FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number:

MAN-000035

Revision #: 03

Revised:

13 Dec 2022

Title: 

ORA Lab Manual Vol. II - Personnel Training and Competency Management 

(ORA-LAB.5.2)

Page 1 of 15

For the most current and official copy, check QMiS.

Sections in This Document

Purpose ................................................................................................................................. 2

Scope .................................................................................................................................... 2

Responsibility ........................................................................................................................ 2

Background ........................................................................................................................... 3

References ............................................................................................................................ 3

Procedure.............................................................................................................................. 4

6.1. Training and Competency Requirements................................................................ 4

6.2. Training Technique ................................................................................................... 4

6.3. Assessment tools...................................................................................................... 5

6.4. Demonstration of Competency................................................................................. 6

6.5. Authorization of Personnel....................................................................................... 7

6.6. Training and Competency Records ......................................................................... 7

6.7. Retraining and Reverification................................................................................... 8

6.7.1. Retraining: ................................................................................................... 8

6.7.2. Reverification: ............................................................................................. 8

6.8. Required Training...................................................................................................... 9

6.8.1. Facility Orientation for all Employees........................................................ 9

6.8.2. Agency-mandated Training for all Employees (includes, but is not limited 

to, the topics below. For additional information, refer to FDA Mandatory 

Training intranet website.............................................................................. 10

6.8.3. Training of Laboratory Analysts new to ORS.......................................... 10

6.8.4. Safety Training as applicable per assigned duty location (may include the 

following topics):....................................................................................... 12

6.8.5. Quality Management System training...................................................... 12

6.8.6. Technical training...................................................................................... 13

6.8.7. Other Training............................................................................................ 13

Glossary/Definitions............................................................................................................. 13

8. Records .............................................................................................................................. 14

9. Supporting Documents ..................................................................................................... 14

Document History ................................................................................................................ 14

Change History.................................................................................................................... 15

Attachments......................................................................................................................... 15
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number:

MAN-000035

Revision #: 03

Revised: 

13 Dec 2022

Title: 

ORA Lab Manual Vol. II - Personnel Training and Competency Management 

(ORA-LAB.5.2)

Page 2 of 15

For the most current and official copy, check QMiS.

Purpose

The purpose of this procedure is to establish and define an internal training 

program and to ensure the competency of laboratory personnel. Training and 

training verification are key factors for successful laboratory operations.

Scope

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 training of 

employees new to ORA/ORS. The training is verified and recorded. The 

training procedure is applicable to new employees, for the introduction of new 

procedures and methods, for retraining of employees, and for reverification of 

employee performance.

Responsibility

A. Laboratory Management

1. Ensures implementation of training procedure. 

2. Ensures resources are allocated for identified training within 

budgetary constraints.

3. 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. 

4. Maintains employee training records as accurate and current. 

5. Ensures proper supervision of trainees until training completed.

6. Ensures training records are complete.

7. Monitors employee performance to identify the need for retraining or 

additional continuing education.

8. Identifies training needs resulting from new or revised procedures 

and processes.

9. Authorizes personnel to perform specific laboratory activities.

10.Ensures and records continued competency of employees. 
FOOD AND DRUG ADMINISTRATION

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Document Number:

MAN-000035

Revision #: 03

Revised: 

13 Dec 2022

Title: 

ORA Lab Manual Vol. II - Personnel Training and Competency Management 

(ORA-LAB.5.2)

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11.Has relevant knowledge of the technology, methods and procedures 

used, purpose of each test, and an understanding of the significance 

of deviations found regarding the normal use of the items, materials, 

products, etc. concerned within their area of responsibility.

B. Quality System Manager (QSM):

1. Ensures training is conducted and recorded for quality management 

system policies and procedures.

C. ORS Employees:

1. Complete required training within specified timeframe(s).

2. Ensure all agency mandated training, such as, but not limited to, 

annual ethics and computer security awareness, is successfully 

completed and a digital copy of the certificate submitted to the 

supervisor as a record of training completion which is maintained 

locally and is available upon request for internal or third-party audits.

