DOCUMENT REVISION HISTORY PAGE Document Number: Rev: Page: Title: 90A0104 H 2 of 15 ENVIRONMENTAL CONTROLS Revision History Of Document Rev CO Number Description of Change Author Effective Date FI ---- First Issue of Document JB 10/02/97 A 1064 Updated per Internal Audit (00-006) findings to reflect actual J.S.B. 12/18/00 Practices and to correct errors. B 1706 Revised per Internal Audit (02-020) findings. Add sections on J.S.B. 10-17-02 Periodic Inspections and Responsibilities C 2054 Updated/revised cleaning tasks and schedules for practicality and clarity. Changed responsibilities to Facility Manager. RJH 03-05-07 D 2470/2548 Added 90F0112 to Associated Documents. Added work area classifications & descriptions. Revised Inside Air Quality requirements (5.1.2). Added food/beverage/tobacco restrictions. Revised Insect and Pest Control requirements (5.5). Specified length of retention for completed checklists. RJH 01-16-09 E 2970 Update environmental controls to reflect 121 Gamma Drive KJ 07-27-11 F 3388 Added section 5.2.3 Lighting per ISO 13485:2012 Audit. Updated ETB 03-07-14 approval page to current Revision. Changed branding from Lifcor to Zoll. G 3817 Revised Manufacturing Engineering Manager (Acting Facility LPW 02-08-16 Manager) to Facility Manager or designee in the Table of Contents, Section 3.1 and Section 3. Responsibilities 3.1. Added or designee to sentences 1 and 3 in Section 3.1. Added Special controls to sentences 1 in Sections 4.1 and 4.4. Revised Section 4.2 sentence 2 by adding See 90E00015.. Changed the to any in Section 4.4 sentence 1. Revised 5.1.4 Tasks and Schedules to clarify responsibilities to fill out Tables 4-3 and 4-4. Updated punctuation in Section 5.2.1. Updated punctuation in Section 5.2.2. Updated punctuation in Section 5.2.3 and added where the monitoring results will be recorded. Updated punctuation in Section 5.4. Revised Tables 4-1 and 4-2 to clarify responsibility and location. Revised Table 4-3 for clarification of dates. Revised Table 4-4 to add responsible person and instructions. Revised Section 5.6 by removing Section 5.6.2. Changed Heading from LIFECOR to ZOLL. ZOLL Form Number: 90A0001-A03 Form REV Level: J
DOCUMENT REVISION HISTORY PAGE Document Number: Rev: Page: Title: 90A0104 H 3 of 15 ENVIRONMENTAL CONTROLS Revision History Of Document Rev CO Number Description of Change Author Effective Date H Add reference to Nonconforming Material procedure, Air Quality 4733 Testing Procedure, Light Monitoring Procedure, and Light JLD 2-16-17 Monitoring Results in Section 2, Add Section 5 Risk Control Measures for Environmental Controls, Add clarification to Section 6.5 Insect and Pest Control ZOLL Form Number: 90A0001-A03 Form REV Level: J
ZOLL Document Number: 90A0104 Page 4 of 15 Table of Contents 1. INTRODUCTION... 5 1.1 PURPOSE... 5 1.2 SCOPE... 5 2. ASSOCIATED DOCUMENTS... 5 3. RESPONSIBILITIES... 5 3.1 FACILITY MANAGER OR DESIGNEE... 5 4. WORK AREA CLASSIFICATIONS... 6 4.1 OFFICE... 6 4.2 PRODUCTION... 6 4.3 RETURNED GOODS... 6 4.4 DOCKS... 6 5. RISK CONTROL MEASURES FOR ENVIRONMENTAL CONTROLS... 7 5.1 TEMPORARY LOSS OF POWER... 7 5.2 LONG TERM LOSS OF POWER... 7 5.3 BUILDING HVAC EQUIPMENT FAILURE... 7 6. ENVIRONMENTAL CONTROLS... 8 6.1 OFFICE & GENERAL... 8 6.2 PRODUCTION... 8 6.3 RETURNED GOODS... 9 6.4 DOCKS... 9 6.5 INSECT AND PEST CONTROL... 14 6.6 DISCREPANCY REPORTING... 14
ZOLL Document Number: 90A0104 Page 5 of 15 1. INTRODUCTION 1.1 Purpose 1.2 Scope The purpose of this SOP is to establish company policy and guidelines to ensure that environmental conditions that could have an adverse effect on product safety and quality during manufacturing and servicing are controlled. This SOP covers interior temperature controls, ESD control, interior air quality, insect and/or pest inspections and cleaning activities. Since the LifeVest is a non-invasive product, clean room and sterilization requirements are not necessary. 2. ASSOCIATED DOCUMENTS 90E0015 Electrostatic Discharge (ESD) Protection Procedure 90A0036 Equipment Maintenance 90F0112 Safe Handling and Procedures for Serviceable LifeVest System Hardware 90F0030 Nonconforming Material 90F0850 Air Quality Testing Procedure 90F0835-AXX Indoor Air Quality Survey Results 90F0918 Light Monitoring for Production Areas Procedure 90F0918-AXX Light Monitoring for Production Areas Test Results 3. RESPONSIBILITIES 3.1 Facility Manager or designee The Facility Manager or designee is responsible for ensuring that the established guidelines of this S.O.P. are followed for interior air quality, lighting, insect and/or pest inspections, and cleaning activities. Inspections will be conducted according to the Inspection Checklist (Table 4-4). The Facility Manager or designee is responsible for ensuring that the established guidelines of this S.O.P. are followed for interior temperature controls and building maintenance. Inspections will be conducted according to the Equipment Maintenance SOP (90A0036).
