According to the U.S. Bureau of Labor Statistics, factory floor employees in manufacturing spend about 41 hours per week on production activities, which translates to roughly 2,000 hours a year.
So, in the time it takes a typical factory worker to produce what’s needed in their role annually, many manufacturers are spending equal - or even more - hours just on compliance.
So, what’s the solution?
Imagine if those 2,000-10,000 compliance hours could be reduced to just a few hundred hours of actual oversight, with a software handling the rest automatically.
That's exactly what manufacturing compliance software delivers - transforming compliance from a time-consuming burden into an automated background process that works while your team focuses on manufacturing. Want to know how? Let’s dive in.
What is Manufacturing Compliance Software?
A manufacturing compliance software is basically a digital solution that helps manufacturers follow all the rules and regulations they need to operate legally and safely. From quality standards and safety regulations to environmental laws, manufacturers have a long list of regulations they need to adhere to when it comes to the production processes.
The manufacturing compliance management software:
- Keeps track of all regulatory and industry standards.
- Monitors daily operations to see if everything is being done correctly.
- Identifies potential compliance risks across operations, assesses their impact, and develops and tracks implementation of risk mitigation strategies.
- Documents all the proof that rules are being followed (important for inspections and audits).
- Reminds you when certifications expire or when reports are due.
- Schedules external and internal audits, assigns responsibilities, and prepares audit checklists.
Understanding Manufacturing Compliances
Manufacturing compliances are the non-negotiable legal rules that you must follow to protect your workers, consumers, and the environment. Some of the major compliances include:
OSHA (Occupational Safety and Health Administration)
It’s a US regulation to keep workers safe at work. Under this regulation, you are required to:
- Provide safety equipment (hard hats, gloves, safety goggles) to your workers.
- Train workers on how to stay safe.
- Keep workplaces clean and hazard-free.
- Report serious injuries within 24 hours.
- Allow OSHA inspectors to visit anytime.
EPA (Environmental Protection Agency)
EPA consists of rules to protect air, water, and land from pollution. It mandates manufacturers to:
- Control smoke and chemical emissions from factories.
- Dispose of waste properly (can't just dump it anywhere).
- Get permits before releasing anything into air or water.
- Clean up any spills immediately.
- Report environmental accidents.
FDA (Food and Drug Administration)
A regulation of the US government that regulates anything people eat, drink, or apply on their bodies, FDA authorizes you to:
- Test products to make sure they're safe.
- Keep detailed records of ingredients and manufacturing.
- Label products correctly (ingredients, warnings).
- Allow FDA inspectors to check facilities.
- Report any problems with products immediately.
GMP (Good Manufacturing Practice)
GMP provides basic cleanliness and quality rules for making products (especially food, drugs, cosmetics). Under its guidelines, you need to:
- Keep your facilities extremely clean.
- Train workers on proper procedures.
- Use only approved ingredients/materials.
- Document every step of your manufacturing process.
- Regularly inspect and maintain equipment.
HACCP (Hazard Analysis Critical Control Points)
Food safety system to prevent contamination and foodborne illness, HACCP protocols expect you to:
- Identify where food could become unsafe (like temperature, bacteria).
- Monitor these danger points constantly.
- Take immediate action if something goes wrong.
- Keep detailed temperature and safety records.
- Train all your food handlers.
What are Essential Manufacturing ISO Standards?
ISO standards are international quality guidelines that you can choose to follow to improve your operations and prove your quality to customers. Unlike government compliances (which are mandatory), ISO standards are voluntary but can give you major competitive advantages.
Some examples of ISO standards that apply to manufacturing include:
1. ISO 9001 (Quality Management System): The most basic production quality management standard that helps manufacturers make products of top quality consistently to keep your customers happy. It's like having a proven checklist for running a well-organized factory that produces reliable products every time.
2. ISO 14001 (Environmental Management): Rules for reducing environmental impact by controlling pollution, minimizing waste, and using resources efficiently. It helps factories operate in an environmentally responsible way while often saving money on energy and materials.
3. ISO 45001 (Occupational Health & Safety): Guidelines for keeping workers safe and preventing workplace accidents. It requires companies to identify dangers, train employees properly, and continuously improve workplace safety conditions.
4. ISO 13485 (Medical Device Manufacturing): Extra strict quality rules specifically for companies making medical devices like surgical tools or pacemakers. It ensures medical products are extremely safe and reliable, as people's health and lives depend on them.
5. ISO 22000 (Food Safety Management): Comprehensive food safety system that prevents contamination and foodborne illness in food manufacturing. It combines HACCP principles with quality management to ensure food is safe from farm to consumer.
6. ISO 27001 (Information Security): Standard for protecting digital information and computer systems from hackers and data breaches. It's becoming essential for modern manufacturers who use connected equipment and store sensitive product designs digitally.
Challenges in Achieving Industrial Compliance
There are several challenges you can encounter while trying to remain compliant with various rules and standards, such as:
- Difficulty in handling complex regulations at the same time.
- Constant changes in the regulations and industry standards.
- Missing or incomplete records.
- Lack of communication and training of employees.
- Difficulty in adopting Industry 4.0 systems (IoT, AI, automation).
- Disconnected workflows across departments .
- Inadequate supplier oversight and undocumented quality checks.
How Can Industrial Manufacturing Compliance Software Help?
A manufacturing compliance software can automate complex tasks and free up your team to focus on production and growth. Here’s how it can address the above challenges:
1. Create a centralized dashboard that tracks all regulations in one place, automatically maps requirements to specific processes, and provides unified compliance status across all standards.
2. Automatically monitor regulatory updates, send alerts when changes affect your operations, and update compliance checklists automatically.
3. Digitize all documentation with automatic backups and create searchable databases that make finding documents instant.
4. Send automatic notifications when training is due, track who completed what training, and provide easy access to current procedures and work instructions for all employees.
5. Integrate with existing ERP, MES, and quality management systems, create shared workflows that cross departments, and provide real-time visibility into compliance status across the entire organization.
6. Manage supplier certifications and audit schedules, digitize quality check forms with photo capabilities, and create automatic alerts when supplier certifications expire.
How to Choose the Right Manufacturing Compliance Software?
Before choosing a manufacturing compliance software, you need to take into consideration certain factors discussed below:
- Assess your specific compliance needs and identify which regulations apply to your business.
- Check compatibility with your current ERP, MES, quality management software, or accounting systems.
- Choose intuitive interfaces that require minimal training for employees.
- Look for automatic task assignments, approval routing, and deadline reminders.
- Ensure the software can handle additional facilities, employees, and compliance requirements.
- Look for reliable data backup, disaster recovery capabilities, and role-based permissions.
- Choose vendors who have proven experience in your specific manufacturing sector.
Why Effivity Stands Out Among Compliance Management Software Solutions?
Effivity is a compliance management platform that completely automates the manufacturing compliance process through its integrated QHSE software. It helps manufacturers cut down on duplicate efforts, automate routine workflows, and make collaboration simple.
With its quick deployment, user-friendly interface, strong data security, and customizable workflows, Effivity ensures businesses can stay audit-ready without losing focus on their core operations.
Backed by excellent customer support and global recognition, Effivity is a compliance partner you can completely rely on. And that’s just scratching the surface explore the full range of Effivity’s features on our website today!
