Slide 1: Not contractual, for information purposes only
The following slides are not contractual in nature and are for information purposes only as of June 2015. 1 ©2015, Lockheed Martin Corporation. All Rights Reserved.
Slide 2: Corrective Action Webinar – Lesson 9: Follow-up for Effectiveness
Corrective Action Webinar Lesson 9 – Follow-up for Effectiveness ©2015, Lockheed Martin Corporation. All Rights Reserved. 2
Slide 3: Agenda
Agenda • Overview of Previous Webinars • Command Media • Follow-up – Verification vs. Validation – Obtaining Objective Evidence – Additional Considerations • Closing the Corrective Actions – Document Results – Monitor and Measure – CAP Failures & Recurrences • Case Studies • Summary 3
Slide 4: Overview of Previous Webinars
Overview of Previous Webinars: SQE CA Initiation: • Webinar 1: Command Media Expectations • Webinar 2: Procedures & Expectations • Webinar 3: CAR Levels & Criteria • Webinar 4: CAR Writing Supplier CA Engagement: • Webinar 5: Containment • Webinar 6: DCMA CARs • Webinar 7: Root Cause Analysis • Webi
Slide 5: What is CA Follow-up?
What is CA Follow-up?? • Definition: – A review conducted with sufficient detail to assess whether the corrective actions have been implemented, are effective, and will prevent recurrence of the original event. • Key Word: EFFECTIVE – Corrective action(s) achieve the desired outcome of eliminating t
Slide 6: Command Media
COMMAND MEDIA 6
Slide 7: Plan-Do-Check-Act Cycle
Plan-Do-Check-Act Cycle • AS9100 and ISO 9001 present a structured process – Define the problem – Determine action to take – Review actions for effectiveness – Make changes as needed Corrective Action is a continuous cycle 7
Slide 8: AS9100 Industry Requirements
AS9100 Industry Requirements 8.5.2 Corrective Action The organization shall take action to eliminate the causes of nonconformities…A documented procedure shall be established to define requirements for… e) records of the results of action taken (see 4.2.4), f) reviewing the effectiveness of the corr
Slide 9: AC-2018 & QX
AC-2018 & QX • AC-2018 – Supplier Approval and Control – Para 3.B.1.C. CAR Responses - SQM will: • Establish validation follow-up date within 30 days of C/A effectivity (effectivity being the point that all corrective actions have been taken, validated and incorporated into the product) • Perform va
Slide 10: Follow-up
FOLLOW-UP 10
Slide 11: Steps for Follow-up
Steps for Follow-up 1. Verification 2. Validation 3. Closure 4. Monitor & Measure Test the CA against the initial plan – adjust as required 11
Slide 12: Supplier CAPs
Supplier CAPs • Suppliers: – Implement corrective actions per the CAP schedule – Verify process reflects corrective actions in place – Notify SQE when CAP is complete – Validate effectiveness and maintain records • SQEs: – Establish separate LM validation follow-up date within 30 days of C/A impleme
Slide 13: Verification vs. Validation
Verification vs. Validation • Verification – Corrective Action Implementation – Confirmation with objective evidence: • corrective action plan was implemented as planned • specified requirements have been fulfilled – Step 1 of Follow-up • Validation – Corrective Action Effectiveness – Confirmation w
Slide 14: Poor Assumptions
Poor Assumptions If a supplier says they did something, then they must have. All actions are effective unless stated otherwise. All CA is directly related to the problem causes, or they wouldn’t have done it. A verbal statement is sufficient for objective evidence. Once CA is implemented, the issue
Slide 15: Objective Evidence (OE)
Objective Evidence (OE) • Definition: any documented statement of fact, other information or record, either quantitative or qualitative, pertaining to the quality of an item or activity, based on observations, measurements or tests which can be verified. • Hard evidence / proof / factual – Records,
Slide 16: Objective Evidence (OE) (continued)
Objective Evidence (OE) (continued) • Communicate your needs – Work with the supplier to set the ECD for follow-up – Tell the supplier what you want to see, when, and why • Follow-up delivery method matters! – Inspect, witness, interview, physical record, electronic record, email attachment, etc. Ob
Slide 17: Objective Evidence (OE) (continued)
Objective Evidence (OE) (continued) • Examples – Physical Inspection – Records / Documents – Procedures / Policies – Planning / Routers – Test log / report – Non-conformance report – Witness statement – Observation / Photos – Quality metric / measurement – ETC…. Select OE appropriate to the CAP 17
Slide 18: Objective Evidence (OE) (continued)
Objective Evidence (OE) (continued) • Examples – Late orders • Review updated procedures, interview 3 employees, review training records and ensure they received the revised training, review 10 recent service records, … – Overdue calibrations • Review updated process, interview personnel, check cali
Slide 19: Additional Considerations
Additional Considerations • Do implemented corrective actions differ from the original plan? – Find out why… the changes may be valid, but need to be documented appropriately. – Ensure CA eliminates the cause(s) & prevents recurrence – Look at the potential impact and consider the outcome. • Have AL
