Staff, skills and training

 

Staffing

It is necessary that all personnel recruited for the laboratory operations have basic qualifications, skills and necessary experience.

The management has to specify the minimum requirements and experience for each position, before recruitment of personnel.

An assessment needs to be done on the following areas to arrive at a conclusion regarding staff recruitment:

Scope of the laboratory activities
Magnitude / quantum of samples to be turned out in each section (present situation and future improvement)
Types of equipment and accessories to be handled.
National / International regulatory requirements

 
Skills

To illustrate the above, a model qualification and expertise requirements are given below:

 

DESIGNATION

TYPICAL QUALIFICATION &
PROFESSIONAL CAPABILITY

SKILLS REQUIRED

Quality Manager / Quality Assurance Unit team member

Should be a Graduate in Science with approximately 2 years laboratory experience. - -Should have knowledge of relevant standards, quality audits, supervision, resolving customer complaints
- -Knowledge of Procedures for recording, reporting, checking & interpretation of test results
- -Familiarity with test & calibration procedures and awareness of limitations of these procedures

Managerial capabilities -Contract review -Equipment calibration requirements
-Familiarity with Method validation, Proficiency testing and QC Checks,
-Familiarity with Management system requirements
-Conduct of audits in the lab
-Awareness of the requirements and conditions for accreditation to ISO / IEC 17025 relating to test reports.

Head of Lab / Group Leader

-Should be a Post -Graduate in Science in relevant field with 5 year laboratory experience.
-Should have knowledge of relevant standards, protocol preparation, supervision, interpretation of test results and reporting
-Knowledge of Procedures for recording, reporting and checking results
-Familiarity with test and calibration procedures and awareness of limitations of these procedures

-Contract review -Equipment calibration requirements
-Design and validation of new methods, Measurement traceability & Uncertainty of measurement
-Evaluation of training of personnel
-Awareness of the requirements and conditions for accreditation to ISO/IEC 17025 relating to test reports

Scientist / Technical Assistant

-Should be a Post Graduate or Graduate in Science with laboratory or testing experience; Should have knowledge of relevant standards.
-Familiarity with test procedures

-Capability of performing the tests as per SOP / Specification
-Capability of operating the instruments as per the requirement
-Equipment calibration and maintenance requirements
-Measurement traceability & Uncertainty of measurement
-Use of standard methods & validation of new methods.
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Training
Training is an essential part of the management system and a vital method for improvement:

This training procedure is used to ensure that training has taken place with each employee for procedures and methods that the employee performs. The procedure applies to on-the-job training, in-house training and new-hire training. The training is verified and documented. The training procedure is applicable to new employees, for the introduction of new procedures and methods, for retraining of employees, and for re-verification of employee performance.
Responsibilities of Staff at different levels
Second Level Manager
  • Ensures implementation of training procedure
  • Ensures resources are allocated for identified training within budgetary constraints
    		•
  • Responsible for the evaluation, training and growth of the technical- and quality related skills of employees by establishing training schedule and rotation for all new employees and by ensuring personnel receive training and demonstrate competence
  • Ensures training is accomplished
  • Submits documentation for completed training for entry into training database or Integrated Management of Personnel Administration through Computer Technology and
  • Identifies training needs and courses of personal under his supervision and make necessary schedule
    		•
    First Level Manager
  • Implements training and maintains employee training files
  • Ensures proper supervision of trainees until training completed
    		•
  • Reviews training received and ensures training files are complete
  • submits documentation for training completed
  • Monitors employee performance to identify the need for retraining or additional continual education, and
  • Identifies training needs resulting from new or revised procedures and processes.
    • Quality Manager
  • Liaison with accreditation bodies.
  • Trains employees in quality control and quality assurance procedures.
  • In case of non -conforming tests, find out the root cause, identify critical areas. Implement corrective actions, identify preventive actions and implement verification of their implementation and effectiveness.
  • To convene Management Review committee meeting at scheduled time, record minutes and verify its implementation.
  • Identification of training needs of personnel and arrangement of conducting the training programs.
  • Planning and conducting internal audits and other quality assurance activity.
  • Approve, issue/amendment and check the control of documents
  • Registration and redress of complaints.
    • Staff / trainees / junior scientists
  • Completes required training within specified timeframe;
  • Becomes Conversant and knowledgeable in procedures and methods performed. Employees are responsible for self-training, through reading current literature, technical papers, publishing technical papers;
    		•
  • Reports all training received and submits documentation for training received; and
    		•
  • Reads and complies with standards, regulations, policies, procedures,and work instructions.
    • Procedure
  • Before starting any work the employee should be familiar with all work related documents. These documents include procedures, work instructions, applicable manuals and regulations.
  • Training requirements are outlined and documented on the basis of the position,its duties and responsibilities.
  • The level of training is determined by the employee's educational qualifications, experience, complexity of the test method, and knowledge of the test method performed.
  • The employee will not perform any procedure, inspection, or method until all applicable training has been completed and competency demonstrated. Employees undergoing training are supervised until training is completed and competency demonstrated.
  • Employees may request training related to their job. Lab posts the training and development services for their staff on an annual basis. Included in these services are classroom courses, downlinks, lending library, certification and web-based courses. A model format for recording the above is given below.
    • S.No Date Location Title of Training Name of Trainee Name of Trainer Result of Assessment
  • Upon completion of training submit documentation such as sign-in sheets for entry into training database.Where evaluation is of capability to perform tests there must also be objective evidence of competence, e.g. results of satisfactory performance of test on reference materials.
    • Date Details of Training Undergone Signature of supervisor/Remarks
  • The effectiveness of training is evaluated by but not limited to reviews performed by management and performance evaluations.
    • TRAINING ASSESSMENT
    Year: __________________
    Name of Employee: _________________________________________
    Designation: ________________________________________
    Sl.No. Training program description Trainer Evaluation criteria * (Enclose details where applicable) Assessment grade * * with date Full signature of assessor / Head of Lab/ Supervisor

    Note: Evaluation criteria shall be based on specific SOP/Standard requirements / Questionnaire. Provide proof of evaluation in terms of Knowledge gained (questionnaire & answers), Skills supervised, Test results, QC checks or competency in analyzing analyte(s) / testing as applicable.
    ** Assessment grade:
    A - Excellent (can extend training on the subject)
    B - Satisfactory (able to implement at work the knowledge gained through training)
    C - Unsatisfactory (requires retraining)
    NA - If evaluation criteria and assessment are not applicable for certain training programmes
  • The training process for technical procedures such as laboratory analysis consists of the following steps:

    • 1. Trainee reads the laboratory procedures, work instructions, or other applicable documents.
    2. Trainee observes demonstration of the procedure by a trainer,
    3. Trainee performs the procedure under observation by a trainer.
    4. Trainee successfully completes the procedure
    Documentation of these tasks is submitted for filing in the employee's training file.
  • The training process for non-technical procedures includes, but is not limited to:
    • 1. Reading laboratory and other related National / International procedures.
    2. Instructions,
    3. Demonstrations,
    4. Lectures and discussions,
    5. Self study,
    6. Computer-based training,
    7. Viewing videotapes, and
    8. Manufacturer's training or demonstration.
    Demonstration of these tasks is submitted for filing in the employee's training file.
  • An employee's performance is verified by measurement against a defined performance standard. The measures used to verify an employee's performance are assessment tools.
  • Assessment tools include the following:

    • 1. Administration of a Written Evaluation: Written evaluations can be used in areas where verification of a participant's knowledge is desired. Knowledge of theory of principles, problem-solving ability, logical sequence used and independent or group decision making may be ascertained.

    2. Observation of procedure, process, or outcome: Observation by a trainer of an employee performing or demonstrating a procedure.

    3. Verification of Response to Situational Problems or Calculations Related to the Procedure

    4. Response to oral query related to a step or procedure: Answers provided by the employee to questions asked by trainer.

