Goals
When you have completed this unit, you should be able to:
a. Perform an audit of a personnel and training system.
b. Know and understand which of the worldwide requirements apply to personnel and training.
c. Use a range of information tools, including the contents of this module in support of a personnel and training audit.
d. Recognize compliance or non-compliance of regulations pertaining to personnel training requirements.
Definitions
Consultant: External company or individual providing a service, normally of an advisory or expert role. They may be self-employed, or paid via a third party.
Contract personnel: People who provide a service or perform a task on behalf of The buyer company, but are not employed by the company.
Competency based training: Training on the skills and techniques an employee needs to perform his/her job with completion of training based on demonstration of learning.
Instructional design: The process of creating training materials that includes needs assessment, design, development, implementation and evaluation.
Job description: A document that defines accountabilities, responsibilities, job function and tasks of a single job title.
Job skills: The necessary skills needed for an employee to perform successfully on the job.
Training plan: A plan established by site management for individual employees or employees within a single department stating what training (both regulatory and job skills
training) is required for the employee to be considered competent in the job.
Explanation of Topic
Introduction
Within the pharmaceutical industry it is agreed that people are the most important element in any pharmaceutical operation. The number of people working at a site needs to be sufficient to ensure that the drug product manufactured, processed, packaged, or held are compliant with all necessary GMP and regulatory requirements. Personnel must be qualified and have the right attitude, training, and supervision to produce good quality product.
Organization
The company or site should have an organization chart and/or clearly defined reporting structure. There should be no gaps or unexplained overlaps in the responsibilities of personnel concerned with the application of GMPs. There should be a Quality unit/Quality Assurance Unit (QA) that is independent from production, up to an appropriate level in the organization. The level of separation of QA from Production is determined by the company’s organization and size.
Personnel Responsibilities
Personnel must assume responsibility for producing a quality product and should understand the impact of their activities on the product and, ultimately, the patient. All personnel are responsible for following company and site policies, procedures, practices, company standards, and quality requirements and regulations. These responsibilities include, but are not limited to:
a. Following established dress codes within the work area
b. Maintaining good hygiene and health that will not compromise a pharmaceutical product
c. Completing documentation correctly
d. Advising management of problem situations
e. Understanding and following SOPs for specific job functions
f. Undergoing training when necessary
g. Refraining from eating, smoking, drinking, or chewing within a production area
h. Assuring that there is adequate supervision for all activities related to drug production
i. Incorporating regulatory requirements into their particular job function
j. Preventing contamination of drug products
k. Avoiding direct contact with exposed product as well as with any part of the equipment that comes in contact with the product
l. Protecting product quality
Personnel Qualifications
Personnel working at a pharmaceutical company are expected to be qualified in the operations that are assigned to them. This qualification can be achieved through training which focuses on job tasks (job skills training) and regulatory requirements, experience, and education or a combination of the three. Employees are considered qualified when they can demonstrate satisfactory proficiency in job performance.
Training
To create qualified employees, companies need to have an effective GMP training system in place. Training should be:
a. Competency based
b. Conducted by a qualified trainer
c. Evaluated for effectiveness
d. Focused on particular job skills and regulatory requirements
e. Documented
f. Joint responsibility between the trainer, trainee and management.
Role of Management in Training
Management should be involved with training. Some of the responsibilities of management include:
Ø Identifying personnel training needs
Ø Developing and establishing a robust training system
Ø Providing adequate resources to successfully accomplish the training
Ø Providing support for employee training
Ø Evaluating the effectiveness of the training
Managers are expected to define appropriate qualifications for each position to help ensure that individuals are assigned appropriate responsibilities.
Job Descriptions and Training Plans
Management is responsible for developing job descriptions. The typical objectives of a job description are to document the:
a. Roles to be played by a person having the associated job title.
b. Responsibilities of a person having the associated job title.
c. Required expertise or training of a person having the associated job title.
Once the job description has been created, an individual training plan can be generated for an employee or job classification. It should indicate what training (skills and knowledge) are required to successfully perform the job, when or in what sequence the training should be completed, and how it can be attained (e.g., on the job training within the company or attendance at seminars, conferences, academic courses.) Auditors are responsible to verify that there is an approved plan for training in place.
Types of Training
As an auditor, you need to review the employee training records to determine what type of training the employee has had and when. Any employee whose job is impacted by GMP should receive ongoing GMP training and technical or job skills training pertinent to their particular job function. Before an employee involved in the manufacture, processing or analysis of pharmaceutical products begins their job function they must complete introductory GMP training in addition to any required job skills training.
