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

Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 Who is R. Darrell Taylor? • Raytheon Corporate AS 9100 QMS Auditor • 27 years experience in the quality field (inspector, engineer, teacher, director) • RABQSA certified Lead QMS auditor, AIEA • ASQ – CQA, CMQ/OE, CQPA • 6 s Master Black Belt, certified Black Belt, Raytheon 6 s Specialist

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

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

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

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

Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 Topics • Process • Corrective Action Initiation • Root Cause Analysis • Corrective Action • Verification & Validation

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

Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 AS 9100 -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 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.

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

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

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

Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 Corrective Action Initiation NOTE: Use AS 9101 form or equivalent

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

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

Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 Example Requirement Source AS 9100, paragraph 8. 2. 2 “Internal Audit” states “The organization shall conduct audits at planned intervals…” At XYZ company there is no audit plan. Nonconformance Source Nonconformance

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

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

Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 Corrective Action Initiation Requirements • Write 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 process – Program plan, procedure, standard (AS 9100), etc. – Always include the violated requirement in the problem description

Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 Problem Description Requirements (cont. ) • Problem 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 description – Is the statement complete and self-sufficient? – Ask yourself … So What? – Where does it say that I have to?

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

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

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

Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 AS 9101 - DRAFT Major Minor NOTE: An observation is not a nonconformity

Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 AS 9101 - DRAFT • 3. 2 Major 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 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.

Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 AS 9101 - DRAFT • 3. 3 Minor 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 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.

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

Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 EXAMPLE • 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: – Inadequate review of procedure needs. • Corrective Action: – Company A will issue Procedure XYZ to Engineering by 12/31/200 X. – Company A will then post Quality Procedures on its intranet with access available to all departments.

Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 Containment Action • 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. Stop the bleeding!!!

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

Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 Root Cause • • 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. * • 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. * • 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. *IAQG - SCMH

Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 Example Requirement Source Requirement • AS 9100, paragraph 8. 2. 2 “Internal Audit” states “The organization shall conduct audits at planned intervals…” • At XYZ company there is no audit plan. Nonconformance Source

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

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

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

Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 Reasons – 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

Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 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? Identify owner and those involved. Gather information: – – – • • Data Employee Input Flowcharts of the process Procedures Records – (quantitative data) Has the problem occurred in the past? Identify Root Cause. Book: Correct! Prevent! Improve!

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

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

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

Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 Root Cause Requirement? M AN DA RY RE IMPACT TO CO M OP M EN Understand the severity of the problem DE D TI O NA NO T L RE QU IR ED 5 WHY’s OBSERVATION FREQUENCY APOLLO MINOR MAJOR Modified from IAQG - SCMH

Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 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 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 problem • Use the cause and effect principle • Facilitate the Root Cause Analysis – Provide the knowledge of RCA tools • When solved, the problem will not recur

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

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

Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 Example • Corrective Action Subject – Residue on contact causing intermittent electrical connection. • 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.

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

Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 • Corrective 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 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

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

Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 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. • 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.

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

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

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

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

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

Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 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? – CONNECT THE DOTS!! • 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?

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

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

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

Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 Definitions • Verification – 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 fulfilled

Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 Verification • Verify that the actions have been completed and are effective • 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

Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 Validation – Effectiveness • We are getting the desired results from our process • Implementation of the actions noted on a corrective action • Look 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

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

Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 Example • 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: – 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

Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 • Root Cause Type • – Vendor Supplied Part was incorrect – Operator Failed to perform process as designed • Root 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.

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

Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 Registration Management Committee (RMC) Auditor Training and Workshop Minneapolis, MN July 30 -31, 2009 Bibliography • Correct, Prevent, Improve – Jeanne Ketola & Kathy Roberts, ASQ 2009 • Apollo Root Cause Analysis, Dean L. Gano, Apollian Publications 2003 • Fundamentals 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. ; 1993 • The ASQ Auditing Handbook, Third Edition - J. P. Russell, editing director; 2006 • Websites: – IAQG Supply Chain Management Handbook; www. sae. org/scmh