“Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution; it represents the wise choice of many alternatives.” William A. Foster
Quality and Quality Management Systems are perhaps two of the most widely written about topics in manufacturing, yet the way in which quality is perceived, monitored, controlled and documented varies drastically across industries and countries. Acronyms like SPC, GMP, ISO and FDA are frequently referenced and quite rightly; they do have a great importance when it comes to quality, but the way in which SPC or statistical process control is used in the food industry might be completely different from that used in electronics. Similarly, the FDA impacts the food, beverage, drug and medical device sectors, but its regulations of product safety do not reach into the automotive sector.
Good Manufacturing Practices or GMP varies by industry and what is a norm in one industry might be unattainable in another. It depends on the process and its inherent complexity, which then impacts what is considered good as a manufacturing practice itself.
Lastly standards, rules and guidelines exist in each industry. ISO guidelines can be considered generic, focused on process and product improvement, but there are specific rules for each industry and additional guidelines which may range from environmental regulations to HR/Labor/workforce-based oversight.
It is amazing how quality of a product and the way in which the manufacturing process ensures that desired quality is achieved can range from a relatively straightforward activity to a highly complex one, which requires top of the line IT applications, data analytics, automated actions and record/documentation creation. Manufacturing of any product involves either processing or assembling of raw materials or parts to deliver a final product.
Depending on the way the product is used and its impact on potential users, regulations and guidelines are put in place to achieve a minimum quality requirement which would deem the product acceptable. However, anyone who has ever set foot in a manufacturing plant would realize that quality today, in the age of Industry 4.0, goes far beyond delivering product that merely reaches ‘acceptable product’ levels. It is all pervasive, covering not only the primary manufacturer but their extended supply chain partners, and the products even after being delivered to the end customer, are monitored and reported for quality and performance.
Quality in Automotive
In one of our posts we explored the regulations which exist in the automotive industry. A large part of the overall industry value exists within the industry’s extended supply chain. In such a market where a single vehicle might have up to 30,000 individual parts, the quality oversight needed right from the manufacture and supply of individual parts to that of second or first tier sub-assembly’s suppliers might seem like a daunting task, which quite frankly it is. Since any car being manufactured by any OEM would most likely have parts manufactured by hundreds of suppliers, unless clear guidelines and rules exist with strict conformance norms, it would become impossible to ensure the final product (the vehicle itself) can perform as designed.
Clearly, having a state-of-the-art QMS (Quality Management System) at the OEM’s plant while having no visibility of what is happening in the lower tiers of the supply chain would not work in the automotive industry. The quality challenge in the automotive industry is not just monitoring your own process, but ensuring that your supply chain partners’ products qualify and meet industry-established quality expectations. The whole value chain must be monitored and controlled, with real-time visibility across the chain.
Most important is the ability to detect issues, collaborate and find solutions which maintain the product/process integrity and conserve the value across the value chain. Even in cases of quality events which lead to failures, systems need to be put in place to avoid at all costs expensive and brand-damaging product recalls. The need changes from continuous improvement to continuous evolution and this is where MES and Industry 4.0 smart manufacturing play a major role.
Quality in MedTech
In the MedTech industry, the FDA is recognized as one of the leading governing bodies. It is responsible for setting up policies, guidelines and regulations for safe manufacturing practices. The FDA’s oversight ensures manufacturers across regulated industries (food, pharmaceutical and medical device) adhere to these policies.
The FDA is now changing its focus from final product’s quality assurance to a more holistic and process verification approach, where quality is built into the product and the processes. This is referred to as the FDA’s case for Quality Initiative. The program in part is designed to identify successful manufacturing practices to help other device manufacturers raise their manufacturing quality level. This shift in the FDA’s focus impacts the way in which industry leaders perceive the role of Quality within their organizations—to use industry ‘best practices’ as a tool to improve the final product and the process involved.
