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CAPA Best Practices

Michael Mallen – Professional Services Consultant, CEBOS

How to get the most out of MQ1 Problem Solver Module

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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

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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

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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

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Definitions and StandardsCAPA Best Practices

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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

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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

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Basic Setup and Best PracticesCAPA Best Practices

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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

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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

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Use of Defect Logs/Cost Logs, Receiving/Production and Shipping Logs

CAPA Best Practices

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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

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Defect LogsCAPA Best Practices

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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

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Cost LogsCAPA Best Practices

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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

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Action Manager and Task Management

CAPA Best Practices

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Second highest number of action manager options in MQ1

Select items that are suitable for your organization

Action ManagersCAPA Best Practices

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Use Filters to help manage tasks and meetingsViews and Managing TasksCAPA Best Practices

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Product DemoCAPA Best Practices

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Michael Mallen: mqq@QAD.comQuestions & AnswersCAPA Best Practices

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Survey

Please visit http://goo.gl/jO5CiY

or

Scan the appropriate QR code on your badge to complete the session survey

CAPA Best Practices

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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

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