Compliance Management 101: Process, Planning, and Challenges
Compliance is required everywhere and has therefore become relevant to most businesses. Whether that’s complying with rules around data, user privacy, or even physical safety, consumers are heavily dependent on regulations and standards to protect them.
When you dive into regulated industries that create sophisticated, tangible products — automotive and medical device, for example — compliance becomes quite intricate. If something is missed early in product development but isn’t discovered later in the workflow, the time and cost needed to go back and fix it can be enormous.
The key to avoiding costly mistakes and risking noncompliance is effective and holistic compliance management.
- What Is Compliance Management?
- Compliance Management Process
- Creating Your Compliance Management Plan
- Challenges in Compliance Management
- Final Thoughts
What Is Compliance Management?
Compliance management is the ongoing process in which managers A) monitor and assess systems, as well as B) organize, plan, control, and lead activities that ensure compliance with applicable legal, regulatory, and industry standards.
As the consequences of noncompliance can devastate a company and its reputation, it’s critical to have a living compliance management process that accounts for the entire product lifecycle.
If that sounds to you like a giant undertaking, you’re right. But with your company — and sometimes lives — at stake, it’s necessary to have a compliance management plan that works.
Compliance Management Process
How you approach compliance management will depend on the standards you must meet, buy-in from stakeholders, and the resources you have available. Understanding and mapping these elements will serve as the foundation for the compliance plan, and will define accordingly the roles, responsibilities, and processes.
The compliance management process and compliance management plan are synonymous. However, there may be a process separate from the plan if you need to obtain/implement new tools, review corporate policies, align corporate leaders, etc. before you can proceed with writing the plan.
To understand what you need to develop a compliance management plan, know that it has to:
- Account for all potential risks in the product lifecycle
- Be clear and understood by all who abide by it
- Clearly allocate responsibilities
- Work seamlessly within your workflows so as not to create inefficiencies
- Make clear when violations occur so they can be corrected
Creating Your Compliance Management Plan
The plan itself will include the steps and activities that must be followed to ensure compliance. It should go hand-in-hand with your internal compliance audit process, as they have shared goals. (Get compliance audit best practices here.)
As you write your plan, follow these tips to help ensure that you cover everything.
1. Conduct a Thorough Risk Assessment
In the majority of industries, regulatory standards are well defined and serve as the foundation of the compliance plan (indicating the potential risks and how to mitigate those by implementing a structured and governed process).
In addition, based on your acquaintance with the business process of your company, you should identify where potential failures could occur, what they look like, how to prevent them, and how to correct them.
This notion doesn’t necessarily need to be tied to a regulation, but to a good understanding of the business, customers, and main pain you are trying to resolve with your product — along with any other business factors that should be considered.
2. Establish Corporate Policies and Procedures
Compliance should be a top-down initiative, and everything your risk assessment covered should sculpt your policies and procedures.
3. Communicate the Plan and Provide Training
Remember that the greater the risk, the more attention to detail is important. Help employees understand the gravity of accuracy. Also make training as easy as possible to understand. That can mean anything from bilingual training to providing specific examples. They cannot follow a process if they don’t understand it.
4. Account for Routine Maintenance
A number of things fall into this category. The compliance manager is responsible for:
- Staying current on standards
- Ensuring that all employees understand requirements
- Aligning business functions with compliance
- Reviewing processes and operations (and making changes when necessary)
- Recording and correcting violations when they occur
5. Conduct Periodic Compliance Audits
If compliance is relevant to you, then you probably get audited routinely. But you should have internal audits as well. They’ll help you avoid mistakes that can be irreparable.
Challenges in Compliance Management
Compliance management itself is challenging. But there are a few things that can make it extra complicated. Here are some hurdles you may want to get ahead of.
Distributed Teams Across Multiple Platforms
In an increasingly remote world, it’s difficult to both assess risk from the complete picture, and also implement procedures across disparate systems. A tight compliance management plan may involve investing in new technology that improves visibility and team alignment.
Volatile Security and Compliance Landscapes
Advances in technology and security threats mean compliance can change quickly. Consequently, swift updates may be needed without much warning, and — as mentioned above — someone has to be responsible for keeping the plan up to date.
Using Third Parties
It’s likely your organization relies on consultants, manufacturers, suppliers or vendors, as well as other external parties as part of your product lifecycle. It is clear that you can’t be there to manage their processes for compliance purposes. What you can do is to notify all third-party entities you’re working with of your compliance management standards, require them to fully align with them (get their commitment to follow the standards you have set forth,) and also provide evidence (audit reports) for doing so.
The best example from the product lifecycle management would be the ability to share requirements and track any change related to those requirements. In the automotive space, the expectation to follow the ReqIF standard for importing/exporting requirements is the way to comply with standards and ensure alignment between all parties involved.
Clarity in Language
This is another issue worth repeating. Think of this like you do the definition of done in testing. Use very clear language, being as specific as possible about what it looks like to be compliant, and consider the complexity of what you’re asking vs how easy it is to read.
Choosing Between a Rigid and Flexible Approach
While some compliance issues are cut and dry, there can be cases where gray areas occur. Sometimes this happens when there are two conflicting sets of standards, and you need to make the call on which is most important.
Enforcing compliance management — and proving compliance — are easiest when you have traceability for the entire product lifecycle, and a single repository that captures every change and every action taken. Furthermore, you want to be able to activate security functions like those that prevent certain users from making changes, or from skipping steps. Compliance management is a much less complicated when you have a tool that automates these things for you.
One such tool is Helix ALM. Not only does it provide end-to-end traceability and offer security controls designed to keep you compliant, it also can be configured to fit your workflow. So implementation does not completely upend whole teams.
Watch the demo recording to see for yourself how Helix ALM simplifies compliance.