Improving the Quality of Training Documentation
Objectives
•
Define what information should be included in
training documentation
•
Demonstrate that training documentation system
can be simple, efficient, and regulatory compliant
•
Demonstrate how system for documenting
training can be designed to facilitate CTBS
recertification.
Of course I documented it!
If you know the
enemy and
know yourself,
you need not
fear the
outcome of a
hundred battles.
The Art of War -Sun Tzu
Know the requirements…
Regulatory Requirements: AATB
J2.100 Training
Training shall be conducted for technical and QA staff to maintain Competency in procedures and familiarity with
applicable federal and state regulations and AATB Standards. Training shall encompass the following areas, as applicable: new employee orientation; the SOPM; technical training; QA; computer; and continuing education. All training activities shall be documented. Training records shall be retained for 16 years after termination of employment or as required by federal, state and/or local law, whichever is longer.
Regulatory Requirements: AATB
J2.200 Competency
Technical staff must demonstrate Competency in the particular operations for which they have received training (including a thorough understanding of the policies, procedures, Process Controls, and regulatory requirements) and to which they are assigned.
J2.300 Continuing Education
Technical staff shall participate in continuing education, which may include training courses, technical meetings, and any
other educational programs pertaining to assigned functions. Such participation shall be documented.
Regulatory Requirements: AATB
J2.400 Training Records
A training file shall be maintained for each employee with documentation of the following:
1) Training checklist for new employees and employees with newly assigned tasks;
2) Delineation of functions that each employee is authorized and trained to perform;
3) Documentation of review and training prior to implementation of new and/or revised sections of the SOPM;
4) Annual review of policies and procedures for which the employee has been trained, including safety procedures;
5) Annual attendance at hazardous materials training; and
6) Attendance at workshops, seminars, meetings, or other continuing education programs.
Regulatory Requirements: FDA cGTPs
§
1271.170 Personnel.
(b)
Competent performance of functions.
You must
have personnel with the necessary education,
experience, and training to ensure competent
performance of their assigned functions. Personnel
must perform only those activities for which they are
qualified and authorized.
(c)
Training.
You must train all personnel, and retrain
as necessary, to perform their assigned
responsibilities adequately.
Regulatory Requirements: FDA CFR 21
§820.25 Personnel.
(a) General. Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly
performed.
(b) Training. Each manufacturer shall establish procedures for
identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented.
(1) As part of their training, personnel shall be made aware of
device defects which may occur from the improper performance of their specific jobs.
(2) Personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job functions.
Know your own weaknesses…
Review Internal Audit Reports
Use your Internal Auditors as a Resource
So we re-designed them…
So we re-designed them…
• Lists staff members by name. • It’s more legible.
• Lists staff members by name. • It’s more legible.
• You can tell at a glance if a signature is missing.
• Easier for the person who tracks the training.
Take a Quality Approach…
Identify different Types of Training…
•
Initial Training
: everyone needs to know
•
Specialty Tasks
: only some need to know
•
New Responsibilities
: new product roll out
•
Changes
to current practices: SOP revisions
•
Retraining
: Supervisory, E&A, complaint
•
Corporate Requirements
:
•
Annual SOP Review
Create a
System
to document each type.
•
Don’t reinvent the wheel
with each training event.
•
Keep your Requirements
in mind.
•
Documenting training
becomes routine and
relatively painless!
Rube Goldberg Training Tips
• DON’T create a complex machine to perform a simple task! • Make training commensurate to the task.
Design Your Documents
Define eval standards Reference SOPs Include Safety… …Training Materials …Forms TCL Revision Control Initial TCL = CP Eval …Equipment
With Careful Planning:
Training Plan
Training Checklist
Cont. Prof. Eval
Annual SOP Review
Satisfy two requirements:
Continued Proficiency Testing Annual SOP Review
My documents look pretty good now!
They’re paper!
• Cumbersome • Take up space
• Not track-able / searchable
• Track training • Search
Employee information Employee training record
You have a paper system…
Keep in mind…
Electronic Systems aren’t magic!
They’re based on logic, process flows, and well-defined data relationships.