3. Become aware and stay knowledgeable in all procedures and 

methods they are or will be expected to perform NOTE: Employees 

are responsible for self-training, through reading current literature, 

technical papers, publishing technical papers, exploring HHS Portal 

and FDA University training resources, etc.

4. Read and comply with all standards, regulations, policies, 

procedures, and work instructions.

Background

None

References

A. FDA staff manual. Guide 3120.1 Personnel – Staff Development and 

Training

B. ISO/IEC 17025:2017, General requirements for the competence of 

testing and calibration laboratories, Section 6.2.

C. AOAC International Guidelines for Laboratories Performing 

Microbiological and Chemical Analysis of Food, Dietary Supplements, 

and Pharmaceuticals – An Aid to Interpretation of ISO/IEC 17025:2017; 

August 2018.
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number:

MAN-000035

Revision #: 03

Revised: 

13 Dec 2022

Title: 

ORA Lab Manual Vol. II - Personnel Training and Competency Management 

(ORA-LAB.5.2)

Page 4 of 15

For the most current and official copy, check QMiS.

Procedure

6.1. Training and Competency Requirements

Before starting any work-related duties, the employee will be familiar with work 

related documents. These documents include procedures, work instructions, 

applicable manuals, and regulations. Employees undergoing training are 

supervised until training is completed and competency demonstrated on an

initial and continuing basis. 

A. Training requirements are outlined and documented based on the 

position description of duties and responsibilities. 

B. Training and competency is determined by the employee’s educational 

qualifications, experience, complexity of the test method, and 

knowledge of the test method performed.

C. The employee will not perform any procedure, inspection, or method 

until all applicable training has been completed and competency 

demonstrated. 

D. Employees may request training related to their duties. The agency

communicates training resources and development services for staff

throughout the year. Included in these resources and services are 

synchronous and asynchronous courses, learning enrichment events, 

webinars, lunch-and-learn, technical symposia, as well as resources for 

professional development and leadership programs, continuing 

education information, and web-based self-paced content. 

E. Employees submit digital copy of records to their supervisor for filing 

and maintenance upon completion of training.

F. Training and competency records shall be maintained according to 

agency, organizational, and local policy. 

G. The effectiveness of training is evaluated by, but not limited to, reviews 

performed by management, performance audits, and performance 

evaluations.

6.2. Training Technique

A. 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.
FOOD AND DRUG ADMINISTRATION

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Office of Regulatory Science

Document Number:

MAN-000035

Revision #: 03

Revised:

13 Dec 2022

Title: 

ORA Lab Manual Vol. II - Personnel Training and Competency Management 

(ORA-LAB.5.2)

Page 5 of 15

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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 independently.

B. The training process for non-technical procedures includes, but is not 

limited to:

1. Reading laboratory procedures,

2. Instructions,

3. Demonstrations,

4. Lectures and discussions,

5. Self-study,

6. Computer-based training,

7. Viewing videos, and

8. Manufacturer’s training or demonstration.

C. 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. 

6.3. Assessment tools 

A. Administration of a Written Evaluation: Written evaluations can be used 

in areas where verification of a participant’s knowledge is desired. 

Knowledge of theory or principles, problem-solving ability, logical 

sequence used, and independent or group decision making may be 

ascertained.

B. Observation of Procedure, Process, or Outcome: Observation by a 

trainer of an employee performing or demonstrating a procedure.

C. Verification of Response to Situational Problems or Calculations 

Related to the Procedure: Example circumstances include resolution of 

a posed and procedure-related situational problem or recommendation 

of procedure-related course of action that is consistent with policies and 

regulations.

D. Response to Oral Queries Related to a Step or Procedure: Answers 

provided by the employee to questions asked by trainer.

