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.