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PLAN
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PLAN
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QUALITY SYSTEM IMPROVEMENT PLAN, TRAINING COMPLIANCE PROGRAM
PURPOSE
The purpose of this project plan is to define the strategies and deliverables to improve training
compliance program.
The objective of this project is to establish a risk-based approach for determining training
effectiveness for training curricula and/or events.
2.0
3.0
CURRENT STATE
2.1
Training Compliance is measured by Personnel’s ability to complete assigned/required
training by effective date (date the training event/item will be implemented). Signatures in
system provide acknowledgement of individual’s completion and understanding of the training
item’s content.
2.2
Training and effectiveness methods utilized are not based upon risk or complexity. All
revisions require training. All manufacturing procedures and test methods are trained by
qualified personnel however effectiveness method is primarily discussion and understanding
of the process and changes thereto.
2.3
Training is primarily conducted for quality system procedures and guidelines within
computerized system in a read and understand method (i.e. user receives notification, link to
copy of item is available, user reads procedure, user signs/acknowledges within system using
e-signature process).
2.4
Equipment Manufacturing procedures and test methods require training. Training is
completed upon release of new procedures or revised procedures by Manufacturing
Engineers. The method used is “instructor-led” and is documented for established training
audience or new training audience. Training event is documented utilizing a manual training
form () which is attached to the Change Order (i.e. in Agile) releasing the item or where
Manufacturing Department Training Coordinator document’s individuals completion within the
computerized system (i.e ComplianceWire).
2.5
Training is considered effective through evaluation of personnel’s performance (bi-annual
performance reviews, confirmation of understanding of instructor-led or computer based
training resulting in the absence of product nonconformities.
APPROACH
Due to the high volume of curricula to review and potential training materials to develop
implementation of this improvement will be completed in phases. This approach will prioritize the
curricula with the highest potential to product or patient safety and/or used most widely across the
site.
3.1
Phase 1 – Identify requirements for program improvement to comply with ISO13485:2016 risk
based approach. Initiate assessment process appropriate for business.
3.2
Phase 2 – Identify manufacturing procedures and test methods previously determined to be
used to mitigated risks or create product safety mechanisms that could impact patient’s safety
or effectiveness of the equipment.
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QUALITY SYSTEM IMPROVEMENT PLAN, TRAINING COMPLIANCE PROGRAM
3.3
4.0
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Phase 3 – Identify cross functional quality system curricula where interrelated subsystems can
impact safety and effectiveness, risks or risk controls.
OBJECTIVES
4.1
Effectiveness Implementation: Implement a program where Originators of Training Events (i.e.
Change Originators such as R&D Engineers, Manufacturing Engineers, Quality Assurance
personnel) qualified in new or revised process conduct a training session where training is
considered effective based upon assessments of trainees understanding of the content.
4.2
Impact assessment: Implement a process that utilizes a risk-based approach to identify the
appropriate training method to use based upon the level of complexity or impact of the change
to the process or release of a new process. Once a risk-based approach is established,
existing training curricula will be reviewed, and where appropriate risk level determined and
effectiveness verification methods developed
4.3
Training Content Determination: Provide responsible parties with guidance in appropriate
method to utilize to ensure training objectives are identified, understood and implemented in
applicable processes.
4.4
Training Assessment and Records: Provide responsible parties with ability to utilize current
systems or methods to document assessments, training and evidence of effectiveness of
training.
ACTIVITIES AND DELIVERABLES
5.1
Primary responsible individual for project is Quality Systems Project Manager.
5.2
Functional area resources identified by Management will review proposed improvements and
provide feedback before implementation of deliverables.
Activities
Identify requirements
Proposed Deliverables
Target Completion Date
1. Revise current procedures to
indicate effectiveness process.
End of Q3 2017
2. Develop new guidance
documents or procedures on
determining appropriate training
content’s objectives to ensure
effectiveness assessments are
favorable and process is sustainable.
3. Communicate proposed changes.
Evaluate feedback and resolve or
incorporate.
4. Acceptance of responsibility of
appropriate functions is received,
evaluated, incorporated or resolved.
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QUALITY SYSTEM IMPROVEMENT PLAN, TRAINING COMPLIANCE PROGRAM
Activities
Proposed Deliverables
Target Completion Date
Develop training impact assessment
process
1. Create a new form or mechanism
to identify and document Training
Impact Assessment
End of Q3 2017
2. Evaluate content of current form
and revise as appropriate to identify
Training Audience changes.

Implement a “user-friendly”
form

Separate out forms to use for
Training Audience changes
only. For example:

Separate out Manufacturing
and Repair Depot into one
form;

Separate out Warehouse into
its own form that may be
needed in conjunction with
updates to other forms.

Separate out QS procedure
plan updates add info
regarding curriculum creation
and changes.
3. Communicate changes to
Department Training Coordinators
and incorporate or resolve feedback.
4. Communicate with functional area
managers proposed form and
incorporate or resolve feedback.
5. Acceptance of responsibility of
appropriate functions is received,
evaluated, incorporated or resolved
Identify and implement a new
curricula creation process
1. Review current training
assignments via training plans and
training matrices with functional area
managers to identify appropriate
‘tiered approach’ for job proficiency.
2. Revise Training Plans as
necessary to align with proficiency
training approach.
2. Implement a curricula creation
process that provides personnel
assignments based upon skills
required for position as determined
by functional area manager.
End of Q1 2018
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QUALITY SYSTEM IMPROVEMENT PLAN, TRAINING COMPLIANCE PROGRAM
Activities
Proposed Deliverables
Target Completion Date
Identify and rank manufacturing
procedures and test methods (Phase
2) according to impact to product and
complexity.
1. Develop training effectiveness
materials to support risk level
determination for Phase 2 curricula.
End of Q1 2018
2. Implement new curricula or
assessment template for items
identified in Phase 2 and assign to
users dependent upon personnel’s
role and responsibilities as required.
3. Develop supporting process for
reviewing Effectiveness Verification
results.
Identify and quality system procedures
and supporting training aides (Phase
3) according to impact to safety and
effectiveness of product.
1. Develop training effectiveness
materials to support risk level
determination for Phase 3 curricula.
End of Q2 2018
2. Implement new curricula or
assessment template for items
identified in Phase 3 and assign to
users dependent upon personnel’s
role and responsibilities as required
3. Develop supporting process for
reviewing Effectiveness Verification
results.
6.0
Train users on new process
Provide instructor-led training
sessions with functional areas
impacted by the improved process
End of Q2 2018
Complete Project
Prepare and release report to
document completion of plan.
End of Q2 2018
RISKS
6.1
7.0
The following risks may adversely affect the project:
#
Description
Priority
Mitigation
1
Resources- inability to obtain cross functional
team participation due to daily responsibilities,
and other projects competing
High

Ensure resources are assigned by
site management. Track
participation and maintain
communication management
2
Potential Unknowns- e.g., additional associated
documents that may require concurrent updates
Medium

Plan & track additional tasks as they
are identified

Communicate concerns QA staff
meetings
ISSUES
7.1
No issues currently adversely affect the project.
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QUALITY SYSTEM IMPROVEMENT PLAN, TRAINING COMPLIANCE PROGRAM
ASSUMPTIONS
8.1
9.0
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Integration of Equipment Sites into ComplianeWire will not impact any deliverables to be
implemented into the system.
CONSTRAINTS
#
Description
Priority
Mitigation
1
Resources- Not all Department Training
Coordinators accounts in ComplianceWire
include role that allows ability to create
curriculums or assessments/tests.
Medium

Ensure resources receive
appropriate training to obtain role in
system.