A Quality Plan clearly defines what the quality management system is supposed to achieve. Quality planning means that you are going to make a device according to the project plan . Beside the project is completed on time and in budget since quality plays an important part means right product is deliverable to the customer . In Quality planning project manager sets the standards for a successful project. Quality planning focuses on taking all of the information available to you at the beginning of the project like customer needs and fitness to use and figuring out how you will measure quality and prevent defects . Make sure project follows the company policy and any government rules or regulations on how to plan quality for your project. The Plan also defines what Total Quality Management document and training are needed to ensure consistent results. It helps to create a plan for periodic review and improvement and how to take corrective action if something went wrong.

A quality management plan is defined in our PMBOK guidebook as "a component of the project or program management plan that describes how an organization's quality policies will be implemented". This is especially important in the biotech field in which products mainly act by interfacing intimately with a patient in such a way that even the slightest defect in the device can result in it causing more harm than good. The FDA was the first major entity to take action against the risks and hazards of faulty medical devices and has since enforced the formation of quality departments within any production company (not just biotech). Quality assurance states the certain standard of acceptability that a device must pass in order for it to further develop, which in turn governs the regulations of quality control who in turn must ensure that a product's output meet its set standards. The necessities for generating a quality plan would be a project to start as well as the proper documents and paperwork that clearly defines the product/project and how the quality plan addresses any and all associated risks/hazards associated with device use.

As mentioned in lecture, an important role of a quality department is to anticipate FDA audits and handle them in a way that all questions are addressed and the product can properly be submitted for animal/human testing or proceed to market. What expectations may the FDA have when conducting their audits in a biotech manufacturing facility? How might their level of scrutiny change depending on the classification of the device? What might be a few reasons as to why an IND (investigational new drug) or IDE (investigational device exemption) might get rejected by the FDA? Are there any known cases of major biotech projects having to stop midway due to an FDA discrepancy?

"A Guide to the Project Management Body of Knowledge (PMBOK Guide)" (2013) project Management Institute, pp 247-248.

In my experience working in clinical diagnostic laboratories I have had to adhere to many quality control standards and guidelines. When a new device is being validated for clinical use it must have a clear quality control procedure and tracking system developed. If the quality control documentation can not be traced back to when the device was first put in use there will be discrepancies during audits which can lead to a lab losing its credentials (in extreme cases but most times if it is a small discrepancy a simple write up or a fine may be issued). More importantly, all the cases that were ran during the time of discrepancy may be deemed invalid, which can cause serious implications, especially dealing with clinical diagnosis of disease. In project management, in addition to compliance and regulations, a quality plan is what is going to ensure that your company is going to be able to output the same standard of service with its devices from day one up until the product comes off the market. For example if you're a producer of artificial hips, a quality control plan sets the standards for the kind of product you are going to release into the market, you need to be able to state with confidence how long that hip will last. If an artificial hip produced according to the proper protocol is supposed to last 20 years, your quality program will make sure that this the kind of quality hip being produced. A good quality plan will in turn reflect positively on your company and allow the customers in the market to purchase from you with confidence.

Quality plans are essential in any project, although in many cases the project manager won't give it the priority. QP can be defined in project management as "a set of planned, systematic actions to ensure that products and services comply with specified requirements. It not only involves checking the final quality of products to avoid defects, as is the case in quality control but also checking product quality in a planned way through all the production stages. It is the development of work and product design procedures to prevent errors from occurring in the first place, based on planning, backed up by quality manuals and tools."
I found this explanation very clear to show the importance of QP in any project, regardless of its size and field.
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Project quality components include :
- Management responsibility
- Documentation
- Design control
- Development control
- Testing/quality assurance
- Risks and mitigation
- Training rquirements

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I think quality planning is a critical part of any project in the medical field. It allows an individual to agree on a set of quality targets with your customer. A quality plan helps you to schedule all of the tasks needed to make sure that the project meets the needs of the customer. It comprises two parts which are the quality assurance plan and quality control plan. Quality assurance plan lists the independent reviews needed and quality control plan lists the internal reviews needed to meet the quality targets. A quality plan is important because it states everything that team is going to do, to ensure the quality of the solution.

