2025 - SSU Internal Audit - US & CAN

Audit Scope: Applicable regulations and standards:

• To ensure compliance with regional, national, and international regulatory requirements for products and management systems, including:
  
  FDA 21 CFR 802, 806, 820 (US): Incorporating OSHA, EPA, and DOT regulations where applicable.
  ISO 13485, ISO 9001 (Canada).
  Applicable CareView Processes:
  
  Processes 2-10 as outlined in SOP-124 and local procedures.
  
  Applicable MDSAP Checklist Sections:
  
  Sections 1-7 as per SOP-124 and local procedures.

• Provide TW Audit Number:

• Date of Audit:

  Date

• Type of Audit:

  On-Site

  Remote

• Lead Auditor:

  Select

• Co-Auditor:

  Select

• Provide SSU Number and Location:

  Select

• SSU Supervisor and Auditee Contact?

• Territory Service Manager (TSM) for the SSU Facility?

  Select

• Regional Service Director (RSD) for the SSU Facility?

  Select

• Facility headcount:

• Facility's square footage? (Can be found in U.S. Service Center Listing)

• What is the previous TW audit number? (Found in 2024 folder, Track and trending Excel sheet)

• What is the date of the previous audit?

  Date

• What was the type of the previous audit?

  On-Site

  Remote

• Provide a summary of the previous audit (Found in TW record)

• Were there any previous findings? If so, provide detailed information on these findings.

• Have those findings been resolved?

  Yes

  No

  N/A

• Provide reasons as to why findings have not been resolved.

  Yes

  No

  N/A

• Review State Licensure Requirements for Rental Operations under State Licensure Requirements for Rental Operations - 100079130. Is the SSU Business license current?

  Compliant

  Non-Compliant

  N/A

• Review Certificate of Liability Insurance for SSU Site: Is the INSURANCE liability current?

  Compliant

  Non-Compliant

  N/A

• US Only: For SteriFab use Facilities: Review Second Hand/Refurbished Mattress Retailer s the permit current? (Foam Only - Disinfectant)

  Compliant

  Non-Compliant

  N/A

• Is the POL-001 Quality Arjo Policy visible and compliant? Updated 2025

  Compliant

  Non-Compliant

  N/A

• Is the POL-002 Environmental Arjo Policy visible and compliant?

  Compliant

  Non-Compliant

  N/A

• Review Bulletin Board. Is there a Federal/State/Province labor law poster?

  Compliant

  Non-Compliant

  N/A

• Review Bulletin Board. Is there a Complaint Reporting Handling Poster Advantum: 100071155?

  Compliant

  Non-Compliant

  N/A

• US Only: Review Bulletin Board. Is there a e-verify right to work poster?

  Compliant

  Non-Compliant

  N/A

• US Only: Review Bulletin Board. Is there a Federal employee right-to-work poster?

  Compliant

  Non-Compliant

  N/A

• According to SOP-SVC-US-0043-A, is the Emergency Procedures Flipchart filled out completely? Rev 3 Effective: 02-MAY-2024

  Compliant

  Non-Compliant

  N/A

• US Only: Review the OSHA-300A form. Is the 2025 form visible?

  Compliant

  Non-Compliant

  N/A

• US Only: Are the previous 5 years' forms available?

  Compliant

  Non-Compliant

  N/A

• Canada Only: Review OH&S-Form 7 (Ontario Only). Is it available? For all provinces show records that have been submitted to H.R. and W.S.I.B. Explain the process and show evidence

  Compliant

  Non-Compliant

  N/A

• Review the latest Service Center Self-Inspection Tool per SOP-SVC-US-0050-A/SOP-SVC-CA-0053-A. Are all steps addressed within the last 6 months? (Review each section - Arjo Requirement)

  Compliant

  Non-Compliant

  N/A

• SOP-101-A. Review Signature Employee Identification Log form: SOP-101-A. Is it available in the current revision form signed by all employees?

  Compliant

  Non-Compliant

  N/A

• SOP-SVC-US-0043-B. Request EcoLab Quarterly Reports. Are the last 4 quarters available?

  Compliant

  Non-Compliant

  N/A

• SOP-SVC-US-0043. Review Pest Control Treatment Records. Are the last 4 quarters available?

