How to Simplify Manufacturing Compliance in 2018

Trends / How to Simplify Manufacturing Compliance in 2018
How to simplify manufacturing compliance

Summary: Compliance is mostly about tracking. Using software to track who made what decision, when they made it, and why will make getting and staying onside with manufacturing compliance much easier.


Compliance is a way of life for manufacturing companies.

It’s nothing new.

But in 2018, the task of remaining compliant is becoming more difficult. Things are changing that make it harder for manufacturers. Things like:

  • Decreased risk tolerance from regulators
  • The increased cost of mistakes (both at a brand and a recall level)
  • Increased incorporation of data via the industrial internet of things (IIoT): with more to defend, there’s a higher price to pay if things go wrong.

What’s more, we’re seeing regulations and compliance standards finally begin to update to match the devices we use every day.

For example, in 2017, the EU threw out the three primary regulation frameworks for med devices and replaced them with two new ones.

Likewise, in the US, the FDA has been steadily rolling out new regulations to make medical devices easier to identify and easier to track/control.

But it’s not just healthcare.

Regulatory requirements are changing for everyone across the supply chain.

Here are 3 things you can do to simplify your compliance processes.

1. Track everything

Staying on top of manufacturing compliance is really about one thing: being able to say who did what, when, and why:

What change was made? Why was it made? Who requested it and who approved it? When did the change happen?

Regulation is so focused on tracking because:

  • It helps assign blame for mistakes when they do happen, and regulators are fundamentally reactive bodies
  • It ensures a clear chain of liability
  • It’s an easy proxy to get the compliant behavior you want.

Basically, if a decision is anonymous, then rules are likely to be broken because there’s no consequence. If you track all the changes within your organization, then people have skin in the game and manufacturing compliance gets a lot easier to enforce.

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2. Invest in software

Tracking is better when it’s digital.

So the second critical step towards simplifying manufacturing compliance is:

Invest in software.

Software that helps you track the who, what, and why of changes and decisions.

Software that helps you track the who, what, and why of changes and decisions.

Using software to answer these questions solves a lot of problems that the manufacturing industry faces with offline tracking:

  • Offline processes struggle to cope with distributed global supply chains
  • Data doesn’t move quickly to where it needs to go, making audit preparation a slow, agonizing process

Second, software opens the door to automation, both streamlining and improving compliance documentation quality. This also frees up staff time to do what they love (which, I assure you, is not document compilation and audit prep).

3. Build in informal communications

Lastly, if manufacturing compliance is based on tracking data and information as it flows through complex supply chains, then organizations need to figure out a way to loop in informal communications.

Formal communication is the sort of thing that happens within industrial software. For example, if an ERP has a defined supplier payment workflow, the documentation generated there would be a formal communication.

Informal communication is how work actually gets done. It’s all the instant messages, emails, attachments, calls, and hallway conversations that make a complex product a reality.

If companies want to meet rigorous manufacturing compliance standards and don’t want to spend hundreds of hours digging through emails looking for something that might not even be there, they need to develop a way to link informal communication with the activity it’s about.

Slack, for instance, solves this problem by bringing all communications into a single, searchable program. For communication within Slack, it tracks amazingly well, and a lot of that informal communication is captured. But it doesn’t do anything for communication not in Slack.

We also solve this problem, but we opted for a project-based approach for the manufacturing industry.

Our system automatically attaches relevant Microsoft Office documents and emails to their relevant projects and allows users to manually do the same. This means that for a specific piece of work, say building a component for the new iPhone, the CAD, bill of materials, and any other documents that have been generated to push that project over the line are all connected and can be collated and analyzed at the push of a button.

Bullet point summary

  • Manufacturing compliance is mostly about tracking decisions and explaining why changes were made.
  • Tracking gets a lot easier when that tracking is digital, especially as more and more suppliers get involved.
  • Tracking informal communication is just as important as tracking formal communication that happens within structured workflows. However, the manufacturing industry often ignores this which makes manufacturing compliance much more challenging.
  • Organizations who can track formal/informal communications and link those together in a project-centric way will see their manufacturing compliance get a whole lot easier.

Image credit: Pexels

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2018-12-12T11:36:28+00:00April 17th, 2018|Categories: Trends|Tags: , , , , |