ZOLL Document Number: 90A0104 Page 6 of 15 4. WORK AREA CLASSIFICATIONS 4.1 Office These areas include Engineering, Sales & Marketing, Support Services, Finance & Administration, Medical Affairs, etc Special controls: No special or contamination controls are required. 4.2 Production These areas include Manufacturing, Quality Assurance, and Materials Stockroom. Special controls: See 90E0015. ESD protection for electronic parts/devices. Eating, drinking, and smoking is not permitted within the manufacturing area. 4.3 Returned Goods 4.4 Docks This area is where returned LifeVest equipment is unpackaged, cleaned & disinfected. Special controls: See 90F0112. These areas include Shipping, Receiving and any bulk storage location. Special controls: No special or contamination controls are required.
ZOLL Document Number: 90A0104 Page 7 of 15 5. RISK CONTROL MEASURES FOR ENVIRONMENTAL CONTROLS 5.1 Temporary Loss of Power (Less than or equal to 24 hours) 5.1.1 Method of Notification 5.1.1.1 A real-time notification is provided from the third party security system provider. 5.1.1.2 The facility is a multi-tenant facility where personnel are present 24 hours a day. In the event of a power outage, facilities personnel are notified. 5.1.2 Risk Control Measures 5.2 Long-Term Loss of Power 5.1.2.1 Emergency response from the power company will ensure no negative impact to environmental controls. 5.2.1 Method of Notification 5.2.1.1 A real-time notification is provided from the third party security system provider. 5.2.1.2 The facility is a multi-tenant facility where personnel are present 24 hours a day. In the event of a power outage, facilities personnel are notified. 5.2.2 Risk Control Measures Temperature data loggers with battery back-up power will continuously monitor the Production and Stock Room area temperatures. If the temperature exceeds the storage limits, the material shall be tagged, segregated, and processed in accordance with Nonconforming Material Procedure 90F0030. 5.3 Building HVAC Equipment Failure 5.3.1 Method of Notification Facilities personnel are notified by the Building Automation System. HVAC service personnel are then dispatched within 30 minutes to address the HVAC equipment failure. 5.3.2 Risk Control Measures Temperature data loggers with battery back-up power will continuously monitor the Production and Stock Room area temperatures. If the temperature exceeds the storage limits, the material shall be tagged, segregated, and processed in accordance with Nonconforming Material Procedure 90F0030.
ZOLL Document Number: 90A0104 Page 8 of 15 6. ENVIRONMENTAL CONTROLS 6.1 Office & General 6.2 Production 6.1.1 Temperature Controls The temperature settings will be adjusted as needed to maintain a comfortable working atmosphere. The limits will be set between 66 and 78 degrees Fahrenheit. Specific departments may find that processes and/or environments may require different temperature settings. 6.1.2 Inside Air Quality Other than maintaining employee comfort, no special requirements exist for Inside Air Quality. 6.1.3 Activities should be organized, scheduled, and focused on achieving specific objectives, especially those related to the protection of health and maintenance or restoration of valuable property. activities occur on three levels - housekeeping, maintenance and restoration. 6.1.4 Tasks and Schedules Tables 4-1 and 4-2 list tasks and schedules for cleaning the building. The fundamentals listed are intended to be a guideline for determining the tasks and schedules for each building area. Table 4-3 will be filled out by the cleaning technicians supervisor or designee after a review of the scheduled tasks performed by the cleaning technicians. Dates when no tasks have been scheduled will be listed as N/A or Not Applicable in the appropriate spaces provided on the check list. Table 4-4 will be filled out by the Facility Manager or designee after reviewing Table 4-3. Completed checklists shall be retained for a minimum period of 12 years by Document Control from the date the checklists were completed. Production areas are subject to the same Environmental Controls as Office & General Areas with the following additions: 6.2.1 Inside Air Quality The air particulate shall be monitored on the first floor, production area. The results of this testing shall be recorded in document number 90F0835-AXX. 6.2.2 ESD Control ESD control will be implemented in accordance with (90E0015) Electrostatic Discharge
ZOLL Document Number: 90A0104 Page 9 of 15 Protection Procedure. 6.2.3 Lighting Light monitoring will be implemented in accordance with (90F0918) Light Monitoring for Production Areas Procedure. The results of this testing shall be recorded in document number 90F0918-A##. 6.3 Returned Goods Returned Goods are subject to the same Environmental Controls as Office & General Areas with the following additions: See 90F0112. 6.4 Docks Docks are subject to the same Environmental Controls as Office & General Areas with the following exceptions: 6.4.1 Temperature Controls The temperatures in the dock areas are variable based on outside environmental conditions. While efforts are made to help control the temperature, any employee working in a dock area should dress accordingly.
