SAMAPLAST & CAQ AG: Moving Step by Step Toward Business Excellence
SAMAPLAST AG, based in St. Margrethen, Switzerland, is a manufacturer of injection moulded medical parts and implants whose portfolio includes sterilisation and final packaging. The company has been developing technical precision parts and assemblies made of all types of plastic since 1960 and produces them, among other things, in three GMP-compliant ISO Class 7 and 8 clean rooms in accordance with EN ISO 14644. In addition to 3D printing, additive manufacturing, and prototypes in 10 days, all injection moulding tools are also manufactured in-house. When it comes to software-supported quality management, the company has been successfully relying on CAQ AG’s CAQ.Net software solutions since 2007.
SAMAPLAST’s medical products are in great demand, especially in the dental industry, but also in many other areas, e.g. for external fixations or medical instruments. Another field of activity of the company is the manufacture of a wide variety of implants, such as spinal vertebral prostheses as disc replacements, components for knee and hip implants, port catheters, or hearing implants. Supported by an experienced team, state-of-the-art development tools and precision tools from their own injection moulding department, SAMAPLAST has been realising the ideas and wishes of its customers quickly, flexibly, and with the highest quality standards for many years.
The international distribution of these products means that SAMAPLAST is confronted with many different standards and directives. The manufacture of its products is not only subject to various European directives (e.g. MDD 93/42/EEC and MDR 2017/745), but also to American (FDA 21 CFR Part 820/Part 11 and QSIT), Japanese (e.g. JPAL and J-GMP), Chinese CFDA, and Brazilian ANVISA regulations such as the GMP checklist RDC 16. Of course, the company is also subject to a large number of internationally harmonised standards such as ISO 13485, ISO 14971, ISO 11607, ISO 11137, ISO 10993, and IMDRF.
CAPA and More
The measures required by the various regulations range from the implementation of a quality management system and the practice of ISO 14971 compliant risk management to aspects of design and change control as well as production and process control (statistical process control, test equipment management, process / GAMP 5 software validation). In the sense of Good Documentation Practice (GDP) and the resulting specifications for traceability and document control, comprehensive documentation and traceability naturally also occupy an important place in everyday production. The continuous recording of complaints and implementation of improvements (CAPAs) as well as a far-reaching risk-based supplier management with regular quality audits round off the international regulation portfolio, which SAMAPLAST must comply with.
CAQ in Operation
In order to be able to meet the diverse demands regarding the manufacturing of their medical products, SAMAPLAST has been successfully using CAQ AG Factory Systems’ CAQ.Net® modular software solutions since 2007. The software has been supporting the company in fulfilling legal requirements and implementing them without gaps for over a decade now. Over the years, in close cooperation with CAQ AG, individual CAQ.Net® software modules have been further optimized to meet the needs of the company and valuable tips have been given regarding other software solutions necessary in the area of medical technology, such as training and qualification management, supplier management, or change management. During this cooperation SAMAPLAST provided key impulses in order to create a tool from practice for practice, with which compliance with the most diverse guidelines can be guaranteed. This helps SAMAPLAST to continuously improve itself and ensure safe products and thus safety for the patient.
Ishikawa-Diagrams and 5-Why Root Cause Analysis
Within the framework of its quality management, the company now, for example, uses the CAQ.Net® software module for complaint management which makes it possible to implement the 8D methodology. The module can be individually adapted to the company’s own processes through customizing. From within this module and virtually all other modules, improvements can be triggered and implemented in the form of CAPAs. Techniques such as the Ishikawa diagram or the 5-Why root cause analysis are fully integrated. The module for action and escalation management is also used as standard. It facilitates the timely implementation of corrective and preventive measures. With these means, two of the most frequently criticised topics in FDA Medical Device Warning Letters are solved in a simple, consistent, and compliant manner.
Risk Management in Accordance with ISO 14971
In order to meet the requirements of the legislators, consistent risk management is necessary. It allows normative matters to be implemented economically and according to the so-called risk-based approach - without leaving the legal framework. At SAMAPLAST, CAQ AG’s risk management module is used for the application of a wide range of risk management techniques such as ISO 14971 or VDA 86. It is consistently linked to the other modules and can be precisely adapted to a wide range of customers or situations by means of individual evaluation criteria.
GAMP 5 Software Validation
The requirements of Good Documentation Practice mentioned at the beginning of this article are implemented by means of CAQ AG’s document management module. This module not only enables complete documentation - it also includes electronic signatures and archiving in accordance with 21 CFR Part 11. In this context, the module AuditTrail.Net will also be used in the near future. It records all changes and entries made in the CAQ system.
For validated conformity to standards and proof of software functionality, SAMAPLAST has developed and implemented a risk-based validation concept that is based on GAMP 5. It makes revalidation easier and more economical.
Employee training and related qualifications naturally also play a role in certified environments. With CAQ AG’s training and qualification management module, SAMAPLAST ensures that the right employees with the necessary level of training are deployed where it is most effective. In addition, training and education needs can be monitored and planned and skills can be displayed in the form of a matrix. Bottlenecks due to a lack of qualified personnel are thus avoided. With the modules for audit management and KPI-management, SAMAPLAST can identify weaknesses and potential for improvement in internal processes and regarding customer requirements.
Gauge Management with PMM.Net
For production and process control, modules such gauge management with measurement systems analysis (MSA) are available at SAMAPLAST. In order to further improve processes, implementation of the module for initial sample inspection and inspection planning / quality inspection / SPC / LIMS is planned within the next few years. This will further deepen the connection between design and production. After implementation, the development process can thus be seamlessly mapped and controlled from risk analysis, document control, and initial sampling to inspection planning and control with process control as well as gauge management and improvement management.
Additive Manufacturing for Prototypes and Small Batch Series
In 2016, the concept "Prototypes in 10 days from hardened steel tools" laid the foundation for prototype production and additive manufacturing of prototypes and small batch series production. Additive Manufacturing (AM) as a "new" technology was implemented in 2018. For this purpose, investments were made in two ARBURG Freeformers (2k and 3k), in a KUMOVIS PEEK printer, and a GMP-compliant ISO Class 8 clean room. The goal of additive manufacturing, namely the production of products for very small series up to batch size 1, if possible also for medical devices and implants, has already been advanced with prototype projects such as implants made of FDA-approved PCU and resorbable materials such as polylactides or components made of two materials with special geometry. For example, a permanent implant for the spinal column area, which serves to stabilise in the event of a slipped disc, was constructed from an FDA-approved PCU (polycarbonate urethane) in the various degrees of hardness 90A, 80A, 55D, and 65D.
DIN SPEC 17071
A central aspect is AM production within the defined framework of a management system that guarantees certification in accordance with DIN SPEC 17071. The interfaces to medical production according to EN ISO 13485 must thereby be observed and transferred into a holistically functioning system. At SAMAPLAST AG this step is currently taking place and will be completed with certification according to DIN SPEC 17071 by the end of 2020. SAMAPLAST also greatly relies on the modular CAQ.Net® software solutions for measures concerning norm fulfilment, compliance with standards, and quality assurance in the area of additive manufacturing.
Moving Step by Step Toward Business Excellence
In summary, it can be said that the CAQ AG modules already implemented and planned at SAMAPLAST guarantee a complete and consistent implementation of legal requirements. They offer the possibility of implementing things in a risk-based manner and, in the sense of 5S and Lean Management, of implementing workflows and processes in a streamlined and thus economical manner. The individual CAQ.Net® modules provide the assurance that, in addition to well-trained employees, the basic requirements for guaranteeing product and patient safety are met. In this way, the company SAMAPLAST is moving step by step towards business excellence.