Information & Training. | Quality Assurance. Quality Management.
Quality Management Plan.
The documentation, buy-in and approval of a quality management plan provides direction and clarity to quality activities within a business. The quality plan may cover a broad range of quality activities ranging from the strategic level, such as overall objectives for product and service quality, customer development objectives, the direction of the organization in terms of quality culture development, down to lower level operational objectives, such as targets for specific in-coming and in-process inspections.
Documentation
CAPA – Corrective And Preventative Action
Calibration Certification
Change Management and Control
Quality Management Training
Product and Process Validation
Supplier Quality Assurance
Audits & Auditing
Ensuring the Quality Management System is Risk based
Etc. …. Etc. …. Etc. …
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The quality management plan has a focus on setting improvement objectives. Do not confuse the plan with the quality manual. The quality manual defines the quality management system, defines responsibilities for quality, outlines the different aspects of the quality system. The quality management plan sets the objectives for improvement across a broad range of quality management system activities. The quality plan is usually revised and re-approved on an annual basis however, the frequency of revision rests with the needs of each organization.
The quality management plan needs to be risk based.
When developing the plan, the potential risks to individuals, the business, the community, business stakeholders needs to be considered. A risk assessment needs to be performed in advance of plan development, so that quality activities defined in the plan are focused on the higher risk activities.The quality plan and quality auditing.
As part of the quality management system an audit schedule will need to be defined. The audit schedule may be a component of the plan or alternatively the plan may reference the audit schedule. However, what is important is that the audit schedule supports the direction of the quality plan. For example, an organizational objective may be to reduce in-process inspection and consequently reduce appraisal costs, the planned means of achieving may be via a program of enhanced process capability combined with reduced process variability. In such a situation the quality plan will outline these strategic objectives and may detail targets for the lower inspection levels, lower variability and increased capability measures. The audit schedule therefore should take the quality plan direction into account and may detail increased audit activity, for example around the area of process capability measurement. In such a scenario, the audit program, is orientated towards supporting the achievement of the quality plan.Quality plan change control and records management.
The plan needs to define the processes for change management and change control. It also needs to define what quality records will be generated and how such records will be retained for future reference.Quality management plans and contractor or project quality.
Quality Management Plans are frequently documented as components of contractor management or project quality management. Specifically for unique once off projects or specific contractor activities, a detailed focussed project orientated quality plan is often a pre-requisite. In such a situation the quality plan needs to be defined in advance of project commencement. The plan needs to be agreed in advance of project commencement by all key stakeholders. The plan needs to define the scope of the project and the respective responsibilities. The plan needs to define all required test and inspection points, the methods of inspection, the frequency of test, the standards to be applied, responsibility for test performance, for test report documentation, review and sign-off. The plan should also define, initial action to be taken where critical quality attributes are not met, also the expected timelines unique to each test, for all on-going test performance, test report review and test sign-off activity.In summary – the benefits of a defined “Quality Plan”.
Quality management plans can help focus the activities of the quality system. They are also highly effective and critically important where there are large project activities with unique requirements. The advantage of the quality plan is that it forces the documentation of clearly defined quality requirements and objectives.Information & Training. | Quality Assurance. Quality Management.
- The Principles of Quality Management
- The Quality Manual
- Quality Standards and Specifications
- The Quality Management System
- Revised requirements of ISO 9001: 2015
- Design Quality – Products & Processes
- Good Manufacturing Practice (GMP)
- Documentation
- CAPA – Corrective And Preventative Action
- Calibration Certification
- Change Management and Control
- Quality Management Training
- Product and Process Validation
- Supplier Quality Assurance
- Audits & Auditing
- Ensuring the Quality Management System is Risk based
- Etc. …. Etc. …. Etc. …
- Information & Training presentation >>>