ZOLL Document Number: 90A0104 Page 10 of 15 Daily Tasks Daily Tasks Daily Tasks Area Task Resp. Area Task Resp. Area Task Resp. Entrances / Common Areas Vacuum Floor Mats Dust Mop Floor Clean Glass and Doors Damp Mop Floor Polish Stainless Steel Clean Receptionist Area Clean Furniture and Tables Adjust Blinds Vacuum Carpet (High Traffic) Clean Drinking Fountains Empty all Waste Baskets Office Areas Production Empty all Waste Baskets Dust and Spot Clean Furniture Spot clean Carpet Vacuum Carpet (High Traffic) High and Low dusting of all vertical services Sanitize Phones Dust Mop Floor Damp mop Floor Dust and Spot Clean Furniture High and Low dusting of all vertical services Dust Mop Floor Restroom s Docks Sweep Floor Damp mop and sanitize Floor Wash and Disinfect all basins, bowls, seats and urinals Spot clean walls, partitions and doors Wash and polish mirrors and shelves Empty all Waste Baskets Restock all consumables Polish all fixtures Sweep Floor Spot Clean Walls, Glass, and Doors Spot Clean Elevators Spot Clean Escalators Sweep / Vacuum Stairways Vacuum Conference Rooms Dust and spot clean conference rooms Clean kitchenette areas Lunch Area Basement Damp Mop Floor Wipe down Tables and Chairs Spot clean Walls, Switches, Glass and Doors Empty Waste Baskets Clean Shower Rooms (Per Restroom ) Empty Waste Baskets Table 4-1
ZOLL Document Number: 90A0104 Page 11 of 15 Monthly Tasks Area Task Resp. Clean Doors, wall and switch plates All Areas Clean overhead vents Wipe clean all windowsills and interior ledges Dust all frames, blinds, chair and table legs, tops of cubicles Table 4-2
ZOLL Document Number: 90A0104 Page 12 of 15 Month: Year: Week Task Checklist Daily Tasks Appropriate dates and initials to be provided by cleaning technicians' supervisor. Empty blocks to be filled in with "N/A" or Not Applicable. Monday Tuesday Wednesday Thursday Friday Saturday Sunday Initial Date Initial Date Initial Date Initial Date Initial Date Initial Date Initial Date Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Monthly Tasks Monthly Tasks TABLE 4-3
ZOLL Document Number: 90A0104 Page 13 of 15 CLEANING INSPECTION LOG Facility Manager or designee to insert the date and their intials upon review of Table 4 3. MONTH/YEAR DATE/INITIAL JAN/ FEB/ MAR/ APR/ JUN/ JUL/ AUG/ SEP/ OCT/ NOV/ DEC/ TABLE 4-4
ZOLL Document Number: 90A0104 Page 14 of 15 6.5 Insect and Pest Control Periodic inspections for insect and pest are conducted by a third party pest control service. Identified or suspected infestations shall be inspected by a third party pest control service and treated at the earliest possible date. Any employee shall report any suspected infestations to the facility manager, supervisor or area manager immediately. 6.6 Discrepancy Reporting 6.6.1 Attachment A illustrates the Hazardous Condition Report. This form should be used to record any hazardous condition including, but not limited to those listed below: Spills, leaks, and other hazardous conditions must be reported immediately to the appropriate supervisor or manager.
ZOLL Document Number: 90A0104 Page 15 of 15 HAZARDOUS CONDITION REPORT REPORT NO: DATE: REPORTED BY: REPORTED TO: DEPT: DEPT: HAZARDOUS CONDITION (to be completed by person reporting the condition): CORRECTIVE ACTION (to be completed by responsible department; i.e. maintenance, mechanical assembly, test, etc.): NOTES: