Compliance indicates that a product or service meets the requirements of a relevant regulation or specification. It is an indicator of the attainment of quality. Indeed, compliance cannot exist without regulations or specifications because it would not make sense to claim that a product, design, or process meets a specific standard unless there is a standard in place that is widely accepted as an adequate measure of quality.
Against this backdrop, national, regional, and international standards organizations were set up and tasked with developing agreed standards. As a result, today, many such bodies have set and are constantly updating standards and regulations. The standards cover virtually all industries, from design to manufacturing and construction. Given the panoply of regulatory standards, getting lost in the sea of specifications and regulations is easy. So, how about we narrow it down for those in the CAD and/or CNC industries? Today, let’s talk about CAD/CNC compliance with regulatory standards.
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Key Regulatory Standards in CAD/CNC Industries
What is a Regulatory Standard?
A regulatory standard is any set of rules, regulations, or guidelines set forth by a regulatory body or industry standards organization and widely accepted by general consent as the most appropriate way of doing things. A standard is often viewed as a recommendation; it provides the minimum requirements. It tells professionals and users how to perform a certain task but does not have an anchoring in law.
Thus, while following the recommendations of a standard can be beneficial, not doing so may not result in a penalty. In fact, you can exceed the requirements stipulated in a standard if doing so has certain demonstrable benefits. The bottom line is that a regulatory standard is not always enforceable.
What is enforceable is a code, which, by definition, is a set of standards that are set and enforced by a body such as a local government for the protection of health and public safety. Therefore, in practice, many standards combine to create a code. And it is only when these standards are part of a code that they become enforceable. Today, there are many codes that cover multiple industries, from design (CAD) to manufacturing (CNC). These include:
- Health code: It contains a set of standards that document the health requirements for ventilation, air conditioning, and plumbing)
- Building code: It is a set of regulatory standards that ensure the structural safety of buildings)
- Fire code: It provides specifications for emergency exits and fire escapes
- Highway code: It documents information, advice, guides, and rules for all road users
Importance of Regulatory Standards
1. Welfare Protection
Regulatory standards and codes help regulatory agencies and governments protect the welfare of the population they serve. For instance, within the context of urban planning and architecture, regulatory standards set limits on what can be designed and developed. This prevents congestion, boosts residents’ quality of life, and avoids straining public facilities.
The same applies to regulatory standards that govern the design and manufacture of vehicles and aircraft. With the safety of road users and passengers being paramount, regulatory agencies require manufacturers to adhere to strict guidelines that reduce the severity of accidents or eliminate them.
Broadly speaking, regulatory standards and codes aim to prevent injuries or loss of life and prevent property damage. They provide pointers that help organizations and professionals to eliminate, reduce, or avoid definable hazards.
2. Conformity
Standards help companies to evaluate the conformance of all parts they design and produce. They provide a template against which to analyze and assess deviations from the recommendation. Moreover, considering the industry-wide adoption of the standards, consumers and companies can make head-to-head comparisons between competing products. Let’s look at the vehicle manufacturing industry to illustrate this point better.
Here, different manufacturers design and manufacture various models for each class of vehicles. Classes in this context refer to coupes, sedans, trucks/pickups, and lorries, just to mention a few. But for a car to be placed in any of these categories, it must meet certain standards and requirements, such as the interior space and number of doors, for example. Such standards ensure conformity. They allow consumers and companies to compare the available models of cars within a particular class, even when they are made by different manufacturers.
3. Performance
As a recommendation, a regulatory standard provides the minimum requirements needed to achieve the minimum level of performance. This means that exceeding the standards can be advantageous if this intervention has demonstratable benefits.
For instance, the IEC 60601-1-11 standard stipulates the general requirements for basic safety and essential performance of medical electrical equipment used in the home healthcare environment. It recommends an operating temperature range of 5°C to 40°C. Yet, some environments have harsh weather and climatic conditions.
To accommodate such areas, manufacturers can design, manufacture, and test equipment that withstands harsh environments. This could benefit customers in such areas, as it would reduce the chances of device failure or regular service. Simply put, meeting performance targets sometimes requires teams to go beyond minimum CAD/CAD compliance.
