Presentation is loading. Please wait.

Presentation is loading. Please wait.

Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009WELCOME! Americas Aerospace Quality Group AAQG Registration.

Similar presentations


Presentation on theme: "Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009WELCOME! Americas Aerospace Quality Group AAQG Registration."— Presentation transcript:

1 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009WELCOME! Americas Aerospace Quality Group AAQG Registration Management Committee RMC Auditor Training and Workshop Session Minneapolis, MN July 30-31, 2009 Value Added Aerospace Auditing

2 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 Who is R. Darrell Taylor? Raytheon Corporate AS9100 QMS AuditorRaytheon Corporate AS9100 QMS Auditor 27 years experience in the quality field (inspector, engineer, teacher, director)27 years experience in the quality field (inspector, engineer, teacher, director) RABQSA certified Lead QMS auditor, AIEARABQSA certified Lead QMS auditor, AIEA ASQ – CQA, CMQ/OE, CQPAASQ – CQA, CMQ/OE, CQPA 6  Master Black Belt, certified Black Belt, Raytheon 6  Specialist6  Master Black Belt, certified Black Belt, Raytheon 6  Specialist

3 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 Root Cause & Corrective Action Analysis Training – Why Needed? At a recent IAAR (Independent Association of Accredited Registrars) meeting the question was asked, why are OEMs, ABs and ICOP all focused on correction, root cause analysis and corrective action? Simply stated, CBs and suppliers are not delivering to the Aviation, Space and Defense (aerospace) industries expectations! It is essential all CBs and auditors support industry in its quest to improve these activities within the CB community, its auditor base and throughout the supply chain. We can make a difference! Reg Blake – Primary IAAR Rep to AAQG RMC and Americas CB Rep to IAQG OPMT

4 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 Root Cause & Corrective Action Analysis The scope of this workshop is to explore how we, as auditors, can analyze auditee corrective action and root cause for accuracy, relevancy, and completeness for the purpose of improving the auditee’s system and have a positive impact on the aerospace industry.

5 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 “It is not necessary to change. Survival is not mandatory.” Quote from : Dr. William Edwards Deming

6 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 What is the Auditors Role? Identify RequirementsIdentify Requirements Verify Conformance to the RequirementsVerify Conformance to the Requirements Verify the effectiveness of the processVerify the effectiveness of the process

7 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009Topics ProcessProcess Corrective Action InitiationCorrective Action Initiation Root Cause AnalysisRoot Cause Analysis Corrective ActionCorrective Action Verification & ValidationVerification & Validation

8 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 Questions to Explore What constitutes real root cause analysis? How is root cause analysis documented? Who should be involved? How do we determine if corrective action is effective? Who should do this?

9 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 AS9100 -8.5.2 Corrective Action The organization shall take action to eliminate the causes of nonconformities in order to prevent recurrence. Corrective actions shall be appropriate to the effects of the nonconformities encountered. A documented procedure shall be established to define requirements forThe organization shall take action to eliminate the causes of nonconformities in order to prevent recurrence. Corrective actions shall be appropriate to the effects of the nonconformities encountered. A documented procedure shall be established to define requirements for –a) reviewing nonconformities (including customer complaints), –b) determining the causes of nonconformities, –c) evaluating the need for action to ensure that nonconformities do not recur, –d) determining and implementing action needed, –e) records of the results of action taken (see 4.2.4), –f) reviewing the effectiveness of the corrective action taken, –g) flowing down corrective action requirements to a supplier when it is determined that the supplier is responsible for the nonconformity, –h) specific actions where timely and/or effective corrective actions are not achieved, and –i) determining if additional nonconforming product exists based on the causes of the nonconformities and –taking further action when required.

10 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009Process Conduct Verification & Validation What We Control What the Auditee Controls Identify a Nonconformity Initiate Corrective Action Approve Corrective Action Implement Corrective Action Containment Root Cause Corrective Action

11 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 What do you like? What can be done better?

12 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 Sample Finding - Observation Despite the procedures in place, a certain amount of undocumented equipment swapping and borrowing occurs. Training should be conducted to ensure that equipment such swapping/borrowing is approved by the assigned owner of the equipment. Otherwise, there is the danger of equipment not being available to the owner when needed, since verbal agreements, as demonstrated above, are easily forgotten. Convincing evidence was given showing that there was no chance of an Out of Tolerance item being used for testing, which is why this is an Observation and not a finding. Further findings of this sort would lead to a minor nonconformance.

