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CAPA Best Practices

How to get the most out of MQ1 Problem Solver
Module
Michael Mallen – Professional Services Consultant,
CEBOS

| A Division of QAD | #simplifyCEBOS

CAPA Best Practices

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Receiving/Production and Shipping Logs Views and Task Management Q&A Survey Next Steps | A Division of QAD | #simplifyCEBOS 3 .CAPA Best Practices Agenda          Session Objectives Definitions Compliance Standards CAPA High-Level Process Flow and Best Practice Use of Defect Logs/Cost Logs.

CAPA Best Practices Objectives Understand CAPA setup and best practices Learn how to log and view defects Learn how to launch CPRs from defect logs Lean how to log costs Learn how to best communicate items to your team  Learn how to set up views to aid in task management      | A Division of QAD | #simplifyCEBOS 4 .

CAPA Best Practices Definitions and Standards | A Division of QAD | #simplifyCEBOS .

shipping | A Division of QAD | #simplifyCEBOS 6 .CAPA Best Practices Definitions  CPR –Configurable Problem Report  Library Task – A predefined step or action  Task Group – the ability to group tasks together with sequence and dependencies  FMEA Lookup Wizard – Link the CPR to an FMEA item  Defect Log – a record of a nonconformance  Cost Log – a record of a cost related to the nonconformance (actions. product.

2 Corrective action  8. and preventive action  ISO 13485  8.2 Nonconformity.3 Preventive action  ISO 14001  4.5.CAPA Best Practices Standards  ISO 9001  8.3 Preventive action  21CFR 820  Subpart J .5.3 Nonconformity.Corrective and preventive action 820. 100 .5.5.5.3.5.2 Corrective action  8. corrective action. corrective action. and preventive action | A Division of QAD | #simplifyCEBOS 7 .Corrective and preventive action  OHSAS 18001  4.2 Corrective action  8.3 Preventive action  TS16949  8.5.5.

CAPA Best Practices Basic Setup and Best Practices | A Division of QAD | #simplifyCEBOS .

CAPA High Level Process Flow CPR Tasks Library Tasks Task Groups CPR Templates CPRs Cost Log Analysis Checklist Issues Deviation Quality Bulletins Defect Log Alert Containment Production Shipping Log Log Customer PPM Shipping Log Receiving Items Log Internal PPM Supplier PPM Production Log Logs Receiving Items Log Defect Log Cost Log | A Division of QAD | #simplifyCEBOS 9 .

CAPA Best Practices Best Practices  Predefine Symptom Codes and related categories  Keep it simple – Try to use as few Library tasks as possible and use task groups and templates to manage CPR types  Use roles to assign tasks | A Division of QAD | #simplifyCEBOS 10 .

CAPA Best Practices Use of Defect Logs/Cost Logs. Receiving/Production and Shipping Logs | A Division of QAD | #simplifyCEBOS .

CAPA Best Practices Defect Logs  Ability to log items by:  Type  Severity  Defect Quantity / PPM Quantity  Symptom  Can link to a cause  Can have disposition assigned  Can link to customers/suppliers/part numbers and trace numbers | A Division of QAD | #simplifyCEBOS 12 .

CAPA Best Practices Defect Logs | A Division of QAD | #simplifyCEBOS 13 .

CAPA Best Practices Cost Logs  Ability to log items by:  Resource (employee/Gage)  Account (for COQ)  Description  Company  Part Number  CPR  CPR Task  Department  Supplier  Supplier Goods  Budget (If linked to a CPR with Budget assigned) | A Division of QAD | #simplifyCEBOS 14 .

CAPA Best Practices Cost Logs | A Division of QAD | #simplifyCEBOS 15 .

CAPA Best Practices Receiving/Production/Shipping Logs  Ability to log Receiving information  Can calculate supplier PPM based on defect QTY and receipts information  Note: Requires supplier management or eSync  Ability to Production log  Can calculate Internal PPM based on defect QTY and production information  Note: Can be manually entered or by eSync  Ability to Log Shipping  Can calculate organizations PPM performance based on defect QTY and QTY of items shipped  Note: can be manually entered or by eSync | A Division of QAD | #simplifyCEBOS 16 .

CAPA Best Practices Action Manager and Task Management | A Division of QAD | #simplifyCEBOS .

CAPA Best Practices Action Managers  Second highest number of action manager options in MQ1  Select items that are suitable for your organization | A Division of QAD | #simplifyCEBOS 18 .

CAPA Best Practices Views and Managing Tasks  Use Filters to help manage tasks and meetings | A Division of QAD | #simplifyCEBOS 19 .

CAPA Best Practices Product Demo | A Division of QAD | #simplifyCEBOS .

CAPA Best Practices Questions & Answers  Michael Mallen: mqq@QAD.com | A Division of QAD | #simplifyCEBOS 21 .

gl/jO5CiY or Scan the appropriate QR code on your badge to complete the session survey | A Division of QAD | #simplifyCEBOS 22 .CAPA Best Practices Survey Please visit http://goo.

CAPA Best Practices Next Steps  Attend these related sessions:  Problem Solver 201  Friday 9:15AM to 10:15AM Ballroom A  Stop by the Open Lab sessions In Salon F  Thursday 1:15PM to 2:15PM  Thursday 2: 30PM to 3:30PM  Thursday 4:00 PM to 5:00PM  Friday 9:15 AM to 10:15 AM | A Division of QAD | #simplifyCEBOS 23 .

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