E. Testing Blind QC Samples: Employees are unaware when blind test 

samples are assigned. They appear identical to other samples, are in 
FOOD AND DRUG ADMINISTRATION

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Office of Regulatory Science

Document Number:

MAN-000035

Revision #: 03

Revised: 

13 Dec 2022

Title: 

ORA Lab Manual Vol. II - Personnel Training and Competency Management 

(ORA-LAB.5.2)

Page 6 of 15

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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.

F. 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.

G. 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 analytical phase 

only.

6.4. Demonstration of Competency 

A. Competency assessment is one method to verify that analysts are 

competent to perform testing and report accurate and timely results. 

B. To be competent, a laboratory analyst must know how to perform a test, 

can perform the test properly without supervision, and know when there 

is a problem with the test that must be solved prior to reporting results. 

C. The major technologies (at minimum the items on accreditation scope) 

and methods being performed require demonstration of initial and 

ongoing competency by any of the following tools: 

Competency Demonstration Examples

Assessment Item Item Description Examples

Direct observation of 

test performance and 

instrument maintenance 

and function checks

This is the actual 

observation of the 

analysis and 

maintenance 

procedures and checks 

of instruments as it is 

being performed by the 

analyst

On-site review
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Document Number:

MAN-000035

Revision #: 03

Revised: 

13 Dec 2022

Title: 

ORA Lab Manual Vol. II - Personnel Training and Competency Management 

(ORA-LAB.5.2)

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Monitoring the 

recording and reporting 

of results

Review of results for 

the proper and correct 

recording and reporting

Worksheet review & 

FACTS entries

Review of intermediate 

checks, QC results, 

proficiency test results, 

FV/PM charts

This is as it is implied, 

review of checks, QC 

results, PT results, 

FV/PM charts

QA spreadsheets 

(chem.) & Pos/Neg 

controls (micro); Control 

within acceptable limits; 

Worksheet review, PT 

review, Completion of 

FV/PM charts properly

Assessment of test 

performance through 

external/internal PT’s

Unknown samples Evaluate results 

obtained with known 

results

Samples analyzed; 

Method validations; 

Accuracy/Precision on 

lab control samples

This is as it is implied: 

number of samples 

analyzed; method 

validations performed; 

QC charting for 

accuracy/precision.

FACTS reports of 

samples by analyst; 

satisfactory completion 

of samples; satisfactory 

completion of method 

validation packet; QC 

charts with criteria

6.5. Authorization of Personnel

A. Laboratory management authorizes personnel to perform specific 

laboratory activities as defined in local policies and procedures, 

including analytical test methods and operation of major technologies 

use for laboratory analyses. 

B. When personnel are authorized for a portion of an analytical test

method or a portion of the operations for a major laboratory analysis 

technology, then training records must enumerate the specific parts of 

the method or major technology operations for which the employee has 

received training, is considered competent, and therefore lab 

management is authorizing that employee to perform. 

6.6. Training and Competency Records

A. Training and competency records are maintained by local management

as current and accurate. 

B. Training records must include a description of the training, the trainee’s 

legal name, the trainer’s legal name, dates of received training, and 
FOOD AND DRUG ADMINISTRATION

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Office of Regulatory Science

Document Number:

MAN-000035

Revision #: 03

Revised: 

13 Dec 2022

Title: 

ORA Lab Manual Vol. II - Personnel Training and Competency Management 

(ORA-LAB.5.2)

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identify whether successful completion has been achieved by the 

named trainee. Training records are archived for exiting employees. 

Examples of training records:

1. Completed training checklist prepared internally for procedure.

2. Completed blind quality control (QC) samples, proficiency surveys, 

acceptable preparation, and analysis of QC samples. 

3. Completed written evaluations.

4. Signed acknowledgment of reading procedural documents.

5. Attendance sign-in sheets for in-house training.

6. A certificate from manufacturer’s training courses, computer-based 

classes, and committees/technical groups served. 

