INFRASTRUCTURE & WORK ENVIRONMENT

To establish guidelines for the work environment and preventative maintenance program for machines and infrastructure

QP 4.5

1) RESPONSIBLIITY:

Facilities Manager/Maintenance Supervisor:

Joe Soria (PSP West)

Harry Evans (PSP East)

Responsibilities:

Walk the facility every day to ensure:
- All machines are operating and monitor their well-being. If a problem is detected, email “Machine is Down” to the executive team, get alarm codes, lock down machine, post warning sign, and schedule maintenance/repairs as needed.
- There are no safety issues present.
- Facilities, especially bathrooms and break rooms, are clean and properly operating.
- Ensure warning signs are posted to alert employees of any hazards.
Create and maintain a maintenance schedule (include warranty periods) on all machines and equipment critical to the running of operations and the facility.
- Ensure that maintenance is performed by the appropriate vendors in accordance with the schedule to protect equipment warranties and value of the equipment.
Ask vendor for and consider whether service agreements make economic sense prior to warranties expiring.
Serve as the lead on all outside audits, regarding OSHA, Fire, and Hazardous materials.

2) RELATED REQUIREMENTS:

ISO 13485

6.3 Infrastructure
6.4.1 Work Environment
6.4.2 Contamination Control

AS9100

7.1.3 Infrastructure
7.1.4 Environment for the Operation of Processes

ISO 13485 Reference

AS9100 Reference

3) QUALITY PROCESS OBJECTIVE:

OBJECTIVE:

Maintain a functioning facility.
Maintain a preventative maintenance schedule.

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.

Sustainability (Resource needs regarding training, equipment, software, manpower):

Monthly Meeting

5) ACTIVITIES AND EXPECTATIONS:

ACTIVITES:

EXPECTATIONS:

6) PROCESS INPUTS:

Source of Input (Machine Maintenance):

Manufacturer recommendations

Source of Input (Facility Maintenance):

Statutory and regulatory requirements

7) PROCESS OUTPUTS:

Source of Output (Machine Maintenance):

Functioning machines according to manufacturer's requirements and recommendations

Source of Output (Facility Maintenance):

OSHA compliant facility

8) RELATED DOCUMENTS:

Policies:

Procedures:

SOP-4.5-001 Infrastructure & Work Environment

Documents:

Work Instructions:

Flow Charts:

Controlled Document Log

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 requirements

Maintenance Supervisor
Facility Manager
Machine Technician
Equipment Maintenance

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 of the following:
- ISO 9001:2015
- ISO 13485:2016
- AS9100 rev D
Corrective actions against this process have been closed and are effective
Training Effectiveness
Status of documented information
- Verify documents are at correct revision and effective date
- All new/revised documents released have all applicable employees trained

Audit Form

Audit Records

Audit Schedule