To provide a standard for methods to be used during inspection, to ensure that all employees from the shop floor to quality, are inspecting each feature in the same method, using the same type of tooling, and in the same order of operations.
QP 3.2
1) RESPONSIBLIITY:
Quality Control Manager:
Robert Castillo (PSP East)
Itzael Colin (PSP West)
Responsibilities:
Collaborate with the upper management team to set quality control department goals
Make crucial decisions in favor of cost-efficiency without compromising on quality
Identify critical features during kick off meetings and ensure the information from kick off meetings are flowed down to the QC team
Ensure Operational Review Board meeting is held daily, and action items are being completed. Escalate as necessary
Assign priorities for QC team utilizing the systems in place, including the responsibility for RMA and NC inspection/completion
Attend MRB meetings (or assign QC team member to attend) and assist with root cause and corrective actions
Quality Control Lead:
Allen Quintanilla (PSP East)
Open (PSP West)
Responsibilities:
Use the systems in place and team members to gather priorities for the QC department on what is required to be inspected to move product through.
Actively engage with the quality team to ensure the work you are producing is conforming to the customer, regulatory and statutory requirements
Monitoring and maintenance of equipment calibration and records to ensure all are performed per the process and timely.
2) RELATED REQUIREMENTS:
ISO 13485
8.2.6 Monitoring and Measurement of Product
8.3 Control of Nonconforming Product
AS9100
8.5.1 Control of Production and Service Provision
3) QUALITY PROCESS OBJECTIVE:
OBJECTIVE:
Ensure parts are conforming to customer requirements
Create inspection standards
Create inspection plans
4) EFFECTIVENESS MEASURE:
Measurable quality objectives are established within the monthly quality meeting report, section quality objectives.
Quality objectives are verified for effectiveness on a monthly basis.
If the quality objectives are not met, management will assign activities to ensure that the quality process will perform within set guidelines, or justification will be noted on the monthly quality meeting.
5) EXPECTATIONS AND ACTIVITIES:
EXPECTATIONS:
ACTIVITES:
Create inspection plans
Review customer requirements
Ensure part conformity
6) PROCESS INPUTS:
Source of Input:
Customer drawing
Specifications
Quality requirements
Inspection Plan
FAI Form
7) PROCESS OUTPUTS:
Source of Output:
Part meeting all dimensional requirements
Parts delivered on-time
8) RELATED DOCUMENTS:
Policies:
Procedures:
Documents:
Work Instructions:
WI-3.2-008 Loading PSP StandardProtocol PiWeb Report ptx Template
WI-3.2-010 Issuing an RMA
WI-3.2-011 Inspecting an RMA
WI-3.2-013 Opening and Completing a Nonconformance
Flow Charts:
FC-3.2-001 RMA-NC Process Flow Chart
9) TRAINING REQUIREMENTS:
Training plans have been created for the positions listed in the responsibilities section
Click on the appropriate link below to see the training plan for that position
The supervisor is responsible for ensuring their employees are completing their training plans within the specified time requirements
Jr. QC Inspector
Sr. QC Inspector
QC Lead
QC Manager
10) INTERNAL AUDIT- VALIDATION AND VERIFICATION:
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)