let desire drive regulatory & compliance changes

Let Desire Drive Regulatory & Compliance Changes

In Quality Management by Frances DonnellyLeave a Comment

let desire drive regulatory & compliance changes

Through 2014 and on into 2015 we will see a host of regulatory changes affecting business in a broad range of industries.  We expect the most significant impacts will be:

  • broad based rules and guidance from FDA for food safety;
  • the expected release of ISO9000:2015;
  • Universal Device Identification for medical devices;
  • Global harmonization for chemical classifications.

Even Companies Without Compliance Requirements Face Regulatory Impacts

With such broad upcoming regulatory changes, companies in the supply chains of those directly affected will be surprised to find they are also being pulled into the regulatory net and may struggle with lack of preparedness for such efforts.

The Challenge of Change is Hardest When Forced

While this kind of mandated change is always difficult, the changes around quality and regulatory requirements can be significantly more challenging when viewed as “forced upon” an organization. This is most clearly seen in the way companies manage their change processes.

This mindset of regulatory needs being “imposed” creates a culture of non-planned change. And this results in resentment for the change, less effective planning and less comprehensive oversight, than in a self-selected scenario.

The Managerial Mindset Shift That Benefits Change

The root of this difference in execution seems to be that it is difficult for management to acknowledge they will need to divert resources in order to:

  • understand the nature of these outside changes
  • adapt existing business systems to adequately fulfill the new requirements

In the absence of the kind of management buy-in that accompanies a self-selected project, we see there is a struggle to:

  • find resources
  • engage participation by staff members
  • complete the projects in a timely and low risk manner

If your team is struggling to adapt your business processes successfully to accommodate the upcoming regulatory changes in your industry, you may find that a “want to do” perspective leads to better outcomes than a “have to do” mindset.

Change that is Self-Selected Creates Commitment to that Change

A best practice for achieving regulatory compliance is to address needed changes as desired quality or business improvement programs, in other words consider them as self-selected projects. This allows your organization to approach change as a core value, rather than a resented enforcement from outside parties.

Doing so allows management to acknowledge that completing the project effectively is a relevant use of resources. Commitment is made with enthusiasm, project scope is completely defined and required resources and timelines are developed and budgeted.

If you find your team is struggling to meet upcoming deadlines consider revamping your processes and actions to look like they belong to a self-selected project.  A thoughtful examination of the data may help you uncover a value to your organization in meeting the requirements that will make it look more like a project people want to do rather than one they have to do.

What are the changes in your industry on regulatory requirements? How do they impact your business?

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