QMS STANDARDS
CONTROLLED DOCUMENT: WI-TLG-0302
BUSINESS UNIT:
The Linc Group 1201 Louisiana, #2700, Houston, TX 77002-5678
STANDARD TYPE:
Work Instruction
PROCEDURE TITLE:
QA - Process Modes and Effects Analysis
AREA: Business Process TYPE OF PROCEDURE: Needs Assessment
DOCUMENT NUMBER: WI-TLG-0302 REVISION: 1.0
PROCEDURE STATUS IMPLEMENTED DATE REVISION DATE
Released 08/12/05 08/12/05
UNLOCK DOCUMENT TO EDIT BEYOND THIS POINT
1.0 PURPOSE/SCOPE When analyzing the needs of a customer, in order to make an informed decision on how to provide value and meet their needs, there are a myriad of tools at our disposal to accomplish this task. To determine which tool to use is dependent on the objective or process at hand. The Process Modes and Effects Analysis (PMEA) is one of the tools The Linc Group uses for the Needs Assessment phase of our Master Business Process. This work instruction will explain when to use and the steps necessary to apply the Process Breakdown Analysis tool. The Needs Assessment Phase is a discovery process. The Needs Assessment Phase ensures “Quality in Perception” by setting the minimum requirements to develop an understanding of the prospective customer’s situation, problems, and opportunities to align with product and service offering. The Needs Assessment Phase ensures “Quality in Fact” by setting the minimum requirements to develop an understanding of the (process) customer’s situation, problems, and opportunities to drive process design and execution. 2.0 RESPONSIBILITIES 2.1 TASK RESPONSIBILITIES It is the responsibility of The Linc Group Corporate Quality Manager and its Business Unit Managers to clearly understand the contents of this Work Instruction and to apply the concepts presented herein. 2.2 APPROVAL / ESCALATION RESPONSIBILITIES The Chief Information Officer is the point of escalation for all notifications in question or contested by users or management.
Procedure Title: Process Modes and Effects Analysis
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3.0
PROCEDURE (SOP OR WI STEPS) 3.1 Background: The Process Modes and Effects Analysis (PMEA) is a step-by-step approach for identifying the modes and effects that a specific process or subject has in order to prioritize their functions and corresponding risks, and address their needs. The Linc Group has adapted this approach from the American Society of Quality’s (ASQ) Failure Modes and Effects Analysis (FMEA) and has modified it to fit our organization’s applications. The approach was originated in the 1940’s by the U.S. Military and further developed by the aerospace and automotive industries, some of which continue to maintain FMEA standards. Where the FMEA focuses on the anticipated or actual failures of a product or process, TLG’s PMEA is used as a tool to evaluate, analyze and address the obstacles that hinder us from delivering customer value. It pro-actively assesses the processes of a business model or project to identify and prioritize function modes in the delivery of customer value, and it re-actively addresses the obstacles that prevent the delivery of customer value. 3. 2 The Linc Group Applications – When will the PMEA approach be applied and by whom? At a minimum, there are currently three events when the PMEA approach will be applied: (A) Application Type Pro-active
(B) Application (1) QMS Deployment
(C) Application Description The PMEA will be applied when determining the priority in which a Business Unit, Location, or Functional Area deployment should occur. It will also be applied during the deployment of a newly acquired operating location, the results of which will provide a roadmap in addressing the subject’s needs and prioritizing any risks or voids identified.
Pro-active
(2) Business Model Assessments
The process is applied to anticipate failures during a project implementation and mitigate risks in the process. In addition, some projects require the assessment of a business model or process in order to identify the modes and effects that will require The Linc Group to address.
Re-active
(3) Breakdown of a Process
The continual improvement in providing customer value is the framework of The Linc Group’s quality management system and measurements. When a process breaks down, the PMEA will be applied to determine what functions failed (modes) and what impact (effects) the failures have on providing customer value.
