Responding to Recalls
Purpose
To respond to recalls in a professional and legally compliant manner, and to protect patient and end user safety.
Objectives
- To ensure that all recalls are promptly and effectively communicated to all relevant stakeholders.
- To ensure that all recalled medical devices are properly quarantined and disposed of if needed.
- To minimize the impact of recalls on patient and end user safety.
Procedure
- The company call center will follow up on any recall notices received from various sources, such as the Saudi Food and Drug Authority (SFDA).
- Any recall that is linked to any of the medical devices under the company's responsibility will be forwarded to the management for action.
- If the recall was not initiated by the device manufacturer, the maintenance engineer will contact the manufacturer by email and phone to inform them of the recall, especially if the problem is critical.
- The maintenance engineer will create a job order that describes the problem and the action to be taken based on the information received from the manufacturer.
- The problem and remedy will be forwarded to the company's NCMDR contact person.
- The problem and remedy will be presented to the end user in writing, and their approval will be obtained before the engineer can proceed.
- Once the remedy has been implemented, the end user will sign the document.
- A copy of the report will be forwarded to the manufacturer and to the SFDA through the company's authorized contact.
- The job order will be closed and the documents will be archived.
- Copies of all relevant documents (recall notices, correspondence, and job orders) will be filed in the RECALL FOLDER.
Installation of Oxygen Connectors
Purpose
To standardize the installation of high-pressure oxygen connectors to ensure zero leaks and prevent combustion hazards in medical environments.
Objectives
- To ensure all threaded connections are secure and leak-free.
- To prevent contamination of oxygen lines with oil or grease.
- To ensure compliance with hospital safety standards for medical gases.
Procedure
- PREP Clean the Flowmeter threads thoroughly with a clean, damp cloth to remove any dust or old sealant.
- DRY Dry the threads using a heat gun on a low setting and wait 5 minutes to ensure no moisture remains.
- SEAL Apply oxygen-safe joint compound sparingly to the male threads only. Do NOT use standard plumbing tape or oil-based compounds.
- INSTALL Screw the connector into the outlet until it is vertical and snug. Do not overtighten as this may crack the brass fitting.
- TEST Pressurize the system and perform a leak test using an approved leak detection solution for 30 seconds.
- QC A second technician must perform a visual inspection and sign off on the installation.
- LOG Record the installation date and pressure test results in the device logbook.
Overtime & Travel Compensation
Purpose
To establish clear guidelines for the authorization, calculation, and compensation of overtime work, ensuring fair treatment of employees while maintaining operational efficiency.
Objectives
- To clearly distinguish between billable working hours eligible for financial compensation and non-billable travel time.
- To ensure that all overtime activities are pre-authorized to prevent payroll discrepancies.
- To maintain accurate records of employee "Time in Lieu" balances.
Procedure
- Eligibility: Overtime applies to technical staff performing duties at customer sites outside of standard working hours (8:00 AM – 5:00 PM).
- Authorization: All overtime work must be approved by the Line Manager in writing at least 4 hours prior to the extra shift, except in emergencies.
- Work Hours (Paid OT): Actual hours spent performing maintenance or repairs at the client site are classified as Paid Overtime. This is compensated financially according to Labor Law rates.
- Travel Time (Time in Lieu): Time spent traveling to and from the customer’s location is strictly classified as Time in Lieu. It is not eligible for cash payment.
- Banking Hours: For every hour of travel outside normal working hours, the employee will accrue one hour of compensatory leave (1:1 ratio).
- Documentation: The employee must log "Site Work Hours" and "Travel Hours" as separate line items on the Timesheet.
- Verification: The Service Report must be signed by the customer, clearly verifying the arrival and departure times.
- Submission: Weekly timesheets must be submitted to the Department Manager every Thursday.
- Filing: Approved records will be forwarded to HR and the accrued leave balance updated in the EMPLOYEE LEAVE FOLDER.
Invoicing Policy and Procedures
Purpose
To ensure that all invoices are organized, documented, and traceable, complying with all accounting and VAT requirements.
Procedure
- Invoices must be issued directly from the ERP accounting system by authorized personnel only.
- Mandatory Attachments: Every invoice must be accompanied by a package containing:
- Cover Letter (Payment Request).
- Original Purchase Order (PO).
- Valid Copies of Certificates (CR, Zakat, GOSI, Chamber).
- Delivery Notice (GRN) signed and stamped by the customer.
- Verification (The Rule of 3): The auditor must verify that the prices and totals match exactly across the PO, the GRN, and the Final Invoice.
- Submission: The complete package is to be hand-delivered or sent via registered courier to the client's Finance Department.
- Recording: Record the creation date, amount, customer name, and invoice number in the Daily Sales Log.
- Archiving: A digital copy must be uploaded to the server, and a physical copy filed in the SALES INVOICES FOLDER.
Logistics & Delivery Control
Purpose
To establish strict movement controls for goods, ensuring inventory integrity and legal proof of delivery (POD).
Procedure
- Dispatch: Warehouse staff must cross-reference physical items against the Packing Slip and Sales Order before loading.
- Transit: Secure all heavy items and double-wrap fragile medical sensors. The driver must coordinate arrival time with the Project Manager (PM).
- On-Site Inspection: The PM or Customer Representative must verify the quantity and condition of goods immediately upon arrival.
- Proof of Delivery (POD): The receiver must sign and stamp the Delivery Note. Any damages or missing items must be written on the face of the POD.
- Claims: Claims regarding missing items that were not noted on the signed POD will be rejected.
- Return to Base: The driver must return the signed POD to the Logistics Coordinator within 24 hours.
- Filing: The signed POD is scanned into the ERP system and filed in the DELIVERY NOTES FOLDER.
Water Treatment Delivery & Commissioning
Purpose
To ensure water treatment assets meet quality standards (TDS, Hardness) before turnover to the CSSD department.
Procedure
- STATIC Perform a 3-hour pressure test on vessels to ensure zero leaks. Check all piping joints.
- LOAD Supervise the layering of gravel, sand, carbon, and resin. Ensure the "under-bed" is level.
- DYNAMIC Run the system at full-load capacity. Measure conductivity, pH, and flow rates.
- CALIBRATE Calibrate all flow meters and quality sensors against a handheld reference device.
- QUALITY Verify TDS is within ±5% of design spec and hardness is < 1 gpg at the softener outlet.
- TRAIN Train the client team on backwashing, salt replenishment, and daily log keeping.
- HANDOVER Submit the Quality Logbook and O&M Manuals to the customer and obtain a signature on the Commissioning Report.
- ARCHIVE File the Commissioning Report in the PROJECTS FOLDER.
Maintenance Call Management
Purpose
To provide timely and effective maintenance and repair services for medical devices, minimizing downtime.
Procedure
- Receipt: All maintenance requests must be received via official email, fax, or formal letter from the customer.
- Triage: Attempt to resolve the issue via phone support. If failed, schedule a site visit.
- Execution (Warranty): If under warranty, rectify the fault, replace parts if needed, and obtain a signature.
- Execution (Out-of-Warranty): Inspect the device and issue a formal Quotation via the cWorks system. Do not proceed without a PO.
- Completion: Once approved work is done, test the device in front of the user.
- Documentation: Record all parts used and labor time in the Service Report.
- Filing: The signed Service Report is submitted to Finance for invoicing (if applicable) and filed in the SERVICE HISTORY FOLDER.