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Wesley Gomez
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Quality Management System Ppt Download 11 __FULL__

Every life science company knows that quality is of the utmost importance. But defining quality and aligning that definition to regulations requires an intentional approach known as a QMS. QMS stands for quality management system and is an acronym used to describe the comprehensive system that a company uses to manage quality throughout its operations.

quality management system ppt download 11

Given that we're defining the quality system, it may be useful to understand the meaning of quality in this context. At a fundamental level, quality means that a product or service meets applicable requirements (customer, regulatory, or other).

For products, quality is often verified by inspecting the product and making sure it is the right size, color, etc., and also looking at materials records to make sure it is made of the correct materials. For a service, quality may look like adhering to processes and procedures for cleaning up a job site, using correct materials and techniques to complete the work, or simply making sure the customer receives the service they are looking for.

The purpose of implementing a QMS is to ensure consistent quality of products or services, especially as the organization grows and must verify that everyone is consistently meeting standards while manufacturing products or providing services.

A QMS structure is much like a pyramid. The pinnacle document that simply and elegantly defines the goals of the QMS is the quality policy. From there it cascades down into a quality manual, quality objectives, procedures, processes, work instructions, and more.

Before developing and implementing a QMS, an organization must find their quality bearings. A QMS starts with a quality policy, which acts as a guiding principle for building the rest of the system. While the quality policy is just a statement, it is the 'north star' of the QMS and will be important for establishing a culture of quality.

A QMS is driven by several top-level documents that guide the development of the rest of the QMS. These documents will act as anchors to ensure consistency as the rest of the QMS is developed. The top level documents for any QMS is the quality policy, quality manual, and quality objectives. When you begin creating a quality management system, the first step should be to draft a quality policy.

A quality policy should be a simple, straightforward statement that makes it clear what the company priorities are. A quality policy can be revised down the road if necessary, but since this is a key anchoring component it is best to take some time to think it through and get it right the first time.

The Widget Company is committed to building quality, compliant widgets to support our customers in their endeavors. This commitment is demonstrated through quality processes that are executed by well-trained personnel to produce consistent results every time. Our management team is dedicated to continually improving and innovating to better meet customer needs.

Based on this policy, it's assumed that the Widget Company will have a strong focus on processes that run well and personnel that are trained to know how to do their jobs well. It also identifies that management is responsible for continual improvement and innovation. This policy can then be used to develop quality objectives to ensure that the values outlined in the policy are adhered to.

A quality manual is an overview of the entire QMS that can be given to a customer or auditor to help them quickly understand how the QMS is structured and which QMS area, if any, the organization is exempt from or otherwise does not apply to their system

The quality manual should be almost an outline format and should not contain details of the procedures or processes. Flowcharts, tables, and other visual representations of the information are helpful and appropriate for the manual. The manual should also identify the hierarchy of quality documents. For example:

The top level documents provide a basic framework and starting point for the QMS, but they do not contain enough detail to ensure quality. A QMS needs various policies, procedures, processes, documents, and records to maintain consistent quality and document evidence of that quality.

A QMS should include a clear and current model of the organization's structure and the responsibilities of all individuals within the organization. This is typically accomplished with an organizational chart, which visually shows the roles and the flow of responsibility. This can be embedded in the quality manual, but is typically managed as a stand alone document and referenced within the quality manual. For ISO 13485, this document should identify who is serving as a Management Representative (usually the Quality Manager).

In a QMS, all documents must be controlled and all records must be retained. Think of documents as procedures, form templates, the quality manual, work instructions, approved supplier lists, and other documents that contribute to making the product in any small way. Document control means that these documents must be revision controlled so that any changes to the documents are correctly approved and evaluated for any potential effect on production or product risk. Further, these document changes must be communicated to all necessary personnel and any copies that have been distributed must be replaced with the new revision. All of these processes must be documented.

The entire QMS approach to quality control is to establish standardized, replicable processes throughout the organization. This means processes out on the production floor just as much as the document control process taking place in the corporate offices. Standards for quality management require organizations to identify and define all organizational processes which use any resource to transform inputs into outputs. Virtually every responsibility in the organization can be tied to a process, including purchasing.

It may be helpful to develop a process map that identifies how all of the processes are interconnected. This is useful not only for identifying potential bottlenecks that will have significant ripple effects, but also to help personnel see how their role and responsibilities has an effect on everything else in the company. Helping personnel see that their role is important to the bigger picture is helpful in building a culture of quality and personnel that know they are valued members of the team.

Having access to data to make data-driven decisions will allow the QMS framework to drive continuous improvement and preventative quality control activities. Data analysis should be used to identify processes or systems that are out of control as early as possible instead of waiting until major nonconformance occurs. The organization must have plans in place for collecting this data and performing statistical analysis on the data. This data may then be used to assess if the quality objectives are being met and/or other metrics that the organization has established. It is common to compile this data to create a quality dashboard to give upper management a snapshot view of how the QMS is performing.

A QMS is most valuable to an organization when the tools and processes built into the QMS are being used for continuous improvement. This shift to innovation and improvement instead of putting out fires as they come up is where a QMS can make a huge difference in the overall trajectory of a company. Maintaining quality and process performance at consistent levels is the most basic goal of any QMS, but when fully implemented and mature, that QMS should allow for improvement of quality and processes.

Auditors like to see corrective and preventive actions (CAPA) that are opened for continuous improvement projects. It signals to them that the systems are in control enough that there are resources being devoted to improvement, but also shows a commitment to quality and improvement.

The control and calibration of tools used to measure quality are integral to the success of a QMS. If machines or equipment are used to validate products or processes, this equipment must be carefully controlled and calibrated according to industry standards. Depending on the instrument, this could involve periodic calibrations or calibration before every measurement.The QMS system design within an organization should dictate a clear policy for the maintenance of quality instruments based on nationally or internationally recognized standards for each piece of quality equipment. This documentation should address:

The most successful QMS implementations balance simplicity and customization. There can't be a one size fits all QMS, since each organization is unique. A QMS needs to be purpose-built to fit an organization's objectives, industry, and compliance requirements to have a meaningful impact on culture. The right QMS design is a mixture of flexibility and standardization. Organizations need enough standardization to produce consistent results and enough flexibility for continuous improvement to create a quality-driven culture.

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