13 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 Corrective Action Initiation NOTE: Use AS9101 form or equivalent

14 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009Definitions ASQ (The Quality Audit Handbook)ASQ (The Quality Audit Handbook) –Finding - A conclusion of importance based on observation (s). Audit Standards (Willborn)Audit Standards (Willborn) –Audit Findings – are the significant conclusions and information needed by the client or audit user for attaining the planned audit objectives.

15 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 Problem Definition - Simple Approach Four Elements:Four Elements: –Source of the Requirement –Requirement –Source of the Finding –Finding Fundamentals of Quality Auditing

16 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009Example AS9100, paragraph 8.2.2 “Internal Audit” states “The organization shall conduct audits at planned intervals…” At XYZ company there is no audit plan. Requirement Source Nonconformance SourceNonconformance Requirement

17 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 Problem Definition 4W:4W: –What was affected –Where did the problem take place –When was the problem discovered –Who Discovered the problem 2H:2H: –How much was affected –How often has the problem occurred 1C:1C: –What is the consequence Correct, Prevent, Improve

18 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 Complete Problem Definition What is the problem?What is the problem? When did it happen?When did it happen? Where did it happen?Where did it happen? What is the significance of the problem?What is the significance of the problem? Apollo Root Cause Analysis

19 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 Corrective Action Initiation Requirements Write complete sentencesWrite complete sentences –The problem description needs to be written clearly –Stick to the facts. Don’t make it a story. –Be precise in defining the requirement and deficiency –Avoid abbreviations, acronyms… Noncompliance issues (Major, Minor) need to “violate” some requirement or they may document the absence of a processNoncompliance issues (Major, Minor) need to “violate” some requirement or they may document the absence of a process –Program plan, procedure, standard (AS9100), etc. –Always include the violated requirement in the problem description

20 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 Problem Description Requirements (cont.) Problem Description SufficiencyProblem Description Sufficiency –Identify What, Where, When, as appropriate –Reference the Evidence –The responsible assignee needs to have enough information from the problem statement to conduct root cause analysis and identify corrective action Self-check the problem descriptionSelf-check the problem description –Is the statement complete and self-sufficient? –Ask yourself … So What? –Where does it say that I have to?

21 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 “A problem well defined is a problem half solved” (anonymous)

22 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 CASE STUDY 1 WRITING A PROBLEM DESCRIPTION

23 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 Levels of Nonconformities

24 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 AS9101 - DRAFT MajorMinor NOTE: An observation is not a nonconformity

25 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 AS9101 - DRAFT 3.2Major Nonconformity3.2Major Nonconformity A non-fulfillment of a requirement which, is likely to result in the failure of the quality management system or reduce its ability to assure controlled processes or products; it can be one or more of the following:A non-fulfillment of a requirement which, is likely to result in the failure of the quality management system or reduce its ability to assure controlled processes or products; it can be one or more of the following: –a nonconformity where the effect is judged to be detrimental to the integrity of the product, or service; –the absence of, or total breakdown of a system to meet a 9100- series standard requirement, an organization procedure, or customer quality management system requirement; –any nonconformity that would result in the probable shipment of nonconforming product; and –a condition that could result in the failure or reduce the usability of the product or service and its intended purpose.

26 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 AS9101 - DRAFT 3.3Minor Nonconformity3.3Minor Nonconformity A non-fulfillment of a requirement which is not likely to result in the failure of the quality management system or reduce its ability to assure controlled processes or products; it can be one of the following:A non-fulfillment of a requirement which is not likely to result in the failure of the quality management system or reduce its ability to assure controlled processes or products; it can be one of the following: –a single system failure or lapse in conformance with a 9100-series standard or customer quality management system requirement; or –a single system failure or lapse in conformance with a procedure associated to the organization's quality management system. NOTE: A number of minor nonconformities against one requirement, e.g. on different sites, can represent a total breakdown of the system, and thus be considered a major nonconformity.NOTE: A number of minor nonconformities against one requirement, e.g. on different sites, can represent a total breakdown of the system, and thus be considered a major nonconformity.

27 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 What do you like? What can be done better?

28 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009EXAMPLE Nonconformance Description:Nonconformance Description: –Some departments are not included in the distribution list of relevant quality procedures such as Engineering was not included on the distribution list for Procedure XYZ, Control of Nonconforming Material, although Engineering is involved in the disposition decisions. Root Cause:Root Cause: –Inadequate review of procedure needs. Corrective Action:Corrective Action: –Company A will issue Procedure XYZ to Engineering by 12/31/200X. –Company A will then post Quality Procedures on its intranet with access available to all departments.

