Improving the Quality of Training Documentation. Dana Weate, Technical Training Manager

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Johnathan Robbins
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1 Improving the Quality of Training Documentation Dana Weate, Technical Training Manager

2 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.

simple, efficient, and regulatory compliant Demonstrate how system

3 Of course I documented it!

4 Do you want to hand this to an auditor?

5 Title / Description are vague and don t reference documents.

6 Improper error correction

7 Legibility has everyone signed?

8 If you know the enemy and know yourself, you need not fear the outcome of a hundred battles. The Art of War -Sun Tzu

9 Know the requirements Regulatory & Self-Imposed

10 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.

federal and state regulations and AATB Standards.

11 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.

thorough understanding of the policies, procedures, Process Controls, and regulatory requirements) and to which they are assigned. J2.

12 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.

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

13 Regulatory Requirements: FDA cgtps 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.

14 Regulatory Requirements: FDA CFR 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.

(b) Training. Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities.

15 Know your own weaknesses Review Internal Audit Reports Use your Internal Auditors as a Resource and then strengthen them

16 Our sign-in sheets were a weakness

17 So we re-designed them Agenda Departmental Sign-In Sheet

18 Reference documents by number, revision level, and title.

19 Provide a detailed description of the training material.

20 Record CEU information.

21 So we re-designed them Agenda Departmental Sign-In Sheet

22 Lists staff members by name. It s more legible.

23 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.

24 Even a basic sign-in sheet is a Quality document.

25 Take a Quality Approach Create a SYSTEM for documenting training.

26 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 Annual Safety Training (Departmental)

27 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!

28 Rube Goldberg Training Tips DON T create a complex machine to perform a simple task! Make training commensurate to the task. You ll have to MAINTAIN whatever you put in place!

29 Design Your Documents Know your requirements and the document designs itself.

30 Initial TCL = CP Eval Define eval standards Reference SOPs Include Safety Training Materials Forms Equipment Product Master Record TCL Revision Control

31 With Careful Planning: Training Plan Training Checklist Cont. Prof. Eval Annual SOP Review Satisfy two requirements: Continued Proficiency Testing Annual SOP Review

32 My documents look pretty good now!

33 But can you find them?

34 The problem with paper files?

35 They re paper! Cumbersome Take up space Not track-able / searchable Track training Search Generate reports

36 Employee information Employee training record Running total of CEUs

37 You have a paper system but you can use electronic tools to help manage it!

38 Training Modules include hyperlinked TCLs

39 and Continued Proficiency Schedules

40 and reports that show who s signed-off on what

41 Keep in mind Electronic Systems aren t magic! They re based on logic, process flows, and well-defined data relationships.

42 Hey IT-Guy Can you throw this into an electronic system for me?

PERSONNEL: TRAINING PROCEDURE. C. Quality Management Systems (QMS) Manager:

PERSONNEL: TRAINING PROCEDURE. C. Quality Management Systems (QMS) Manager: Page 1 of 10 Sections Included in this Document/(Change History) 1. Purpose 2. Scope 3. Responsibilities 4. Background 5. References 6. Procedure /(6.1 d. spelling of analytical corrected in last bullet;