recall system for M&TE shall be used to assure timely recalibrations.

  40. 5.5 Outside Suppliers Highlights Outside suppliers shall be required to meet the applicable requirements of the calibration system.

  41. ANSI/NCSL Z540.3-2006 - Section 6 • Calibration System Assessment and Improvement • 6.1 Management Review • 6.2 Calibration System Audit • 6.4 Customer Assessment, Verification, and Feedback • 6.5 Corrective and Preventive Action

  42. 6.1 Management Review Highlights • The organization shall: • Ensure the systematic review of the calibration system at planned intervals to ensure the continual: • Adequacy, • Effectiveness, • And suitability of the system to achieve established objectives.

  43. 6.2 Calibration System Audit Highlights • The organization shall: • Ensure the systematic and independent audit of the calibration system. • Objectively evaluate the results to determine the extent to which the audit criteria are fulfilled.

  44. 6.4 Customer Assessment, Verification, and Feedback Highlights All operations of the calibration system shall be subject to assessment and verification by the customer.

  45. 6.5 Corrective and Preventive Action Highlights • When a relevant calibration system functional component does not meet the specified requirements, or when relevant data shows an unacceptable pattern, action shall be taken to identify the cause and eliminate the discrepancy. • Action shall be taken to determine if preventive measures are appropriate to preclude occurrence of other discrepancies in another area of the calibration system.

  46. Question and Answer Mike is doing a process review of calibration equipment; he asks the Quality Manager for his/her recall system so he can sample some of the M&TE. The Quality manager balks and asks, “What ANSI/NCSL Z540.3-2006 section directs him to keep a Recall document?” • 5.2.1 Identification • 5.3 Calibration of Measuring and Test Equipment • 5.4.1 Measuring and Test Equipment Calibration Intervals • 5.3.3.2 Measurement Traceability

  47. Question and Answer Mike found a piece of M&TE equipment in use on the shop floor that does not have evidence of calibration. To which section of ANSI/NCSL Z540.3-2006 should he refer the Quality manager? • 5.2.1 Identification • 5.3 Calibration of Measuring and Test Equipment • 5.4.1 Measuring and Test Equipment Calibration Intervals • 5.3.6 Influence Factors and Conditions

  48. Surveillance Methods and Calibration Nuances Lesson Topics: Calibration Requirements Calibration Standards ANSI/NCSL Z540.3-2006 Requirements Surveillance Methods and Calibration Nuances

  49. Topic 4: Surveillance Methods and Calibration Nuances • M&TE evidence of calibration • Calibration surveillance methods

  50. M&TE Calibration Label (1 of 5) Unique Measure and Test identification number

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