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Continued Process Verification Plan for the Heat

ABC Company Sealing Process using Tyvek Lids and Number/Rev: CPV001
Thermoform Trays Effective Date: See ECO 14-032

1. Purpose
1.1 This procedure defines the continued process verification activities and requirements for
the Heat Sealing Process using Tyvek Lids and Thermoform Trays at ABC Company.

2. Scope
2.1 The scope of this procedure is to describe the following continued process verification
activities and requirements for the Heat Sealing Process using Thermoform Tyvek Lids at
ABC Company.

2.1.1 Sampling of the Process

2.1.2 Process Variables, Testing of the Process, and Test Specifications

2.1.3 Statistical Methods Used for Data Analysis

2.1.4 Data Analysis Review

2.1.5 Reporting of the Continued Process Verification

.
3. Definitions
3.1 Cp Estimates what the process is capable of producing if the process mean were to be
centered between the specification limits. Assumes process output is approximately
normally distributed.

3.2 Cpk Estimates what the process is capable of producing, considering that the process
mean may not be centered between the specification limits. (If the process mean is not
centered, overestimates process capability.) if the process mean falls
outside of the specification limits. Assumes process output is approximately normally
distributed.

3.3 p-Chart Percentage Non-conforming Chart

4. Responsibilities
4.1 Quality Control Department is responsible for the following activities:

Performing the Inspection of the Heat Sealed Trays for each production lot
Logging the data into the database for the analysis

4.2 Manufacturing Engineering is responsible for the following activities:

Performing Data Analysis of the Heat Sealing Process using Thermoform Tyvek
Lids at ABC Company
Writing and approving the Continued Process Verification Plan and Report
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Continued Process Verification Plan for the Heat
ABC Company Sealing Process using Tyvek Lids and Number/Rev: CPV001
Thermoform Trays Effective Date: See ECO 14-032

4.3 Quality Assurance is responsible for the following activities:

Reviewing the Data Analysis of the Heat Sealing Process using Thermoform Tyvek
Lids at ABC Company
Writing and approving the Continued Process Verification Plan and Report

5. Procedure

5.1 Sampling of the Process

5.1.1 The sampling for this process will be the first and last part of the production run
and single part in the middle of the run. Hence, three parts will be tested for each
production run for the continued process verification.

5.2 Process Variables, Testing of the Process, and Test Specifications

5.2.1 The process variables for the Heat Sealing Process using Tyvek Lids and
Thermoform Trays is the following variables listed below:

Process Inputs Process Outputs

Sealing Pressure Tensile Strength (lbs. Force) of Seal
Sealing Temperature Seal Integrity
Sealing Time

5.2.2 The Testing of the Process and Test Specifications for the Heat Sealing Process
using Tyvek Lids and Thermoform Trays is the following tests and methods listed
below:

Sealing Tests Test Methods Test Specifications

Seal Strength SOP 7.5 2.50 lbs. < Sample > 5.00 lbs.
Dye Penetration SOP 9.3 No leaks

5.3 Statistical Methods Used for Data Analysis

5.3.1 The statistical methods used for the data analysis of the Heat Sealing Process
using Tyvek Lids and Thermoform Trays will be the Process Capability Ratios (Cp
and Cpk) for the seal strength and a p-Chart for the dye penetration.

5.3.2 Cp and Cpk values should be <1.33 for the seal strength and there should be a
limited number of failures for the dye penetration (less than 0.5% failures).

5.4 Data Analysis Review

5.4.1 The data analysis will be performed for the Heat Sealing Process using Tyvek
Lids and Thermoform Trays on a monthly basis.
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Continued Process Verification Plan for the Heat
ABC Company Sealing Process using Tyvek Lids and Number/Rev: CPV001
Thermoform Trays Effective Date: See ECO 14-032

5.5 Reporting of the Continued Process Verification

5.5.1 A report will be written each month, documenting the data analysis and results of
the Heat Sealing Process using Tyvek Lids and Thermoform Trays.

6. References
6.1 Controlled Documents

VP10-098 Validation Protocol and Report for the Heat Sealing Process using Tyvek Lids
and Thermoform Trays

6.2 Reference Procedure

QMS18
SOP 7.5
SOP 9.3

6.3 Reference Literature

Process Validation Guidance for Medical Device Manufacturers, Global Harmonization

Task Force
Guidance for Industry Process Validation: General Principles and Practices
Code of Federal Regulations 21 CFR 820