4. Ensure Quality and Reliability
CAD/CNC compliance with the various regulatory standards maintains the quality and reliability of manufactured parts. For instance, as we detail below, specific standards require process validation, which helps identify flaws. Process validation helps machinists and companies to confirm whether the CNC machine can fabricate parts that meet specifications and do so repeatedly. In this way, compliance produces consistent production results. Similarly, machinists can consistently produce quality products by complying with standards that require safe machine operation.
Regulatory Standards in CAD and CNC Industries
There are various government regulatory standards and bodies that require CAD/CNC compliance, including:
- ISO standards like 9001 and 14000
- The US Food and Drug Administration (FDA) regulations
- The US Federal Aviation Administration (FAA) regulations
- EU’s Restriction of Hazardous Substances (RoHS) directive
- The International Traffic in Arms Regulations (ITAR)
- The American National Standards Institute (ANSI) standards
- Eurocode standards
- The International Electrotechnical Commission (IEC) standards
- The Institute of Electrical and Electronic Engineers (IEEE) standards
- American Society of Mechanical Engineers (ASME) standards
This section covers a few regulatory standards from these bodies that specifically apply to the CAD and CNC industries. These include:
1. ISO 9001 Quality Management Systems
The ISO 9001 standard helps companies address all elements of managing the quality of their product. It emphasizes customer satisfaction and the continuous enhancement of the formalized system of processes, procedures, and responsibilities for implementing quality policies and achieving quality objectives.
2. ISO 14001 Environmental Management Systems
The ISO 14001 standard guides the implementation of ISO 14000. For its part, ISO 14000 is a family of environmental management standards covering greenhouse gas accounting, carbon footprint measurement, and verification and emissions trading. ISO 14001 provides a guide that helps organizations, including those in the CAD and CNC industries, minimize the environmental impact of their operations. CAD/CNC compliance with this standard helps organizations to improve their environmental performance on an ongoing basis.
3. ISO 23125 Machine Tools Safety
The ISO 23125 standard specifies the compliance requirements as well as measures to reduce the risks or eliminate the hazards in a specific group of CNC machines called turning centers and turning machines. It ensures the safe operation and use of turning centers and machines.
4. ISO 12100 Safety of Machinery
The ISO 12100 standard is designed for companies that design machinery, including but not limited to CNC machines. It specifies the principles of identifying, assessing, estimating, evaluating, and reducing risk with the aim of achieving safety. It helps designers of CNC machines to design safe machines.
5. ISO 45001 Occupational Health and Safety
The ISO 45001 standard provides a framework CNC machinists and companies can use to identify, assess, manage, and reduce the risks associated with health and safety within the workplace. It also helps organizations to improve operational health and safety (OH&S) performance. It establishes criteria for OH&S objectives, policies, auditing, review, operation, implementation, and planning.
6. IEC 60204-1 Safety of Machinery
The IEC 60204-1 standard applies to the electrical, electronic, and programmable electrical parts or equipment found in CNC machines and other machines. It helps minimize or eliminate occupational hazards while operating machines that use either direct current or alternating current. It helps operators and machinery manufacturers to adopt the best industry safety requirements.
7. ISO 13485 Medical Devices
The ISO 13485 standard aims to ensure the safety, quality, and effectiveness of medical devices. It is designed for companies and businesses that design, produce/manufacture, install, and service medical devices. It outlines requirements that ensure CAD/CNC compliance within the medical devices industry.
In a bid to promote consistency in the regulation of medical devices, the FDA in February 2024 issued the Quality Management System Regulation (QMSR) Final Rule. The rule becomes effective two years after publication and incorporates the ISO 13485 standard. This regulation includes requirements that specify recommended methods for designing, manufacturing, and servicing medical devices.
8. AS9100 Aerospace Management Systems
The AS9100 standard is based on and works in conjunction with ISO 9001. It is a standardized quality management system for the aerospace (aviation, space, and defense) industry. The standard sets the basic quality management system requirements, adding more than 100 compliance requirements to the ISO 9001, with these additional requirements applying only to the aerospace industry. AS9100 is designed for companies that design and manufacture aerospace products or components as well as those that supply materials to the industry. Thus, AS9100 required CAD/CNC compliance within the aviation, space, and defense industries.
