Information & Training. | Quality Assurance. Quality Management.
Document Management
Documentation is generated in every organization. Document Management is focused on ensuring all essential documents are organized, controlled, retained as necessary to ensure the efficient and compliant operation of the organization.
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 >>>
Why document activity within the organization?
The requirement for controlled documentation is explicitly defined in a vast range of international quality and regulatory requirements. For example the ISO 9000 series of Quality Management System standards, specifically requires all quality impacting activity to be documented. Similarly the US Food and Drug Administration requires comprehensive, accurate, up to date policies, procedures, specifications, work instructions and records to be maintained. The existence of documents allows organizations to demonstrate compliance with standards, similarly the documents allow auditors to verify adherence to identify failings with standard requirements.The requirement to have documentation reduces the risk of errors via reliance on oral communication. Written communication stays constant, documents can be easily rechecked. There will be fewer misunderstandings with written communication. There will be direct back-up evidence of the communication where such communication is based on written instructions.
Documentation defines the system of control. Once documented the system of control takes on a tangible dimension.
Documentation ensures consistency. In manufacturing, product can be repeatedly produced in the same way to the same standards each and every time, if manufactured to defined documented requirements. The sign-off on procedures puts accountability for proper performance of procedures with the person who does them.
Documentation allows for traceability. This traceability facilitates audits, permits investigations into deviations from expected practice or where results vary from planned. Documentation can act as a baseline of information for continual improvement projects. Permits investigation and tracing of defective product.
Documents such as operating procedures, protocols, methods and specifications help to ensure that people know what to do, so that tasks and decisions can be consistently and safely completed each and every time.
Records, such as product history records (PHR’s), device master records (DMR’s), cleaning logs, and laboratory test records, provide evidence that actions and decisions were correctly made in keeping with procedures and best documentation practices.
Each document and record must be uniquely identified and include all applicable QMS requirements.
The function of Documentation Management.
The heart of an effective Quality Management System is the establishment of well written procedures for each step of an organization’s quality management system.Written procedures give the necessary controls to minimize the chance of mix-ups and errors in the manufacture of products or the provision or services, both to the external customer and across all functions within an organization.
By carefully following written procedures, you not only ensure compliance with the requirements of a quality management system (QMS) but, more importantly, you ensure the consistent quality of products and services from the organization.
Written procedures serve six important functions:
1) They establish the expected standards of performance.
Written procedures are important in establishing and enforcing work standards. Written procedures help us see that the same job is consistently performed.
2) As a method of instruction.
Written procedures help instruct employees at all levels of the organization. For example, a new employee trying to learn the job or an experienced employee assigned to a different job, written procedures serve as a training guideline.
3) They act as a reference source.
It is difficult to remember every step involved in manufacturing a “quality” product or service. Written procedures provide us with the time-saving checklist we need to make sure each step is carefully followed.
4) Documented procedures act as a method of control.
Written procedures, when well developed, have important control characteristics. They tell us what to look for when we verify and how to evaluate our results for compliance.
5) Facilitate continual improvement.
Putting our procedures down on paper provides us with the opportunity to see how we can improve our operations and plan for improved performance.
6) Are a record of how activities were performed.
Documented procedures are a record of how we do certain operations. They are a basic business document and critical to organizational success. For example, if a complaint is received concerning a product manufactured by a business, the documented procedures are critical in permitting an investigation into what happened, how the product was manufactured and can help identify potential causes of the complaint.
Types of documents.
There are vast arrays of documents which are utilized in organizations. Some of the widely applied forms of documents are …Instructional documents:
Standard operating procedures, SOPs
Specifications
Standards
Records and Reports:
Batch manufacturing records
Quality control results
Change control records
Deviation reports
Validation protocols and reports
Training records
Cleaning logs
Shipping details
Purchasing records
Research and development reports
Regardless of the name, purpose, format or the document, there are well established rules for good documentation practice which should be followed to ensure documentation integrity.
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 >>>