  Compliant

  Non-Compliant

  N/A

• US Only: Review MyLearning HIPAA, Patient Rights & Responsibilities training records. Is the training certificate available for each employee? (2025 training)

  Compliant

  Non-Compliant

  N/A

• US Only: Review MyLearning Bloodborne Pathogen. Is the training certificate available for each employee? (2025 training)

  Compliant

  Non-Compliant

  N/A

• Review the Safety Meetings record sheet. Is the last 3 months available? (Required monthly per SOP-SVC-US-0043)

  Compliant

  Non-Compliant

  N/A

• Are Weekly Gemba walks (Service Center Walkabouts) available for SSU? (*US - SOP-SVC-US-0050-C rev 4. Effective 21-MAR-2024. *CAN regular Service Center Walkabout)

  Compliant

  Non-Compliant

  N/A

• Review Regulated Waste Log. If there was any regulated waste disposed of in the last 12 months, was the form filled out completely? (Required for Pennsylvania State)

  Compliant

  Non-Compliant

  N/A

• WI-SVC-US-0091. Review 11 records for Asset Disposal/Forms. Are they filled out completely and using the latest revision? (Including signature and value)

  Compliant

  Non-Compliant

  N/A

• US Only: Per SOP-SVC-US-0039 review Federal and State Department of Transportation (DOT) Hours of Service (HOS) Regulations for Property Carrying Vehicles for any employees currently On-site.

  Compliant

  Non-Compliant

  N/A

• Canada Only: Per regulation is the employee's driver's license current?

  Compliant

  Non-Compliant

  N/A

• SOP-082. Inspect Rental Operations Facility Floor. Are the physical assets inside the designated areas "Clean, In-Process, Dirty" clearly marked and separated?

  Compliant

  Non-Compliant

  N/A

• Is there a designated Customer Owned area. Is it defined and Sepaerate?

  Compliant

  Non-Compliant

  N/A

• Is there a washer and dryer available?

  Compliant

  Non-Compliant

  N/A

• Review Washer Water Temperature Check Procedure. Does the PT know how to check the temperature? 

  Compliant

  Non-Compliant

  N/A

• Are the laundry baskets labeled "Dirty, Clean, Transport Bin"?

  Compliant

  Non-Compliant

  N/A

• Is the Dirty laundry basket covered?

  Compliant

  Non-Compliant

  N/A

• Is the dryer reservoir at the bottom of the dryer clean from debris and residue?

  Compliant

  Non-Compliant

  N/A

• SOP-SVC-US-0099. Inspect cushion testing. Is the mattress tester control available and compliant?

  Compliant

  Non-Compliant

  N/A

• SOP-SVC-US-0030. Review Preventative Maintenance label on cushion tester. Is it current?

  Compliant

  Non-Compliant

  N/A

• Can the process tech demonstrate proper usage of the Mattress Tester? (Describe process and name of PT)

  Compliant

  Non-Compliant

  N/A

• WI-SVC-US-0082. Review the T-cards System. Are they available?

  Yes

  No

  N/A

• Review a random Daily T-card. Is it signed and dated according to process?  

  Compliant

  Non-Compliant

  N/A

• Review a random Weekly T-card. Is it signed and dated according to process?  

  Compliant

  Non-Compliant

  N/A

• Review a random Monthly T-card. Is it signed and dated according to process?  

  Compliant

  Non-Compliant

  N/A

• Review a random Quarterly T-card. Is it signed and dated according to process?  

  Compliant

  Non-Compliant

  N/A

• Review a random Yearly T-card. Is it signed and dated according to process?  

  Compliant

  Non-Compliant

  N/A

• Check the T card system for Truck Unit(s). Is the date on the back of the card current?

  Compliant

  Non-Compliant

  N/A

• Review overdue T-cards

  Compliant

  Non-Compliant

  N/A

• Ask a PT to test the Emergency Eye Wash station for 2 minutes.

  Compliant

  Non-Compliant

  N/A

• Is it properly maintained and clean of debris? (Does it have a Tag, if it does needs to be initial and signed by employee)

  Yes

  No

  N/A

• SOP-SVC-US-0044 - 100071065 [1] Review proper hand-wash posters. Are they visible?

  Compliant

  Non-Compliant

  N/A

• SOP-SVC-US-0044. Review Infection Control Hand Hygiene Procedure Poster. (How to prevent infection) Is it clear and visible?

  Compliant

  Non-Compliant

  N/A

• 100071066. Review Chemical Mixing and Testing Poster. Is it clear and visible?

  Compliant

  Non-Compliant

  N/A

• 100071065. Review Personal Protective Equipment (PPE) equipment removal process. Is it clear and visible?

  Compliant

  Non-Compliant

  N/A

• Review Personal Protective Equipment (PPE) supplies storage. Example: Are there safety glasses, disposable garments, disposable gloves or disposable shoe covers available?

