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
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