Book:LIMS Selection Guide for Manufacturing Quality Control/Standards and regulations affecting manufacturing labs/Globally recognized manufacturing standards

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2. Standards and regulations affecting manufacturing labs

Societies around the world have grown to expect and depend on high-quality products that prove safe to their health, fully functional, and as-advertised. However, all manufacturers have not been equal in striving for and meeting such goals over the years, requiring standardization and regulatory tools to better drive the development and production of safe, high-quality products. As we learned in the previous chapter, manufacturing-based laboratories are critically involved in that manufacturing goal, and as such, those laboratories are in part guided and driven by manufacturing standards and regulations. After all, accurate and timely laboratory results are critical to the processes of research and development (R&D), quality control (QC), and post-production analyses. Naturally, standards and regulations may differ slightly from country to country, which should not be surprising. However, international efforts towards standards harmonization are ongoing as a means to make international trade more productive and to expand quality processes beyond national borders.

That said, "manufacturing" is a broad realm, as noted at the beginning of Chapter 1. The standards and regulations impacting textile manufacturers, for example, may differ greatly from those applied to pharmaceutical or electric vehicle manufacturers. As such, it's difficult to broadly make statements about standardization and regulation of the manufacturing industries. However, this chapter will attempt to examine some of these aspects from the 30,000 foot view, while focusing on providing examples across multiple manufacturing industries. Here we'll briefly examine the standards, regulations, guidance, and other factors globally driven by not only the demand for safer products, but also that in many cases dictate what and how quality activities are conducted towards ensuring product safety around the world inside and outside the manufacturing-based laboratory.

2.1 Globally recognized manufacturing standards

Manufacturing industries of all types depend on well-defined and -justified standards to better ensure the quality of their products. Implementing and maintaining conformance to internationally recognized and benchmarked safety and quality standards benefits the manufacturer in a number of ways[1][2][3][4]:

  • It increases customer confidence through the organization's audited certification to the standard, taking the place of customers' own auditing methods to ensure quality and authenticity, in turn reducing time and costs.
  • It drives organizations to better monitor their activities for non-conformities, identify root causes, and develop preventative controls, while clearly reporting such efforts to customers, further reducing the need for customer audits.
  • It better ensures a rigorous and comprehensive approach to product safety, quality, integrity, and legality, in many cases meeting or exceeding local, state, federal, and/or international legislative requirements.
  • It drives organizations to better vet their suppliers and service providers for meeting required product safety management practices.
  • It enables organizations to better demonstrate auditable compliance with modern product safety management practices.
  • It allows organizations to limit product recalls, reduce customer complaints, and better protect their brand.

As such, manufacturers adopt standards from one or more organizations around the world, not only to benefit their operations but also meet or exceed regulatory requirements for their industry. What follows are some of the more critical standards and guidelines that apply to a wide variety of manufacturing industries.

2.1.1 Food and beverage

FDA Food Safety & Applied Nutrition Lab (3830) (7944692320).jpg

Food and beverage researchers and manufacturers adopt standards from one or more organizations around the world, not only to benefit their operations but also meet or exceed regulatory requirements for their industry. What follows are some of the more critical standards and guidelines that apply to the food, beverage, and feed industries. British Retail Consortium (BRC) Global Standard for Food Safety (GSFS)

In 1998, the British Retail Consortium (BRD) published the first edition of its Global Standard for Food Safety (GSFS), going on to become an internationally recognized standard of best practices in food manufacturing, storage, and distribution, and the first food safety standard to be recognized by the Global Food Safety Initiative (GFSI; discussed later). The standard covers stakeholder buy-in on continual improvement, food safety plan development, food quality management system development, manufacturing and storage site standardization, product and process control, personnel management, risk management, and trade product management.[3][4][5][6] The standard is implemented by an organization through gap assessment, documentation development, consultation and assessment, internal auditing, and resolving non-conformances to the standard.[4] Codex Alimentarius

The Codex Alimentarius is a collection of internationally recognized food and feed standards and guidelines developed as a joint venture between the United Nation's Food and Agricultural Organization (FAO) and the World Health Organization (WHO).[5] The Codex "is intended to guide and promote the elaboration and establishment of definitions and requirements for foods to assist in their harmonization and in doing so to facilitate international trade."[7] Scope of the standards is broad, covering food hygiene; food additives and contaminants, including pesticides and drugs; packaging and labeling; sampling and analysis methods; and import and export inspection and certification.[7] It's not unusual for governments to approach the FAO seeking help with harmonizing national legal frameworks of food safety with the Codex Alimentarius.[8] Among the Codex, some of the more broadly useful standards include General Principles of Food Hygiene (CXC 1-1969)[9], General Standard for Contaminants and Toxins in Food and Feed (CXS 193-1995), and General Methods of Analysis for Contaminants (CXS 228-2001).[10] Global Food Safety Initiative (GFSI)

