Corrective Action Knowledge Share_2024.pptx

Corrective Action overview

1. Corrective Action / Preventive Action Training

2. Corrective Action Training Contents Definitions Purpose of CAPA Action Path Non-conforming Product Understanding Defects Containment and Examples Risk Analysis and Examples Investigation Tools and Examples Root Cause and Examples Action Plan and Approval Implementation Verification of Effectiveness Timeliness & Expectations 2

3. Definitions Correction: An immediate remedial action taken to correct a detected product or process nonconformity, but does not always address the root cause of the issue. Examples include containment, machine repair, or change in operator. Corrections are documented as part of the initiating quality event. Corrective Action: Action taken to eliminate the root cause of nonconformities in order to prevent recurrence. The corrective action should eliminate recurrence of the event within the product/process in which it was detected as well as related product/processes in which it could occur. Preventive Action: Action taken to eliminate potential causes of discrepancies or nonconformities to prevent occurrence. Root Cause: The underlying reason for a nonconformity or nonconforming event. 3

4. What is CAPA? CAPA: Corrective Action / Preventive Action System used to document nonconformance information. We use a CAPA system to collect and analyze information, investigate product and quality issues and take action to correct and prevent reoccurrence of the nonconformance. Processes that impact/drive CAPAs and stakeholders of those processes: Complaints (Quality, Manufacturing): Role – Quality: confirm complaints, immediate containment, Q/M: investigation and prevent additional defect escape Return Material Authorization (RMA) requests (Customer Service, Supply Chain, Manufacturing/Quality): Role – CS: collect defect information, customer communication. Supply Chain: Support and drive resolutions for supplier issues. M/Q: immediate containment, investigation, prevent additional defect escape Audits (Leadership Team, Quality Manager): Role – Leadership: investigation, system evaluation, plan for conformance/prevention. QM: Support, drive improvements, provide resources. Stop Flow (Manufacturing, Quality): Role – M/Q: investigation and prevent additional defect escape MRBs (QE’s and ME’s): Role – QE/ME: investigation and prevent additional defect escape Continuous Improvement Projects (CIP) Manufacturing, Quality): Role – M/Q: Open PA’s for actions prior to a nonconformance Change Assessments (All departments): Role – Department managers need to deploy adequate resources to drive change control and follow any CAPA related initiatives. Key Process Indicators (KPI) Metrics (All departments): Role – Department managers align on metrics. Metrics will help to gage processes and system performance, identify resource needs and business risks. Identify the knowledge, skills and abilities required to perform the current business processes. 4

5. Action Paths Correction: Action taken to correct the known defect cause. Example: High gates - dull de-gator. Correction: Issue RMA, Contain additional lots, Replace blades, set up PM to change on frequent basis. Corrective Action: Requires an investigation to identify the cause of the nonconformance and action to prevent reoccurrence. Example: Damage – unsure, need to identify what is causing and how it can prevented. What caused the damage, how can we fix and prevent? Preventive Action: Requires action before a non-conformance occurs. Example: Putting in sensors to verify insert presence on a new fixture. 5

6. Non-Conforming Product Quality Notification: An issue or non-conformance that requires a production stop to evaluate nonconforming product. This is documented on the Stop Flow Form or Quality Defect Report in SAP. Quality Defect Report (QDR): This is an internal report for an issue or non-conformance that requires escalation into corrective or preventative actions. When risk and frequency are low and no CAPA is indicated, action is still taken. Using the Stop Flow investigation form, you can include additional information for correction and future prevention. Items to consider: What is the source of the problem? What standard that has not been met, print reference? Part number and revision number? How big is the problem? How many times has it occurred? Where did it occur? When did it occur? 6

7. Understand the Defect It is critical to adequately understand the complaint/defect notification. If you don’t understand the suspected part defect or systemic defect, GET MORE DETAILS! Review prints/documents Call the Customer/Supplier Collect photos, examples, sample parts Work with customer service to help drive resolution/support quickly For RMA’s – they should not be granted until you’ve done due diligence to understand the issue. This requires knowing your parts, the manufacturing process, and your customer. Work with them to confirm defects, collect accurate information, and scope the problem. 7

8. Containment Containment: Keep nonconforming things under control or within limits. For containment, it is critical to identify all suspected nonconforming product and insure complete containment. You must evaluate all product locations, not just on hand. Document any impacted lots and where the parts are located to prevent additional use. Inventory (Storage location, on hold, work in progress (WIP)) Subcontracted Inventory (At supplier, in transit, Vendor Managed Inventory (VMI) warehouse) Released Inventory (In-transit to customer, at customer, released from customer) Future Inventory (Open Orders, Scheduled Jobs) Coordinate with the engineering on the disposition as required. 8

