Two E-Signature For Gage Calibration

Overview

In regulated manufacturing environments, gage calibration requires rigorous documentation and approval controls to ensure measurement system integrity and regulatory compliance. The 1factory system implements a dual electronic signature requirement for gage calibration activities, providing enhanced accountability and traceability in accordance with FDA 21 CFR Part 11, ISO 13485, AS9100, and IATF 16949 standards.

The dual signature requirement serves critical quality and compliance functions by establishing a clear separation of duties between calibration execution and independent verification. This two-person control mechanism prevents unauthorized changes to calibration records and ensures that all measurement equipment released for production use has been properly validated by qualified personnel.

Dual Signature Roles and Responsibilities

First Signature - Calibration Performer
The technician or metrologist who physically performs the calibration procedure signs to verify that:

• Calibration was performed according to approved procedures
• All measurements were taken accurately using traceable equipment
• Equipment used was traceable to national standards (NIST or equivalent)
• Results are recorded truthfully and completely

Second Signature - Calibration Reviewer
A qualified second party (typically a supervisor or quality engineer) signs to verify that:

• Calibration data has been reviewed and is acceptable
• Results meet defined acceptance criteria
• Documentation is complete and accurate
• The gage is suitable for return to service

Important Note: To utilize the dual electronic signature capability for your calibration process, your organization must first enable the E-Signatures feature and configure the Gage setting for "Two E-Signatures for calibration" to YES.

Configuration Setup

Configure Gage Setting for Two E-Signatures

1. Click the dropdown menu in the top right corner to access your profile settings
2. Navigate to the Gage Settings section
3. Locate the "Two E-Signatures for calibration" parameter
4. Use the dropdown menu to select Yes
5. Click the Save button to apply the configuration

This setting ensures that all subsequent calibration activities will require both performer and reviewer signatures before completion.

Conducting Gage Calibration with Dual E-Signatures

Step 1: Navigate to the Gages Module

1. From the main dashboard, click the Gages tab
2. Select the Gages tile to access the gage management interface

Step 2: Record First Signature - Calibration Performance

The calibration performer completes the physical calibration and provides the first electronic signature:

1. On the Gages main page, either:
   • Open an existing gage record that requires calibration, or
   • Create a new gage record if needed
2. Navigate to the Calibration tab
3. Click the Add Calibration button to initiate a new calibration record
4. Enter all required calibration data, including:
   • Calibration date and time
   • Cal Type
   • Vendor
   • Calibration data
   • Cal. Freq. Unit
   • Cal. Freq
   • Action taken
   • Label Note,
   • Notes
   • Attachments
5. In the E-Signature field, enter your password to authenticate
6. Click the Save button to complete the first signature

Step 3: Record Second E-Signature - Calibration Reviewer

An independent reviewer provides the second electronic signature to approve the calibration:

1. In the Calibration tab, locate the calibration record requiring review
2. Click in the Review column for the corresponding calibration entry
3. The system will navigate to the Manage Calibration interface
4. Scroll down to the bottom of the page where the second signature field is located
5. Review all calibration data for accuracy and compliance
6. In the E-Signature field, enter your password to authenticate the review
7. Click the Save button to complete the dual signature process

Critical Compliance Note: The second signature must be performed by a different user than the calibration performer. This separation of duties is essential for maintaining regulatory compliance and ensuring independent verification of calibration activities. Using the same person for both signatures violates the intent of the dual signature requirement and may result in audit findings or the system deny in service.

Step 4: Download Calibration Certificate with Signature Proof

Once both electronic signatures are complete, generate official calibration documentation:

1. Navigate to the Calibration tab for the gage
2. Locate the calibration record with completed dual signatures
3. Click the Certification icon to generate the calibration certificate
4. The system will generate and download the certificate in Excel format

Certificate Verification:

 Open the downloaded calibration certificate to verify that it contains documented proof of both signatures:

• First Signature - Calibration Performance: Shows the name, date, and timestamp of the technician who performed the calibration
• Second E-Signature - Calibration Reviewer: Shows the name, date, and timestamp of the quality professional who reviewed and approved the calibration

This certificate serves as official documentation of the calibration activity and provides complete traceability for regulatory audits and quality system requirements. The dual signatures ensure that measurement equipment has been properly validated and approved before being returned to production use.