Procedure Title: Process Modes and Effects Analysis
(D) Trigger Events
(E) Who: PMEA Owner
Business Unit Deployment
Corporate Quality Manager
Functional Leader; Integration Manager
Project Manager
New Acquisitions
Project or Initiative
Corrective or Preventive Actions Ad Hoc Requests
Corporate Quality Manager
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CONTROLLED DOCUMENT: WI-TLG-0302
3.3 PMEA Roles and Definitions: ROLE
DEFINITION
PMEA Owner
Based on Section 3.2, Column E: Has ownership of process and recommendations. Responsible for:
PMEA Initiator
PMEA Worksheet PMEA Task Plan Management PMEA Application
Pro-active Application
May be the same as PMEA Owner Re-active Application
Person who requested assistance from Corporate Quality Manager Main contact from operating entity (process, location, department, etc.); could be the same as PMEA Initiator
PMEA Champion
PMEA Team Member
All affected users or process stakeholders/owners
3.4 The PMEA Worksheet The Process Modes and Effects Analysis is accomplished using an Excel worksheet. There are two master templates that will be used according to the Application Types identified in Section 3.2. The templates and sample worksheets can be accessed by clicking on the links below. Application Type
Master Template Link
Pro-active
R-WI-TLG-0302-1 PMEA Pro-active Template and Interview Form
Re-active
R-WI-TLG-0302-2 PMEA Re-active Template and Interview Form
3.4.1 Sample PMEA Worksheet Please click on the link below to view a sample PMEA worksheet initiated by an Ad Hoc Request.
Sample Worksheet 3.5 Procedures for using PMEA: STEP
WHAT
1.
Enter a request for Quality Manager assistance
PMEA Trigger Event – See 3.2, Column D: Applications 1 and 3 only or if coaching is required for application 2
PMEA Initiator
QMS Policy Request
2.
Request creation of PMEA WIP Site
PMEA Initiator
Portal Assistance Request
3.
1Initiate invitation to PMEA . team and update new PMEA WIP Site as necessary
Proactive Application 2 PMEA Trigger Event = Project or Initiative Before initiating the process
PMEA Owner - See 3.2, Column E
Team Site link will be sent to PMEA Owner by Corporate Quality Manager
4.
Update initial call event
WHEN
COMPETENCY (WHO)
HOW (TOOLS)
Click here to view a Sample Copy of the PMEA WIP Site Before the call
Procedure Title: Process Modes and Effects Analysis
PMEA Owner
PMEA WIP Site: Events: Initial
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STEP
WHAT
WHEN
COMPETENCY (WHO)
record and meeting workspace as necessary
HOW (TOOLS) Interview Session Link to Event Record - Sample Copy Click here to view a Sample Copy of the Meeting Workspace
5.
6.
7.
Clearly identify and have PMEA Team confirm the objective of the application of PMEA
During the interview and before proceeding any further
PMEA Owner
Conduct interview with subject stakeholders or process owners, hereon known as PMEA Team
When gathering data for worksheet
PMEA Owner
Confirm data gathered with PMEA Team
Upon finalization of PMEA Interview Form
PMEA WIP Site Initial call meeting workspace Click here to view a Sample Copy of the Meeting Workspace PMEA WIP Site Initial call meeting workspace Click here to view a Sample Copy of the Meeting Workspace
PMEA Owner
PMEA Template Section 3.3 Above Tasking Tool
8.
Populate worksheet
Upon confirmation of data gathered
PMEA Owner
PMEA Template Section 3.3 Above
9.
Calculate RPN and Criticality
Next step
PMEA Owner
PMEA Template Section 3.3 Above Columns 8 and 9
10.
Analyze and interpret results of RPN and Criticality
Prior to identifying recommended actions
PMEA Owner
11.
Conduct meeting with the PMEA Team to go over worksheet and confirm data with team Revise worksheet based on meeting outcome Create project task plan
Upon completion of worksheet
PMEA Owner & Team
Based on results of calculations, take the highest RPN and this will be the starting point or focus in achieving PMEA Application. Criticality results should support RPN or serve as a tiebreaker if multiple causes of mode receive the same RPN. PMEA Worksheet
Following confirmation of worksheet Next step
PMEA Owner
PMEA Worksheet
PMEA Owner
Your PMEA WIP Site
12. 13.
Click here to view a Sample Copy of the PMEA WIP Site 14.
Manage tasks for completing recommended actions and target due dates Conduct status meetings with PMEA Team
Next step
PMEA Owner
PMEA WIP Site PMEA Task Plan
During stabilizing period
PMEA Owner
PMEA WIP Site Events Entry: Meeting Workspace
16.
Repeat PMEA approach on completed recommended actions only
Reassessment date
PMEA Owner
PMEA Worksheet
17.
