Download - 5A CAPA Best Practices (I)(MQ1)
| A Division of QAD | #simplifyCEBOS
CAPA Best Practices
Michael Mallen – Professional Services Consultant, CEBOS
How to get the most out of MQ1 Problem Solver Module
| A Division of QAD | #simplifyCEBOS 2
The following is intended to outline CEBOS general product direction. It is intended for information purposes only, and may not be incorporated into any contract. It is not a commitment to deliver any material, code, functional capabilities, and should not be relied upon in making purchasing decisions. The development, release, and timing of any features or functional capabilities described for CEBOS products remains at the sole discretion of CEBOS.
Safe Harbor StatementCAPA Best Practices
| A Division of QAD | #simplifyCEBOS 3
Session Objectives Definitions Compliance Standards CAPA High-Level Process Flow and Best Practice Use of Defect Logs/Cost Logs,
Receiving/Production and Shipping Logs Views and Task Management Q&A Survey Next Steps
AgendaCAPA Best Practices
| A Division of QAD | #simplifyCEBOS 4
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
ObjectivesCAPA Best Practices
| A Division of QAD | #simplifyCEBOS
Definitions and StandardsCAPA Best Practices
| A Division of QAD | #simplifyCEBOS 6
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 non-
conformance (actions, product, shipping
DefinitionsCAPA Best Practices
| A Division of QAD | #simplifyCEBOS 7
ISO 9001 8.5.2 Corrective action 8.5.3 Preventive action
TS16949 8.5.2 Corrective action 8.5.3 Preventive action
ISO 14001 4.5.3 Nonconformity, corrective action, and preventive action
ISO 13485 8.5.2 Corrective action 8.5.3 Preventive action
21CFR 820 Subpart J - Corrective and preventive action 820. 100 - Corrective and
preventive action OHSAS 18001
4.5.3.2 Nonconformity, corrective action, and preventive action
StandardsCAPA Best Practices
| A Division of QAD | #simplifyCEBOS
Basic Setup and Best PracticesCAPA Best Practices
| A Division of QAD | #simplifyCEBOS 9
CAPA High Level Process Flow
Task GroupsLibrary Tasks CPR Templates
CPR Tasks
Cost Log
Analysis
Deviation
Alert
Containment
CPRs
Issues
Quality Bulletins
Logs
Production Log
Receiving Items Log
Defect Log
Shipping Log
Cost Log
Checklist
Defect Log
ReceivingItems Log
Production LogShipping Log
Internal PPM Supplier PPMCustomer PPM
| A Division of QAD | #simplifyCEBOS 10
Best PracticesCAPA 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
Use of Defect Logs/Cost Logs, Receiving/Production and Shipping Logs
CAPA Best Practices
| A Division of QAD | #simplifyCEBOS 12
Defect LogsCAPA Best Practices
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 13
Defect LogsCAPA Best Practices
| A Division of QAD | #simplifyCEBOS 14
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)
Cost LogsCAPA Best Practices
| A Division of QAD | #simplifyCEBOS 15
Cost LogsCAPA Best Practices
| A Division of QAD | #simplifyCEBOS 16
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
Receiving/Production/Shipping LogsCAPA Best Practices
| A Division of QAD | #simplifyCEBOS
Action Manager and Task Management
CAPA Best Practices
| A Division of QAD | #simplifyCEBOS 18
Second highest number of action manager options in MQ1
Select items that are suitable for your organization
Action ManagersCAPA Best Practices
| A Division of QAD | #simplifyCEBOS 19
Use Filters to help manage tasks and meetingsViews and Managing TasksCAPA Best Practices
| A Division of QAD | #simplifyCEBOS
Product DemoCAPA Best Practices
| A Division of QAD | #simplifyCEBOS 21
Michael Mallen: [email protected] & AnswersCAPA Best Practices
| A Division of QAD | #simplifyCEBOS 22
Survey
Please visit http://goo.gl/jO5CiY
or
Scan the appropriate QR code on your badge to complete the session survey
CAPA Best Practices
| A Division of QAD | #simplifyCEBOS 23
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
Next StepsCAPA Best Practices