9. Containment Actions: There are multiple options for containing inventory and/or preventing additional defect escapement. Inventory – containment email, Stop Flow/Red Table, work with customer service to place sales order on hold. Subcontracted Inventory – Documentation to incoming receipt to prevent use, return shipment request, notify vendor, work with shipping for arrival status. Released Inventory – Notify customer, recall shipments for serious complaints. Future Inventory – Assess upcoming orders against Bill of Materials(BOM), remove equipment from service, place work orders on hold, work with scheduling to address scheduled jobs Depending on the severity of the defect, any and all containments may be needed or none required. 9

10. Containment Examples No Containment: Process issues that are systemic; no physical containment. A rationale for why no product is impacted should be included. Limited Containment: Scratches on a part – additional containment could be a visual assessment of additional parts in inventory or evaluation of equipment used to product. No physical containment – rationale: Additional part handling introduces more opportunity to scratch the parts. Normal processing and inspection mitigates this risk. Full containment: Machine fails all testing. Machine is on hold, impacted components on hold, shipments stopped, orders on hold, customer notified. When evaluating containment, the defect and impact needs to be understood and you need to know your parts. 10

11. Risk Analysis CAPA initiation is typically driven by risk. Risk Analysis reviews frequency and severity of the defect. Understanding what your defect is, how often it happens, and what it can impact is critical. Frequency - Consider actual occurrence rate and document calculation Timeframe (6 months, 3 shipments, 1 month) Lot information (provide lot numbers and quantities) Nonconforming rate ((# of failures / # of parts produced in time period) x 100) Compliance/Risk – Consider actual impact of failure For item specific events, if you do not know impact of nonconformance talk to your customer, consult manufacturing, engineering or quality as needed. For systemic issues, consult Quality Manager or Leadership Team. Frequency is typically easier to evaluate, Severity/Compliance requires an understanding of the defect and what it can impact. If you ever unsure – ASK for help! 11

12. Risk Analysis Examples Company ABC: Customer complaint for a broken e-stop button. Customer provided photos and defect is confirmed. Replacement sent and installed. Historical Review: There have been no other notification, stop flow, QDR or corrective actions initiated for breakage with the item. This is an isolated incident. Frequency could be assessed as Unlikely – less than 1% defect rate. Severity could be assessed as Major. Risk to finished machine, unable to take emergency action. However, customer contained machine and did not run. Therefore, there is no anticipated risk to operation or function of the machine. This evaluation determines no CAPA is indicated. Why: The defect rate is low, the machine was removed from service and button was replaced prior to use. The team needs to understand the defect, component/device functionality to determine the risk and be thoughtful about what can happen. 12

13. Risk Analysis Examples Company 123: Customer complaint for product jams. Customer provided video and defect is confirmed. Requires onsite repair and reconfiguration. Historical Review: There have been no notification, stop flow, QDR or corrective actions initiated for Customer 123. This is an isolated incident. It is possible, customer machine jams 50% of the time when used based on complaint detail. Frequency is assessed as Probable: Likely to occur – 45-75%. Severity is assessed as Critical: Requires intervention for correct machine functionality This evaluation indicates a Corrective Action is needed. There is a high frequency and severity of the defect. Why: The frequency rate is high. The machine is not able to function without intervention making the severity rate high. Knowing parts and processes allows for appropriate determination of risk and thoughtfulness about what can happen. 13

14. Risk Analysis Examples Supplier XYZ: Internal complaint for missing screws. PAUD provided photos and defect is confirmed. Two parts returned to supplier. Historical Review: There have been several stop flows, QDRs and RMAs for this supplier/part/defect. For this lot of 10 parts, 2 defects is 20% occurrence rate. Frequency could be assessed as Occasional: occurrences are possible 10% - 45%. Severity could be assessed as Negligible: No risk of personal injury; no impact on function of finished device. Screws can be replaced. This evaluation determines No CAPA indicated. Why: The defect rate is higher but there is no harmful risks and no risk to the machine leaving in that condition. Screws must be present for assembly. customer cannot assemble the component. This defect would not enter the field – again you need to know your parts to determine the risk and be thoughtful about what can happen. 14

15. Investigation Tools Investigation is important to understand the issues and identify potential root causes and improvements. Some of the best information comes directly from observation of the manufacturing process – including suppliers. Review lot inspection data, lot history records, any hold information and BOM docs for the lot. Additional information can be obtained from historical CAPAs, Quality Defect Reports, Stop Flow Forms, Quality Gates, Validations, Trainings, etc. Look for the ROOT CAUSE of the product nonconformance or problem. Use of multiple investigation tools may be needed to identify root cause and document the investigation. Set up a meeting with key people for your CAPA team – Manufacturing, Quality, Suppliers, Shipping, Customer Service, Associates, Engineers any one that could influence or impact the process. Get the right people involved and that have a vested interest in improvement of the non-conformance. Arriving at the true Root Cause will more likely result in a corrective action that will last and prevent recurrence of a problem. 15

