FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number:

MAN-000066

Revision #: 03

Revised: 

10 Aug 2022

Title: 

ORA Lab Manual Vol. IV Section 13 - Engineering (IV-13) Page 1 of 6

For the most current and official copy, check QMiS.

Sections in This Document

Purpose .................................................................................................................................... 1

Scope ....................................................................................................................................... 1

Responsibility............................................................................................................................ 1

Background............................................................................................................................... 2

Supporting Documents ............................................................................................................. 3

Procedure ................................................................................................................................. 3

6.1. New Hire or Previous Training ....................................................................................... 3

6.2. Engineering Laboratory General Training...................................................................... 3

6.3. Local Systems................................................................................................................ 3

6.4. Engineering Laboratory Methods/Procedures/Techniques ............................................ 3

6.5. Engineering Laboratory Instrumentation........................................................................ 4

6.6. Engineering Laboratory Sample Training....................................................................... 4

6.7. Scope or Program Analyses .......................................................................................... 4

Glossary/Definitions.................................................................................................................. 5

Records .................................................................................................................................... 5

References ............................................................................................................................... 5

Document History ..................................................................................................................... 5

Change History......................................................................................................................... 6

Attachments.............................................................................................................................. 6

Purpose

The purpose of this document is to outline the general training program to 

ensure engineering personnel competence.

Scope

This procedure is an introductory and general training outline for analysts 

working in an Engineering Laboratory.

Responsibility

A. Supervisor
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number:

MAN-000066

Revision #: 03

Revised: 

10 Aug 2022

Title: 

ORA Lab Manual Vol. IV Section 13 - Engineering (IV-13) Page 2 of 6

For the most current and official copy, check QMiS.

1. Ensures implementation of this procedure.

2. Ensures resources are adequately allocated to complete necessary 

training.

3. Ensures all training records are updated and complete.

4. Identifies training needs individually and on an ongoing basis.

B. Trainer

1. Prepares, coordinates, and implements training to analysts as 

needed/directed.

2. Ensures analyst meets all applicable requirements of directed 

training.

3. Ensures applicable training is documented and reported correctly.

C. Analyst - Trainee

1. Completes required training within given timeframes.

2. Becomes and stays knowledgeable in procedures and methods 

performed.

3. Participates, reads and complies with standards, regulations, 

policies, procedures and work instructions as part of training.

4. Documents and reports all training received as directed.

Background

It is understood that an analyst has a basic knowledge of engineering, 

scientific, and laboratory principles. This procedure serves only to provide 

guidance on specific methods and procedures within a regulatory engineering 

laboratory environment. Responsibility for the scientific background material 

and actual topics covered is left to the individual, the trainer, and the 

supervisor.

Because of the great diversity of disciplines and the multitude of instruments 

used by analysts, no specific laboratory sample information is presented here. 

Instead, a broad program is outlined to introduce or refresh knowledge in 

several engineering fields. A major portion of the program is the introduction of 

the new employee to specific laboratory practices, equipment, techniques, and 

concepts. 

Not every topic is required to be covered for all analysts and may be tailored to 

suit laboratory and individual needs. Specialized training will be given as 

identified and needed.
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number:

MAN-000066

Revision #: 03

Revised: 

10 Aug 2022

Title: 

ORA Lab Manual Vol. IV Section 13 - Engineering (IV-13) Page 3 of 6

For the most current and official copy, check QMiS.

Supporting Documents

A. Specific user and technical manuals as needed

B. Applicable published standards, test methods and regulations

C. MAN-000035 ORA Lab Manual Vol. II Personnel Training and 

Competency Management (ORA-LAB.5.2)

Procedure

6.1. New Hire or Previous Training

Prior to beginning the activities outlined within this procedure, it is expected 

that the analyst will have started or completed required laboratory training as 

part of the on-board process.

6.2. Engineering Laboratory General Training

In addition to higher level training on various systems, new analysts will be 

trained in specific practices within the engineering laboratory environment.

