Equipment validation refers to a series of independent procedures used to verify if a product meets the specifications and requirements for its intended purpose. Global regulatory bodies have stringent standards for quality, performance testing, safety checks, and other areas, covering a vast range of products.
Why Equipment Validation Matters for Your Product Quality and Compliance
Minor inaccuracies in precision instruments, lab equipment or specialized machinery can cause major issues and result in incomplete or inaccurate outcomes. Equipment validation guarantees that your product performs consistently within a specific range. For most consumers, quality management system certification, such as International Organization for Standardization (ISO), is an essential factor in their purchasing decision. Therefore, an inadequate equipment validation system can jeopardize your adherence to industry standards, as well as your certifications and compliances.
Validation Process Checklist
Here are some of the protocols that need to be kept in mind for successful equipment validation:
Documentation Availability
Ensure that all required documentation such as electrical schematics, mechanical and instrument drawings, spare parts lists, and utility and supply ratings are verified and available.
Component and Design Verification
Verify the design of the equipment and its components in accordance with specifications and verification norms.
Electrical Connections and Supply
Thoroughly check all electrical connections and power supply to the equipment before starting the validation process.
Utility Supply
Verify the quality of hydraulic, pneumatic, and other input supplies and connections and check for leaks.
Safety Compliance
Test safety checks, ensure noise levels are within applicable standards, and check electrical connections and fail-safes. Wiring should be checked for leaks, and radiation and interference levels should be within acceptable limits.
Critical Instrument Calibration
Calibrate any sensors or monitoring instruments appropriately. Ensure the accuracy of primary monitoring instruments and controls within the limits of traceable standards and resolution within the required range.
Environmental Verification
Check instruments for operation in various environments, including testing within the required ranges of temperature, humidity, light, electrostatic discharge isolation, and other conditions.
Standard Operating Procedures
Ensure that SOPs for various procedures such as cleaning, periodic maintenance, software configuration, disaster recovery, etc. are available.
Instrumentation for Validation
List and verify the instruments used to validate the installation qualification, and ensure they are within the due date for re-calibration.
These protocols provide a solid foundation for any validation process. Depending on the specific industry the instruments are built for and the unique requirements of the validation, additional aspects may need to be taken into account.
Validating Instruments: The Five Categories of Qualification
Instrument validation begins with a validation master plan that defines the steps in each process. Traditionally, these steps can be categorized into 5 separate qualification categories:
1. Design Qualification (DQ)
The first step is to demonstrate whether the proposed design of the instrument can cope with the functional requirements of the end user. A proposed design must satisfy the DQ before construction and procurement of parts.
2. Installation Qualification (IQ)
The instrument, with all its components and documentation, is placed correctly and checked for performance according to the requirements.
3. Operational Qualification (OQ)
All the major parts of the instrument are tested to ensure they all perform correctly and are in sync with the entire system.
4. Performance Qualification (PQ)
The instrument is monitored over a period of time to check if it consistently delivers results within the required parameters.
5. Component Qualification (CQ)
Auxiliary components and parts that are sourced from a third-party manufacturer are periodically subjected to random tests for quality and performance to ensure they are manufactured to the right specifications and won’t hamper the performance of the instrument.
Benefits of Equipment Validation Services for Your Business
Creating a calibrationprocess that encompasses all the requirements can be time-consuming and cumbersome. Validation services can help you save both time and money by streamlining your validation procedures. Let’s look at the detailed benefits of validation services below:
Your validation and quality checking processes may contain unnecessary tests and procedures that can extend your delivery time and consume valuable labor resources. A validation service that can enhance the validation lifecycle by streamlining the necessary steps and evaluations.
Purchasing equipment for validating products can be expensive, and so can hiring experienced and qualified staff to manage the validation process. A validation service can offset costs without compromising the end results.
Equipment validation services can provide independent verification and documentation of your system’s performance, while experienced validation services can conduct routine checks to further improve your process and avoid lapses in quality.
Although it may seem like an extensive and time-consuming process, validating your products is an essential step. By ensuring that your products meet industry requirements and perform consistently, the value of both your brand and product will increase significantly. And who doesn’t love that?