The FDA’s guidelines which govern MedTech and define their GMP (Good Manufacturing Practices) have laid out in detail the need to maintain detailed records right from design to testing of a product, and records related to the device’s manufacturing history. These guidelines have been instrumental in shaping both how quality is managed and what the industry leaders’ perception of what quality is, and how it needs to be managed.
As the FDA’s focus shifts and ease of digitization evolves the way in which MedTech manages quality, the argument for using an MES strengthens. A modern MES specialized for MedTech adapts to both accommodate existing guidelines and future directives. It has base functionality to fully document the process, generating needed evidence for compliance and GMP, and ensuring process insight and improvements using a rigorous QMS for future proofing quality in manufacturing.
Quality in Other Industries
In other industries, be it Aerospace, Ship Building, Industrial Equipment, or Electronics/High Tech, which are classified as complex discrete industries (where individual products are manufactured as a lot of one) or in Chemical, Pharmaceutical, or Food/Beverage manufacturing (where manufacturing happens in lots or batches), the need to have lower cycle times, high asset utilization and a better/more efficient process and optimized product quality resulting from a controlled and continually improving process, supply chain visibility and bottom line profitability remain common imperatives.
QMS is an essential part of all manufacturing processes and general guidelines like the ISO 9001:2015 standard exist for manufacturers to establish a world-class QMS which is customer focused and aims for continuous improvement through leadership, personnel involvement and fact-based decision making.
In addition to ISO 9001, there are regulations from ASTM, IEEE and other governing bodies which exist for a given industry. Each industry has a set of very specific drivers which shape the perception and pursuit of quality within that industry.
In the era of Industry 4.0 with its accompanying digital transformation technologies, implementing an adaptive, flexible QMS system has become easier. MES systems designed for Industry 4.0 create an information platform to share and leverage intelligence from the process. It underscores GMP and helps to build a responsive, transparent value chain.
As an example, let’s consider the use case that in the Aerospace industry segment, supply chain partners of an OEM start 3-D printing their parts, deploying ‘Additive Manufacturing.’ This requires that the OEM’s QMS/MES to be capable of reviewing, comparing and qualifying these parts, which are manufactured in an entirely different manner traditional methods.
In a Pharmaceutical value chain, the need to accommodate 3-D printing may never exist, but ascertaining the quality of products that supply chain partners provide – reagents and ingredients – are following and strictly adhering to validated recipes and test procedures might be an extremely important aspect of the Pharma QMS. Using a MES specifically designed for a pharmaceutical sector is not only feasible, but again critical, to underscore and support a validated process.
Parting thoughts: Industry 4.0 for Quality
Industry 4.0 brings a myriad of possibilities for digitizing, and therefore improving, the manufacturing process: better overall control, increased yield, reduced cycle times, process visibility, and the use of advanced technologies such as AR/VR, Digital Twin and AI/ML.
A modern MES/MOM forms the basis for ensuring the benefits of Industry 4.0 are derived in your operation. Each industry segment has different definitions and drivers for Quality and its management; not every MES will be suitable for your specific needs.
As showcased in the examples above, an OEM manufacturing fighter jets will have completely different quality needs from a Pharmaceutical manufacturer making pain-killers, although the foundational strategies and philosophies of safety are in common.
A MES which is responsible for managing the quality in these manufacturing value chains will need to be focused on completely different aspects and parameters when it comes to quality. SPC and engineering control derived from AI/ML trends charts and reports might be a priority for the aerospace company, followed by supply chain management and supplier quality control, whereas for the pharma company the adherence to set recipes, recording of each batch’s process parameters and labelling might be top drivers for the QMS.
This distinction between industry segment needs is a primary reason that MES products are specialized by industry. Getting a MES/QMS system that captures the distinct processes, nomenclature, manufacturing modes and quality regulations is driven by industry-specific functionality. The selection of a specific vendor should include the focus, functionality and roadmap for that industry. Tools such as the 2021 Gartner Magic Quadrant for MES can help in both identification and selection of vendors that meet your industry-specific quality needs, to help you build out your Quality Management System.