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LESSON 3 Higher-Level Quality Requirements and Supplier Responsibilities

Learn about the purpose and specifications of higher-level quality requirements in contracts, the relationship between Quality Management Systems (QMS) and higher-level requirements, and the supplier's responsibilities related to Quality Assurance (QA). Discover why suppliers may choose to use a Single-Standard Quality System.

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LESSON 3 Higher-Level Quality Requirements and Supplier Responsibilities

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  1. LESSON 3Higher-Level Quality Requirements and Supplier Responsibilities 15November2013

  2. Lesson Introduction Given a contract, you will be able to identify the supplier’s responsibility to higher-level quality requirements.

  3. Lesson Objectives Upon completion of this lesson, you should be able to: • Describe the purpose for higher-level quality requirements in a contract. • Identify the required quality specifications for contracts. • Describe the relationship of Quality Management System (QMS) to higher-level quality requirements. • Identify the supplier’s responsibilities pertaining to Quality Assurance (QA). • Explain why a supplier would choose to use a Single-Standard Quality System.

  4. Lesson Topics This lesson will cover the following topics: • Purpose of Higher-Level Contract Requirements • Required Quality Standards for Contracts • QMS and Higher-level Quality Requirements Relationship • Supplier’s Responsibility to QA • Supplier’s Use of Single- Standard Quality System

  5. WIIFM? This lesson will help you: • Work with the supplier in upholding their responsibilities when higher-level requirements are in place in a contract • Understand your QA responsibilities when a contract requires the supplier to perform QA activities • Understand why a suppliermight choose to use a single-standard quality system for multiple contracts

  6. Authority • Federal Acquisition Regulation (FAR) 42.302(a)(38) – Ensure supplier complies with contractual QA requirement • FAR 46.202-4 – Requires compliance with higher-level quality standards in contracts for complex or critical items to control work operations, in-process inspections, ….. • FAR 52.246-11 – Specific format for the inclusion of Higher-Level Contract Quality Requirement(s) in a contract

  7. Definitions – Contract Items • Complex – Items with quality characteristics not wholly visible in the end item • Critical – Application of an item in which failure of the item could injure personnel or jeopardize a vital agency mission • Critical items – Items having significant effect on the production realization and use of the product

  8. Definitions – Quality Management System Quality Management System (QMS) – System of quality management that includes all activities of the overall management function that determines the quality policy, objectives, and responsibilities and their implementation QMS

  9. Purpose of Higher-level contract requirements Lesson Topics: Purpose of Higher-Level Contract Requirements Required Quality Standards for Contracts QMS and Higher-Level Quality Requirements Relationship Supplier’s Responsibilities to QA Supplier’s Use of Single-Standard Quality System

  10. Topic 1: Purpose of Higher-Level Contract Requirements • Typical quality requirements • FAR • Industry • Military • Purpose of higher-level quality requirements

  11. Typical Quality Requirements - FAR • 52.212-4, Contract Terms and Conditions – Commercial Items • 52.246-1, Contractor Inspection Requirements • 52.246-2 through -9, Standard Inspection • 52.246-11, Higher-Level Contract Quality • Requires a Standard Inspection clause and standard cited in contract

  12. Typical Quality Requirements - Industry • International Organization for Standardization (ISO) 9000 series (1987 to Present) • 9001:1987, QA in Design/Development, Production, Installation and Servicing • 9002:1987, QA for Production, Installation, Servicing • 9003:1987, QA for Inspection and Test • 9001:2000, Single Standard for QMS (9001:2008 update) • Aerospace Standard (AS) 9100 (1999), AS9100:2009, QMS Requirements for Aerospace, Defense, and Space • SAE International Aerospace Standards (SAE AS) • Other approved standards

  13. Typical Quality Requirements - Military • MIL-I-45208A (1960-1996), Inspection System Requirements • MIL-Q-9858 (1959-1996), Quality Program Requirements

  14. Purpose of Higher - Level Quality Requirements Higher-level quality requirements: • Control work operations, in-process controls, and inspections • Bring attention to organization, planning, work instructions, documentation control, and advanced metrology • Help ensure quality requirements are met on complex and critical items

  15. Question and Answer Contracts with FAR 52.246-11 as one of the listed clauses should always also list _______________. • Drawings or specifications • A supplier’s manufacturing plan • Quality standards • Surveillance plans

  16. Required Quality Standards for Contracts Lesson Topics: Purpose of Higher-Level Contract Requirements Required Quality Standards for Contracts QMS and Higher-Level Quality Requirements Relationship Supplier’s Responsibilities to QA Supplier’s Use of Single-Standard Quality System

  17. Topic 2: Required Quality Standards for Contracts A documented QMS is required for contracts with a higher- level quality requirement.

