PRODUCTION
To ensure all product is manufactured in controlled conditions and fulfills the customer and regulatory requirements prior to release of product to the customer.
Embedded Files
QP 3.0
1) RESPONSIBLIITY:
Operations Manager:
Lisa Silveira (PSP West)
Responsibilities:
Lead Gemba walks and ensure Supervisors and Leads maintain the data for the Gemba meetings.
Deep dive when standards are not met to develop root cause and corrective actions.
This includes machine efficiency, machine to man ratios (Labor Efficiency) and quality to meet and exceed Overall Equipment Efficiency (OEE).
Support the escalation process when any standard is not met to ensure timely corrective action.
Support the process of and attend Single Minute Response Team (SMRT) meetings to ensure the concern is clear, process is followed, and the corrective action loop is closed.
Support and actively participate in the 6S daily safety walks.
Follow up with ‘machine down’ situations until the machine is running again.
Attend Management meetings with the executive team.
Attend weekly operations meetings with the COO to ensure strategic continuity between sites.
Partner with Supervisors, Leads and support staff to ensure productive, healthy, and balanced operations.
Minimize any potential manufacturing issues by attending Kick Off Meetings when necessary to mitigate the risk of new parts or parts that had prior nonconformances.
Coordinate with the Quality department to maintain quality standards.
Manufacturing Engineer:
Mike Doran
Responsibilities:
Milling Lead:
Medel Seguritan (PSP East)
Cody Henderson (PSP West)
Responsibilities:
Manage department by supporting and developing staff, holding employees accountable by assisting Production Supervisor with feedback for employee evaluations, and employee disciplinary process.
Encourage growth in staff through new opportunities, accountability, and learning from mistakes, with emphasis on recovery and future prevention.
Ensure department is performing timely maintenance on all equipment including station cleaning per PSP SOP. Report any issues to supervisor, maintenance and management as appropriate
Work closely with the production supervisor to ensure on-going visibility for MFG forecasting needs and plans. Communicate any potential changes/problems or issues in MFG that could effect on time delivery, i.e. set-up and cycle time changes, operator absences, machine down time, etc.
Lathe Lead:
Nate Roby (PSP East)
Loc Tran 1 (PSP West)
Responsibilities:
Manage department by supporting and developing staff, holding employees accountable by assisting Production Supervisor with feedback for employee evaluations, and employee disciplinary process.
Encourage growth in staff through new opportunities, accountability, and learning from mistakes, with emphasis on recovery and future prevention.
Ensure department is performing timely maintenance on all equipment including station cleaning per PSP SOP. Report any issues to supervisor, maintenance and management as appropriate
Work closely with the production supervisor to ensure on-going visibility for MFG forecasting needs and plans. Communicate any potential changes/problems or issues in MFG that could effect on time delivery, i.e. set-up and cycle time changes, operator absences, machine down time, etc.
Swiss Lead:
Nate Roby (PSP East)
Alberto Salazar (PSP West)
Responsibilities:
Manage department by supporting and developing staff, holding employees accountable by assisting Production Supervisor with feedback for employee evaluations, and employee disciplinary process.
Encourage growth in staff through new opportunities, accountability, and learning from mistakes, with emphasis on recovery and future prevention.
Ensure department is performing timely maintenance on all equipment including station cleaning per PSP SOP. Report any issues to supervisor, maintenance and management as appropriate
Work closely with the production supervisor to ensure on-going visibility for MFG forecasting needs and plans. Communicate any potential changes/problems or issues in MFG that could effect on time delivery, i.e. set-up and cycle time changes, operator absences, machine down time, etc.
Finishing Lead:
Robbie Miller (PSP East)
Eddie Jimenez (PSP West)
Responsibilities:
Lead the Finishing team, which includes: communicating priorities, providing trainings, ensuring product in the department is properly handled/identified, managing and maintaining the cleaning solutions, overseeing the preventative maintenance for the department, and representing the team/department in meetings.
Review methods for finishing parts, identify and suggest possible improvements.
Handle all parts delicately, maintain traceability, and take proactive measures to prevent cross-contamination.
Submit all First Article Inspection (FAI) parts to the QA department in accordance with applicable processes. Work with QA to correct any issues on failed parts, and ensure all submitted FAI parts are appropriately documented and approved before performing work on an entire batch.
Ensure supplies and substances are handled, returned, and stored safely per applicable policies and procedures. If new or additional personal protective equipment is needed in your area, communicate the needs to your supervisor and Purchasing team.
2) RELATED REQUIREMENTS:
ISO 13485
6.4.2 Contamination control
7.5.1 Control of Production and Service Provision
7.5.2 Cleanliness of Product
7.5.8 Identification
7.5.9 Traceability
7.5.9.1 General
7.5.11 Preservation of product
AS9100
8.5 Production and Service Provision
8.5.1 Control of Production and Service Provision
8.5.1.1 Control of Equipment, Tools, and Software Programs
8.5.1.3 Production Process Verification
8.6 Release of Products and Services
3) QUALITY PROCESS OBJECTIVE:
OBJECTIVE:
To produce quality parts to customers on-time.
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) ACTIVITIES AND EXPECTATIONS:
ACTIVITES:
Manufacture quality parts
EXPECTATIONS:
Flow down of requirements and objectives (customer, legal and quality) to communicate what is to be achieved to ensure quality of product
Review and assessment of all applicable risks in relation to producing the product to ensure product and employee safety
Ensure quality production of each job to hit customer on-time delivery
6) PROCESS INPUTS:
Source of Input:
Customer drawing and contract requirements
ERP work order
Manufacturing program, setup book, tool list
FAI Inspection plan
Sampling plan
7) PROCESS OUTPUTS:
Source of Output:
Product that conforms to customer, statutory and regulatory requirements
Parts delivered on-time
8) RELATED DOCUMENTS:
Policies:
Procedures:
SOP-8.5-003 (Preservation of Product)
Work Instructions:
Guide ID 15 (Accessing Electronic Travelers)
(Program Saving)
(Inspection Log Instructions)
(Locating Part Count from E2)
(Logging in and out of Jobs)
WI-8.5-027 (Zoll Qual Sheet)
Guides & References:
GDT Color Chart
GDT Symbols Reference Guide
(C=0 Sampling Plan)
(High QA Balloon Meaning Cheat Sheet)
(Chemical Expiration Guide)
Employee Dashboard Job-Qty clock on and off
Employee Job-Qty clock on and off
DOC-8.5-033 (Deburring Guide)
FC-7.5.1-002 (FOD CLEANING MATRIX)
FC-7.5.1-003 (POLISHING AND DEBURRING TOOL MATRIX)
Clock in-out sheet- FOR REFERENCE ONLY
Employee Dashboard Job-Qty clock on and off - FOR REFERENCE ONLY
Employee Job-Qty clock on and off - FOR REFERENCE ONLY
Audit Ready Reminders_Finishing (For Reference Only)
Audit Ready Reminders_Manufacturing (For Reference Only)
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
Operations Manager
Manufacturing Engineer
Supervisor or Lead
Machinist I
Machinist II
Machinist III
Machinist IV
Machinist V
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)
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