  Compliant

  Non-Compliant

  N/A

• SOP-SVC-US-0044-B. Inspect chemicals in the storage area. Are expiration dates current?

  Compliant

  Non-Compliant

  N/A

• SOP-SVC-0044-A. Has the facility implemented the use of Rapid Cleaner for Arjo Products?

  Yes

  No

  N/A

• SOP-SVC-0044-B. Are the opened date and expiration date labeled on the bottle properly?

  Compliant

  Non-Compliant

  N/A

• SOP-SVC-0044-A. Is the facility using ECOLAB Chemicals Mikro-Quat, Eco-Sand (Laundry Detergent). AdvaCare (Sanitizer)? (If not used marked N/A)

  Compliant

  Non-Compliant

  N/A

• SOP-SVC-0044-B. Is it complaint to expiration dates and opened dates written on the bottle? (Check AdvaCare)

  Compliant

  Non-Compliant

  N/A

• Are Eco-sand strips in the facility current?

  Compliant

  Non-Compliant

  N/A

• Are Mikro-Quat strips in the facility current?

  Compliant

  Non-Compliant

  N/A

• Review Chemical mixing solutions on cleaning buckets. Are the secondary safety health labels legible?

  Compliant

  Non-Compliant

  N/A

• US Only: SOP‐SVC‐US‐0044‐C. Review the Steri-Fab Treatment log. Is it available and filled out correctly? (Signature, dates and PM dates)

  Compliant

  Non-Compliant

  N/A

• SOP-SVC-US-0030, Check WI-SVC-US-0010 Annex 3 for Approved Tools at SSU. Is the calibration for equipment current and well maintained? Test equipment should be: Kept clean, in working order, easily accessible and organized.

  Compliant

  Non-Compliant

  N/A

• Digital Safety Analyzer (Required Service Center tools and equipment)

  Compliant

  Non-Compliant

  N/A

• IN/LB Torque Wrench (Required Service Center tools and equipment)

  Compliant

  Non-Compliant

  N/A

• Pressure/Flow Meter (AutoLogic/DFS) (Required Service Center tools and equipment)

  Compliant

  Non-Compliant

  N/A

• Pull Force Gauge MedSurge/MedPulse (Required Service Center tools and equipment)

  Compliant

  Non-Compliant

  N/A

• Manometer (Required Service Center tools and equipment)

  Compliant

  Non-Compliant

  N/A

• 3 Gauge Air Flow Tester (Required Service Center tools and equipment)

  Compliant

  Non-Compliant

  N/A

• Multimeter (Required Service Center tools and equipment)

  Compliant

  Non-Compliant

  N/A

• Amprobe/Clamp Meter (Required Service Center tools and equipment)

  Compliant

  Non-Compliant

  N/A

• FT/LB Torque Wrench (Required Service Center tools and equipment)<br>

  Compliant

  Non-Compliant

  N/A

• Dial Torque Wrench <br>MedSurge/MedPulse (Required Service Center tools and equipment)

  Compliant

  Non-Compliant

  N/A

• Are the emergency flashlight and radio operating correctly?

  Compliant

  Non-Compliant

  N/A

• Are weights calibrated

  Compliant

  Non-Compliant

  N/A

• Inspect fire extinguisher(s) tag. Are they current? (Green mark, Review PASS Process with employee, to determine if they know the process in case of fire emergency)

  Compliant

  Non-Compliant

  N/A

• SOP-SVC-US-0043. Is there a defined container for battery disposal with ventilation holes?

  Compliant

  Non-Compliant

  N/A

• POL-HS-CA-0002-G / SOP-SVC-US-0050.Inspect First Aid Kit. Is it properly stocked with Roll of Adhesive, paramedic scissors, bandage rolls, adhesive strips, Gauze pads (at least 4 x 4 inches), Two large gauze pads (at least 8 x 10 inches), Box adhesive bandages (band-aids), One package gauze roller bandage at least 2 inches wide, Two triangular bandages, Wound cleaning agent such as sealed moistened towelettes, Scissors, At least one blanket, Tweezers, Splint, Directions for requesting emergency assistance. per OSHA requirements? (Check for expiry items)

  Compliant

  Non-Compliant

  N/A

• Request Asset Inventory Report from SAP - (Transaction: IH08 - Filter by plant 68xx: 9070 Overflow, 9100:Quality, 9200:Repair, 9999:Missing, 9050 To be Scrapped, etc.).

