The quality plan is a very essential document, because it outlines the procedures/methods you intend to follow in the project to ensure that the product you develop meets all quality standards of your company and regulations of the governing body. 21 CFR 820 Subpart B states, "Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured. The manufacturer shall establish how the requirements for quality will be met.” I would say yes, it is really needed, because if you don't have a strategy in place to define how you are going to assess the quality of the product, how can you be confident that you will be able to develop a product of high quality? It follows the same concept as the planning phase in project management. Can you just skip the planning phase and move right into execution? As we learned, the planning phase is a vital phase of project management to make sure the rest of the project runs smoothly and ultimately is successful. I believe the same concept applies to the quality plan.

I am unable to post the link to the article I referenced, but the website is MDDI (Medical Device and Diagnostic Industry), article title is Medical Device Quality Planning.

In the purpose section of the QSPT (quality system plan template) the question of “Why?” must be answered. The purpose of this document is to ensure a quality system plan is in compliance with new and revised regulatory requirements. I think its advised to do research on existing products to learn about any new issues that happen to previous companies that had a similar device. This is a job for the project manager speaking of it. However, this document will help with preventing recurring quality issues. From MDA website it states also “maybe a faster development cycle”. This document can improve this cycle by improving the planning of these devices in coordination with speaking to manger wither operational, functional, project etc… I

I agree with krp67 -- the question of why is very important when it comes to any sort of development. Why is something being created? Why must it go through quality? Why did other companies fail at certain points? That why allows the project manager to understand what must be dealt with and in what way.

For example, the FDA just released a new document that lists out the rules and regulations for 3D printed devices meant for medical use. Therefore, any project manager that heads a current or future 3D printed medical device must consider the why of each regulation and ensure that they follow the guidelines to avoid any issues that might be have been caused in the past.

The quality plan or quality manual of a company shows the commitments of the company to quality and compliance. Upper management has executive responsibility. Some companies adopt clauses written within ISO13485:2016 to show compliance. The Quality Plan is designed to monitor, maintain and control the processes and to drive and sustain the continuous quality improvement of the products. You need a team of cross-functional members to carry out the actions associated with the quality plan. So to answer merzkrashed's question, yes the quality plan is essential to have.

I think that the quality plan is important because the quality plan defines how quality can be achieved in a project. Quality plans determine a plan for meeting relevant quality standards and maintaining quality through the project with quality events. Planning these quality elements can be important in meeting the overall requirements and goals of the project while ensuring that the project is on track throughout the process. Creating a quality plan also gives the team a single document with a lot of information regarding the product.

The Quality plan is an important and essential part that should be implemented. As stated by puneet, there is a certain quality standards that must be maintained throughout the project. Also, “...deploying and executing a quality plan incorrectly can lead to compliance gaps and actually create more problems than it solves”. A correctly produced quality plan can save time as well as catch small problems.

You can read more about the importance of the Quality Plan on Medical Device Quality Planning | MDDI Online

I agree with hc225 that most countries adapt the structure of their plans from the standards written in ISO13485:2016. Medical products need to be of highest quality to deliver confidence and reliability for the health care professionals and patients using the product. Being said, the project quality plan and its trace matrix are essentially the backbone to the project. These documents restate the project scope/plan from the DDP, define the quality criteria, and the list of procedures based from regulatory requirements to manufacture a product of high quality demands. The project quality plan and its traceability to other relating plans and reports are live documents that are updated from project inception to product launch. The Quality Plan incorporates cross-functional input, intertwining plans such as the project management plan, market strategy plan, product development plan, systems and software plans, regulatory plan, operations plan, reliability plan, etc.

Quality will eventually be one of the largest resources a company has is its ability to be confident that the product is able to perform after distribution. The quality testing will also come under high scrutiny from the FDA. After Research and development has been completed and clinical trials are finished the quality procedures is what will maintain the product being sold being the same product that was approved. The audits that will come will often focus strongly on the quality department. All aspects of a project should be planned from the beginning of the project to ensure that a higher quality product is the outcome.

Regardless of the project’s type, size and scope, it is important to create a high-performance quality plan template that includes all the tasks and activities required for setting up quality targets, assuring expected performance levels, controlling changes occurring in the project, and implementing the quality management process. Planning for project quality in advance allows you to understand possible problems and investigate root causes of those problems.

It’s nearly impossible to successfully implement improvement strategies in any project if there are no management procedures for developing quality vision and setting up quality expectations.

Managers consider quality planning in conjunction with the rest of the project planning because it influences costs, scheduling and other factors. Without strong quality planning, a project carries an increased risk that the client won't be satisfied with the results.

In quality planning, the project manager defines and systematizes the principles the project will be required to meet to be successful, and how those guidelines will be accomplished and affirmed. Managers consider quality arranging in conjunction with whatever remains of the project planning since it impacts costs, scheduling and other factors. Without strong quality planning, a project carries an increased risk that the customer won't be happy with the outcomes. Quality assurance systems should be defined and executed, regardless of whether that comprises of audits, product testing, peer review or other measures.

Okay so discussing about "quality plan" for medical devices and so it outlines policies, procedures, guidelines, and activities relevant to that device. The manufacturer shall establish how the requirements will
be matched. Summarising I would say that quality plans are powerful tools in demonstrating compliance. But not writing it properly would create more gaps than company is trying to close.

I think quality control plays a big role for the project. Quality control set the expectation of requirement before the project goes to mass production. I believe many companies may do the same product. However what differentiates one from the other is the quality of the product. the set expectations vs the output of the product. It about developing the project to meet customer need and expectation with the highest quality output.

A quality plan is a document, that together specify quality standards, practices, resources, specifications, and the sequence of activities relevant to a particular product, service, project, or contract. Quality plans should define Objectives, steps in the processes that constitute the operating practice or procedures of the organization, allocation of responsibilities, authority, and resources during the different phases of the process or project, specific documented standards, practices, procedures, and instructions to be applied, suitable testing, inspection, examination, and audit programs at appropriate stages, a documented procedure for changes and modifications to a quality plan as a process is improved, a method for measuring the achievement of the quality objectives.