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Process Reviews for DCMA QA Surveillance

This lesson introduces the importance of process reviews to Defense Contract Management Agency (DCMA) Quality Assurance (QA) surveillance. It covers topics such as selecting processes for review, differentiating between manufacturing and support processes, documentation requirements, and notification requirements.

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Process Reviews for DCMA QA Surveillance

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  1. LESSON 3Process 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.

  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 52.246-2 through -9 and -11 • Provides the QAS authority to perform GCQA when and where necessary. • DCMA Policy, Process Review – QA http://guidebook.dcma.mil/226/226-13/index.cfm

  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. QA Process Review • Plan • 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 Reference ISO 9000 concepts relating to process and product • Inputs • 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

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

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

  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 Manufacturing 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: MANUFACTURING PROCESS REVIEW CHECKLIST

  25. Common Support Processes Common Business Systems/Support Processes

  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 • 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 • Process review • Sequence • Frequency • Risk likelihood • Scope • Three steps to plan a process review • Process Review Checklist

  33. Process Review Sequence • 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 Consequencerisk statement. • When the likelihood risk is rated at a moderate or high level, andprocess review is the onlysurveillance 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. ConsequenceInfluences Scope Higher Consequence Lower Consequence The consequenceof the Risk Statement influences the scope of review.

  36. Likelihood Influences 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)

  38. Planning the Process Review (2 of 3)

  39. Planning the Process Review (3 of 3)

  40. QAS Process Review Checklist (1 of 6) • QAS Process Review Checklist should include the • following types 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 • Method of review, findings, and correction actions taken • Full or incremental • Incremental schedules • General process, supplier, and QAS information • 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 PROCESS REVIEW CHECKLIST

  41. QAS Process Review Checklist (2 of 6) • QAS Process Review Checklist should include the • following types 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 • Method of review, findings, and correction actions taken • Full or incremental • Incremental schedules • General process, supplier, and QAS information • 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 PROCESS REVIEW CHECKLIST

  42. QAS Process Review Checklist (3 of 6) • QAS Process Review Checklist should include the • following types 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 • Method of review, findings, and correction actions taken • Full or incremental • Incremental schedules • General process, supplier, and QAS information • 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 PROCESS REVIEW CHECKLIST

  43. QAS Process Review Checklist (4 of 6) • QAS Process Review Checklist should include the • following types 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 • Method of review, findings, and correction actions taken • Full or incremental • Incremental schedules • General process, supplier, and QAS information • 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 PROCESS REVIEW CHECKLIST

  44. QAS Process Review Checklist (5 of 6) • QAS Process Review Checklist should include the • following types 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 • Method of review, findings, and correction actions taken • Full or incremental • Incremental schedules • General process, supplier, and QAS information • 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 PROCESS REVIEW CHECKLIST

  45. QAS Process Review Checklist (6 of 6) • QAS Process Review Checklist should include the • following types 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 • Method of review, findings, and correction actions taken • Full or incremental • Incremental schedules • General process, supplier, and QAS information • 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 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.

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