7. Submission of technical papers and handouts of presentations 

given.

8. College transcripts for courses taken, licenses, memberships held, 

and special conferences attended.

9. Completed paperwork on safety briefing, orientation modules, and 

in- or out-processing steps for new hires and those employees

leaving the organizational unit.

10.Memorandums on additional appointments or duties.

6.7. Retraining and Reverification

6.7.1. Retraining:

A. Employees will be retrained whenever significant changes occur in 

policies, values, goals, procedures, processes, and methods or 

instruments.

B. Employees will be retrained when the level of performance is 

unsatisfactory.

6.7.2. Reverification:

A. Reverification occurs when employees attend required courses, 

continuing education, presentations, workshops, conferences, and 

scheduled training either in house or manufacturer’s training.

B. Performance reverification occurs when proficiency surveys, blind QC 

samples, or duplicate testing are submitted. 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number:

MAN-000035

Revision #: 03

Revised: 

13 Dec 2022

Title: 

ORA Lab Manual Vol. II - Personnel Training and Competency Management 

(ORA-LAB.5.2)

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6.8. Required Training

All analysts and laboratory staff members are to undergo training in several 

procedures, policies, and practices upon entry of employment and during their 

career with FDA. 

To best prepare laboratory analysts for the analytical work which they will be 

expected to perform, all analysts new to ORS must complete an ORS 

regulatory science-focused training process during which they demonstrate 

competence in their core lab functions in accordance with both enterprise and

ORS local program office/lab processes. Laboratory analysts include, but are 

not limited to, all the following positions: biologists, chemists, engineers, 

entomologists, interdisciplinary scientists, microbiologists, physicists, etc. 

ORA/ORS management may use Level I Analyst Certification as part of the 

demonstration of competence for laboratory accreditation purposes. 

However, Level I Analyst Certification is not all that is needed for laboratory 

analysts to achieve ISO demonstrated competence. Codified in the ORA 

Laboratory Manual (LM) are specifications on requirements for assessment 

and documentation of “demonstration of competency” in ORA/ORS 

laboratories to meet ISO 17025 requirements. 

To meet ISO 17025 competence requirements, all laboratory analysts must 

demonstrate initial and ongoing competency in all the major technologies and 

methods which they will be expected to perform. Therefore, regardless of 

education level or prior laboratory experience. all analysts must complete 

additional training above and beyond that which is specified for ORA Level I 

Analyst Certification. 

The current ORS supported and approved regulatory science-focused training 

process is composed of both Level I Analyst Certification and the specific 

laboratory activities defined in ORS enterprise and local lab policies and 

procedures. Upon successful completion of ORA’s Level I Analyst curriculum, 

the laboratory analyst becomes eligible for Level I Analyst Certification. 

What follows are types of required training, which may vary from employee to 

employee based upon duties and core functions specified in the job position 

description.

6.8.1. Facility Orientation for all Employees

A. New employees complete required administrative forms and procedures

as part of initial agency and organizational onboarding process. 
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Title: 

ORA Lab Manual Vol. II - Personnel Training and Competency Management 

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B. Introduction to co-workers, personnel policies, working conditions, daily 

routine, issuance of manuals, quality assurance system and any 

miscellaneous matters.

6.8.2. Agency-mandated Training for all Employees (includes, but is not 

limited to, the topics below. For additional information, refer to FDA 

Mandatory Training intranet website.

A. Annual Ethics Training

B. Computer Security Awareness Training

C. Records Management Training

6.8.3. Training of Laboratory Analysts new to ORS

A. Quality Management System (see 6.8.5)

B. ORA Laboratory Manual

C. ORS documents and procedures

D. Local program office/lab documents and procedures

E. Foundational concepts and scientific technical courses for laboratory 

analysts ORA Level I Analyst Certification 

1. Level I Certificates are issued by the Office of Training, Education, 

and Development (OTED) which is one component of ORA’s Office 

of Regulatory Management Operations. OTED’s issuance of a Level 

I Analyst Certificate reflects that OTED staff have verified the 

laboratory analyst has successfully completed a curriculum of 

defined regulatory science-focused analyst training supported by 

ORS and that OTED has received materials endorsed by aboratory 

management which indicates that the analyst has successfully 

demonstrated the technical skills to pass the Level I Analyst 

performance audit. 