16. Investigation Tools Define a clear problem statement. It will help scope the investigation. Focus on facts – what is wrong and what should it be. Teamwork and investigation tools like those listed below drive to resolution. 16 5 Whys 5W2H Fishbone Diagram Is / Is Not Flow Charts Failure Mode & Effects Analysis (FMEA) Pareto Chart Scatter Diagram Fault Tree Analysis 8D Problem Solving Affinity Diagram Brainstorming

17. Investigation Example - Fishbone 17

18. Investigation Example – 5W2H 18 Example: Problem: Explanation: What Issue (Describe the problem task, or project purpose) Where Location (Describe the location, place, machine/component involved) When Time (Find out the time, date, schedule when the situation took place) Who Responsible Person or Team (Involvement of people, external supplier, etc.) Why Root Cause (Know the reason behind the facts) How Actions (Method of implementation, deployment of correction/prevention) How Quantity (Number, Cost, etc.)

19. Investigation Example - Brainstorming 19

20. Investigation Example – 8D Problem Solving

21. Investigation Example – Is, Is Not

22. Root Cause Root Cause: The underlying reason for a nonconformity or nonconforming event. A thorough investigation will help direct to the correct root causes. The ultimate goal is to identify why the problem occurred. Effective root cause identification starts with a well defined problem statement and understanding the end goal. Also, keep in mind, not every cause has to be resolved. It is about risk of the nonconformance. Examples: Customer received 22 parts, item 6600 from lot 547 with molding defects. Why: The parts had a cosmetic defect in the inside diameter of the part. Why: Defect was caused during molding process of 6600-1182-000-MLD Why: Cold plastic resin pushed into the mold and hot plastic flowed over causing deformation inside the part. Why: The plastic was not fully melted creating a cold slug in the part. Cold slugs are an occasional defect in tool 3486 during injection molding. Why: Tool 3486 was not designed to have a cold slug well due to gate design.   Root Cause: No cold slug well 22

23. Action Plan and Approval Identify and create a plan that addresses the root cause, not symptoms. The plan needs to address the root cause – if it requires an investment from company or the customer it needs to be addressed. This doesn’t mean we do nothing or only propose low cost, easy to implement plans. It means we identify a plan to address the root cause. We work with our customer or internally to identify an agreed path forward. Implementing the wrong solutions is costly in time and money and doesn’t protect the customer or our business. Action plans need to be reviewed and should include department managers that plans impact. Plans should be approved by appropriate management level stakeholders. 23

24. Implementation & VOE Recommendation Once Plan approved – execute. Assign actions to CAPA team members and clearly define the timeline. At the time of implementation, a recommendation of Verification of Effectiveness (VOE) should be identified. This will help confirm corrective and preventive actions taken have worked. The VOE recommendation should be specific to the CAPA. It is not just 3 lots and done. Identify early detection points to monitor for recurrence/occurrence. Verification of effectiveness plan should consider: Frequency of runs and lot sizes Similar product that could be used to perform verification 24

25. Verification of Effectiveness Verifier will be assigned from within trained associate teams. When verifying you must include a thorough review of what you verified and evidence. What did you do specifically? How many lots, parts, etc. did you inspect? What did you inspect for? Attach evidence if appropriate Example verification of effectiveness: Performed a 2.5 AQL of lot 55678094 Vs Performed a 2.5 AQL inspection on part number 7743255-000 lot 55678094 for splay. Lot 55678094 produced 5000. 29 pcs were randomly selected and inspected. No scratches found. Parts are acceptable. CAPA is effective. 25

26. Verification of Effectiveness - Is it ineffective?? If you are performing a VOE and it seems ineffective Review CAPA to ensure you understand what you are verifying. Contact implementation team to verify you are performing the task correctly. If it is still ineffective, indicate ineffectiveness in CAPA. Document: What you looked at? What you found ? Explain the reason for being ineffective Notify Quality 26

27. Timeliness & Expectations Not all Quality Events, Corrections, CAPAs are the same. Timeliness equates to risk. The purpose of the Quality Event and CAPA system is to prevent nonconformance's from continued escape. CAPAs are a priority and all members of the CAPA team are required to support and drive to timely resolution. Be thoughtful but realistic with action items. When an extension is needed, it must be requested prior to overdue status. Accurately assess frequency and risk to ensure appropriate ranking. Perform each investigation with a TEAM! Know When to Get Help and Don’t be afraid to Ask! Use the provided tools as a guide to ensure you capture all steps. Document each Correction, CAPA and Preventative Action thoroughly, clearly, and with enough information that it can standalone during an audit without your support. THANK YOU! 27