• For the US Only: Check Power BI for PM Status (https://app.powerbi.com/Redirect?action=OpenReport&appId=24e4ed8b-f656-42aa-ad81-8353fca3822f&reportObjectId=710fd932-86c8-4cbf-be77-4ac2de16cd16&ctid=bcb82b95-fa1b-47b2-adf6-e475b431e3f0&reportPage=ReportSection&pbi_source=appShareLink&portalSessionId=1646e2a1-a77a-4aa8-8ed6-05fd5d1c52af)

• Provide 11 (Minimum) Serial Numbers of products that will be inspected for this audit: (Rotoprones, Citadel, Citadel Plus, Pumps, Mattresses, Patient Handling Lifts, Trapeze, etc.)

Assets Review - 11 Minimum (Pictures and Notes are required

• Is the asset properly located within the designated Quality, Repair, and Ready areas?

  Compliant

  Non-Compliant

  N/A

• Inspect the QC sheets for the assets. Are they available and compliant? (Validate each step for QC Sheet)

  Compliant

  Non-Compliant

  N/A

• Inspect the asset's PM records. Are they current and compliant?

  Compliant

  Non-Compliant

  N/A

• Inspect the asset's battery stickers. Are they current and compliant?

  Compliant

  Non-Compliant

  N/A

• Do the assets have a current IFU QR Code or IFU booklet? Are they compliant?

  Compliant

  Non-Compliant

  N/A

• Is the Quality Reference Guide (QRG) attached to the bed? (Rental - QR Codes - QRC hard copy only for the CommonSpirit accounts)

  Compliant

  Non-Compliant

  N/A

• After conducting a detailed inspection of the asset. Are they visibly cleaned in all areas? Provide any areas of improvement in the notes: (i.e., footboard, castor frame, castors, headboard, side riles, clear of any visible stains, rips, or tears in the mattress)

• Are the wires of the assets in good condition (i.e.,, no damaged or exposed wires)?

  Compliant

  Non-Compliant

  N/A

• Are there Demo Assets available?

  Compliant

  Non-Compliant

  N/A

• Are the items tagged and compliant?

  Compliant

  Non-Compliant

  N/A

• Please provide details, including checking for the current PM sticker and any stains

• For US: Log in to SAP. Transaction: IW73
  1. Check Completed
  2. Unchecked Outstanding and In Process
  3. Order Type: ZRCE (Cleaning Orders)
  4. Main Work Center: 68*** e.i.; 6849* - San Antonio (Make sure to add an astheric * after plant number)
  5. Period 1 Quarter = Previous 3 months
  6. Click Execute = Green check
  Note: List will come up. Set Layout.
  1. Add UserStatus (To look for FTRE)
  2. Click Column, then Sort and Ascending Order Pyramid.
  Look for any FTRE Service Orders Swaps/Damaged (Preferable Beds, Pumps, Tub Baths, etc., Skin IQ mostly is not an FTRE)
  SAP Asset Compliance Inspection ETA - 60 min
  

• Provide Serial Number 3 Serial Numbers of Customer Allegations - (Review Beds)

In SAP Continue reviewing: Cleaning Order (ZRCE)

• WI-SVC-US-0141-A Rev 5. In SAP review an FTRE Service Call for Swaps or Damaged Items. SAP Instructions are above, Provide 3 Service Order #s

• Failed line for QC?

  Compliant

  Non-Compliant

  N/A

• Person Responsible Filled Correctly? provide QC Copy and name on notes

  Compliant

  Non-Compliant

  N/A

• Activity Codes (AC95)?

  Compliant

  Non-Compliant

  N/A

• Is description of problem Provided

  Compliant

  Non-Compliant

  N/A
In SAP Continue reviewing: Repair Order (ZR)

• Did the employee pick the correct code? For the initial Pick-Up

  Compliant

  Non-Compliant

  N/A

• Item Code

  Compliant

  Non-Compliant

  N/A

• Reason Code

  Compliant

  Non-Compliant

  N/A

• Activity Code

  Compliant

  Non-Compliant

  N/A

• Description Provided/Tested in Accordance

  Compliant

  Non-Compliant

  N/A

• Date of ZSR moved< 72 hours

  Compliant

  Non-Compliant

  N/A

• Was Order Closed Correctly?

  Compliant

  Non-Compliant

  N/A
In SAP Continue reviewing: PM (ZM)

• PM Compliant?

  Compliant

  Non-Compliant

  N/A

• Battery Compliant?

  Compliant

  Non-Compliant

  N/A

• Open TAN's

  Compliant

  Non-Compliant

  N/A

• Software Version Compliant?

