How to Implement a Quality Management System

Once you’ve established the framework for your QMS along with the necessary processes to support the system, you can focus on the resources, training, and timeframe needed for a successful implementation.

At this point, you should have already selected the QMS platform or tool that best suits the needs of your business. If your QMS is restricted to a single process or team, you will most likely implement the full solution all at once. However, if you are using an enterprise QMS solution that encompasses multiple teams and processes, you might consider using a phased approach to implementation.

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6 STEPS FOR IMPLEMENTING A QMS

Assign a team to oversee the implementation

The group overseeing the implementation will vary based on the size of your organization and the type of QMS that is being deployed. Typically, the implementation team is comprised of employees representing various roles (i.e., engineering, quality, operations, procurement, IT).The team will be responsible for handling quality processes and data.

In the case of an enterprise QMS platform, team members will also oversee functions such as user administration, system configurations, access policies, and QMS integrations. Hence, they will require in-depth training far in advance of the scheduled deployment.

Establish a timeframe for deployment

When establishing a date for your QMS implementation, consider employee training and other key action items that need to occur beforehand. Also consider any significant activities that will be impacted such as an upcoming regulatory inspection or audit. Finally, allow for unforeseen bottlenecks that may deter the deployment.

Perform a risk assessment

Identify potential risks that are associated with the implementation. This could include lost resources, lack of employee adoption/buy-in, or technical issues. Formulate ways to either avoid or mitigate each risk prior to deployment.

Educate and train employees

Distribute the quality policy, manual, and other QMS materials to all employees to ensure that they have a clear understanding of their role in helping the organization meet its quality and compliance objectives.

If you are using an enterprise QMS solution, coordinate onboarding and application training with your software vendor. Ensure that trainings address the different types of users across your organization (i.e., account administrators, functional users, power users, team leaders).

Deploy the system

Deploy the QMS using either an all-at-once or phased approach. If you choose a phased approach, prioritize phases according to your current organizational structure and business initiatives. Start with the data and processes that are most critical to addressing your current weaknesses and helping you succeed. With each rollout, ensure that your business needs are being met, before moving to the next phase.

Measure effectiveness and adjust

Once the system has been deployed for a set period, conduct an internal audit and management review to evaluate its performance against targeted business objectives. Enterprise QMS solutions may include dashboards and analytics tools to help you easily assess performance data.

Key performance metrics include:

• Customer satisfaction
• Product nonconformances/CAPAs
• Engineering change order (ECO) cycle time
• Scrap and rework
• Employee training

Based on your findings, make the necessary adjustments. This may involve updating processes, retraining, or adding more resources.

DRIVING CONTINUOUS IMPROVEMENT

Assessing your QMS at regular intervals will provide a realistic view of how the business is performing and keep you on track with meeting your compliance goals. By keeping employees informed and up to date on performance outcomes, they will be encouraged to make process improvements that contribute to the organization’s success.