  18. QMS Documentation • Contracts with higher-level quality requirements require supplier to establish and maintain a documented QMS • QMS documentation may consist of: • Supplier Quality Manual or contract-specific Quality Plan • Support process procedures, may be part of Quality Manual/Plan • Manufacturing process procedures, to include inspection and testing DCMA does NOT approve/accept supplier’s QMS, but reserves the right to disapprove procedures based on the results of Government Contract Quality Assurance (GCQA) surveillance.

  19. QMS Required Documentation Six specific ISO9001 clauses require documented procedures: • Control of documents (4.2.3) • Control of records (4.2.4) • Internal audit (8.2.2) • Control of nonconforming product (8.3) • Corrective actions (8.5.2) • Preventive actions (8.5.3)

  20. Question and Answer What documentation would be included in a supplier’s ISO9001 QMS? • Manufacturing Maintenance Schedule • Supplier’s Quality Manual • Supplier’s Personnel Work History • Production Maintenance Records

  21. QMS and Higher-Level Quality Requirements Relationship Lesson Topics: Purpose of Higher-Level Contract Requirements Required Quality Standards for Contracts QMS and Higher-Level Quality Requirements Relationship Supplier’s Responsibilities to QA Supplier’s Use of Single-Standard Quality System

  22. Topic 3: QMS and Higher-Level Quality Requirements Relationship Higher-level quality requirements include: • QMS information • ISO9001 standards • AS9100 standards • ISO9001/AS9100 clauses AS9100

  23. QMS Information Quality Management System’s: • Limited allowable exclusions must be listed in the Quality Manual • Purpose is customer satisfaction and continuous improvement • Intent is to prevent nonconformity • Documentation via records • Not required by DoD to be third party certified QMS

  24. ISO9001 and AS9100 Standards • ISO9001 standards are meant to include small companies to larger organizations • AS9100 includes ISO9001 standards, but enhances with requirements for the aerospace industry • AS9100 is more stringent than ISO9001, adding a significant number of requirements and notes to the ISO9001 QMS defining clauses

  25. ISO9001 • ISO9000 first published in 1987 to: • Meet product-related statutory and regulatory requirements • Ensure organizations met the needs of customers and stakeholders • Based on British Standards (BS) 5750 standard series from British Standards Institution (BSI) • Current version ISO9001:2008

  26. AS9100 Americas Aerospace Quality Group (AAQG) formed in 1995 to standardize quality requirements for the industry. Inputs D1-9000 Company-specific Requirements ISO-9001 • Inputs from: • International Aerospace Quality Group (IAQG) • European Aerospace Quality Group (EAQG) • Asia Pacific Aerospace Quality Group (APAQG) MIL-I DoD NASA MIL-Q FAA AAQG Process AS9100 Output Used with permission of SAE and Mr. Dale K. Gordon

  27. Question and Answer Besides controlling nonconformities, what is the purpose of the QMS? • Listing quality standards from the Government • Ensuring customer satisfaction and continuous improvement • Documenting GCQA surveillance plans • Compiling AS9100 and ISO9000 standards

  28. ISO9001/AS9100 Clauses ISO9001:2008/AS9100 has eight clauses, last five define QMS: • Scope • Normative Reference • Terms and definitions • Quality Management System • Management responsibilities • Resource management • Product realization • Measurement, analysis, and improvement

  29. ISO9001/AS9100 Clause 4 • Quality Management System • 4.1 General Requirements • 4.2 Documentation Requirements • 4.2.1 General • 4.2.2 Quality Manual • 4.2.3 Control of documents (required documentation) • 4.2.4 Control of records (required documentation)

  30. ISO9001/AS9100 Clause 4 (cont.) Clause 4 requires the supplier to: • Establish, document, implement, and maintaina QMS and continually improve its effectiveness • Document its quality policy, objectives, and manual • Manual should reflect QMS scope • Document procedures for control of documents and records • Procedures will vary depending on size and type of activity performed, process complexity, and personnel competency

  31. ISO9001/AS9100 Clause 5 • Management Responsibilities • 5.1 Management Commitment • 5.2 Customer Focus • 5.3 Quality Policy • 5.4 Planning • 5.5 Responsibility, Authority, and Communication • 5.6 Management Review

  32. ISO9001/AS9100 Clause 5 (cont.) Clause 5 requires the supplier’s top management to: • Demonstrate commitment to developing and implementing the QMS and continuously improving the system • Determine customer requirements and enhance customer satisfaction • Ensure quality policy is appropriate to the organization • Establish measurable quality objectives consistent with the quality policy • Appoint a management representative with necessary authority relative to the QMS • Ensure management reviews QMS for suitability, adequacy, effectiveness, and improvement opportunities

  33. ISO9001/AS9100 Clause 6 • Resource Management • 6.1 Provision of Resources • 6.2 Human Resources • 6.3 Infrastructure • 6.4 Work Environment

