1. LESSON 3 Process Review
15November2013

2. Lesson Introduction
Given a process surveillance requirement, the student will be able to complete a process review.

3. Lesson Objectives
Upon completion of this lesson, you should be able to:
Relate the importance of process reviews to Defense Contract Management Agency (DCMA) Quality Assurance (QA) surveillance.
Describe process inputs.
Explain how supplier’s processes are selected for DCMA QA review.
Distinguish the difference between manufacturing processes and common support processes.
Identify documents related to process reviews.
Determine the scope of the process review.
Identify the documentation requirements of a process review.
Describe the requirements for notifying the supplier and/or customer of the process review results.
Lesson 4: Safety Stock

4. Lesson Topics This lesson will cover the following topics:
Process Reviews
Selecting Processes for Review
Manufacturing Processes vs.
Support Processes
Process Review Documents
Determining the Scope of
Process Review
Process Review Documentation Requirements
Notification Requirements

5. WIIFM? This lesson will: Familiarize you with process review.
Identify the benefit of selecting the process review method for GCQA surveillance.
Identify the requirements of performing a successful process review.

6. Policy and Authority Federal Acquisition Regulation (FAR) 46.104
Describes the QAS’s responsibilities
for QA surveillance activities.
FAR through -9 and -11
Provides the QAS authority to
perform GCQA when and where
necessary.
DCMA Policy, Process Review – QA

7. Tools/Additional Guidance
Tools and Additional Guidance
Process Review Flowchart
Sample Process Review Checklist
Sample Manufacturing Process Review Checklist Form

8. Definitions
Process - A set of interrelated or interactive activities that transform inputs into outputs to satisfy one or more customer requirements
Process Review - An assessment to determine the suitability, adequacy, and effectiveness of a process
Quality Management System (QMS) Audit - A periodic, documented examination/verification of activities, records, processes, and other elements of a quality system to determine their conformity with contract requirements

9. Process Reviews Lesson Topics: Process Reviews
Selecting Processes for Review
Manufacturing Processes vs.
Support Processes
Process Review Documents
Determining the Scope of Process Review
Process Review Documentation Requirements
Notification Requirements

10. Topic 1: Process Reviews
One of three Government Contract Quality Assurance (GCQA) surveillance methods
PDCA (Plan, Do, Check, Act) process
Process flow
Inputs
Process
Products
Customer/stock

11. GCQA Surveillance Method

12. Plan Do Act Check QA Process Review Plan Do Plan Do Check Act Act
Start process review
Determine process review Do
Perform process review
Check
Product examination on the output
Analyzing data
Act
Documenting results
Issue CAR
Adjust risk and surveillance plan
Plan Do
Plan Do
Act
Check
Act
Check

13. Standard Process Flow Inputs Process Product (Output) Customer/ Stock
Procedures to carry out an activity or process
4Ms&E
Materials
Methods
Manpower
Machinery
Environment
Process
Set of interrelated activities that transform inputs into desired outputs that meet customer requirements
Product (Output)
Result of process
Customer/ Stock OR
Next Process
Reference ISO 9000 concepts relating to process and product

14. Standard Process Flow - Examples
Inputs
Materials
Methods
Manpower
Machinery
Environment
Process
Manufacturing
Support
Product
Goods
Services
Design
Schedule
Reports
Products
Reference ISO 9000 concepts relating to process and product

15. Question and Answer
What is the importance of process reviews to DCMA QA surveillance?
Determines the extent to which a manufacturing process consistently meets contractual requirements
Determines the adequacy of a support process that could influence the process inputs and resulting output
Determines Quality Management System (QMS) process adequacy

16. Selecting Processes for Review
Lesson Topics:
Process Reviews
Selecting Processes for Review
Manufacturing Processes vs.
Support Processes
Process Review Documents
Determining the Scope of Process Review
Process Review Documentation Requirements
Notification Requirements

17. Topic 2: Selecting Processes for Review
Processes identified for review are cause/potential cause of risk statement(s)
Process reviews determine process adequacy to consistently produce quality product

18. Support Process (Including System Processes) Manufacturing Process
Process Selection
Processes selected for process review are identified during Risk Assessment
Risk Assessment
Support Process (Including System Processes)
Manufacturing Process
Process Review
Potential Risk Cause

19. Other Process Review Drivers
Customer requests:
Quality Assurance Letters of Instruction (QALIs)
Memorandums of Agreement (MOAs)
Letters of Commitment
Letters of Delegation (LODs)

20. Other Process Review Drivers (cont.)
Other reasons may include:
Critical Safety Item (CSI) requirements indicate important manufacturing processes exist
New or significant changes to existing processes require adjustments to risk levels
Supplier performance changes
Corrective Action Requests (CARs)
Results of Data Analysis
Product Quality Deficiency Reports (PQDRs)

21. Question and Answer
When is a process likely to be selected for review?
When Critical Safety Items are NOT identified
When there is a high risk factor
When the production costs are high
When the process is lengthy

22. Manufacturing Processes vs. Support Processes
Lesson Topics:
Process Reviews
Selecting Processes for Review
Manufacturing Processes vs.
Support Processes
Process Review Documents
Determining the Scope of Process Review
Process Review Documentation Requirements
Notification Requirements

23. Topic 3: Manufacturing Processes vs. Support Processes
Physically transforms the product
Support Processes
Processes that support the manufacturing process

24. Manufacturing Processes
Important Manufacturing Processes may include, but are not limited to:
Shot Peen
Welding
Riveting
Machining
Brazing
Cleaning
Drilling
Anodizing
Forming
Heat Treat
Honing
Torquing
Swaging
Soldering
Assembly
Grinding
Stress Relief
Electroplating
Nondestructive Testing (NDT) Processes
Pressure Testing
Surface Hardening
Protective Finishing
Electrochemical Bonding
Electro-Static Discharge (ESD) Control
MANUFACTURING PROCESS REVIEW CHECKLIST

25. Common Support Processes
Common Business Systems/Support Processes
Quality Management System
Quality Assurance Management
Manufacturing Management
Manufacturing Engineering
Manufacturing Planning
Facility Management
Work Measurement
Production Scheduling and Control
Packaging, Handling, and Transport
Quality Control Planning
Work Instructions/Records
Nonconforming Supplies
Corrective Action
Processing Acceptance Documents
Metrology and Calibration
Subcontract Acquisition Management/Purchasing
“High-Interest” Processes
Advanced Subcontract Planning
Subcontract Negotiation or Award
Subcontract Administration
Counterfeit Mitigation
Purchasing
Drawing and Specification Control
Receiving Inspection
Product Realization Planning

26. Question and Answer
Electroplating is an example of a manufacturing process; an example of a support process is ______________.
Stress relief
Calibration
Alignment
Machining

27. Process Review Documents
Lesson Topics:
Process Reviews
Selecting Processes for Review
Manufacturing Processes vs.
Support Processes
Process Review Documents
Determining the Scope of Process Review
Process Review Documentation Requirements
Notification Requirements

28. Topic 4: Process Review Documents
Documents related to process review come from various sources and contain information necessary to the process review.

29. Documents Related to Process Review
Contract
Quality Requirements
Supplier’s QMS Procedures and Quality Manuals
Contractual Technical Specifications and Requirements
Supplier’s Process Procedures
QAS’s Process Review Checklist
Most critical requirements
4Ms&E
Inspection points
Technical aspects of the contract
Sets tone for subsequent procedures
Detail and depth driven by supplier's QMS system requirements
Drives detail and depth of supplier's process procedures

30. Question and Answer
What document drives the detail and depth of the supplier's process procedures?
Supplier’s Process Procedures
QAS’s Process Review Checklist
Contractual Technical Specifications and Requirements
Supplier’s QMS Procedures and Quality Manuals

31. Determining the scope of process review
Lesson Topics:
Process Reviews
Selecting Processes for Review
Manufacturing Processes vs.
Support Processes
Process Review Documents
Determining the Scope of Process Review
Process Review Documentation Requirements
Notification Requirements

32. Topic 5: Determining the Scope of Process Review
Sequence
Frequency
Risk likelihood
Scope
Three steps to plan a process review
Process Review Checklist
Likelihood of Risk Cause Occurring
(See Performance Factors)
High
Moderate
Low
Process Review
Incremental or Full
Interval
Schedule

33. Process Review Sequence
Risk-Based/Customer Process Selection
Manufacturing Processes
Support Processes
Determine Adequacy of Supplier’s Procedures (if required)
Meet Contract Requirements
Meet Supplier’s Requirements
QAS Process Review Checklist Includes
Applicable 4Ms & E
Other Process Inputs
Evaluation Techniques
Determination of Supplier Compliance
Witness Performance
Evaluate Outputs
Document Results
Document Results

34. Process Review Frequency
As per DCMA policy:
Process reviews shall be scheduled at intervals of no greater than one year when:
The identified risk cause is a special process (requires conformance verification through witnessing the process, as the characteristic cannot be subsequently measured).
Process is associated with a High Consequence risk statement.
When the likelihood risk is rated at a moderate or high level, and process review is the only surveillance method used, frequencies shall be semiannually as a minimum.
If PE is also used to mitigate risk, the frequency of PR may be extended up to three additional months.

35. Consequence Influences Scope
Broader scope may include:
High – All process elements will be reviewed.
The Process Review Checklist shall identify the steps or elements of the process to be reviewed.
Narrow scope may include:
Moderate or Low – Incremental review of portions or specific elements of the process are scheduled and reviewed over a specified time.
Higher Consequence
Lower Consequence
The consequence of the Risk Statement influences the scope of review.

36. Likelihood Influences
Increased intensity and frequency
High likelihood increases the frequency and intensity of the methods and techniques used.
– Intensity: “How much” surveillance to perform.
– Frequency: “How often” surveillance is performed.
Reduced intensity and frequency
Lower likelihood extends the frequencies and/or reduces intensity of methods and techniques used.
Higher Likelihood of Cause Occurring
Lower Likelihood of Cause Occurring
Likelihood of risk cause drives the frequency/intensity of review.

37. Planning the Process Review (1 of 3)
IDENTIFY supplier’s procedures for controlling the process
Review supplier’s procedures to ensure that:
All contractual technical requirements are addressed (e.g., ISO requirements, drawings, SOW, specifications, etc.) and/or incorporated in the procedures
The 4Ms&E are addressed as applicable
Develop Process Review Checklist
Identify process characteristics and outputs

38. Planning the Process Review (2 of 3)
Identify supplier’s procedures for controlling the process
REVIEW supplier’s procedures to ensure that:
All contractual technical requirements are addressed (e.g., ISO requirements, drawings, SOW, specifications, etc.) and/or incorporated in the procedures
The 4Ms&E are addressed as applicable
Develop Process Review Checklist
Identify process characteristics and outputs

39. Planning the Process Review (3 of 3)
Identify supplier’s procedures for controlling the process
Review supplier’s procedures to ensure that:
All contractual technical requirements are addressed (e.g., ISO requirements, drawings, SOW, specifications, etc.) and/or incorporated in the procedures
The 4Ms&E are addressed as applicable
DEVELOP Process Review Checklist
Identify process characteristics and outputs

40. QAS Process Review Checklist (1 of 6)
QAS Process Review Checklist should include the
following types information
General process, supplier, and QAS information
Determination of supplier process procedure adequacy to contract requirements
Supplier process requirements, steps, outputs, elements, or operations to be reviewed. Supplier or process requirements related to 4Ms&E inputs and other process inputs
Description of how the specific process steps or operations will be reviewed by the QAS
Witness or verify
How many units
How long
Where
How much
Method of review, findings, and correction actions taken
Full or incremental
Incremental schedules
PROCESS REVIEW CHECKLIST

41. QAS Process Review Checklist (2 of 6)
QAS Process Review Checklist should include the
following types information
General process, supplier, and QAS information
Determination of supplier process procedure adequacy to contract requirements
Supplier process requirements, steps, outputs, elements, or operations to be reviewed. Supplier or process requirements related to 4Ms&E inputs and other process inputs
Description of how the specific process steps or operations will be reviewed by the QAS
Witness or verify
How many units
How long
Where
How much
Method of review, findings, and correction actions taken
Full or incremental
Incremental schedules
PROCESS REVIEW CHECKLIST

42. QAS Process Review Checklist (3 of 6)
QAS Process Review Checklist should include the
following types information
General process, supplier, and QAS information
Determination of supplier process procedure adequacy to contract requirements
Supplier process requirements, steps, outputs, elements, or operations to be reviewed. Supplier or process requirements related to 4Ms&E inputs and other process inputs
Description of how the specific process steps or operations will be reviewed by the QAS
Witness or verify
How many units
How long
Where
How much
Method of review, findings, and correction actions taken
Full or incremental
Incremental schedules
PROCESS REVIEW CHECKLIST

43. QAS Process Review Checklist (4 of 6)
QAS Process Review Checklist should include the
following types information
General process, supplier, and QAS information
Determination of supplier process procedure adequacy to contract requirements
Supplier process requirements, steps, outputs, elements, or operations to be reviewed. Supplier or process requirements related to 4Ms&E inputs and other process inputs
Description of how the specific process steps or operations will be reviewed by the QAS
Witness or verify
How many units
How long
Where
How much
Method of review, findings, and correction actions taken
Full or incremental
Incremental schedules
PROCESS REVIEW CHECKLIST

44. QAS Process Review Checklist (5 of 6)
QAS Process Review Checklist should include the
following types information
General process, supplier, and QAS information
Determination of supplier process procedure adequacy to contract requirements
Supplier process requirements, steps, outputs, elements, or operations to be reviewed. Supplier or process requirements related to 4Ms&E inputs and other process inputs
Description of how the specific process steps or operations will be reviewed by the QAS
Witness or verify
How many units
How long
Where
How much
Method of review, findings, and correction actions taken
Full or incremental
Incremental schedules
PROCESS REVIEW CHECKLIST

45. QAS Process Review Checklist (6 of 6)
QAS Process Review Checklist should include the
following types information
General process, supplier, and QAS information
Determination of supplier process procedure adequacy to contract requirements
Supplier process requirements, steps, outputs, elements, or operations to be reviewed. Supplier or process requirements related to 4Ms&E inputs and other process inputs
Description of how the specific process steps or operations will be reviewed by the QAS
Witness or verify
How many units
How long
Where
How much
Method of review, findings, and correction actions taken
Full or incremental
Incremental schedules
PROCESS REVIEW CHECKLIST

46. Performing the Process Review
Determine compliance of supplier's procedures/instructions to the process selected by:
Assessing process inputs (i.e., 4Ms&E) against contract technical requirements
Ensuring process, operation, or step utilizes correct practices and requirements
Performing product examination to assess conformity to stated requirements (Output)
Statistical sampling not required when selecting samples for examination.

47. Question and Answer
Complete the following sentence: When there is a high risk impact _____________________________.
Process reviews shall be scheduled every six months.
All process elements will be reviewed.
Product examinations are performed only if required by Quality Letter of Instruction (QALI).
There is a decrease in the frequency and intensity of the method and techniques used.

48. Process Review Documentation Requirements
Lesson Topics:
Process Reviews
Selecting Processes for Review
Manufacturing Processes vs.
Support Processes
Process Review Documents
Determining the Scope of Process Review
Process Review Documentation Requirements
Notification Requirements

49. Topic 6: Process Review Documentation Requirements
DCMA Process Review - QA Policy requires process review documentation.

50. Documenting the Process Review
DCMA policy requires the following documentation for process review:
Review date
Person accomplishing review
Supplier Name
Review location
The process reviewed
Supplier procedure or documentation references, revision number, and date
The items being processed at the time of the review by nomenclature, part number, serial number, batch number, etc.

51. Documenting the Process Review (cont.)
Elements of the process reviewed (e.g., 4Ms&E)
Steps of the process reviewed
Nonconformances found
Must be documented in accordance with DCMA Corrective Action Policy
Must be traceable to corrective actions

52. Complete the Top of the Form
SUPPLIER ABC
R. LEIGHTON
LYNN, MA
10 JUNE 2013
HEAT TREAT
1. Stress relief, 2. Preheating, 3. Austenizing, 4. Quenching, 5. Tempering
AMSE B46.1, SURFACE TEXTURE
REVISION A, MARCH 10, 2003
SHOULDERED STUD
99207/3024T25P03

53. Process Review Checklist Elements (1 of 5)

54. Process Review Checklist Elements (2 of 5)

55. Process Review Checklist Elements (3 of 5)

56. Process Review Checklist Elements (4 of 5)

57. Process Review Checklist Elements (5 of 5)

58. Question and Answer Which of the following are inputs to the process?
Material
Manpower
Machinery
All of these

59. Notification Requirements
Lesson Topics:
Process Reviews
Selecting Processes for Review
Manufacturing Processes vs.
Support Processes
Process Review Documents
Determining the Scope of Process Review
Process Review Documentation Requirements
Notification Requirements

60. Topic 7: Notification Requirements
DCMA Process Review Policy necessitates results notification according to specific requirements.

61. Process Review Notification Requirements
Discuss results of the process review with the supplier
(and customer, if applicable)
Include possible opportunities for improvement for processes exhibiting variations
QAS shall initiate immediate corrective action
when the results indicate a
contractual nonconformity

62. Discuss Results of Process Review
CORRECTIVE ACTION REQUEST

63. Summary Having completed this lesson, you should understand:
DCMA is emphasizing more process review oversight
Process review surveillance is based on potential risk causes identified in Risk Assessment
Process review
Ensures supplier’s process procedures, work instructions, and controlling documentation meet contract requirements
Verifies suppliers follow procedures, inputs accurate, and conforming outputs
Lesson 4: Safety Stock

64. Summary (cont.) Having completed this lesson, you should understand:
DCMA’s policy on process review intervals
No more than one year if risk cause is special process OR process associated with high consequence risk statement
Semiannually if risk cause likelihood moderate to high AND process review only method
The QAS maintains records detailing review activities, results, and corrective actions
Lesson 4: Safety Stock

65. Questions

66. Review Question 1
Processes selected for process review are identified during what part of the GCQA process?
Process Review
Support Process
Risk Assessment
Manufacturing Process

67. Review Question 2 What is a process review?
An examination to determine process outputs meet contract requirements
An assessment to determine the suitability, adequacy, and effectiveness of a process
A periodic verification of a quality system to determine conformity with contract requirements
A set of interrelated activities that transforms inputs into outputs to satisfy customer requirements

68. Review Question 3 Which of the following are Support Processes?
Riveting and Brazing
Machining and Forming
Cleaning and Anodizing
Metrology and Receiving Inspection

69. Review Question 4 What’s the final step in validating a process?
Product Examination of the output
Perform a System Audit
Document the results
Issue a Corrective Action Request

70. Review Question 5
What drives the frequency and intensity of a process review?
Risk
Machinery
Manpower
Environment

71. Review Question 6 Which of the following is NOT an input to a process?
Methods
Machinery
Manpower
Rework

72. Exercise: Process Review Checklist
Students work in pairs to complete a Process Review Checklist.
One student open CMQ101_M4_L3_E1_Checklist.pdf file.
One student open the exercise and reference documents:
CMQ101_M4_L3_E1_ProcessReviewChecklist.pdf
CMQ101_M4_L3_E1_WeldProcedure004.pdf
Time: 15 minutes