9. ITAR Compliance
For US companies that design, manufacture, sell, and distribute defense and space-related products and services defined in the United States Munition List, compliance with the International Traffic in Arms Regulations (ITAR) requirements is paramount. It restricts access to data related to defense and military technologies to US citizens only.
10. CAD Standards
Revisiting our discussion that provided a comprehensive guide to help you navigate the world of CAD standards, we can deduce that those standards can apply to various sectors that need CAD/CNC compliance. After all, for a CNC machine to fabricate a part, there is a high likelihood that a CAD drawing of the part exists. To deliver that CAD drawing, the designer or engineer must follow a set of rules that have been accepted within their organization or industry as CAD standards.
Compliance Requirements for CAD/CNC Operations
These standards and regulatory bodies place requirements such as audit trails, risk management, document control, safety, and more. For simplicity, we have grouped the requirements into three categories: data management, design, and manufacturing safety.
Compliance Requirements for Data Management
CAD and CNC operations involve the generation and use of data, usually stored in files. The data can contain privileged and proprietary information, necessitating the need to regulate access. Additionally, for traceability, it is essential to track changes and record the names of the people who made them. Against this backdrop, common regulatory requirements for data management include:
- Provision of information about changes like the user information and timestamps that are made to files
- The need for specific permissions for accessing, editing/modifying, and approving files
- Documentation of electronic approval or review mechanisms such as digital signatures
- Ability to track outdated files
- Separation of the different levels of access and control for documents and detailing exactly which documents have controlled access
- Retention of old versions of files
- Provision of the ability to search and find documents within a database
- Training requirements for system administrators
Compliance Requirements for Design
In the vehicle manufacturing sector, regulators require manufacturers to implement measures that facilitate easy access to the car, make the car easier to operate, and improve the safety of occupants and pedestrians. For this reason, the European Commission’s Directorate for Mobility and Transport, for example, lists the recommended dimensions for the height of door frames above ground, seat height above ground, width of door openings, door opening angle, doorsill height, and more. These dimensions are incorporated early in the product lifecycle during the design phase.
Similarly, regulatory bodies like the US Federal Aviation Administration (FAA) and the European Union Aviation Safety Agency (EASA) have stringent requirements for emergency exits, aisle widths, video monitor position, fittings, and more. In addition, the FDA has compliance requirements related to the methods used for designing medical devices. The body mandates device manufacturers to formulate and follow quality systems known as current good manufacturing practices (CGMP).
Compliance Requirements for Manufacturing Safety
A lot can go wrong during manufacturing, leading to injuries, damage, or loss of life. However, proper safeguards can prevent or eliminate these adverse events. To achieve this, machine manufacturers have to design their machines for safety. They must include safety features like spindle or foot brakes for CNC lathe machines and reachable emergency stop buttons. Moreover, manufacturers need to provide clear instructions and make it easy for users to perform regular maintenance.
What’s more, regulatory bodies require manufacturers to establish and abide by quality systems that help them ensure their products consistently meet relevant specifications and applicable regulatory requirements.
Implementing CAD/CNC Compliance Strategies
Compliance with regulatory standards and regulations should start during the early design process. This approach eliminates surprises that can lead to missed milestones, delays, penalties, and expensive reworks. And given that funding for small companies and start-ups in industries like medical device manufacturing is tied to regulatory milestones, missing such milestones can lead to closure or bankruptcy. It is, therefore, essential to implement the following CAD/CNC compliance strategies that ensure adherence to regulatory standards:
- Identify and understand applicable/relevant regulatory standards
- Consult regulatory affairs experts and incorporate their expertise
- Develop a compliance management system
- Implement training programs
- Conduct regular reviews and compliance audits
- Use compliance software tools
- Validate CNC machining capabilities and other fabrication processes
- Implement traceability
Identify and Understand Applicable Regulatory Standards
The foundational step involves identifying regulatory standards that require CAD/CNC compliance. These standards will, of course, vary from one industry to another. This means that you do not expect that certain regulations that medical device manufacturers follow should apply to a woodworking workshop.
To further illustrate the fact that standards are not always universally applicable, let’s take the example of ISO 9001. This standard is broadly designed to provide a template against which companies across all industries can implement quality management systems. However, as we have highlighted, some industries have used this standard as the basis for creating customized compliance requirements for the organizations therein.
