IMPROVEMENT
Inspecting the product to determine whether it meets the accepted criteria, and ensure its safety and effectiveness. And to ensure that our company is consistently improving upon our QMS.
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QP 4.4
1) RESPONSIBILITY:
Chief Quality Officer:
Daniela Kozar
Responsibilities:
Quality Control Manager:
Itzael Colin (PSP West)
Rob Castillo (PSP East)
Responsibilites:
The Quality Control Inspectors are responsible for all items pertaining to this Quality Process.
Individual responsibilities are defined within the job descriptions, Standard Operating Procedures, documents and work instructions.
2) RELATED REQUIREMENTS:
ISO 13485
8.3 Control of Nonconforming Product
8.5 Improvement
AS9100
8.7 Control of Nonconforming Outputs
10.1 Improvement
10.2 Nonconformity and Corrective Action
10.3 Continual Improvement
3) QUALITY PROCESS OBJECTIVE:
OBJECTIVE:
Inspection of products to ensure they meet accepted criteria
Stable, conforming production process
Reduce the number of escapes to the customer
QP-4.4 Improvement
Control of nonconforming product
Corrective actions (located in the Corrective Action Log)
Preventative Actions (located in the Continual Improvement Log)
Continual Improvements (located in the Continual Improvement Log)
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.
EFFECTIVENESS MEASURES (KPI's):
Sustainability (Measured on resource needs regarding, training, equipment, software, man power): Y
Length of time to process nonconformances): ≤ 30 days
Length of time an FAI is in QC (Measured through inspection log): ≤ 8 Hrs
100% inspection: ≤ 3 jobs per month
NOTE:
The team will start with an estimate for the goal each month as a base line, and will adjust as we see fit throughout the year
A comment shall be added to the goal each time it is adjusted
5) ACTIVITIES AND EXPECTATIONS:
EXPECTATIONS:
FAI to be entered electronically during FAI
Complete FAIR documentation for shipping to print
Complete, clear, and close looped nonconformance process
6) PROCESS INPUT:
Source of Input:
Operations (internal)
Customer Requirements
Risk Management
Inputs:
First article inspection reports and parts from production
Material certifications and product
Outside service certifications and product
Customer Returns
7) PROCESS OUTPUT:
Receivers of Output:
Customer
Operation (internal)
Quality
Supplier
Management
Output:
FAIR ready to send to a customer
Completed NC and RMA reports
Conforming product
8) RELATED DOCUMENTS:
Policies:
Procedures:
SOP-10.0-001 Improvement Process
SOP-4.4-002 Escalation Procedure
Work Instructions:
WI-10.0-001 Issuing an RMA
WI-10.0-002 Opening and completing a nonconformance
WI-10.0-004 Vendor Return WI
WI-10.0-006 RMA Status Review
WI-10.0-007 Inspecting an RMA
Forms:
DOC-10.0-002 Continual Improvement Form
DOC-10.0-003 5 WHY CAR
DOC-10.0-005 Concession Request Form
DOC-10.0-007 Continual Improvement Project Log Master
Nonconformance Template - For Reference Only
CMM and Quality Equipment Operations and Etiquette Guide (For Reference Only)
MRB Cabinet Log
Documents:
DOC-4.4-001 Corrective Action Report
DOC-10.0-010 In-Process Floor Inspections
QC Floor Monitoring Log (Reference Only)
Flow Charts:
FC-10.0-001 RMA-NC Process Flow Chart
9) TRAINING REQUIREMENTS:
Request training plan for new employees from Training Coordinator.
Training plans are issued through Training Keeper and are the responsibility of the employee and manager, to ensure all training is completed per the required due dates.
Any exceptions to this shall be discussed with the Training Coordinator, documented and/or adjusted.
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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