The GFSI is a collection of private organizations that has developed a set of benchmarking requirements for improving food safety management programs, with a goal of making them balanced enough to be broadly applicable while remaining relevant to different countries and regions of the world.[5] Previously known as the GFSI Guidance Document[11], the GFSI Benchmarking Requirements act as a set of criteria and professional framework for food safety management programs to fulfill, formally allowing an organization to be recognized and certified by the GFSI. Certification to the GFSI Benchmarking Requirements "demonstrates an organization’s serious commitment to food safety to customers and potential customers across the world."[5] An organization seeks out a third-party certification program owner (CPO) and undergoes the auditing process, which is driven and supported by the GFSI Benchmarking Requirements.[12] GFSI is also responsible for ensuring CPOs and certification bodies meet the necessary requirements. Hazard analysis and critical control points (HACCP)

The hazard analysis and critical control points or HACCP system has been adopted and integrated in various ways over the years[13], but at its core, the system directs organizations to focus on key areas or "critical control points" (CCPs) of vulnerability and hazard within the production process and mitigate their impact on overall food safety.[5] Though the seeds of HACCP go back to the 1970s, it wasn't until the mid-1990s that it began finding its way into formal regulatory structures in the United States, first codified as 9 CFR Parts 304, 308, 310, 320, 327, 381, 416, and 417 in July 1996.[13][14] HACCP also found its way into other standards benchmarked by the GFSI.[13] The concept of HACCP has perhaps changed slightly over the years, but the main principles remain[5]:

  1. Conduct a hazard analysis.
  2. Identify CCPs.
  3. Establish critical limits for those CCPs.
  4. Establish monitoring procedures for those CCPs.
  5. Establish corrective action for failed limits.
  6. Establish verification procedures.
  7. Establish record keeping and documentation procedures. International Featured Standards (IFS)

The IFS framework is made up of a group of eight food and non-food standards, covering various processes along the food supply chain. IFS Management, who is responsible for the standards, notes that "IFS does not specify what these processes must look like but merely provides a risk-based assessment"[15] or "uniform evaluation system"[5] for them. Organizations such as food manufacturers and logistics providers can certify to the standards. Some of the more relevant to food and beverage laboratories include IFS Food (for food manufacturers), IFS Global Markets Food (for food retailers), IFS PACsecure 2 (for packaging manufactures), and IFS Global Markets PACsecure (for packaging suppliers).[15] International Organization for Standardization (ISO) 22000

The ISO 22000 series of standards addresses how a food safety management system should be set up and operated, and how organizations can be certified to the standard by a third-party auditor.[16] ISO 22000 is based off the ISO 9000 family of quality management system standards and, like other standards, incorporates elements of HACCP.[13] The standard claims to be advantaged compared to other standards due to its comprehensive applicability across an entire organization, and across the entire food chain.[17] Major standards applicable to manufacturers with laboratories include:

  • ISO/TS 22002-1:2009 Prerequisite programmes on food safety — Part 1: Food manufacturing[18]
  • ISO/TS 22002-4:2013 Prerequisite programmes on food safety — Part 4: Food packaging manufacturing[19]
  • ISO/TS 22002-6:2016 Prerequisite programmes on food safety — Part 6: Feed and animal food production[20] Safe Quality Food (SQF) Program

The SQF Program, headlined by the SQF Institute and recognized by the GFSI, is a food "safety-plus-quality" management certification mechanism that covers the food supply chain from farm to fork.[5] Those who wish to be certified to SQF must comply with SQF Code, which covers a variety of topics, from aquaculture and farming to food packaging and food and feed manufacturing.[21] Like other standards, the organization wanting to be accredited finds a certified third-party auditor to administer program certification.

2.1.2 Materials

Mechanical Testing Lab (5426178594).jpg

An internet search for "materials engineering standards" reveals dozens of university library research guides discussing what standards are, why they are important to materials science and engineering, and how to find them via the university's library system. Take for example UCLA's Materials Science and Engineering guide and its relatively succinct description of why standards are important to materials scientists[22]:

Standards and specifications are described as documents that describe the rules and conditions for how materials and products should be manufactured, defined, measured, tested, and applied. They are used to establish baselines or a minimum level of performance and quality control to ensure that optimal conditions and procedures for the purpose of creating compatibility with products and services from different periods and a range of sources. Specifications have a more limited range of application than standards and generally establish requirements for materials, products, or services. Standards and specifications may be issued by voluntary technical or trade associations, professional societies, national standards bodies, government agencies, or by international organizations ... Standards and specifications are of greatest utility to engineers, scientists, and those working with new innovations.