  34. ISO9001/AS9100 Clause 6 (cont.) Clause 6 requires the supplier to: • Provide resources to implement and maintain QMS, its improvement, and to enhance customer satisfaction • Ensure personnel assignments are relative to and effectively achieve the quality objectives • Provide and maintain an infrastructure to include buildings, hard/software equipment, and support services • Manage work environment to achieve conformity to product requirements

  35. ISO9001/AS9100 Clause 7 • Product Realization • 7.1 Planning of Product Realization • 7.2 Customer-related Processes • 7.3 Design and Development • 7.4 Purchasing • 7.5 Product and Service Provision • 7.6 Control of Monitoring and Measuring Equipment

  36. ISO9001/AS9100 Clause 7 (cont.) Clause 7 requires the supplier to: • Plan product realization to include surveillance and testing for acceptance • Determine requirements as specified by the customer and product usage in addition to contractual requirements • Plan design/development reviews, surveillance and change controls • Ensure quality of purchased product and that product satisfies purchase requirements • Identify calibration requirements for equipment and devices, including software if used to monitor/measure

  37. ISO9001/AS9100 Clause 8 • Measurement, Analysis, and Improvement • 8.1 General • 8.2 Monitoring and Measurement • 8.2.2 Internal Audit (required documentation) • 8.3 Control of Nonconforming Product (required documentation) • 8.4 Analysis of Data • 8.5 Improvement • 8.5.2 Corrective Actions (required documentation) • 8.5.3 Preventive Actions (required documentation)

  38. ISO9001/AS9100 Clause 8 (cont.) Clause 8 requires the supplier to: • Implement measurement, analysis, and improvement for products and QMS conformity/effectiveness • Monitor/measure customer satisfaction, internal audits, processes, and product • Three types of audits: First Party, Second Party, and Third Party • Ensure control of nonconforming products • Analyze relevant data on customer satisfaction, product requirement conformity, and process and product trends • Ensure continual improvement through quality policy/objectives, audit results, corrective/preventive actions and management review

  39. Allowable Exclusions ISO9001:2008, 1.2 Application • Based on the premise that all ISO9001 requirements are generic and intended to be applicable to all organizations • Where requirement(s) cannot be applied due to the nature of an organization and its product, consider for exclusion • When exclusions are made, claims of conformity to ISO9001:2008 are not acceptable UNLESS: • Exclusions are limited to the requirements within ISO9001:2008, Clause 7 • Exclusions do not affect organization's ability/responsibility to provide product that meets customer, statutory, and regulatory requirements

  40. Higher-Level Quality Requirements and QMS Higher-level quality requirements specify quality controls for product/service and the QMS details the supplier’s plan and implementation of actions to fulfill those requirements.

  41. Question and Answer “Product Realization” is the title of ISO9001/AS9100 clause ____. • 4 • 5 • 6 • 7

  42. Question and Answer ISO 9001/AS9100 clause 5 that deals with customer focus, quality policy, and planning is titled “___________________.” • Quality Management System • Resource Management • Product Realization • Management Responsibilities

  43. Question and Answer Which are required documentation for ISO9001/AS9100 clause 4? (Select all that apply.) • Control of documents • Control of measuring equipment • Control of records • Control of nonconforming product

  44. Supplier’s Responsibilities to QA Lesson Topics: Purpose of Higher-Level Contract Requirements Required Quality Standards for Contracts QMS and Higher-Level Quality Requirements Relationship Supplier’s Responsibilities to QA Supplier’s Use of Single-Standard Quality System

  45. Topic 4: Supplier’s Responsibilities to QA FAR Part 46 outlines: • Contractor (supplier) responsibilities • Inspection by contractor (supplier) • Exceptions to contractor (supplier) inspections

  46. FAR Requirements FAR Part 46 • 46.105, Contractor Responsibilities • 46.202, Government reliance on inspection by contractor

  47. Contractor (Supplier) Responsibilities According to FAR 46.105, supplier must carry out contractual QA obligations by: • Controlling quality of product/ service • Ensuring their vendors have acceptable quality control system • Maintaining evidence that products/services conform to contract quality requirements • Tendering to the Government ONLYproducts/services that conform to contract requirements

  48. Inspection by Contractor (Supplier) FAR46.202-2, Government relies on the contractor to ensure products/services acquired at or below the simplified acquisition threshold conform to contract quality requirements by inspecting and testing prior to Government submission. Supplier Approved

  49. Inspection by Contractor (Supplier) Exception Government shall not rely on inspection by contractor if the contracting officer determines a need: • For Government test of supplies in advance of tender for acceptance • To pass judgment on adequacy of contractor’s internal work processes Government Approved

  50. Question and Answer What is the most important facet of FAR 46.105 in terms of the supplier’s contractual responsibilities to quality assurance? • Relying only on the Government’s inspection of products/services • Tendering to the Government only products/services that conform to contract requirements • Acquiring only products/services below the simplified acquisition threshold • Submitting to the customer products/services inspected only by the supplier

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