Consult Regulatory Affairs Professionals
Companies can – and should – incorporate regulatory affairs professionals or professionals with extensive regulatory experience directly into the CAD design teams. This incorporation ensures that the professionals address regulatory concerns and requirements early during the planning and design phases. This strategy ensures that team members create designs that subsequently allow the manufacture or construction of products, parts, or buildings that align with compliance requirements and regulatory standards.
Develop a Compliance Management System
A compliance management system captures the compliance policies and procedures that detail approaches to follow in order to comply with regulatory requirements. Thus, to build the system, you implement the following:
- Identify compliance requirements
- List compliance policies and procedures and assign responsibilities
- Inform employees of the regulatory requirements and their role in ensuring compliance in the CAD and CNC industries
- Schedule CAD/CNC compliance audits and mechanisms to monitor regulatory changes
- Implement measures to update policies and procedures based on identified changes
Implement Training Programs
Frequent compliance training workshops, seminars, or programs enable employees to learn about the regulatory requirements. The programs also allow them to learn their roles in promoting CAD/CNC compliance. These training programs often cover a variety of topics, including regulations and guidance, quality, safety, and more.
Companies can conduct the training in-house or enroll their employees in training programs offered by third parties. The programs keep employees abreast with the latest regulations, providing resources that promote CAD/CNC compliance with the standards. It also equips machine operators and CNC machinists with the knowledge and proficiency to safely operate machinery, deal with emergencies, and identify and manage hazards.
Perhaps to supplement the training initiatives by companies, regulatory bodies can – and often do – offer training programs. For instance, the FAA’s Regulatory Standards Division provides technical training to inspectors, engineers, and pilots. This training program aims to help the professionals work together to set and maintain the highest standards of safety. It is also designed to enable them to provide the public with the safest national airspace. This training covers the fields of manufacturing, avionics, aircraft certification, and more.
Conduct Reviews and Compliance Audits
Regulatory standards are updated from time to time. At the same time, regulatory agencies regularly introduce new rules that come into effect after a predefined period. Companies, therefore, need to always be on the lookout for changes. They must also ensure their internal policies and procedures, training programs, and tracing methods align with the changes. This is where auditing comes in.
Compliance audits evaluate policies and procedures, training programs, data management, and traceability methods to identify non-compliance. They aim to identify gaps in your CAD/CNC compliance system. They also provide the information needed to take corrective action. Moreover, the audits illuminate compliance risks and point out ways to avoid them.
In addition to the in-house audits that companies conduct, regulatory bodies like the FDA usually perform their own regulatory audits. Such bodies hire out this task to recognized auditing organizations. These inspections/audits aim to assure compliance with regulatory requirements.
Reviews, on the other hand, are essentially internal discussions that involve various team members from different departments. They assess designs, manufacturing and metal fabrication processes, and technologies (like the digital twin and digital thread) to identify and resolve regulatory issues. The discussions can create opportunities to change designs, averting costly modifications later during other stages of the product’s lifecycle. They can also birth decisions to change manufacturing approaches or the technologies used. The main objective of the reviews is to ensure that at no point is any underhand approach used to circumvent regulatory compliance or obscure them.
Use Compliance Software and Tools
Technology, if used as intended, can help to streamline processes. Today, there are a multitude of tools that can simplify compliance with complex compliance requirements. A few examples of software tools that aid in CAD/CNC compliance include:
- Tekla Tedds Integrator: this CAD tool can check whether steel connections in a Tekla Structures model comply with Eurocode design. The tool includes built-in automatic data transfer for simple steel connections, structural concrete, and precast concrete elements.
- STAAD.Pro: this CAD design tool can perform design based on specific provisions of various design codes. These include the British, American, Australian, Canadian, European, German, French, Japanese, Russian, South African, and Indian codes, just to mention a few.
- CAVA (CATIA Automotive Extensions Vehicle Architecture): CAVA is an industry-proven add-on software by Technia. It helps vehicle manufacturers to validate design and architecture compliance. The tool provides, as CATIA features, rules, norms, and standards that vehicle manufacturers must fulfill. It then checks the vehicle geometry against the rules, ascertaining that it meets legal requirements. CAVA fully integrates with CATIA V5, CATIA V6, and CATIA 3DExperience.
