WELCOME! Value Added Aerospace Auditing ROBUST!!!!
Shulman, Marcia, Executive Vice President has reference to this Academic Journal, PHwiki organized this Journal WELCOME! Americas Aerospace Quality Group AAQG Registration Management Committee RMC Auditor Training in addition to Workshop Session Minneapolis, MN July 30-31, 2009 Value Added Aerospace Auditing Who is R. Darrell Taylor Raytheon Corporate AS9100 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 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 in addition to ICOP all focused on correction, root cause analysis in addition to corrective action Simply stated, CBs in addition to suppliers are not delivering to the Aviation, Space in addition to Defense (aerospace) industries expectations! It is essential all CBs in addition to auditors support industry in its quest to improve these activities within the CB community, its auditor base in addition to throughout the supply chain. We can make a difference! Reg Blake Primary IAAR Rep to AAQG RMC in addition to Americas CB Rep to IAQG OPMT
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Root Cause & Corrective Action Analysis The scope of this workshop is to explore how we, as auditors, can analyze auditee corrective action in addition to root cause as long as accuracy, relevancy, in addition to completeness as long as the purpose of improving the auditees system in addition to have a positive impact on the aerospace industry. It is not necessary to change. Survival is not m in addition to atory. Quote from : Dr. William Edwards Deming What is the Auditors Role Identify Requirements Verify Con as long as mance to the Requirements Verify the effectiveness of the process
Topics Process Corrective Action Initiation Root Cause Analysis Corrective Action Verification & Validation 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 AS9100 -8.5.2 Corrective Action The organization shall take action to eliminate the causes of noncon as long as mities in order to prevent recurrence. Corrective actions shall be appropriate to the effects of the noncon as long as mities encountered. A documented procedure shall be established to define requirements as long as a) reviewing noncon as long as mities (including customer complaints), b) determining the causes of noncon as long as mities, c) evaluating the need as long as action to ensure that noncon as long as mities do not recur, d) determining in addition to 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 as long as the noncon as long as mity, h) specific actions where timely in addition to /or effective corrective actions are not achieved, in addition to i) determining if additional noncon as long as ming product exists based on the causes of the noncon as long as mities in addition to taking further action when required.
Process Conduct Verification & Validation What We Control What the Auditee Controls What do you like What can be done better Sample Finding – Observation Despite the procedures in place, a certain amount of undocumented equipment swapping in addition to 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 as long as gotten. Convincing evidence was given showing that there was no chance of an Out of Tolerance item being used as long as testing, which is why this is an Observation in addition to not a finding. Further findings of this sort would lead to a minor noncon as long as mance.
Corrective Action Initiation NOTE: Use AS9101 as long as m or equivalent Definitions ASQ (The Quality Audit H in addition to book) Finding – A conclusion of importance based on observation (s). Audit St in addition to ards (Willborn) Audit Findings are the significant conclusions in addition to in as long as mation needed by the client or audit user as long as attaining the planned audit objectives. Problem Definition – Simple Approach Four Elements: Source of the Requirement Requirement Source of the Finding Finding Fundamentals of Quality Auditing
Example AS9100, paragraph 8.2.2 Internal Audit states The organization shall conduct audits at planned intervals At XYZ company there is no audit plan. Problem Definition 4W: What was affected Where did the problem take place When was the problem discovered Who Discovered the problem 2H: How much was affected How often has the problem occurred 1C: What is the consequence Correct, Prevent, Improve 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
Corrective Action Initiation Requirements Write complete sentences The problem description needs to be written clearly Stick to the facts. Dont make it a story. Be precise in defining the requirement in addition to 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, st in addition to ard (AS9100), etc. Always include the violated requirement in the problem description Problem Description Requirements (cont.) Problem Description Sufficiency Identify What, Where, When, as appropriate Reference the Evidence The responsible assignee needs to have enough in as long as mation from the problem statement to conduct root cause analysis in addition to identify corrective action Self-check the problem description Is the statement complete in addition to self-sufficient Ask yourself So What Where does it say that I have to A problem well defined is a problem half solved (anonymous)
CASE STUDY 1 WRITING A PROBLEM DESCRIPTION Levels of Noncon as long as mities AS9101 – DRAFT Major Minor NOTE: An observation is not a noncon as long as mity
AS9101 – DRAFT 3.2 Major Noncon as long as mity 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 noncon as long as mity 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 st in addition to ard requirement, an organization procedure, or customer quality management system requirement; any noncon as long as mity that would result in the probable shipment of noncon as long as ming product; in addition to a condition that could result in the failure or reduce the usability of the product or service in addition to its intended purpose. AS9101 – DRAFT 3.3 Minor Noncon as long as mity 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 con as long as mance with a 9100-series st in addition to ard or customer quality management system requirement; or a single system failure or lapse in con as long as mance with a procedure associated to the organization’s quality management system. NOTE: A number of minor noncon as long as mities against one requirement, e.g. on different sites, can represent a total breakdown of the system, in addition to thus be considered a major noncon as long as mity. What do you like What can be done better
EXAMPLE Noncon as long as mance Description: Some departments are not included in the distribution list of relevant quality procedures such as Engineering was not included on the distribution list as long as Procedure XYZ, Control of Noncon as long as ming 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 12/31/200X. Company A will then post Quality Procedures on its intranet with access available to all departments. 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 in addition to 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!!! Root Cause Analysis
Root Cause Type Vendor Supplied Part was incorrect Operator Failed to per as long as m process as designed Root Cause Corrective Action Issued Corrective Action to Vendor as long as Flashing left in the unit. Verified process in place to check as long as flashing . Reviewed Process with all assigned personnel to ensure correct process would be per as long as med Added requirement as long as QA Inspector to r in addition to omly check as long as Flashing in the material in addition to record results on Roving Inspection Sheet. Added requirement as long as the Lead to per as long as m the same r in addition to om check in addition to record results on the Roving Inspection Sheet. Questions 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 as long as Total Quality Management, Anderson, Gaylord F.; Dell, Larry D.; Wilson, Paul F.; 1993 The ASQ Auditing H in addition to book, Third Edition – J.P. Russell, editing director; 2006 Websites: IAQG Supply Chain Management H in addition to book; www.sae.org/scmh
Shulman, Marcia Executive Vice President
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