HR & TRAINING
To ensure that the company has the resources needed to meet applicable regulatory and customer requirements, as well as for the establishment, implementation, maintenance, and continual improvement of the quality management system.
Embedded Files
QP 4.1
1) RESPONSIBILITY:
Quality Process Administrator:
Daniela Kozar
Responsibilities:
Item one
Item two
Item three
Document Control Specialist:
Amanda Breen
Responsibilities:
Train on Quality procedures
Save and Maintain employee training records
Assist with safety trainings (PSP East)
Human Resources:
Roberta Barone
Responsibilities:
Create job descriptions
Assist employees with requests regarding human resources issues, regulations, company policies, time off, benefits etc.
Compile and update employee records (hard and soft copies)
Coordinate HR projects (HR related trainings, meetings, performance evaluations)
Process and maintain new hire, termination, and benefits enrollment paperwork.
Ensure all new hires have a job description on their first day and that it is signed and given to Training Coordinator to save for records.
2) RELATED REQUIREMENTS:
ISO 13485
6.1 Provision of Resources
6.2 Human Resources
AS9100
7.1 Resources
7.1.2 People
7.2 Competence
7.3 Awareness
3) QUALITY PROCESS OBJECTIVE:
OBJECTIVE:
Ensure that personnel performing work that affects product quality, is competent, educated, has the applicable training and skills required to ensure that product conforms to requirements.
Ensure that training is verified for effectiveness and all training and re-training activities are documented.
4) EFFECTIVENESS MEASURE:
Measurable KPI's are established within the monthly quality meeting report, section Key Performance Indicators.
KPI's are verified for effectiveness on a monthly basis.
If the KPI's are not met, management will assign activities to ensure that the quality process will perform within set guidelines.
Sustainability (Reported resource needs regarding, training, equipment, software, man power)
Turnover rate for direct labor (measured in number of employees): ≤ 5
Turnover rate for indirect labor (measured in number of employees): ≤ 2
Number of annual evaluations not performed as scheduled (13 months after hiring date): 0
Employee workers comp incident: 0
5) ACTIVITIES AND EXPECTATIONS:
VERIFICATION OF EFFECTIVNESS:
Effectiveness of training is verified through gate tests and observations
RETRAINING IS INITIATED:
Minimum every 3 years for the Quality Process
When there is a gap between the activities and the expectations (this can be identified through a corrective action, nonconformance, audit, observation or peer feedback)
When any documented information in a Quality Process changes, and the change affects the process approach, then all applicable employees (reference section 1 of each quality process) are subject to re-training
EXPECTATIONS:
Perform annual evaluations (evaluations must be performed no later than 13 months after the hiring date)
All training must be completed as scheduled (see training matrix)
New employee orientation must be completed within first week of employment
Quality process specific training must be completed within 30 days of employment
On the job training will be performed on an as needed basis
6) PROCESS INPUTS:
Source of Inputs:
Hiring requisitions
Job descriptions
Training requirements
Performance review schedule
Performance review form
PIP form (performance improvement plan)
7) PROCESS OUTPUTS:
Source of Outputs:
Training and re-training records (located in training records folder in Q:drive, Google Drive)
Annual evaluation records (located in H:drive)
Verification of effectiveness of training (located in training records folder in Q:drive, Google Drive)
Verification of competency (offer letter located in H:drive)
Signed job description (located in Q:drive, Google Drive)
Note: Continual improvement project CIP011822 implemented to consolidate all training records and create a searchable data base for trainings
8) RELATED DOCUMENTS:
Policies:
Procedures:
Documents:
Work Instructions:
9) TRAINING REQUIREMENTS:
Mandatory training (to be completed within the first 30 days of assignment)
10) INTERNAL AUDIT- VALIDATION AND VERIFICATION:
Internal audit performed on: _______
Auditor: _________
Findings: _______
The following elements will be validated and/or verified as part of the scheduled internal auditing process.
Validation:
Quality system validated as part of the internal audit
Verification:
Compliance with all applicable requirements
Corrective actions against this process have been closed and are effective
Training Effectiveness
Status of documented information (have there been any changes or new documents issued and if documents have been changed or added have all applicable employees trained)
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