UCLA helpfully goes on to describe the types of standards one should expect to find in regards to materials science and engineering, including categorical (e.g., dimension, structure, grade, durability, safety), method-based (e.g., manufacturing, design, operational safety), testing-based (e.g., analyzing, measuring, verifying), term-based (e.g., abbreviations, symbology, preferred units), and design (e.g., execution method, safety conditions) standards.[22] As such, it would be practically impossible to address all materials-related standards in this guide. However, a small selection of examples is provided to give varying contexts of what materials engineers and manufacturers may need to consider. American Society of Civil Engineers (ASCE) materials standards

The ASCE is a professional organization with its own library of standards, including materials standards for engineering. Examples include ASCE/T&DI/ICPI 58-16 Structural Design of Interlocking Concrete Pavement for Municipal Streets and Roadways, ASCE/SEI 19-16 Structural Applications of Steel Cables for Buildings, and ASCE/SEI 48-05 Design of Steel Transmission Pole Structures. ASTM International Volume 15.04

ASTM International has numerous volumes of standards for materials, including Volume 15.04. This volume covers the chemical requirements for soaps and other detergents, the properties of polishes, various properties and test methods of leather, and the properties of floor coverings.[23] Canadian Standards Association (CSA) A3000 series

The CSA produces standards for a variety of materials, including cementitious materials through its A3000 series of standards. These construction materials standards address the basics of cementitious materials, their appropriate test methods, and the equipment best used for those methods.[24] International Organization for Standardization (ISO) 10993

Generally speaking, there are no ISO or government-sanctioned standards for the materials that can be used in medical devices, but rather there are standards that apply directly to medical devices, largely given that the overall manufacturing process has a tendency to modify the reactivity of the material used in the medical device.[25] That being said, there is an ISO standard for biocompatibility, "the ability of a device material to perform with an appropriate host response in a specific situation"[26]: the ISO 10993 series of standards.[25] These standards requires manufacturers of medical devices to collect "qualitative and quantitative data on the materials in the context of biological safety" to ensure the device's material is actually biocompatible.[25] ISO 10933 addresses chemical characterization, allowable limits of leachable substances, and in vitro cytotoxicity of medical device materials, among other things.[25] Metal Powder Industries Federation (MPIF) Standard 35 family

The MPIF "issues standards to provide the design and materials engineer with the information necessary for specifying powder metallurgy materials which have been developed by the powder metallurgy and metal injection molding parts, powder, and equipment producers."[27] Among them is the Standard 35 family, which addresses powder metallurgy structural parts and self-lubricating bearings, as well as powder-forged steel and metal injection molded parts, including materials aspects such as "minimum strength value, grade selection, chemistry, proof testing, typical property values, and processes."[27]

2.1.3 Pharmaceutical and medical devices

A technician looks at samples at the pharmaceutical lab in Rockville, Maryland LCCN2011631564.tif

Of the various manufacturing domains, pharmaceutical and medical device manufacturing arguably requires some of the most rigorous standards to ensure the good health of end users. Speaking to consumer expectations of safe, high-quality pharmaceutical products, Atouf and Venema note[28]:

The consistency in both the safety and efficacy of the drug supply required to achieve this assurance is based mainly on our reliance on compendial standards for quality and performance of drug development, review, and ongoing manufacturing. These standards are recognized in the [Food, Drug and Cosmetic Act] and play a critical role in its adulteration and misbranding provisions ... The impact of established and accepted standards—in the form of measurements and methods as well as reference materials—being a norm for drug development often goes unnoticed and unmeasured, even by those intimately involved in the field. By the very fact of being the norm, they are taken for granted. Their impact is nonetheless fundamental to the current and future efficiency of drug development as well as to the pursuit of providing safe, high-quality medicines at a reasonable price.

