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Documentation – Policies and Procedures.
Documentation Policies.Policies define the top level approach of an organization within a specific area of responsibility to ensure alignment and achievement of the business with the strategic plans.
For example the “Quality Policy” will define the approach of the organization towards the delivery of quality products and processes. Similarly the “Documentation Policy” will define the approach of a business in implementing document controls and practices across the business.
Policies define the rules of operation across the organization.
A Policy will normally define who is generally responsible for implementing the Policy, why the Policy is necessary and specifically will detail the organization policy approach within the specific area of responsibility.
Procedures.Procedures provide detail as to how a particular task is to be performed. Procedures cover a range of documents such as work instructors, reference guides or the widely applied SOP (standard operating procedure).
Procedures will detail the task to be performed, who is responsible for performing the task, step by step instructions on how to perform the task, details of information to be documented as a result of performing the procedure. The procedure will reference follow-on procedures.
The procedures need to be in alignment with the related policy. By accurately performing a procedure, organization staff will understand that they are contributing to achieving the related organizational policy and ultimately the organizational objectives and strategy.
Documentation Policies and Procedures – Generic requirements.Policies and procedures must be uniquely identified.
Documents must bear a title, an identification or control number which is unique to that document, a current revision number and a date of effectivity.
Current versions of documents must be readily available to necessary users.
Outdated versions of documents need to be removed from operational use. Personnel should never have to decide which document should be used.
Personnel are trained on the procedure or method before they use it.
The key is to be certain that personnel can perform the task exactly as described in the procedure.
Policies, procedures and related documents are followed.
Procedures are designed so that, if followed, products will comply with their quality specifications and assure compliance with the best practices.
Documents will become key quality management system records.
Records are used to rapidly and reliably reconstruct an action, event, or decision. They provide evidence, and therefore assurance, that all prescribed specifications, standard operating procedures (SOP’s) have been followed. The importance of accurate complete records needs to be fully understood by those tasked with completing records across the organization.
Quality Assurance. Quality Management Systems.
- 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)
- 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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