29 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 Containment Action Containment addresses the immediate issue.Containment addresses the immediate issue. –For example, you have a car that will not start. Containment gets it started. –If we have a controlled process to keep measuring equipment calibrated and someone finds un-calibrated or delinquent calibration dates, the containment would be to get the equipment calibrated. During development of Containment, the auditee will determine how big is this issue.During development of Containment, the auditee will determine how big is this issue. Stop the bleeding!!!

30 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 Root Cause Analysis

31 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 Root Cause DEFINITIONS:DEFINITIONS: Root Cause (s): The original event (s), action (s), and/or condition (s) generating (directly or in cascade) an actual or potential undesirable condition, situation, nonconformity or failure.*Root Cause (s): The original event (s), action (s), and/or condition (s) generating (directly or in cascade) an actual or potential undesirable condition, situation, nonconformity or failure.* Note : There are often several root causes for one problem*Note : There are often several root causes for one problem* Contributing Causes: Contributing causes are causes that taken alone would not cause the problem but can increase the risk of the issue to happen. Analysis for these causes generally require taking small steps (or a finer look) to be identified and fixed.*Contributing Causes: Contributing causes are causes that taken alone would not cause the problem but can increase the risk of the issue to happen. Analysis for these causes generally require taking small steps (or a finer look) to be identified and fixed.* Root Cause Analysis: The process of identifying all the causes (root causes and contributing causes) that have or may have generated an undesirable condition, situation, nonconformity or failure.*Root Cause Analysis: The process of identifying all the causes (root causes and contributing causes) that have or may have generated an undesirable condition, situation, nonconformity or failure.* Examples of traditional root causes tend to focus on lack of, or currency of a procedure, training of stakeholders in applicable policy/procedures, lack of an effective tool to perform a task, etc.Examples of traditional root causes tend to focus on lack of, or currency of a procedure, training of stakeholders in applicable policy/procedures, lack of an effective tool to perform a task, etc. * IAQG - SCMH

32 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009Example AS9100, paragraph 8.2.2 “Internal Audit” states “The organization shall conduct audits at planned intervals…”AS9100, paragraph 8.2.2 “Internal Audit” states “The organization shall conduct audits at planned intervals…” At XYZ company there is no audit plan.At XYZ company there is no audit plan. Requirement Source Nonconformance SourceNonconformance Requirement

33 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 Root Cause Analysis 5 Why’s Apollo Fishbone DMAIC Process Maps Process FMEA DOE 5 Why’s Design FMEA Control Charts Pie Charts Histograms Control Plans Pareto Charts Force Field Analysis Affinity Diagrams Interrelationship Digraph Scatter Diagram Brainstorming Flowcharts Run Charts Barrier Analysis Change Analysis Tree Diagrams Process Capability Events & Causal Analysis Risk Tree Analysis

34 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009Response Containment – N/AContainment – N/A Root Cause Analysis – Did not understand the requirementRoot Cause Analysis – Did not understand the requirement Corrective Action – Write planCorrective Action – Write plan COMMENTS?

35 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 Why do we have poor root cause analysis?

36 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009Reasons – We have not set criteria about what makes an acceptable corrective action plan (we are satisfied when we don’t receive any more defective parts and stop here) – We continue to accept bad answers (even if say we will not, reality of life makes us accepting ) – People (internal and external) have not the Root Cause Analysis culture, don’t know any process or are not effectively trained *IAQG - SCMH

37 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 Investigation Checklist Describe the fast fix that was taken, Is it working?Describe the fast fix that was taken, Is it working? Identify owner and those involved.Identify owner and those involved. Gather information:Gather information: –Data –Employee Input –Flowcharts of the process –Procedures –Records – (quantitative data) Has the problem occurred in the past?Has the problem occurred in the past? Identify Root Cause.Identify Root Cause. Book: Correct! Prevent! Improve!

38 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 Rules of Investigation Use proven root cause analysis toolsUse proven root cause analysis tools Think “out – of – the – box”Think “out – of – the – box” Take the time neededTake the time needed Put a plan togetherPut a plan together Book: Correct! Prevent! Improve!

39 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 Actions and Conditions Oxygen Oily Rags Match Strike TIME Apollo: Root Cause Analysis

40 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009Apollo There is no such thing as a single root cause!!There is no such thing as a single root cause!! Action Condition Action Condition Action Condition Action Condition STOP Beyond your area of control

41 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 NOT REQUIRED FREQUENCY IMPACT OPTIONAL RECOMMENDED MANDATORY Modified from IAQG - SCMH OBSERVATIONMINORMAJOR5 WHY’sAPOLLO Understand the severity of the problem Root Cause Requirement?