Slide 20: Additional Considerations
Additional Considerations • Does the problem exist on other parts / assemblies / processes / areas? – This should be included in the investigation and/or corrective action implementation. – This important question is frequently overlooked. • Is the fix a Band-aid? – Need to ensure corrective actions
Slide 21: Additional Considerations
Additional Considerations • Are employees aware of the changes? – Procedural / Process changes – Updated / new required training – All-hands meetings, employee communications • Have the appropriate parties been notified? – Partner/sister companies, other divisions / business units – SQM, SCM, TSM, Q
Slide 22: CA Closure
CA Closure • Document the follow-up actions – Date conducted – Verification + Validation results – Objective Evidence witnessed • If Validation is Successful: – Close CAR / ICA issue • If Validation is Unsuccessful: – Reject / Revise corrective actions • **Perform further root cause analysis – Sched
Slide 23: Monitor & Measure
Monitor & Measure • Going forward, what will show sustainment?? – Trend Analysis – Sampling Plans – Acceptance Inspections – Spot Checks – Re-test the process – Internal Audits – Variation Management, CPK, SPC, PCD, PFMEA **Routinely review closed CAPs Measure Analyze Improve 23
Slide 24: Recurrences
Recurrences • AC-3031 definition: – Repeat of an issue within 12 months after the date, item, unit, lot number or other commitment for which CA was validated and attributed to the same cause. • Required Actions: – Reopen Corrective Action or Create new Corrective Action and note that the issue is a
Slide 25: Case Studies
CASE STUDIES Squawk: “Whining sound heard on engine shutdown." Corrective Action: “Pilot removed from aircraft." Squawk: “Aircraft handles funny." Corrective Action: “Aircraft told to straighten up, 'fly right,' and be serious." Squawk: “Evidence of hydraulic leak on right main landing gear." Correc
Slide 26: Case Study #1 – Oversized Hole
Case Study #1 – Oversized Hole • Problem Description – 0.380 max hole diameter checks 0.393. • Containment – Check parts in WIP • Root Cause Analysis – Operator error • Corrective Action – Re-train operator – Add additional inspection step 26
Slide 27: Case Study #1 – Oversized Hole (cont.)
Case Study #1 – Oversized Hole (cont.) • Problem Description – 0.380 max hole diameter checks 0.393. • Containment (REVISED) – Check parts in WIP, stores, previously delivered, and all similar processes. • Root Cause Analysis (REVISED) – Direct Cause – manual lathe not capable due to poor maintenanc
Slide 28: Case Study #1 – Oversized Hole (cont.)
Case Study #1 – Oversized Hole (cont.) • Corrective Action (REVISED) – Train operator in use of chamfer gauge and preventive maintenance – Move process to NC machine capable of meeting tolerance requirements – Revise/improve preventive maintenance plan for all machines – Complete capability analysis
Slide 29: Case Study #1 – Oversized Hole (cont.)
Case Study #1 – Oversized Hole (cont.) • Corrective Action (REVISED) – Train operator in use of chamfer gauge and preventive maintenance – Move process to NC machine capable of meeting tolerance requirements – Revise/improve preventive maintenance plan for all machines – Complete capability analysis
Slide 30: Case Study #2 – Pump Tube
Case Study #2 – Pump Tube • Problem Description – Found that pump assembly p/n 12345 cannot function properly during acceptance testing. Upon investigation, we found rubber flashing within the pump tubes prohibiting air flow. Tubes p/n 2320 thru 2339 are all affected. • Containment – Developed repai
Slide 31: Case Study #2 – Pump Tube (cont.)
Case Study #2 – Pump Tube (cont.) • Corrective Action – Issued Corrective Action to sub-tier for Flashing left in the unit. – Verified process in place to check tubes during receiving. Added verbiage to specifically check for flashing. – Added planning for assembler to visual check tubes prior to in
Slide 32: Case Study #2 – Pump Tube (cont.)
Case Study #2 – Pump Tube (cont.) • Suggested Follow-up Actions – Verification • Review sub-tier CAR response • Review planning changes – receiving, assembly, inspection, test • Review training records – Validation • Check next receiving lot of tubes from sub-tier • Witness new process to ensure cha
Slide 33: Case Study #3 – Ineffective CA
Case Study #3 – Ineffective CA • Follow-up Results – Your follow-up confirms that all corrective actions have been implemented within a heat treat process that previously failed, which was identified due to a cracked parts. – The next 3 heat treat batches that you witness all follow the improved pro
Slide 34: Case Study #3 (continued)
Case Study #3 (continued) • Required Actions – Reject the follow-up in SQM Web Aps • Notify the Supplier – Conduct further root cause analysis with supplier • Suggest use of more in-depth tool or new approach – Create new corrective action plan • Reject or Validate previous actions • Additional cont
Slide 35: Summary
Summary • Verification – Objective Evidence of CAP implementation • Validation – Objective Evidence of CAP effectiveness • Closure – Records of the results • Monitor & Measure – Gauge effectiveness results and prevent recurrence Follow-up for Corrective Action Effectiveness 35