Create QMS deliverables based on successful
Next step
PMEA Owner and Quality Manager
PMEA WIP Site QMS Deliverables - Drafts
15.
Procedure Title: Process Modes and Effects Analysis
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CONTROLLED DOCUMENT: WI-TLG-0302
STEP
18.
WHAT recommended actions. Successful recommended actions are those that no longer appear on the reassessment worksheet Repeat process for RPNs that still exist or until PMEA Team agrees that the objective identified in step 3 above has been satisfied
WHEN
COMPETENCY (WHO)
HOW (TOOLS) Update QMS Policy Request entered in step 1 above
Next step
PMEA Owner
PMEA Worksheet Update Document Production Request entered in step 1 above
4.0 SPECIAL DEFINITIONS THE FOLLOWING TERMS ARE REFERRED TO IN THIS WORK INSTRUCTION: TERM ASQ
DEFINITION American Society of Quality http://www.asq.org/about-asq/who-we-are/index.html
CA/PA
Corrective Actions and Preventive Actions Library of action logs and tasks used to address and manage incidents that require correction or prevention. https://tlgportal.thelincgroup.com/sites/qmslinks/wiplibrary/pages/CA %20and%20PA.aspx
Effect Mode PMEA RPN
Impact that failures have on purpose of function Current state of function that precipitated the application of PMEA Acronym for Process Modes and Effects Analysis Risk Priority Number Refer to PMEA Worksheet Work in Progress
WIP
5.0 ASSOCIATED REFERENCE DOCUMENTS THE FOLLOWING DOCUMENTS PROVIDE ADDITIONAL INFORMATION: DOCUMENT NAME R-WI-TLG-0302-1 PMEA Worksheet – Proactive R-WI-TLG-0302-2 PMEA Worksheet - Reactive R-WI-TLG-0302-3 PMEA Process Map SOP-0053 BP – Needs Assessment
LOCATION QMS Links: QMS Released Library: Templates QMS Links: QMS Released Library: Templates QMS Links: QMS Released Library: Reference Documents QMS Links: QMS Released Library: SOP's
6.0 ASSOCIATED KNOWLEDGE DATABASE THE FOLLOWING KNOWLEDGE DATABASES PROVIDE ADDITIONAL INFORMATION:
Procedure Title: Process Modes and Effects Analysis
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CONTROLLED DOCUMENT: WI-TLG-0302
KNOWLEDGE DATABASE R-SOP-0057-1 Continuous Improvement Logic Flowchart
LOCATION QMS Links: Released Library: Reference Documents
7.0 ASSOCIATED TOOLS THE FOLLOWING TOOLS MAY BE REQUIRED FOR COMPLIANCE TO THIS STANDARD: ASSOCIATED TOOLS PMEA WIP Site – Sample Copy
LOCATION QMS Links: QMS WIP Library: PMEA
8.0 REVISION HISTORY REVISION (X.X) DATE OF LAST REVISION
1.0 08/12/05
LAST APPROVAL DATE
08/12/05
(MM/DD/YY) (MM/DD/YY)
DOCUMENT AUTHOR: Melissa Cipriani
DOCUMENT MANAGER: Melissa Cipriani
REASON FOR CHANGE:
SECTION / PARAGRAPH CHANGED
Revision
1.0
All
CHANGE MADE
Initial Entry
DATE OF REVISION MM/DD/YY
08/12/05
9.0 ELECTRONIC NOTIFICATION LIST: ELECTRONIC NOTIFICATIONS PLEASE CLICK HERE TO VIEW THE NAMES OF PERSONNEL CURRENTLY HOLDING THESE POSITIONS. Business Unit Presidents Chief Information Officer Chief Operating Officer Corporate Quality Manager Information Management Group
Procedure Title: Process Modes and Effects Analysis
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QMS STANDARDS
CONTROLLED DOCUMENT: WI-TLG-0302
10.0
APPROVALS FIRST APPROVER NAME: GREG LUSH TITLE: CIO SIGNATURE:
SECOND APPROVER NAME: DAVE WHALEY TITLE: COO SIGNATURE:
THIRD APPROVER NAME: TRACY K. PRICE TITLE: CEO SIGNATURE:
DOCUMENT HISTORY SECTION: Document Created on 08/12/05 by Melissa Cipriani
Procedure Title: Process Modes and Effects Analysis
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