42 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 What Makes a Good Root Cause? Document the primary cause (s) of the nonconformanceDocument the primary cause (s) of the nonconformance –Understand the problem statement –Don’t assume that people know or understand the problem well enough to determine root cause –Data collection and analysis Involve people who have an understanding of the problemInvolve people who have an understanding of the problem Use the cause and effect principleUse the cause and effect principle Facilitate the Root Cause AnalysisFacilitate the Root Cause Analysis –Provide the knowledge of RCA tools When solved, the problem will not recurWhen solved, the problem will not recur

43 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 Analyzing a Root Cause How does an auditor evaluate a root cause?How does an auditor evaluate a root cause? –CONNECT THE DOTS!! Does the root cause fit the problem statement?Does the root cause fit the problem statement? Does the root cause fit the containment?Does the root cause fit the containment? Is there any indication of the use of “tools”?Is there any indication of the use of “tools”? –Is this a repetitive root cause? –Is this a point analysis, or a system analysis?

44 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 What do you like? What can be done better?

45 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009Example Corrective Action SubjectCorrective Action Subject –Residue on contact causing intermittent electrical connection. Problem Description:Problem Description: –Found 2 units of XYZ which has intermittent electrical connection. Contact pieces are found with glue residue. This is non- conforming to note 3 of assembly drawing XYZ rev G.

46 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 Root Cause AnalysisRoot Cause Analysis –After investigation it was discovered that the adhesive permabond did not have a regulating component to restrict the amount of flow that was being applied. This caused an overflow of glue into the area and the timing of the subsequent assembly did not allow for the detection of the contamination. None of the documentation identified the need for this regulation device. This was indicated during the initial build however the documentation did not reflect what was considered a common practice.

47 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 Corrective Action Short TermCorrective Action Short Term (immediate action for existing material) –Amend work instructions to emphasize that board and domes must be thoroughly cleaned and domes are not to be installed for eight hours after board installation. Corrective Action Long TermCorrective Action Long Term (long term preventive action) –The bottle that contains the adhesive was modified with a regulator to control the flow of the glue and to limit the expansion of the glue once pressure is added. Also the Immediate Corrective Action will be a secondary action applied to further safe guard

48 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 Evaluating Corrective Actions Definition – Action taken to eliminate the causes of an existing nonconformity, defect, or other undesirable situation in order to prevent recurrence – ASQ Audit Handbook

49 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 Corrective Action This is the specific action (s) you take to address the root cause of a problem.This is the specific action (s) you take to address the root cause of a problem. They will only be effective if you have identified the true root cause of the problem.They will only be effective if you have identified the true root cause of the problem. –For example, cleaning battery terminals or replacing a battery in your car will not resolve the problem of a car that will not start if the root cause of the problem is a bad alternator. Corrective action includes the changes in policy, procedure and training to affected stakeholders with assignments to specific individuals and scheduled dates for task completion.Corrective action includes the changes in policy, procedure and training to affected stakeholders with assignments to specific individuals and scheduled dates for task completion.

50 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 Elements of a Corrective Action Containment – Stop the BleedingContainment – Stop the Bleeding Root Cause AnalysisRoot Cause Analysis Design, Implement Corrective Action PlanDesign, Implement Corrective Action Plan Verify Corrective Action Plan is ImplementedVerify Corrective Action Plan is Implemented Validate the effectiveness of the Corrective Action PlanValidate the effectiveness of the Corrective Action Plan

51 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 Traditional vs. Apollo Match Strike Operator Unaware of the Requirements Train Operator Oxygen Oily Rags Match Put in locked fireproof container on the North side of the building Put in fireproof container on the South side of the building, empty daily Nothing – too costly ROOT CAUSE CONDITIONS

52 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 Point Solution System Solution ROBUST!!!! Individual Management CULTURE SHIFT NowFuture

53 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009Pitfalls Binary Thinking – Understand there are grades of solutionsBinary Thinking – Understand there are grades of solutions Incomplete or Faulty Information – Accepting facts to be true when they are notIncomplete or Faulty Information – Accepting facts to be true when they are not Desire to Believe – Self prophesiesDesire to Believe – Self prophesies Failure to Develop alternative Hypothesis – OptionsFailure to Develop alternative Hypothesis – Options Making the pieces fit the puzzle – focus on preferred solutionMaking the pieces fit the puzzle – focus on preferred solution Root Cause Analysis