6.3. Local Systems

Analysts will be trained on various systems, subsystems, and forms specific to 

engineering lab practices. This may include but is not limited to:

A. FACTS 

B. LIMS

C. QMiS

D. Access and use of local quality procedures, documents, and forms

E. Lab specific worksheets and forms

F. Lab specific safety and environmental procedures

6.4. Engineering Laboratory Methods/Procedures/Techniques

Analysts will be trained on various engineering methods, procedures and 

techniques that are specific to their engineering laboratory. These may include 

but are not limited to:

A. Test methods/methodology

B. Use of standards (e.g., weights, pin gauges, calibrators)

C. Method validation and/or verification
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number:

MAN-000066

Revision #: 03

Revised:

10 Aug 2022

Title: 

ORA Lab Manual Vol. IV Section 13 - Engineering (IV-13) Page 4 of 6

For the most current and official copy, check QMiS.

D. Instrument verification/calibration

E. Creating and using memos of analysis (MOA)

F. Use of consensus and/or published standards and CFRs

6.5. Engineering Laboratory Instrumentation

Analysts will be trained on various engineering instrumentation and equipment, 

as needed. This may include but is not limited to:

A. Cameras and lighting

B. Microscopes and magnifiers (for visual inspection)

C. Force measurement equipment (e.g., for tensile, compression, 

adhesion)

D. Dimensional measurement equipment (e.g., for lengths, diameters, 

geometric dimensioning)

E. Conditioning / environmental equipment (e.g., environmental chamber, 

temperature, humidity, water bath)

F. Electronic instruments (e.g., multimeters, oscilloscopes, simulators)

6.6. Engineering Laboratory Sample Training

Analysts will be trained on specific methods and practices associated with 

engineering regulatory samples. This will involve a variety of training 

techniques such as reading/reviewing procedures, observation/shadowing, 

and/or hands-on practice. This may include but is not limited to:

A. Attend/review presentations, methods, procedures, and/or forms.

B. Observe demonstrations or watch a trained analyst perform testing on a 

regulatory sample.

C. Hands-on testing using a practice sample.

D. Test a regulatory sample under Trainer supervision.

E. Perform a regulatory analysis with Trainer review.

6.7. Scope or Program Analyses

Analysts are trained to perform analyses specific to a variety of ongoing 

programs. These programs may require specific training, certification, and/or 

the use of specific methodologies to established standards or regulations. This 

may include but is not limited to:

D. Medical gloves

E. Clinical thermometers
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number:

MAN-000066

Revision #: 03

Revised: 

10 Aug 2022

Title: 

ORA Lab Manual Vol. IV Section 13 - Engineering (IV-13) Page 5 of 6

For the most current and official copy, check QMiS.

F. Laser devices

Glossary/Definitions

None

Records

Training files and documentation

References

None

Document History

Revision

# I Date Author Name and Title Approving Official Name and Title

1.2 R 02/02/2010 LMEB LMEB

1.3 R 02/14/2013 LMEB LMEB

02 R See QMiS LMEB LMEB

03 R See QMiS LMEB LMEB

* - D: Draft, I: Initial, R: Revision
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number:

MAN-000066

Revision #: 03

Revised: 

10 Aug 2022

Title: 

ORA Lab Manual Vol. IV Section 13 - Engineering (IV-13) Page 6 of 6

For the most current and official copy, check QMiS.

Change History

Revision 

# Change

1.2

Contents – added section 3.15

13.1 – minor revision to paragraphs 1 and 3.

13.2 B. – deleted 3 topic bullets and 2 equipment bullets

13.5 B. – deleted “including mercury-in-glass”

13.6 B – added “and temperature” to third bullet

13.8 B and 13.9 B – changed “will” to “may”

13.9 B. – deleted last two bullets; revised fifth bullet

13.11.5 A – added “digital and film radiography”

13.11.5 B. – added “may” to first sentence; deleted last paragraph

13.12.1 B. – deleted last part of second paragraph

13.12.7 B. – deleted equipment list

13.12.8 B – deleted second sentence

13.15 – section added

Footer - updated

1.3 Header – Division of Field Science changed to Office of Regulatory Science

02 Complete rewrite to restructure and more accurately reflect current training practices 

within Engineering.

03 Grammar and format corrections made. No changes to process content with this revision.

Attachments

None