The Quality Management Plan documents the necessary information required to effectively manage project quality from project planning to delivery. It defines a project\’s quality policies, procedures, criteria for and areas of application, and roles, responsibilities and authorities. Quality is the degree to which the project fulfills requirements.
The purpose of the Quality Management Plan is to describe how quality will be managed throughout the lifecycle of the project. Quality management planning determines quality policies and procedures relevant to the project for both project deliverables and project processes, defines who is responsible for what, and documents compliance. A Quality Management Plan is developed by a contractor.
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Quality and cost are two of the top criteria most companies look at when seeking a contract manufacturer. The reasons are obvious. If your product doesn’t meet the definition of quality defined by industry standards or the consumer your product is doomed to failure. Every product development project whether a new product or changes to an existing one has a Quality Management Plan.
What Is Quality Management?
Quality management all comes down to how you make sure everything you create in a project is of value and maintained well. It may be seen throughout all phases and roles of a project if implemented well.
To understand quality management, we also need to understand what “quality” refers to. There are two key aspects of quality management:
Product Quality
This is your actual, tangible product. It could be the app you have built, the design prototypes your designer team built, or even the code documentation your developers wrote.
Process Quality
As project managers, we are responsible for creating and maintaining processes. However, in the context of quality management, we must also consider the quality and impact our processes have on our team’s ability to deliver results. Quality here might be measured by metrics such as velocity.
Commonly Used Qms Types in the Medical Device Industry:
- ISO 13485
- FDA QSR (Quality System Regulation)
- MDSAP (Medical Device Single Audit Program)
- GMP (Good Manufacturing Practice)
Why Is Quality Management Important?
Deliver a Quality Product
When you are practicing quality management, the actual results of what your team has created will be significantly better and more stable. Your end-users will be happier and more satisfied with what you were able to ship.
Decrease Overhead
By integrating quality management throughout your work, quality is present at every step. This means that there is less room for error because the process, plan, and alignment is stable and may have built-in contingencies. There are fewer unknowns, which opens up more space for your team to create great results.
Increase the Delivery Pace of your Team
Results are met on a healthier cadence, which creates trust with your users and stakeholders. Your team becomes known for quality, consistent output, and can be trusted to continue to do so.
Increase Collaboration and Review
Because quality is part of every phase and everyone’s role, all team members help ensure the project is of the highest quality. Developers may engage in test-driven-development. Stakeholders may speak into defining acceptance criteria and what acceptable quality means. Test engineer roles focus on exploratory testing and finding edge cases.
The reasons for creating a Quality Management Plan and insisting on seeing your contract manufacturer\’s quality plan are many. The quality plan:
- Directs conformance to the customer’s requirements.
- Verifies your own external and internal standards and procedures.
- Provides traceability.
- Provides objective evidence.
- Indicates where training is needed.
- Offers insight into the effectiveness of the organization’s quality management system.
A Quality Management Plan, rightly applied, protects the project, the product, the customer and the contract manufacturer/supplier because it lays out all the expectations in writing beforehand.
The components of the Quality Management Plan are discussed and agreed upon before anything else happens. The goal is no surprises of the negative kind.
What to Include in Your Quality Management Plan
- Goals/objectives – This should include the product specifications, use, aesthetics, cycle time, materials, and cost.
- Process steps or procedures
- Distribution of responsibilities – Who does what and when?
- Standards – What are the practices and procedures that need to be applied?
- Testing requirements – When does testing take place? Who performs it, and where?
- Change/modifications documentation procedure – Gives you a way to track changes to the project or process.
- Quality process measurement – A way to measure the value of the quality document itself.
- Other actions as needed to meet the objectives.
In conclusion, Quality Management Plan is a robust framework that touches all aspects of your project from start to finish. It requires the involvement of all project team roles and stakeholders; however, with the template in this article, you can quickly get started on a robust plan of your own. Once implemented, you will be able to instill a deep quality focus throughout your team’s work that will be represented by those who will see the results of your project.