The quality plan is needed for many different reasons. The quality plan document verifies the internal and external standards and procedures. Besides that, the document also provides some insight as the business' quality management system because it requires one to gather information regarding the quality assurance methods, specifically the results that are yielded from implementing such methods. A quality plan protects the project, product and customers from legal liability because it lists all of the expectations beforehand. Some of the things that are included in a Quality Plan include: goals/objectives, procedures, testing requirements, and roles/responsibilities of the individuals involved. The goals/objectives are the purpose of the plan document and describe the expected results. The testing requirements are details such as the testing site, ad who runs the tests at the location. The roles and responsibility of the members involved should be written in the document so that everybody is aware of what is expected of him/her.

Quality plan is very important because as other stated it helps test the quality of the product that is going to be release to the public. There are so many risk that a new product can have and in order to avoid causing harm to their customer and their reputation. They must layout all possible risk. The first step that the quality department must do is analysis the risk and from there, use test/management solutions to fix the issues that the product may have in harming. The quality plan helps reach the customer's requirements. It is a way to keep the product safe, effective, and dependable. Any test, method, or step procedures must be documented in order others can be able to inspect the quality of the product.

Quality plan itself defines the quality of the product, which includes certain policies, documentation, procedures and tests for the medical devices. As the medical devices already overcomes with many researches and many test on animals as well as in humans. Then it goes into documentation and approval tests where quality requirements are taken into consideration. Then finally medical product comes into the market. so that's why Better quality makes the medical device best.

Quality plan is a documented plan that outlines the quality policies, procedures, practices and guidelines for the project while establishing quality expectations and metrics. These plans are written which are used as the checklist to ensure that the process or the project is satisfying the quality requirements for the project. I think Quality plan is needed because it ensures that the products of the company meet the applicable requirement and specifications. It helps to achieve greater consistency in the activities which involves providing products or services, it helps to reduce expensive mistakes and increases the efficiency by improving the use of time and resources. It is needed to coordinate and direct the activity of the organization to meet the customer and regulatory requirements and improve the effectiveness and efficiency on the continuous basis. Quality plan also improves the processes and reduces the waste. The components of a project quality plans include: Responsibility of management which describes how the management is responsible for achieving the project quality. Document Management and control which is used for communication between the team members, project management, senior management. Requirement scope which includes the abstraction of the requirement of the sign-off documents. Then the quality plan requires the design control which specifies the controls and procedures used to design phase of the project. Development control and rigor is next step in the quality plan, by this control. The project management makes sure the project is progressing in the correct path. Testing and quality assurance includes the project quality takes precedence over other components. Quality assurance identifies the objectives for the project and approach to achieve them. Risks and Mitigation identifies the project quality risks. The project management teams should come up with appropriate mitigation plans to address each quality risk. Then next step includes quality audits which is used to measure the adherence to the quality standards. These audits can be done by an internal or external team. Defect management is next step in quality plan which ensures that the plan follow the guidelines and instruction on how to manage the defects. Training requirements, every team requires training before the project commences. Conclusion is one of the mandatory documents for the project.

Quality planning refers specifically to the actions of the project management team and or the project management team leader to engage in the action of establishing and conducting a process for the purposes of identifying and determining exactly which standards of quality are in fact relevant to the project. All these are contained in a quality plan document which also includes or specifies quality standards, practices, resources, specifications, and the sequence of activities relevant to a particular project, and that goes together with a project plan.

A quality plan in project management planning is very important because it helps to determine the scope of what’s going to be measured, what metrics will determine whether the project is successful, and how those will be satisfied, from beginning to end. Which will includes some of these objectives like metrics that are specific, measurable, cost, agreed-upon, realistic and time-bound. Project managers must go beyond the traditional metrics of scope, time, and cost. A key aspect of quality planning is for the project manager to understand the processes his or her project is impacting. The project manager must then develop process measures for the project so as to measure the impact of recommended changes to those impacted processes.

Also, it helps to keep the project on course and help identify quality problems early. Without strong quality planning, a project carries an increased risk that the client won't be satisfied with the results.

Reference: PMBOK 3rd edition