Abstract
A manufacturing plant in Tijuana focused on providing medical device solutions to improve the quality of life of patients. The company has developed thanks to its innovative products in the market considerably. As a business strategy at the corporate level, opportunities were detected and involved the transfer of the manufacturing of products to different facilities in Mexico. In order to manufacture a product that complies with standards to ensure the sterile barrier standards to ensure sterilization barrier of the product, this project consists of validating the Max Tray Sealer machine of the kit kat two production lines. The validations process covers all the quality system requirements governed under the ISO-13485 standards, which define the validation stages. The stages of the validation include the installation qualification, the operational qualification, and the performance qualification.
TopIntroduction
The case study company focuses on medical technology dedicated to offering superior medical device solutions to improve patients' quality of life. In recent years the company at the corporate level has developed thanks considerably to its innovative products in the market; as a business strategy at the corporate level, opportunities were detected that involved the transfer of the manufacturing of products to its different facilities in Mexico. Within these identified projects, the decision was to transfer to Mexico a particular line consisting of kit assembly projected to be functional for products from two sister plants in facilities A (Mexico) and B (United States). Based on a demand study for the different products projected to be assembled in the Mexican facilities, the corporate concluded it would be necessary to install two kitting lines in the Tijuana plant to cover the demand of both plants (A and B). This is how the manufacturing lines called kit kat one (kitting line one) and kit kat two (kitting line two) were created.
To manufacture a product that complies with standards to ensure the sterilization barrier of the product. This project consisted of validating the Aergo® 2 Max Tray Sealer machine of the kit kat line two production line. The validations of each process cover all the requirements of the quality system that is governed under the ISO-13485 standards, which define the stages of validation.
The first stage of the validation is the Installation Qualification (IQ), which consists of verifying that the equipment and tools are installed correctly, and the installations are adapted to the requirements of the machine, as well as the supplies it requires to operate, with the purpose that all the needs of the installation qualification are fulfilled satisfactorily, these results will be reflected in its respective report of results. It is a requirement of the validation procedures that, for each of the phases after the validation of the equipment necessary for production, a protocol must be created before executing any activity. This protocol must be approved by the functional group in charge of the validation. Once the OQ (Operational Qualification) protocols are ready, they can be executed, and results can be obtained, which will later be evaluated in their respective report. Once this phase is completed, the Performance Qualification (PQ) is started. The project ended after the successful performance qualification (PQ), demonstrating that the product is safe, complies with and represents the company's quality policy. It is worth mentioning that the product in this last phase is saleable once its respective report is approved.
The main problem to solve will be; the correct installation of the equipment to operate in high, low, and nominal parameters. The latter will be those used in normal production conditions. These are called engineering tests, performed as an experiment to delimit a gap of parameters that will be challenged in the design of experiments as part of the validation. For these tests can be taken as a reference the parameters that were present in the sealing machine of the component grouping line one by the same project department, as well as parameters recommended by the supplier of the machine, or parameters of similar machines in other plants of the corporate. Likewise, the assembly problems that could arise must be considered; despite being a non-complex assembly, part of the criteria that must be fulfilled involves the aesthetic appearance of the seal, minimum force of detachment of the seal, and uniformity of the sealing area.
The project's overall objective was to validate the sealing process on the Aergo® 2 Max Tray Sealer machine for the kit kat dos production line. The specific goals included:
- 1.
100% validation of the sealing process for the PMP, PARA, Small Peg, and Large Peg families.
- 2.
Find the preliminary parameters (engineering study for characterization) of operation in the equipment for the different trays to be sealed.
- 3.
Apply the design of experiments (DOE) methodology, detecting significant changes in the treatment means of the selected levels for a 22 factorial design.
- 4.
Challenge the parameters established by the DOE methodology employing Operational Qualification to determine that the functionality of the equipment is consistent.
- 5.
Meet the quality system criteria for attribute testing in products free of contamination, dents, scratches, ink test (no presence of channels).
- 6.
Meet quality system criteria for testing by variables, requirement more remarkable than 1 lb/force.
- 7.
Comply 100% with quality system acceptance criteria.
Key Terms in this Chapter
OQ (Operational Qualification): It consists of testing equipment in the field in order to check if it is able to provide all the performances declared by the manufacturer (and approved by the structure) within the specified limits and under the expected operating conditions for the considered process. The test includes the execution of tests (according to pre-established protocols) whose criteria and acceptability limits must be clearly defined.
ISO 13485: It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements (ISO 13485).
Validation Process: Validation is an essential part of good manufacturing practices (GMP), which makes it an important element in the quality assurance of processes, whose purpose is to verify that the manufacture of products complies with the established requirements, i.e.: the product must meet the requirements of quality, safety, and efficacy.
Acceptable Quality Level (AQL): It represents the maximum number of defective units, beyond which a batch is rejected. Importers usually set different AQLs for critical, major, and minor defects. Most Asian exporters are familiar with this type of setting (ISO 2859-1).
IQ (Installation Qualification): It verifies the proper installation and configuration of a system. This may include ensuring that the necessary files have been uploaded, equipment has been installed, power supplies (whether air, power, software, internet, etc.) have been installed, necessary procedures have been approved, or appropriate personnel have been trained. The requirements to properly install the system were defined in the design specification. Installation qualification must be performed prior to completing the operational qualification or performance qualification.
DoE (Design of Experiments): DOE is defined as a branch of applied statistics that deals with planning, conducting, analyzing, and interpreting controlled tests to evaluate the factors that control the value of a parameter or group of parameters. DOE is a powerful data collection and analysis tool that can be used in a variety of experimental situations (ASQ, 2021).
PDCA: The Plan-do-check-act cycle is a four-step model for carrying out change. Just as a circle has no end, the PDCA cycle should be repeated again and again for continuous improvement. The PDCA cycle is considered a project planning tool (ASQ, 2021).
PQ (Performance Qualification): It is a collection of test cases used to verify that a system performs as expected under simulated real-world conditions. The performance qualification test requirements defined in the user requirements specification (or possibly in the functional requirements specification).