Information & Training. | Quality Assurance. Quality Management.
Quality Assurance Training
A competent workforce, fully skilled and knowledgeable, with the appropriate attitude are pre-requisites for an effective quality management system. When staff join an organization, the expectations may be that new employees will have all the necessary capabilities and attitudes, however, there will always be a requirement to implement a quality assurance training program to understand where current capabilities do not meet requirements and to ensure continued positive staff development.Definition of Training.
“The provision of experiences and opportunities to help learners attain specific skills and knowledge and to develop appropriate attitudes”
Training versus Education.
Training differs from education in that it seeks to impart a set of established facts and skills and to obtain a uniform predictable behaviour from the trainees without the necessity of their understanding why they should act in the prescribed manner.
Education on the other hand, seeks to have the student learn skills and to understand why actions are taken or not. (Andrew L. Carney)
Training is focused on changing and improving the skills, knowledge and attitude of individuals.
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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Skills, Knowledge, Attitudes.
Skill – Developed aptitude or ability in a particular intellectual or physical field
Knowledge – Information which is specific to a subject, enabling you to understand a subject to an acceptable level
Attitude – An internal state which affects your choice of action towards some objects, persons or events.
Training to deliver a Quality Management System (QMS).
Training is essential in the implementation of an effective quality system, however, there are certain pre-requisites which need to be in place in order to facilitate the implementation of a training program. These can be summarized as follows:
Understanding customer expectations (external & internal customer, regulatory agencies, standards bodies, employees, the community, etc.).
Development of defined and approved operating procedures to meet customer expectations.
Continual review and improvement of processes.
Continual measurement, monitoring of performance.
Performance of audits and inspections.
With the above in place, then a gap analysis can be performed between the required skills, knowledge, understanding and attitude of staff, versus the actual situation. With this knowledge, then the training requirements can be identified, a plan or schedule to implement the training can be agreed and the training can be provided.
Where-ever training is provided, the effectiveness of the training should be assessed. Additionally, the experience of all involved should be ascertained. Input should be sought on positives and negative experiences and suggestions for improvement.
Where training is provided and effective, the outcome of the training process will be competent staff, (i.e. will have the appropriate skills, knowledge, understanding, attitude) and records which can be used to plan future training and to demonstrate compliance with training requirements versus standards and regulations.
Driving forces for training.
The need for quality assurance training can derive from numerous sources, for example:– The need to provide consistent high quality products and services can only be achieved by comprehensively trained staff.
– Training is defined in numerous quality management standards
– Training is mandated in virtually all regulatory body requirements.
– The achievement of organizational financial targets, requires skilled staff performing tasks to defined requirements, the alternative being unexpected process variation, equipment malfunctions, product defects and rework, etc.
– Health, Safety and Environmental compliance requires staff with the necessary capabilities.
– Etc.
Training Policy
A key document in a training process is the training policy. The training policy is a high level document which will outline the:
Commitment of the organization to the training and development of all employees.
Training that is available or which the organization intends to provide.
The purpose of this training.
How the training process relates to the overall “Vision”, “Mission” and “Objectives” of the organization.
The training policy will normally be approved by the highest level of management within the organization or organizational facility. This may be at Plant Manager, General Manager, Managing Director or Chief Executive Level. The policy will then be visibly posted for all to see and included or referenced in relevant documentation.
It is important the organizational staff are aware of the approach and commitment to training within the organization and can see that the training policy as stated by management is actively implemented across the organization.
Management need to ensure that the policy aspirations are truly implemented.
Quality Assurance Training needs to be approached in a systematic manner.
For training to be effective it must be planned in a systematic and objective manner. The necessary training processes must be available, approved by the appropriate level of management and actively and effectively implemented.In systematic training, everything is planned in a logical step-by-step sequence. The key steps are:
– Identify the training need.
– Plan the training.
– Implement the training.
– Evaluate the effectiveness of the training.
This follows the Deming “Plan”, “Do”, “Check”, “Act” cycle.
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 >>>
Reference sources:
FDA – Training and Continuing Education portal
ISO 9000 – Quality Management Standards