Accuracy and repeatability in testing processes are vital in industrial product development and manufacture. The importance of advanced testing software in reaching these industry goals must not be undervalued; it aids in ensuring that products and materials adhere to relevant standards.
Image Credit: Mecmesin
This article explores the critical requirements for software that tests physical properties in the industrial and medical sectors. It focuses on using “artificial intelligence,” which should work with human users to deliver “real intelligence” in quality assurance testing.
Consistent quality is vital in the fast-moving field of manufacturing, where manufacturer’s reputations are built and maintained. The software that tests physical properties is the key to automating testing procedures. It maximizes results' repeatability, accuracy, and reproducibility to ensure product excellence.
Repeatability is the proximity of successive measurements when performed by one person or instrument on the same item and under the same conditions. Minimizing differences between the results of identical tests on the same sample is vital.
Reproducibility is the ability of a different person or instrument to replicate a test and obtain similar results. It describes measurements taken from one day to the next and can also be used in a business with multiple domestic or global sites. Reproducibility is vital in providing consistent quality to the end customer, regardless of the geographical point of manufacture.
Software-controlled universal testing machines are popular in the industry for performing mechanical strength tests for quality assurance. Investing in a single machine that can carry out multiple tests through software-controlled adjustments (with interchangeable fixtures) can be more cost-efficient than procuring numerous specialized testing machines.
Human Interaction
All stages of process automation require some human interaction. The software used in this integration of humans and machines is responsible for those processes where it is best fit. This remit must incorporate robust internal architecture and the core functionality that all software must deliver:
- Compatibility (data exchange and communication)
- Flexibility (futureproofing, scalability, and upgradeability)
- Maintainability (standard IT methodologies and protocols)
- Security (confidentiality, accountability, and integrity)
Software at the Forefront
Software’s functionality must enable the human user’s needs to achieve business objectives. Product-testing software must control and record whether test specimens comply with legislative standards or meet functional performance targets.
Implementing such a quality practice is a core aim, as is protecting a brand’s reputation and the safety of the end consumer.
Software UI intelligently connects to a compatible machine, guides the human operator through hardware configuration and specimen selection appropriate to the test, and then controls the test routine automatically. Image Credit: Mecmesin
Fully featured software directs and protects the user within the explicit purpose of their duties. A user interface that allows seamless interaction with the software, hardware, and network enables a human of any skill level to perform their role consistently.
Software designed for a force or torque tester should guarantee the appropriate machine is used, relevant accessory instrumentation is connected, recommended grips are fitted, and the appropriate test procedure is selected from an approved library. The objective should be a guided, error-free workflow, with the software facilitating high repeatability and reproducibility levels in the process.
Quick Start Guide
Human interaction with automated processes and software creates a synergy that improves efficiency and effectiveness.
The user’s role during testing is critically important and includes appropriate test selection, sample loading, and checks following the procedure to determine the process’s success.
The operator’s flexibility complements the software’s repetitive, rigid task performance. Humans and machines most closely interact during the software’s workflow guidance.
Once a test routine is established and programmed, an intuitive interface helps prevent errors and safety compromises and controls the machine in each operational step of the test.
Security for Users
Authorized administrator super users can build the operations required to perform the test’s procedural steps and author the calculations to determine appropriate results, shown here in a ‘drag-and-drop’ UI. Some software comes with industry-standard calculations, e.g., material properties or food texture profiling. Image Credit: Mecmesin
Role-based logins are a vital security measure integral to industrial software applications. Permissions associated with operators, administrators, and supervisors are managed like those on general office computer systems.
Networking and Active Directory functionality align the architecture with standard IT practices, making maintenance tasks well-established processes.
Enabling Accountability and Security
Employing software solutions internally to meet business needs makes up only part of certain industries' obligations.
The pharmaceutical and medical devices field is highly regulated, with stringent physical testing standards for most functional aspects of a product, from verifying the glide force of a syringe plunger to measuring the opening torque of a drug container closure.
The United States Federal Drug Agency (FDA) mandates adherence to its code of regulations before approval is granted for using drugs and medical devices.
Compliance is non-negotiable, with FDA 21 CFR Part 11 being one essential aspect of regulatory requirements. This specifically addresses electronic records and signatures stored as submissions to the FDA for regulatory approval.
As testing software contains electronic data often employed in the regulatory approval process, the software solution must allow for a robust and reliable audit trail.
Validating System Quality
FDA 21 CFR Part 11 addresses electronic signatures and audit trail implementation via software. The industries to which it is applicable are also regulated by FDA 21 CFR Part 820 - Quality System Regulation, or Current Good Manufacturing Practice for Medical Devices.
This provides a framework for the design, manufacture, packaging, labeling, installation, storage, and servicing requirements of medical devices. It establishes the quality system requirements that manufacturers must adhere to ensure their product’s safety and effectiveness.
Software OEM Services
Despite not being software-specific, companies validating FDA 21 CFR Part 820 via a qualification plan must implement their chosen software solution under this regulation. Integral elements of this regulation are the installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
OEMs can provide end customers with a service to ensure qualification standards regarding the supplied systems are met.
IQ is essential for confirming the correct installation of the testing system and its software and that these align with specified requirements. This involves thorough verification of hardware and software components, comprehensive documentation of installation procedures, and confirmation that the system is ready for operational use.
OQ focuses on validating the operational functions of the testing system and its software. This involves testing features and functionalities under various conditions to guarantee consistent and accurate performance.
PQ ensures the testing software consistently produces accurate and reliable results within its intended environment. Execution of test cases, detailed analysis of results, and comprehensive documentation all contribute to confirming the software’s overall performance.
Conclusions
Industrial and medical product testing software has become indispensable because it guarantees accuracy, repeatability, and reproducibility.
Testing software is becoming the cornerstone of manufacturing excellence by meeting stringent data security requirements and adhering to IQ, OQ, and PQ standards.
As industries evolve, investing in robust, user-friendly testing software is becoming strategically imperative for ensuring the delivery of high-quality and reliable products to consumers.
Acknowledgments
Produced from materials originally authored by Carl Bramley from PPT UK Ltd.
This information has been sourced, reviewed, and adapted from materials provided by Mecmesin.
For more information on this source, please visit Mecmesin.