Procedure for Infrastructure and Work Procedure

1.0 Purpose

This procedure outlines the infrastructure requirements and work procedures for the manufacturing and
distribution activities of Foshan Linke Medical Instrument Co., Ltd. The purpose is to ensure that all
manufacturing processes for Root Canal Files, Dental Burrs, Sonic Irrigators, and Oral Mirrors are
conducted in a controlled environment, maintaining high standards of quality, safety, and compliance
with relevant regulations.

2.0 Scope

This procedure applies to all areas of the manufacturing facility located at Unit 01, 5th floor, D6 Building,
New Light Source Industry Base, Foshan, China. It covers the infrastructure setup, maintenance, and
work procedures required for the entire lifecycle of the products, from raw material receipt to final
distribution.

3.0 Responsibilities

 Facility Manager

o Ensure the infrastructure meets all regulatory and safety requirements.

o Oversee facility maintenance, ensuring all equipment and utilities are operational.

o Coordinate with the QA team for regular audits and compliance checks.

 Quality Assurance (QA) Team

o Ensure work procedures comply with quality standards and regulatory requirements.

o Review and approve SOPs related to infrastructure and manufacturing processes.

o Conduct regular audits to ensure adherence to procedures and report any deviations.

 Production Manager

o Implement work procedures and ensure that manufacturing processes align with
established guidelines.

o Monitor production activities to ensure efficient workflow and timely completion of

tasks.

o Ensure that all production personnel are trained in relevant SOPs and safety protocols.
  Maintenance Team

o Perform regular maintenance on all equipment and infrastructure to prevent

breakdowns.

o Keep detailed records of maintenance activities and equipment calibration.

o Respond promptly to any infrastructure-related issues that may arise during production.

4.0 Infrastructure Requirements

 4.1 Building Structure

o The facility should be designed to provide a clean, safe, and controlled environment.

o Include adequate ventilation, lighting, temperature, and humidity control systems to

meet product-specific requirements.

o Emergency exits, fire suppression systems, and safety signage must be installed in
accordance with local regulations.

 4.2 Equipment Layout

o The layout should be optimized to ensure smooth workflow, minimizing the risk of
cross-contamination and bottlenecks.

o Equipment should be strategically placed to facilitate easy access for operators and
maintenance personnel.

o All equipment must be validated and calibrated as per the manufacturer's specifications
before use.

 4.3 Utilities

o Reliable power supply with backup generators must be available to prevent production
interruptions.

o Water and gas supplies should meet the purity and pressure standards required for the
manufacturing processes.

o Regular maintenance of utility systems is essential to ensure uninterrupted service.

 4.4 Storage Areas

o Separate storage areas for raw materials, in-process materials, and finished products.

o Ensure controlled temperature, humidity, and lighting conditions as required for each
type of material.

o Implement a first-in, first-out (FIFO) inventory system to manage stock levels.

5.0 Work Procedures

 5.1 Manufacturing Process

o All manufacturing activities must follow Standard Operating Procedures (SOPs) specific
to each product.
 o Procedures include raw material inspection, component assembly, sterilization,
packaging, and labeling.

o Regular training sessions must be conducted to ensure that personnel are familiar with
the SOPs and any updates.

 5.2 Quality Control

o Quality checks should be integrated at each stage of the manufacturing process, from
raw material receipt to final product testing.

o In-process inspections must be performed at critical control points (CCPs) to identify and
address any deviations.

o Final product testing should be conducted as per the quality standards, and only batches
that meet all criteria should be released.

 5.3 Equipment Operation and Maintenance

o Only qualified and trained personnel should operate manufacturing equipment.

o Regular maintenance schedules must be followed, and all activities should be

documented in maintenance logs.

o Equipment calibration should be performed according to the manufacturer's

recommendations, with records kept for audit purposes.

 5.4 Cleaning and Sanitation

o Documented cleaning procedures should be followed to maintain a hygienic

manufacturing environment.

o Routine cleaning of equipment, work surfaces, floors, and other areas should be
conducted as per the schedule.

o Cleaning agents and disinfectants should be approved for use in medical device
manufacturing, and their usage should be documented.

 5.5 Employee Training

o All employees involved in the manufacturing process must undergo regular training on
SOPs, equipment operation, safety protocols, and regulatory requirements.

o Training sessions should be documented, with records maintained for each employee.

o Refresher courses should be provided periodically, especially when there are updates to
SOPs or new equipment is introduced.

6.0 Documentation

 6.1 Maintenance Logs

o Maintenance activities, including preventive and corrective maintenance, should be

recorded in detailed logs.

o Logs must include dates, descriptions of activities performed, and the names of the
personnel involved.
  6.2 Calibration Records

o Records of equipment calibration should include the date of calibration, the person
performing it, and the results.

o Calibration certificates should be stored securely and be readily accessible for review.

 6.3 Cleaning Schedules

o Cleaning schedules should detail the frequency, method, and materials used for cleaning
different areas of the facility.

o Logs should be maintained to verify that cleaning activities are performed as per the
schedule.

 6.4 Employee Training Records

o Training records should include details of the training provided, the date, the trainer,
and the names of employees who attended.

o Records should be reviewed regularly to identify any gaps or needs for additional
training.

7.0 Compliance

 The facility and all work procedures must comply with relevant local and international
regulatory standards for medical device manufacturing. Regular audits should be conducted to
ensure ongoing compliance with these standards.

8.0 Revision History

 This document should be reviewed and updated periodically or whenever significant changes
occur in infrastructure or work procedures.

Revision Number Date Description of Change Approved By

1.0 [Date] Initial release [Name/Title]

1.1 [Date] Minor revisions to Infrastructure Requirements [Name/Title]

2.0 [Date] Major update to Work Procedures section [Name/Title]

[X.X] [Date] [Description of Change] [Name/Title]