Risk-based Compliance

Digitize your quality system to fulfill the new ISO, IATF, and FSMA compliance standards

Manufacturing Risk-based Compliance

Connect and Comply

Leverage built-in compliance capabilities to link compliance requirements to your processes, audit history, and corrective actions to more easily become and stay certified—mitigating risk to your customers and your business.

At a Glance

Document compliance standards and quality processes in a single, cloud-based system.

Speed audits by having all data available, accessible, and linked together in a single system.

Link compliance requirements to fulfillment activities, processes, and evidence documents.

Manage and maintain always-available historical records.

Error-proof your operations by operationalizing quality to prevent non-compliant behavior.

Make procedural instructions and contingency plans accessible from any connected device.

Why Risk-based Compliance?

The threat of quality failures is something that likely keeps you up at night. Despite industry efforts to institutionalize quality, failures still happen at an alarming rate resulting in recalls, personal injury, and deaths.

Many industries are trending toward risk-based quality compliance that focuses on mitigating quality risks through prevention versus detection. A few examples include:

  • The new ISO 9001:2015 standard for quality management systems (QMS) —which has been the basis for quality standards across most manufacturing industries--has been revamped after 25 years of use.
  • Many OEMs in the global automotive industry came together as the International Automotive Task Force (IATF) to develop more detailed quality management guidelines on top of ISO 9001:2015 specific to their automotive supply chains, The IATF 16949 will go into effect on September 14, 2018.
  • The food and beverage industry is experiencing monumental changes with the Food Safety Modernization Act (FSMA) to give the US Food and Drug Administration (FDA) greater authority over how food (both human and animal) is grown, harvested, and processed. The FSMA follows the ISO example by focusing on protective and preventative approaches with current good manufacturing processes (cGMPs), hazard analysis and critical control points (HACCP) as well as hazard analysis and risk-based preventative controls (HARPC).

What’s striking in all of these standards, is the increased accountability is being passed on to manufacturing suppliers. 

“When I audit a Plex user, I’m am confident that they will at least have the foundation for being compliant. The biggest problem I find with Plex users is that they don’t use enough of the software’s compliance capabilities.” Shannon Craddock, Programs and Accreditations Manager, Perry Johnson Registrars

The Plex Manufacturing Cloud for Risk-based Compliance

The Plex Manufacturing Cloud helps you mitigate compliance risks by linking specific articles from relevant standards to documentation and activities directly within the system, giving you the single source of truth that everyone can access. And to comply with documentation retention requirements, the Plex Manufacturing Cloud never deletes any data, so all historical data is preserved—offsite—forever. And because this documentation is “off-site” in the cloud, it can be accessed by anyone with appropriate permissions even after a catastrophic system or facility failure (such as fire, explosion, earthquake, etc.).

Operationalize Quality

  • “Operationalize” control plans by not allowing production to proceed without the proper setup, confirming the operator is qualified to operate a work center, or loading the wrong material.
  • Force compliance with checklists that may need to be completed and workflows to validate compliance requirements with documented accountability.
  • Checksheets automatically created from control plans and automatically presented to the operator as specified (every X pieces, every Y minutes, etc.).
  • Error-proofing such as field locations that are randomized to discourage operators from filling in “by rote” and can be populated directly from automated inspection devices.
  • Approved measurement devices are listed and may not be used if they are out-of-calibration.

Leverage High-Resolution Traceability

  • Rigorous track and trace using barcode labels and scanners.
  • A high-resolution traceability tree traces back to any process or quality failure and forward to any product that may have been shipped to a customer.
  • Ability to respond to recalls in minutes versus the hours (the FDA requires a four-hour response time) or days that are typical.

Gain Quality Visibility and Control

  • A workflow engine routes policies and procedural designs (as well as any changes) for management approval and accountability.
  • Encourages broad involvement in development of the quality system including visibility and/or involvement from leadership as well as customers and suppliers.
  • Automates the process of reviewing quality plans by notifying responsible parties of up-coming re-certification requirements before they are due.

Automate Contingency Plans

  • Contingency plans can be documented directly within the compliance framework and may contain checklists to ensure critical steps are completed.
  • Notify customers that a contingency activity has been initiated with automatic texts/emails/alerts and copy supervisors.
  • Initiate alternate documentation processes and complete contact lists for process owners, emergency contacts, and executives all from within one system.


Error-Proofing Your Business

Discover 6 Ways error-proofing protects your manufacturing business from costs of small product defects to a missed alert that results in machine failure.

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Data Sheet

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Overall Equipment Effectiveness

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Why should you choose Plex?

Discover more about the cloud ERP benefits Plex offers.

Plex is Built for Manufacturers

Smart manufacturing solutions are not all the same. For example, historical ERP software solutions involve painful implementation projects followed by challenging periodic updates – often forcing companies to go years without updating their ERP system. Meanwhile, these same companies lose value day after day as new features and functions elude them, only implemented with the next painful ‘big bang’ upgrade.

Smart manufacturing technology from Plex takes a different approach. No more waiting. No more upgrades. New features are added daily to a single line of code, shared instantly with all Plex customers. Those customers not only realize renewed value daily, but share best practices real time with other peer Plex customers, all of whom have access to exactly the same features, functions and capabilities enabled by a true, single software code SaaS cloud offering.

Smart manufacturing should truly be just that; solutions. Manufacturers are often tempted by vendors touting strong financial, accounting, and even retail ERP software solutions and systems. None of these, however, do the one thing they need particularly well – manufacturing.

Plex is different, offering the only smart manufacturing solution built from the ground up in the cloud and focused exclusively on manufacturing. At Plex, we know manufacturing isn’t just part of the business: manufacturing is the business. Plex smart manufacturing solutions are purpose-built to fit your manufacturing business needs, evolving with you while adding value daily.

Smart manufacturing technology is not all the same. Plex can help you be different. Find out how.

Manufacturers have moved beyond the need for non-integrated point solutions to solve their challenges – they require a true ERP system. Beyond individual, bolt-on products, an ERP system enables connectivity between companies, their customers and their suppliers.

An ERP system must fit the business needs of a given company, while offering a broad array of capabilities designed for that business. With an eye toward the future, the right ERP system gives companies the power to scale at their pace while adding constant value in real time.

Move your business forward with a true ERP system. Find out how.