2. Laboratory analysts hired after January 1, 2002, are required to 

complete a standard training curriculum, along with local laboratory

training, and must achieve Level I Analyst Certification regardless of 

education level or prior laboratory experience. To that end, local 

management must assure the appropriate first-line supervisor 

confirms and verifies their lab analyst has successfully completed all 

pertinent training and documents in QMiS as part of the initial 

competency demonstration. See MAN-000054 ORA Lab Manual

Vol. IV Section 1 - Laboratory Orientation for reference.
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Document Number:

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Revision #: 03

Revised:

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Title: 

ORA Lab Manual Vol. II - Personnel Training and Competency Management 

(ORA-LAB.5.2)

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3. For those laboratory analysts hired prior to January 2002, there is a 

process for experienced analysts to achieve Level I Analyst 

Certification. The supervisory analyst, along with the local branch 

director (if any), and the lab director must complete and submit the 

“Experienced Analyst Level I Certification Concurrence Form” to 

ORA’s Office of Training, Education, and Development (OTED). 

The experienced analyst must have demonstrated competency in 

the elements identified in the Level I Analyst Certification Program 

Performance Audit criteria. 

3. Laboratory science technicians are not eligible to attain Level I 

Analyst Certification.

4. To achieve Level I Analyst Certification, the laboratory analyst must 

also pass the Level I Analyst performance audit. Level I Analyst 

Auditors are those supervisors and managers at the local laboratory 

who have listed on their OTED transcript the successful completion 

of OTED’s specified auditor training. As of October 2022, OTED 

auditor training is as follows: Basics of Auditing (ID: MP150) course 

and associated exam, followed by the Level I Analyst Certification 

Performance Auditor (ID: MG122R100) course. If earlier versions of 

the Level I Analyst Certification Performance Auditor course appear 

on transcripts (Ex. MG122, MG122L100, etc.), then completion of 

such should be sufficient to be considered equivalent. Prior to

evaluating an analyst on Level I Analyst performance audit criteria, 

laboratory management must ensure that supervisory staff have 

successfully completed the training required to achieve the Level I 

Analyst Auditor designation. Laboratory management must also 

actively monitor and track the status of all their 

supervisors/managers to assure those staff members will be 

available to evaluate Level I Analyst performance audits in a timely 

manner. Analysts must work with their immediate supervisor and 

local management to schedule that audit. 

5. To pass the performance audit, analysts must demonstrate 

competency in all elements of the analyst audit criteria. The sample

analysis selected for the performance audit must reflect the work 

covered during the candidate’s new hire Level I Analyst Curriculum 

and ORS program office/local laboratory training. Once ORS local 

lab management concurs that the candidate has met all 

requirements for Level I Analyst Certification, including satisfactory 

completion of the analyst performance audit, the candidate’s 

laboratory management must submit the performance Level I 
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Document Number:

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Revision #: 03

Revised:

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Title: 

ORA Lab Manual Vol. II - Personnel Training and Competency Management 

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Analyst certification package audit results and any supporting 

materials to OTED along with their endorsement of completion. 

OTED will issue Level I Analyst Certification after they verify 

successful completion of Level I Analyst training and the Level I 

Analyst performance audit.

6. However, laboratory analysts must still successfully demonstrate 

initial competency in specific local laboratory activities which do not 

appear on ORA’s Level I Analyst curriculum in order to meet ISO 

17025 competency requirements so that laboratory management 

can authorize them to perform local laboratory work. Refer to 

Sections 6.1 through 6.6 in this document, the other volumes of the 

ORA Laboratory Manual, and all local laboratory policies and 

procedures, to find specifications on how to assess and document 

training activities to achieve ISO 17025 demonstrated competence. 