  Compliant

  Non-Compliant

  N/A

• Is there a designated repair available. Is it defined and labeled?

  Compliant

  Non-Compliant

  N/A

• Are spare parts labeled and organized?

  Compliant

  Non-Compliant

  N/A

• Do all assets in the repair area have Down Tags? Is it completed correctly? (Inspect 11 Down-Tags) (US: SOP-SVC-US-0069)

  Compliant

  Non-Compliant

  N/A

• Review the asset's serial numbers in repair for service repairs in TrackWise, Is the CC records complaint?

  Compliant

  Non-Compliant

  N/A

• Review the asset's serial numbers in repair for customer complaints in TrackWise, Is the SR records complaint?

  Compliant

  Non-Compliant

  N/A

• Provide reasoning of open records, waiting on parts? Under Warranty item? Provide summary of inspection items

• SOP-SVC-US-0042/SOP-QA-CA-0028. Request SSU Arjo employees to explain the basic process of reporting a complaint. Is the process known by the employee?

  Compliant

  Non-Compliant

  N/A

• Request SSU Arjo employee to explain where to find SOP's and WI's. Is the process known by the employee? 

  Compliant

  Non-Compliant

  N/A

• Is the fire drill process known by SSU employees, and is the fire meeting location known by the employee?

  Compliant

  Non-Compliant

  N/A

• Request SSU Arjo employee to explain how to locate chemical SDS/MSDS electronically through the 3E system/connect. Is the process known by the employee? Explain to an employee where to locate it and how to access it

  Compliant

  Non-Compliant

  N/A

• Request an SSU Arjo Driver for a Vehicle Accident reporting processes (WI-SVC-US-0208) Describe what to do in case of an accident

  Compliant

  Non-Compliant

  N/A

• :Optional training material. Is the process known by the employee? Explain how to "Auto Enroll" for future training

  Compliant

  Non-Compliant

  N/A

• Are the DOT medical employee cards for every SSU employee current?

  Yes

  No

  N/A

• Do all drivers have up to date licenses?

  Yes

  No

  N/A

• Driver logs available?

  Yes

  No

  N/A

• Review truck delivery for unit Inspection for Arjo CMVs (delivery trucks). Are there any trucks available to be inspected? Take pictures of cabin and cargo areas.

  Yes

  No

  N/A

• Are the exterior of the trucks washed?

  Compliant

  Non-Compliant

  N/A

• VA-19-04-AH. Is there a physical poster for loading instructions available in the back of the truck?

  Compliant

  Non-Compliant

  N/A

• SOP-SVC-US-0023. Is there loading foam around the truck available and in good condition?

  Compliant

  Non-Compliant

  N/A

• Are there safety hazards straps: 2x10', 10x4', and t-straps available?

  Compliant

  Non-Compliant

  N/A

• US Only: Are there safety hazard straps for Rotoprone available?

  Compliant

  Non-Compliant

  N/A

• US Only: Is there a safety hook on pneumatic door on the back of truck

  Compliant

  Non-Compliant

  N/A

• Is there a compliant fire extinguisher available?

  Compliant

  Non-Compliant

  N/A

• Is the front cabin of the truck clean and organized? Provide Pictures

  Compliant

  Non-Compliant

  N/A

• Is there a safety hazards kit available? (Hazard Triangle Kit)

  Compliant

  Non-Compliant

  N/A

• Are the lights of vehicles working?

  Compliant

  Non-Compliant

  N/A

• Are there any trucks NOT in service: Provide reasoning and date(s) since it was taken out of use.

• In the last 12 months was there a PM performed for vehicle(s)? Provide evidence of List of Truck Unit(s).

  Compliant

  Non-Compliant

  N/A

• US Only: Is there a binder content available for Service Consultant Vehicle(s)? (Good condition)

  Yes

  No

  N/A

• Is the Vehicle Registration card current?

  Compliant

  Non-Compliant

  N/A

• Is the Insurance current?

  Compliant

  Non-Compliant

  N/A

• Is the gas card available and does it match the Truck Number for mileage and record purposes?

  Compliant

  Non-Compliant

  N/A

• Inside the folder is there a map for the designated fleet area avaliable?

  Compliant

  Non-Compliant

  N/A

• WI-SVC-US-0083 Annex 3. Public Safety Letter in the binder?

  Compliant

  Non-Compliant

  N/A

• California Only: Annex 2 Is Safety Letter available?

  Compliant

  Non-Compliant

  N/A

• Auditor Signature

  Select

• SSU Facility Observations