Similarly, harmonized medical device standards are valuable to manufacturers and end users, making it "possible to apply essential requirements" of development and manufacturing "in a uniform way." Manufacturers can adopt harmonized standards in such a way that design and documentation costs are reduced, while at the same time giving end users more confidence in the safety and efficacy of manufactured devices.[29]

Like materials standards, it's beyond the scope of this guide to try and list all pharmaceutical and medical device standards. What follows are a few examples of more critical standards in this industry. ASTM International Volume 14.01

ASTM International covers pharmaceutical and biopharmaceutical manufacturing in its Volume 14.01. In particular, it "covers the application of process analytical technology (PAT) within the pharmaceutical and biopharmaceutical industry, highlighting PAT system management, implementation, and practices."[30] European Pharmacopoeia standards

The European Pharmacopoeia is a compendium of standards—in the form of monographs and other documents—that provides "a legal and scientific basis for quality control during the development, production and marketing" of pharmaceuticals and their ingredients. These standards address the compositions, testing, and handling of medicines and their ingredients to better ensure the safety of consumers and a more effective product.[31] The eleventh edition contains more than 2,400 monographs, 380 general texts, and 2,800 descriptions of reagents.[32] While legally binding in European member countries, the standards also have international relevance.[31] International Organization for Standardization (ISO) 10993, 13485, and 16142-2

As described in the previous subsection, the ISO 10993 series of standards addresses the biocompatibility of medical device materials, and the standard is worth mentioning here. However, other ISO standards are also relevant. ISO 13485 is the primary quality management system (QMS) standard for hardware- and software-based medical devices and their demonstration of meeting or exceeding customer and regulatory requirements. By meeting the requirements of ISO 13485, the manufacturer facilitates "an improvement of processes" within their workflows over the complete lifecycle of operations.[33] ISO 16142-2 "identifies and describes the six general essential principles of safety and performance ... that apply to all medical devices, including IVD medical devices (in vitro diagnostic)," while also addressing the safety and performance requirements for designing and manufacturing medical devices.[34] United States Pharmacopeia and National Formulary (USP-NF) standards

Like its European counterpart, the USP-NF acts as a compendium of thousands of quality standards for pharmaceutical products and their active and inactive ingredients, helping manufacturers better protect patient safety while also producing higher-quality medicines. Three broad types of standards make up the compendium: monographs, general chapters, and material reference standards. Monographs "articulate the quality expectations for a medicine" and "describe the tests to validate" the medicine's ability to meet those expectations.[35] General chapters take a broad approach to product development and manufacturing, discussing accepted processes, tests, and methods for pharmaceuticals. Material reference standards complement monographs and general chapters with their quality testing methods to ensure medicines adhere to the state requirements of monographs and general chapters.[35]

2.1.4 Other industries and standards

COVID-19-related research (49938485863).png

From our North American Industry Classification System (NAICS)-derived list of manufacturing industries in Chapter 1, we know there's more to manufacturing than food and beverage, materials, and pharmaceuticals and medical devices. Apparel, electronics, furniture, plastics, and petrochemical manufacturers—to name a few—have their own standards. It is beyond the scope of this guide to cover every industry; however, this subsection will highlight a few examples of standards that are applicable to a wide variety of other industries, including the all-important ISO 9001 standard. British Standards Institution (BSI) standards

BSI is appointed by the United Kingdom as the national standards body and seeks to "improve the quality and safety of products, services and systems by enabling the creation of standards and encouraging their use."[36] BSI works in tandem with the ISO to address the standards needs of the U.K. Addressed among its standards are the topics of quality, supply chain, health and safety, and automation.[37] An example of a manufacturing standard is BS EN 1090, which addresses "structural/construction steel and aluminum products that are installed in a permanent manner."[38] Global Standard's Global Organic Textile Standard (GOTS)

Global Standard's GOTS is described as "the worldwide leading textile processing standard for organic fibres, including ecological and social criteria, backed up by independent third-party certification of the entire textile supply chain."[39] The standard's breadth covers the entire spectrum of textile manufacturing, from design and processing to final distribution. Global Standards also provides an implementation manual for organizations with questions about the standard's implementation.[40] International Organization for Standardization (ISO) 9001

ISO 9001 specifies the requirements for a QMS within any organization providing products and services, particularly those seeking to prove their products and services consistently meet customer and regulatory requirements and necessarily enhance customer satisfaction.[41] While it does not define product quality, by focusing on the QMS, a manufacturer typically by extension produces products of a higher quality. (Though, broadly speaking, such improvement is partly driven by the fact that there is a tendency for better performing companies to seek ISO 9001 certification.[42]) The standard applies to manufacturers big and small across any industry, and as such, ISO 9001 requires the organization to closely consider its context within its industry and business environment in order to make the most of the standard.[43] Underwriter Laboratories (UL) standards

UL says its standards "are used to assess products; test components, materials, systems and performance; and evaluate environmentally sustainable products, renewable energies, food and water products, recycling systems and other innovative technologies."[44] When looking at their catalog of standards, the breadth of products—and therefore industries—becomes more apparent, from electrical conduit, thermostat wiring, energy storage systems, and fire extinguishers to electric gardening devices, elevator door locks and contacts, garment finishing appliances, and gasoline.[45] If it can be manufactured in your industry, UL may have a standard for it.


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