6.8.4. Safety Training as applicable per assigned duty location (may include 

the following topics):

A. Blood-borne pathogen standard, 

B. Hazard communication standard (Right to Know), 

C. Universal precautions, 

D. Exposure control plan, 

E. Medical surveillance program,

F. Personal protective equipment,

G. Security briefing,

H. Safety briefing, 

I. Radiation protection training,

J. Fire extinguisher training,

K. Emergency evacuation,

L. Safety practices in the laboratory,

M. Chemical Hygiene, and

N. Hazardous Waste Management that includes annual training on 

handling, storage, and disposal of hazardous materials

6.8.5. Quality Management System training

Examples include:
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Document Number:

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Revised: 

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A. Course-1436 Introduction to ORA’s Quality Management System (in 

QMiS Training Module)

B. Auditor training

C. Root Cause and Corrective Action procedures

D. Quality Management Information System (QMiS) training

6.8.6. Technical training

A. Managers and employees will work together to identify training needs in

accordance with core job function and per the employee’s job position 

description of duties. 

B. Supervisors will discuss local or external training on policies, 

regulations, procedures, methods, and instruments based on position 

description of duties and responsibilities. 

6.8.7. Other Training

Laboratory staff may have an opportunity to attend auxiliary training which is 

not core scientific technical training for ORS if such auxiliary training is

available and resources permitting. This type of training includes: 

A. Attendance at presentations, courses, learning events, and special 

emphasis group meetings or conferences

B. Computer courses such as in-house training, instructional, and 

manufacturer’s training for business software use such as Microsoft 

business products. 

C. Interpersonal communications and communications upskilling. 

Glossary/Definitions

A. FV/PM – Function Verification/Preventive Maintenance.

B. Procedure – This is a description of the sequence of steps leading to a 

defined outcome or product. A procedure can be technical or 

administrative.

C. Retraining – Retraining is required when assessments show less than 

satisfactory performance or whenever significant changes occur in 

procedures or processes. 
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Document Number:

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D. Reverification – This is a process that ensures employees remain at an 

acceptable level of performance. 

E. Trainer – Trainers are persons that are knowledgeable in and regularly 

perform the procedures in which they instruct others. Necessary 

attributes include good verbal skills, demonstrated attention to detail, 

and objectivity.

F. Training Methods - The process of training and criteria for success are 

defined.

G. Training checklist – The training checklist is prepared from the 

procedure by defining all steps to perform a procedure for the 

verification of employee’s competency.

H. Training Verification – This is a systematic approach to demonstrate 

that the training outcome is successful. 

8. Records 

Training and competency management files and records

9. Supporting Documents 

None

Document History

Revision

#

Status*

(D, I, R) Date Author Name and Title Approving Official Name and Title

1.2 R 11/16/05 LMEB LMEB

1.3 R 02/02/10 LMEB LMEB

02 R 05/15/2019 LMEB LMEB

03 R REFER TO 

QMIS 

Rebecca Shelby, 

ORS/ORCET Training 

Coordinator

LMEB

* - D: Draft, I: Initial, R: Revision
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Document Number:

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Revision #: 03

Revised: 

13 Dec 2022

Title: 

ORA Lab Manual Vol. II - Personnel Training and Competency Management 

(ORA-LAB.5.2)

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Change History

Revision 

# Change

02 Revisions made to align this procedure with new ISO/IEC 17025 and AOAC 

requirements. Revision to formatting and policy clarifications were also made.

03

Specific language added for L1 analyst certification and Training/Competency records 

management. Clarified which sections relate to all ORS employees vs. analysts only.

Other changes are highlighted. Document was transferred to ORA SOP template and 

formatting updated.

Attachments

None