GMP training may consist of basic GMP awareness, regulatory changes, review of inspection outcomes or other on-going training that keeps the employee familiar with GMP requirements applicable to his/her job. GMP training may also include information on Quality incidents (e.g., deviations, complaints and recalls), recurring problems, trends, as well as new or revised SOPs.
Employees should also receive job skills training. It should be competency based or performance based. This training, sometimes known as technical or job skills training, should consist, at a minimum, of a performance standard, training material which is based on objectives, an opportunity to practice the training, and a performance checklist/ evaluation / assessment. Only when the employee is assessed that he/she is able to perform critical tasks will the employee be considered sufficiently qualified to work independently.
Training should be determined to be effective. Performance and completion of training must be documented.
Employees may also need remedial training as a corrective action to unsatisfactory job performance. This training should also be documented.
Certification/Assessment of Training Efficacy
All personnel should have training evaluated, possibly in conjunction with a certification program. Certification could include successfully completing an approved curriculum of courses pertinent to the certification, successfully passing a comprehensive knowledge test, and demonstrating competency through a performance measure.
Training Documentation
When auditing, one of your responsibilities is to determine how training attendance is tracked. All training attendance must be documented and tracked, either electronically or manually. Training documentation may be kept in an electronic format as part of a validated learning management system, or a paper based system. If an electronic system is used, it should be validated as required by the regulations.
The tracking system should be established to identify both those personnel who have attended the training and those who were absent from the training. There should be a process in place to ensure that those absent during scheduled training receive the training at a later date.
Training documentation includes:
a. An overall SOP for management of the training system
b. Training SOPs, guidelines
c. Attendance records/sheets containing name of trainee, date, title and/or brief summary of training, type of training, identification of trainee (e.g. company ID #, distinct password, etc.), name of trainer if appropriate
a. Training materials
b. Individual training records which list all of the employee’s training
c. Training plan
A training management SOP should define:
a. Roles and responsibilities of all parties involved in training
b. Who should be trained
c. What training is mandatory and required
d. What method is used for the training, if appropriate
e. When and how often the training should be given
f. Who maintains training records
g. What constitutes qualification
SOPs or Training Plans may be generated by the individual departments, specifying which tasks the employee is to be trained on, or there may be a general site training SOP.
All training records should be complete, accurate and current. Training records should be in-place and easily retrievable. At a minimum, the record should contain the name of the trainee, topic discussed, trainer and the date of the training. The Training Records should document, not only training performed at the job site but also external sessions, such as conferences, educational courses, and/or training performed by a vendor.
A Training Summary should be a history of all the training the employee has received.
This can be electronically maintained in a validated tracking system or manually maintained. The Training Summary should be in agreement with the job description and/or training plan for the respective position.
Training records should be retained according to the site or company retention policy. They should be readily accessible for inspection. Records for consultants should be maintained associated with the activities and responsibilities for which they have been assigned to perform. Such records include previous experience and qualification, on the job training, policies and procedure reviews. The consultant’s contract, which is the responsibility of the supervisor for which he/she is performing work, should require conformance with the respective training program.
Trainer Qualification
You also need to check trainer’s qualifications for the training being delivered. Qualified individuals should give training. The individuals may be internal to the company or external. Recommended skills are:
a. Good communication skills
b. Ability to prepare presentations
c. Good organizational skills
d. Knowledge of training design principles
e. Good knowledge in the topic that is to be trained
Trainers may be members of the training department, supervisors and members of quality or anyone who meets the company’s qualification criteria for the training being performed.
Frequency of training
Frequency of training should be specified in the site’s training SOP. Training should be conducted to ensure that the employee is current with all procedures and policies, regulatory requirements, as well as changes within their job function. Under a quality system, continued training is critical to ensure that the employees remain qualified in their operational functions and in their understanding of GMP regulations. In certain areas, such as aseptic processing, more frequent training is appropriate.
Conditions for Training
Training should be conducted based on the needs of the person(s) within the job. A job description or training plan should be the basis for the technical or skills training needed.
Training should also be conducted under the following conditions:
a. Introduction of new equipment, processes, or procedures
b. Modifications/changes to equipment, processes, or procedures
c. Changes to GMP or other regulatory requirements
d. Special training requirements for a specific job (e.g., gown training for work in an aseptic area)
e. Hiring of new employees
f. Return of an employee from an extended absence
Employees may also be retrained. Retraining may be conducted because of a lack of demonstrated knowledge in correct practice, a response to a regulatory citation, the root cause in a deviation investigation, or a planned review of current job skills.