54 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009Pitfalls Correlation vs. Causation – look at different pathsCorrelation vs. Causation – look at different paths Technical Terminology – cloudy solutionTechnical Terminology – cloudy solution Words vs. Meaning – buzz words, acronyms…Words vs. Meaning – buzz words, acronyms… Not checking thinking and opinions – accepting the first solutionNot checking thinking and opinions – accepting the first solution Root Cause Analysis

55 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 Analyzing a Corrective Action How does an auditor evaluate a corrective action?How does an auditor evaluate a corrective action? –CONNECT THE DOTS!! Does the corrective action fit the:Does the corrective action fit the: – problem statement? – the containment? –the root cause? –Does the Problem Statement connect to the Containment to the Root Cause to the Corrective Action Plan?

56 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 Analyzing a Corrective Action (cont.) –Is this a repetitive corrective action plan? –Is this a point solution, or a system solution? –Is the corrective action plan realistic?

57 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 CASE STUDY 2 Analyzing a Root Cause and Corrective Action

58 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 Verification & Validation

59 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009Definitions Verification – Confirmation by examination and provision of objective evidence that specified requirements have been fulfilledVerification – Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled Validation - Confirmation by examination and provision of objective evidence that the particular requirements for a specified intended use are fulfilledValidation - Confirmation by examination and provision of objective evidence that the particular requirements for a specified intended use are fulfilled

60 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009Verification Verify that the actions have been completed and are effectiveVerify that the actions have been completed and are effective What does this mean?What does this mean? –We must see evidence that the containment actions and corrective actions are completed –Example - documentation released, training completed with attendance sheets

61 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009Validation –Effectiveness We are getting the desired results from our processWe are getting the desired results from our process Implementation of the actions noted on a corrective actionImplementation of the actions noted on a corrective action Look at the process to ensure that the problem documented on the corrective action has been eliminatedLook at the process to ensure that the problem documented on the corrective action has been eliminated –Good to have a couple of examples of the new process being implemented

62 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 What do you like? What can be done better?

63 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009Example Problem Description:Problem Description: –Found that pump assembly p/n 12345 cannot function properly. Upon investigation, we found rubber flashing within the pump tubes is prohibiting air flow. Tubes p/n 2323, 2424, 2525 and 2626 are all affected. Units from lotcode XYZ are affected. Immediate Corrective Action:Immediate Corrective Action: –Determined Scope of problem by reviewing WIP and Finished Goods for the described defect. –Found defect in parts and developed repair method to eliminate –Eliminated defect from in house WIP and Finished Goods Parts

64 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009 Root Cause TypeRoot Cause Type –Vendor Supplied Part was incorrect –Operator Failed to perform process as designed Root Cause Corrective ActionRoot Cause Corrective Action –Issued Corrective Action to Vendor for Flashing left in the unit. –Verified process in place to check for flashing. –Reviewed Process with all assigned personnel to ensure correct process would be performed –Added requirement for QA Inspector to randomly check for Flashing in the material and record results on Roving Inspection Sheet. –Added requirement for the Lead to perform the same random check and record results on the Roving Inspection Sheet.

65 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009Questions???

66 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009Bibliography Correct, Prevent, Improve – Jeanne Ketola & Kathy Roberts, ASQ 2009Correct, Prevent, Improve – Jeanne Ketola & Kathy Roberts, ASQ 2009 Apollo Root Cause Analysis, Dean L. Gano, Apollian Publications 2003Apollo Root Cause Analysis, Dean L. Gano, Apollian Publications 2003 Fundamentals of Quality Auditing, B. Scott Parsowith, ASQ 1995Fundamentals of Quality Auditing, B. Scott Parsowith, ASQ 1995 Root Cause Analysis: A Tool for Total Quality Management, Anderson, Gaylord F.; Dell, Larry D.; Wilson, Paul F.; 1993Root Cause Analysis: A Tool for Total Quality Management, Anderson, Gaylord F.; Dell, Larry D.; Wilson, Paul F.; 1993 The ASQ Auditing Handbook, Third Edition - J.P. Russell, editing director; 2006The ASQ Auditing Handbook, Third Edition - J.P. Russell, editing director; 2006 Websites:Websites: –IAQG Supply Chain Management Handbook; www.sae.org/scmh


Download ppt "Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30-31, 2009WELCOME! Americas Aerospace Quality Group AAQG Registration."

Similar presentations


Ads by Google