- SolidWorks PDM can facilitate compliance with government regulatory requirements and industry standards. It can help organizations secure, track, and protect their product data.
- PTC’s WindChill ships with productivity tools that comply with the FDA’s Unique Device Identification (UDI) requirements. The UDI requirements call for the capturing of product numbering, version information, and configuration data. In addition, the UDI capabilities support review and approval workflows that automate the processes of submitting product data to the FDA.
- PTC’s Creo automatically checks tolerances for compliance with the American Society of Mechanical Engineers (ASME) Y14.5 standards.
Validate CNC Machining Capabilities
Quality management standards like ISO 9001 or AS9100 have process validation requirements. Process validation helps companies ascertain that their subtractive manufacturing (CNC machining) or additive manufacturing processes result in parts that conform to specifications. One of the ways to validate manufacturing processes is through first-article inspections (FAI).
In FAI, an external inspector takes a random sample from the initial production run. They then use the custom specifications to evaluate conformity. Usually, the inspector uses scrape testers, calipers, micrometers, millimeters, 3D scanners, and coordinate measuring machines to measure dimensions and features to confirm whether they conform with the engineering drawing.
Another validation method is the process capability analysis (PCA). Like FAI, PCA also involves sampling. Under PCA, however, data is corrected from multiple parts manufactured during the initial run. These data are then used to predict whether the manufacturing process can repeatedly fabricate or create parts that conform to specifications.
FAI and PCA validate a CNC machine’s ability to fabricate a designed product. It ensures CNC compliance with quality management standards.
Implement Traceability
Traceability is the next logical step that follows the discovery that a production process or machine is flawed. This requires tracing parts or errors to an operator, machine, method, measurement system, material, and environmental conditions. Traceability helps companies improve processes, ensuring CAD/CNC compliance with quality management standards.
The Impact of Non-Compliance
There are several consequences of non-compliance, including:
1. Delayed Approval
Regulatory bodies only issue approvals when they are satisfied with the demonstrated level of compliance with regulatory standards, codes, rules, and regulations. For instance, a lack of CAD/CNC compliance during the design and manufacturing stages can lead to multiple rounds of regulatory reviews.
In some cases, the non-compliance may be because of a lack of information on the applicable regulatory requirements. And while this is no excuse, it is an understandable oversight. However, in other cases, the non-compliance results from a deliberate effort to game the system to speed up processes. But as it quickly becomes clear, delayed approvals greatly slow down the processes. They lead to missed milestones and deadlines.
2. Added Expenses
In addition to wasting time, non-compliance can be costly. The delays, which affect the delivery of products, lead to missed revenues. Additionally, the numerous rounds of regulatory review mean the company spends more on outsourced review experts, which adds a substantial cost to the development budget. Additionally, non-compliance can – and often does – lead to penalties. One company that best illustrates this is Boeing. In 2021, the FAA ruled that Boeing should pay at least $17 million due to non-compliance. This was on top of other penalties announced that year.
3. Injuries and Loss of Lives
Non-compliance can have disastrous consequences. Injuries and loss of lives become likely outcomes in cases where safety is disregarded. And if it is proven that the injuries or deaths resulted from a deliberate disregard for safety, a company could incur additional monetary liabilities. Another intangible loss that would likely follow is reputation damage.
4. Poor Quality of Products
Certain regulatory standards emphasize quality. Design or manufacturing processes that disregard the quality recommendations will likely produce poor-quality products.
Conclusion
Navigating the complex web of regulatory requirements can be daunting, from the complexity of the regulations to the fact that they are constantly updated. This makes compliance a not-so-straightforward process. Fortunately, there are compliance strategies and tools you can use. To comply with these requirements, you must identify applicable regulations, create policies and procedures that guide compliance, conduct regular audits, train employees, validate processes, implement traceability measures, and more. Within the context of CAD/CNC compliance, software can be handy compliance tools that help simplify certain aspects of otherwise complex processes. Given that adhering to the regulatory requirements offers benefits such as welfare protection, savings, prompt approvals, performance, and quality, the decision to comply with the standards and regulations is indeed wise.