Training materials
Reviewing training materials is also part of your audit. Training materials should follow principles of instructional design. They should have objectives based on a training needs analysis and, if appropriate, contain an assessment for training effectiveness. They should also be up-dated and maintained, using a change control procedure. Functional areas and/or Quality should approve them.
Delivery of training
The training format and methodology should be determined by the content of the materials, and the audience. Training may be instructor led, self study, computer based, instructor led with video supplements, a facilitated discussion, or other methods.
Whichever method is chosen, it should meet the same requirements, i.e., reviewed and approved by management, documented, evaluated for effectiveness.
Personnel Requiring Training
All personnel, both full and part-time, whose job functions are impacted by GMP and regulatory requirements, should receive regulatory training, job skills and ongoing training.
Contract personnel should be trained to perform the services they are contracted for and have knowledge of GMP if working in a GMP area. Qualification of contractors should be documented and kept on file.
Visitors or untrained personnel should not be taken into restricted areas. These areas include research and development facilities, document archive areas, production, storage and quality control areas. If this is unavoidable, they should be given sufficient information in advance regarding hygiene, safety, protective clothing, GMPs and other restrictions. They should be closely supervised following the sites written procedure for visitors.
Audit strategy
A suggested strategy is to
1) Select employees with differing times of service and different job functions.
2) Review their training records for completion of all training requirements.
3) Observe them while they perform their duties.
4) Ensure that personnel are following procedures.
Summary
Personnel must follow regulatory requirements as well as company policies, guidelines and procedures. They are responsible for practicing good hygiene and remaining in good health as a safeguard to protecting the quality of the drug product. To achieve this they must be qualified as a result of training, education and experience to perform their job functions. One way to assure this is to provide necessary training.
Training is a process, not an event. It is similar to other processes in that it needs to be controlled, documented, and focused. To determine if training is adequate and compliant, SOPs, job descriptions in conjunction with training qualification plans, training records/histories, and training materials need to be reviewed. To determine if training is effective, employees using the trained skills and knowledge should be observed.
Key Parameters of Auditing a Personnel and Training System
Prior to the audit
a. Determine the site’s main functions (manufacturing, packaging, etc.)
b. Request an organizational chart.
c. Review the chart for appropriate separation of Quality and Production units
During the audit
a. Ensure that there is a procedure defining responsibilities of quality and production.
b. While touring the plant, observe the employees.
Ø Verify that employees are complying with the area dress code.
Ø Verify that employees are following approved and accepted procedures.
Ø Verify that employees are completing documents concurrently with the production activities.
c. Ensure that there is a documented training system in operation at the site by reviewing actual training documentation for selected employees.
d. Ensure that training records are compliant with GMPs and use good documentation practices.
Ø Verify that the records are complete and accurate.
Ø Verify that cGMP training is as indicated in the site’s training plan or SOP.
Ø Verify that training in the training record is appropriate for the job description.
Ø Verify that no chronological gaps appear in the training records unless documented.
e. Ensure that training materials meet their stated objectives and are developed to support specific job functions as defined in the job description.
Ø Verify that the materials have been approved by the functional area and/or quality.
Ø Verify that the materials, if used on a repetitive basis, (i.e., task training on equipment) are reviewed and up-dated on a regular basis and follow some form of change management.
f. Ensure that a training plan/curricula has been developed for each job classification and that it is recorded.
Ø Verify that the training plan matches the job description.
Ø Verify that it contains both ongoing GMP and job skills training.
Ø Verify that it contains training on procedures.
g. Ensure that there is a method to track training.
Ø Verify that there is a provision within the training system that ensures that personnel who have missed scheduled training receive the missed training.
Ø Verify that training information is readily accessible.
h. Ensure that trainers are qualified to conduct specific training according to site procedures.
Ø Verify that there is a system to determine trainer’s competency.
i. Verify that there is an SOP in place defining what is included in the training system.
j. Verify that there is an assessment method in place to determine employee’s competency.
k. Ensure that contractors/consultants have the necessary education, training and experience, to perform their assigned job function.
l. Verify that the training program incorporates requirements for temporary employees and consultants.
m. Ensure that training is conducted with sufficient frequency to assure that employees remain familiar with applicable regulations.
n. Ensure that laboratory personnel are receiving both GMP and job skills training that it is documented.
o. Ensure that all personnel involved in the manufacturing, packaging, testing, and quality control activities for pharmaceutical products have training records. These should meet the GMP requirement of assuring that staff is appropriately trained to perform their job function.