Information & Training. | Quality Assurance. Quality Management.
Records Management
Records management is focused on ensuring that records are created, identified, fully described, filed, stored for the required time periods, then destroyed when no longer required.The value of records management?
Records are evidence of the activities performed by an organization, the reason for performing those activities and the basis for decision making within the organization. Records are a reference source which can facilitate and demonstrate improvement. They can provide value to an organization, or can expose failings. Therefore, it is critical to organizational success, that records are properly identified, retained as necessary and suitably destroyed when no longer needed.
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 >>>
Rules of Good Records Management.
For good records management, there are nine standards which every organization should implement to ensure records are correctly prepared.Records need to be permanent for the required duration.
If a record needs to be retained for 5 years then it must be clear that the record will not degrade within the required 5 year period. On hand written documents use ink to create a permanent record so the information can’t be changed, erased, or washed off. Electronic documents will be backed-up so they cannot be lost within the 5 year period. The storage environment needs to be considered so as to minimize the potential record degradation.
Records need to be legible.
With all hand written records, it is important that staff write neatly and legibly so the information can be easily read by others. It must be possible to link signatures to those signing off a document.
Records must be accurate.
When entering information into a document that has been identified as important to the organization, it is critical that the data entered is accurate and truly reflects the activity performed, the observed situation, the results obtained. Individuals tasked with recording information must understand that ambiguous, incomplete or in-accurate records are not acceptable.
Information should be recorded in a prompt manner.
Information needs to be recorded in a timely manner. Activities must always be documented immediately after they are performed, never before. Records should be completed as soon as reasonably possible. An example of poor record practice is where a range of similar activities are completed over a period of a month, then at month-end the records are completed from memory or from rough notes. In fact in this situation, the rough notes could be identified as records and retained as necessary.
Records need to be clearly understandable.
Everyone who reads the document has the same understanding of what it means. There should be no interpretation of what the record actually meant. When identifying the information to be recorded, all the necessary information required for a clear understanding should be included within the record.
Records need to require consistency.
All information entered into a record such as dates, times and abbreviations should be standardized so there is no chance of confusion.
Records must be complete.
All required information must be included. Where sections of a hard copy or soft copy document are not completed, there should be clear reasons for not entering information.
Information should be entered directly into the record.
Information is recorded immediately or as soon as possible onto the proper form, record, or computer system. Poor record practice is creating a rough record with the intention of updating the official record at a later more suitable time.
Records must be truthful.
All information included in a document, software system, email, etc., to the writer’s knowledge, needs to reflect what really happened or current understanding of the situation.
Document and Record Retention requirements.
Every organization needs to identify the minimum retention times for records. Additionally maximum retention times are also valuable as record retention has cost implications, also excessively old records which may describe a very different organizational culture or environment may be an actual liability to the organization.Retention times will be influenced by legal, regulatory, strategic, customer, competitor, operational, environmental influences. The defined retention times will be based on the relevant influences, for example:
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 >>>