Compliance Management: Process and Planning

Compliance is needed everywhere and has thus become significant to the majority of businesses. Consumers rely heavily on regulations and standards to protect them, whether it’s data privacy, user privacy, or even physical safety.

Compliance becomes quite complicated when you dive into regulated industries that create complex, tangible products, such as automotive and medical devices. If something is missed early in the product development process but isn’t discovered until later in the workflow, the time and money required to go back and fix it can be enormous.

In our previous article, we explained what compliance is and its importance. We also discuss the compliance issues faced by HR in the USA. If you missed it, click here.

Effective and holistic compliance management is the key to avoiding costly mistakes and the risk of non-compliance. In this post, we are going to explain the compliance process and planning. 

Understanding Compliance Management

Compliance management is an ongoing process in which managers A) track and evaluate systems and B) prepare, strategize, control, and lead activities to comply with applicable legal, regulatory, and industry standards.

Because the consequences of noncompliance can be devastating to a company’s reputation, it’s crucial to have a living compliance management process that takes into account the entire product lifecycle.

If that sounds like a massive undertaking, you’re right. But, when your company’s reputation — and often just lives — are on the line, you need a solid compliance management strategy.

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Compliance Management Process

The approach you take to compliance management will be determined by the standards you must meet, the buy-in of stakeholders, and the assets you have available. Understanding and mapping these components will set the stage for the compliance plan, defining roles, responsibilities, and processes accordingly.

The terms compliance management process and compliance management plan are interchangeable. However, there may be a separate process if you need to acquire additional tools, review corporate policies, align corporate leaders, and so on, before you can write the plan.

To understand what you need to create a compliance management plan, keep in mind that it must:

• Consider all potential risks throughout the product’s lifecycle
• Be clear and understandable to all who follow it
• Assign responsibilities clearly
• Seamlessly integrate within your workflows to avoid inefficiencies
• Indicate when violations occur so that they can be corrected

Constructing Your Compliance Management Plan

The plan will outline the steps and activities that must be completed in order to ensure compliance. It should work in tandem with your internal compliance audit process because they have similar objectives.

Follow these tips as you write your plan to make certain that you cover everything.

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Conduct a Comprehensive Risk Assessment

In the majority of industries, regulatory standards are well-defined and serve as the backbone of the compliance plan (indicating the potential risks and how to mitigate those by implementing a structured and governed process).

Furthermore, you should be able to spot possible failures, what they look like, how to avoid them, and how to correct them based on your familiarity with your company’s business process.

This concept does not have to be tied to regulation but rather to a thorough understanding of the business, customers, and primary pain points you are attempting to address with your product—as well as any other business factors that should be considered.

Create Corporate Policies and Procedures

Compliance ought to be a top-down initiative, with your policies and procedures shaped by everything your risk assessment uncovered.

Provide Training and Communicate the Plan

Remember that the higher the risk, the greater the importance of attention to detail. Assist employees in understanding the importance of accuracy. Make training as simple to understand as possible. This can include anything from multilingual training to specific examples. They cannot follow a procedure if they do not comprehend it.

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Consider Routine Maintenance

This category includes a variety of items. The HR manager working on compliance is in charge of:

• Keeping up with standards
• Make sure that all employees understand what is expected
• Aligning business functions with a regulatory requirement
• Examining processes and operations and making changes as needed
• Violations are recorded and rectified when they occur

Perform Periodic Compliance Audits

If compliance is important to you, you are most likely audited on a regular basis. However, you should also conduct internal audits. They will enable you to avoid costly mistakes

Conclusion

Attempting to enforce compliance management and clearly demonstrating compliance is made easier when there is traceability throughout the product lifecycle and a single repository that records every change and action taken. Furthermore, you should be able to activate security features such as those that prevent specific users from making changes or skipping steps. When you have a tool that automates these tasks, compliance management becomes much less complicated.

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[To share your insights, please write to us at sghosh@martechseries.com]