corrective & preventive action (capa) with lighthouse ... · with lighthouse instrument purnomo...

Corrective & Preventive Action

(CAPA)

with LIGHTHOUSE Instrument

Purnomo P NegoroSales Manager

Purpose of the Corrective and Preventive

Action Subsystem

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• To collect and analyze information to identify actual and potential product and quality problems

• To investigate product and quality problems and take appropriate and effective corrective or preventive action

• To verify or validate the effectiveness of corrective and preventive actions

• To communicate corrective and preventive actionsto the appropriate people

• To provide information for management review

• To document activities

Definition: Correction

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“Correction” action to eliminate a detected nonconformity.

1. A correction can be made in conjunction with a corrective action.

2. A correction can be, for example, rework or regrade

ISO 9000:2005(E)

Definition: Corrective Action

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“Corrective action” action to eliminate the cause of a detected non-conformity or other undesirable situation.

1. There can be more than one cause for a nonconformity.

2. Corrective action is taken to prevent recurrence.

3. There is a difference between correction and corrective action.

ISO 9000:2005(E)

Definition: Preventive Action

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“Preventive action” action to eliminate the cause of a potential non-conformity or other undesirable situation

1. There can be more than one cause for a potential nonconformity.

2. Preventive action is taken to prevent occurrence.

ISO 9000:2005(E)

Where to Start? Planning

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Plans should include…

I. Establishing Data Sources and Criteria

II. Measuring and Analysis of Data Sources

III. Improvement Plans

IV. IV. Input to Management

Establishing Data Sources

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Data Analysis

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Analyze processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems.

21 CFR 820.100(a)(1)

Investigate to Determine Root Cause

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Investigate the cause of nonconformities relating to product, processes, and the quality system

21 CFR 820.100(a)(2)

Lighthouse Family of Products

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ApexZ

• Each data record contains diagnostic information about the sensor• Dirty Sensor

• Laser Failure

• Photo Detector Failure

• Flow Errors

• Helps ensure compliance between calibrations

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SelfDiagnostics

DataIntegrity

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User names

User passwords

Location names

Recipes

Room names

Reports

FleetManagement

DataCollection

Build Save and Send Complete Instrument Configurations that include….

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AuditTrail▪ Tracks all changes and

operations within the unit. • Who is logged in

• What changes where made

• What time the changes where made

▪ The audit trail can be exported and saved for future reference.

▪ Storage of 20,000 messages

DataCollection

▪ Administrator• Can Create new users

• Can access Configuration

• Full use of the Instrument operation and sample settings

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UserLevels

DataCollection

▪ Power User• Full use of the Instrument

operation and sample settings

▪ Operator• Full use of instrument pre-configured

recipes and sample settings

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ActiveCount100H

ISO 14698

Compliant

HEPA Filtered

Exhaust

Continuous/Periodic

Sampling

Removable

Petri Dish Holder

Remote/Gas

Sampling Options

Suitable for

Aseptic Conditions

Ease of Use: Security

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Security Password Entry

▪ A Password can be

set for gaining

access to the

sample settings

menu

▪ Password can be

up to 16 characters

AC100H only

Ease of Use: Sample Log

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▪ Storage of unlimited records

with USB key plugged in.

▪ Information Stored:

• Date

• Time

• Location

• User

• Sample Duration

• Sample Volume

• Cycles

• Instrument Status

Sample Log

Ease of Use: Status Screens

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▪ The AC100H will automatically notify the user

when a sample is complete, aborted,

insufficient flow or insufficient battery life to

complete a sample.

Liquid Particle Counter and Sampler: LS-20

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Designed for 21 CFR Part 11 Compliance

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Unique User Log-in

Automatic Log-Out

Password Aging

Login Attempts

User Management

Rights

Permissions

User Configuration

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User Management

Rights Level

User Groups

Rights for Groups of

Users

Apex Remote for Monitoring System

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Local Display

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• Integrated Display

• Real Time Results

• Data Displayed

• Last Recorded Value

• Date/Time

• IP Address

• Location ID

Integrated Web Browser

Access Real Time Data Locally or Anywhere in the Building

• IPHONE

• IPAD

• ANDROID

• Windows Tablet

• View Current Data

• View 5 Previous Samples

• View Flow Status

• View Date and Time

• Serial #

• Model #

• Location ID

Integrated Web Browser: Data View

Integrated Web Browser: Data View

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• Calibration Date

• Laser Current

• Laser Power

• Laser Supply

• Flow

• Photo-detection Analyzer

Power Supply

• PA Health

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ThankYou