1. LESSON 3 Higher-Level Quality Requirements and Supplier Responsibilities
15November2013
Lesson 4: Safety Stock

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.
Lesson 4: Safety Stock

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 supplier might choose to use
a single-standard quality system for multiple
contracts

6. Authority
Federal Acquisition Regulation (FAR) (a)(38) – Ensure supplier complies with contractual QA requirement
FAR – Requires compliance with higher-level quality standards in contracts for complex or critical items to control work operations, in-process inspections, …..
FAR – 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
, Contract Terms and Conditions – Commercial Items
, Contractor Inspection Requirements
through -9, Standard Inspection
, Higher-Level Contract Quality
Requires a Standard Inspection clause and standard cited in contract

12. Typical Quality Requirements - Industry
International Organization for Standardization (ISO) 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 ( ), Inspection System Requirements
MIL-Q-9858 ( ), Quality Program Requirements

14. Purpose of 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 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 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.
FAA
D1-9000
ISO-9001
MIL-Q
DoD
AS9100
AAQG
Process
Output
Inputs
Company-specific Requirements
Inputs from:
International Aerospace Quality Group (IAQG)
European Aerospace Quality Group (EAQG)
Asia Pacific Aerospace Quality Group (APAQG)
MIL-I
NASA
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

30. ISO9001/AS9100 Clause 4 (cont.) Clause 4 requires the supplier to:
Establish, document, implement, and maintain a 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.
Higher-Level Quality Requirements:
The QMS:
Are listed in the contract:
ISO9001
AS9100
Others
Outlines supplier’s actions to meet higher-level quality requirements
Control the quality of complex and critical items
Identifies quality controls intended to prevent nonconforming items
Require documentation to substantiate that products/services meet requirements
Documents quality requirement fulfillment through process procedures, work instructions, and records

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 , 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 ONLY products/services that conform to contract requirements

48. Inspection by Contractor (Supplier)
FAR , 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 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

51. Supplier’s Use of Single-Standard Quality System
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

52. Topic 5: Supplier’s Use of Single-Standard Quality System
Single-standard quality system is a system of control that applies to both Government and Commercial material.
Supplier’s Single-Standard Quality System
Contract 1: ISO9001 Quality System
Contract 2: Boeing Quality Management System
Contract 3: AS9100 Program
Contract 4: Ford Motor Company Quality System

53. Single-Standard Quality System
Supplier chooses single-standard quality system because it eliminates duplication of effort.
Supplier must:
Track product quality requirements on a contract-by-contract basis
Identify a hold point in the production cycle to segregate Government items if identical/similar to commercial items

54. Summary Having completed this lesson, you should now know that:
Higher-level quality requirements are inserted in a contract to better control those items that are complex or critical in nature and bring awareness to the associated planning and processes
Both the supplier and QAS have specific responsibilities when higher-level quality requirements are specified in a contract
ISO9001 and AS9100 standards are identified in contracts to ensure the supplier’s product/service meet specific quality requirements
Single-standard quality systems allow the supplier to more efficiently control and generate products/services
Lesson 4: Safety Stock

55. Summary (cont.)
Having completed this lesson, you should now know that:
QAS is responsible for providing oversight to the supplier in its efforts to create products/services that conform to contract quality requirements
Supplier is ultimately responsible for the quality of its products/services prior to submission to the Government for acceptance
Lesson 4: Safety Stock

56. Questions

57. Review Question 1
In addition to controlling work operations and bringing attention to planning, higher-level requirements also _________________________.
Provide higher-level management product examination reports
Ensure quality requirements are met on complex and critical items
Guide the supplier’s process review scheduling
Mandate the supplier’s use of a single-standard inspection system

58. Review Question 2
Which of these documentation items is found in a supplier’s Quality Management System?
Applicable ISO9001 Clauses
Technical Drawings
Manufacturing Deliverables
Quality Manual

59. Review Question 3
Higher-level quality requirements specify quality controls for product/service and the QMS does what in relation to this?
Specifies the product/service surveillance activities
Details the DCMA’s plan to inspect the supplier’s product/service
Outlines the product/service the supplier will manufacture
Details the supplier’s plan and implementation of actions to fulfill the higher-level requirements

60. Review Question 4 Which of these is a supplier’s responsibility to QA?
Inspecting products/services after the Government has made an initial inspection
Applying the DCMA’s process review criteria to their internal reviews
Ensuring their vendors have an acceptable quality control system
Recording the results of the Government’s GCQA activities in their facility

61. Review Question 5
In addition to being easier to manage and less costly to maintain, what other benefits does a single-standard system offer the supplier?
Fulfills higher-level requirements with in subcontracts
Eliminates duplication of effort
Ensures all products are manufactured using identical processes
Uses less personnel to manage the facility quality assessment procedures