    5. Testing blind QC samples: Employees are unaware when blind test samples are assigned. They appear identical to other samples, are in routinely used containers, and are from a similar source. The intent is to provide simulated samples to measure realistic analytic conditions. This tool assesses all phases of laboratory performance.

    6. Testing of known samples : Participants know and often plan for known testing events, such as external proficiency surveys and commercially prepared quality control samples. Samples for quality assurance or quality control purposes are identified immediately upon receipt in the laboratory. It is considered a waste of time and resources to conduct more careful handling and analysis on these samples or perform duplicate testing. This tool assesses the analytical phase only.

    7. Testing previously analyzed samples: Duplicate or replicate testing provides accessible internal comparisons and contributes to the validation of the analytic phase. These sources may be previously tested samples, samples of known constituents, and already reported proficiency testing samples. This tool assesses the analytic phase only.
  • Documentation of Training Verification includes:

    • 1. Completion of training checklists prepared internally for all procedures that an employee performs;
    2. Completion of the procedure with submission of written evidence;

    3. Completion of blind quality control (QC) samples, proficiency surveys, QC samples, and duplicate testing with submission of results that are within acceptable criteria limits;

    4. Completion of written evaluations, signing acknowledgement of reading assigned work instructions;

    5. Attendance sign-in sheets (See Attachment) on in-house training, certificates from manufacturer's training courses and computer classes, and committees served on;

    6. Submission of technical papers and handouts of presentations given, college transcripts for courses taken, licenses and memberships held and special conferences attended

    7. Completed paperwork on safety briefing, orientation modules, and in or out-processing steps for new hires or those leaving the organizational unit; and

    8. Memorandums on additional appointments or duties.
  • Retraining

    • 1. Employees will be re-trained whenever significant changes occur in policies, values, goals, procedures, processes, and methods or instruments.

    2. Employees will be re-trained when the level of performance is unsatisfactory as shown by any of the assessment tools discussed above.
  • Re-verification
    		•

    1. Re-verification occurs whenever employees attend required courses, continuing education, presentations, workshops, conferences and schedules training either in house or manufacturer's training.

    2. Performance re-verification occurs whenever proficiency surveys, blind QC samples, or duplicate testing are submitted.
  • All analysts and laboratory staff members are to undergo training in a number of procedures, policies and policies upon entry of employment and during their career with the lab. What follows are types of required training:
    • 1. Facility orientation includes:
    i. New employees completing required administrative forms as part of initial processing; and
    ii. Introduction to co-workers, personnel policies, working conditions, daily routine, issuance of manuals, quality assurance system and any miscellaneous matters.
    2. New Training often includes:
    i. Quality Manual and other policies.
    ii. Management systems and ISO/IEC 17025 requirements.
    iii. Quality Systems and Audit workshop,
    iv. Investigative Interviewing course, and
    v. Lab computer based training modules.
    3. Safety Training may include the topics of :
    i. Hazard communication standard ( Right to Know )
    ii. Universal precautions (e.g., hand washing and aids awareness),
    iii. Medical surveillance program,
    iv. Personal protective equipment,
    v. Security briefing,
    vi. Safety briefing,
    vii. Fire extinguisher training,
    viii. Emergency evacuation, and
    ix. Safety practices in the laboratory
    4. Chemical Hygiene
    5. Hazardous Waste Management that includes annual training on handling, storage, and disposal of hazardous materials.
    6. Quality Assurance including annual training on quality control (QC), quality assurance (QA), the Labs Quality Management System (QMS) and related procedures.
    7. On-the-job training..
    8. Training on policies, regulations, procedures, methods and instruments.
    Often laboratory staff has an opportunity to attend auxiliary training when available and resources permitting. This type of training includes:
    i. Attendance at presentations, courses and conferences; and
    ii. Computer courses such as in-house training, instructional, and manufacturer's training on software in use such as Microsoft Work and Excel, Chem-Station, and Outlook.
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