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Safelink Consulting Tips

Did You Know:

  • OSHA regulates dental laboratories (some exemptions apply).
  • An effective safety program helps you reduce worker’s comp claims.
  • OSHA has the right to conduct a random inspection - just show up!
  • The most frequently cited standards for dentistry are Hazard Communication Standard, Bloodborne Pathogen Standard, Emergency Preparedness, Respiratory Protection, Lockout/Tagout.
  • OSHA requires written documentation of your safety program.
  • Your safety program must be evaluated for its effectiveness.
  • Dental labs are subject to OSHA recordkeeping rules.

A Health & Safety Program Must Cover:

  • Chemical Hygiene - Hazard Communication Plan
  • Infection Control - Exposure Control Plan
  • Hazard Assessment and Safety Procedures
  • Personal Protective Equipment Assessment
  • Annual Safety Training
  • Annual Evaluation of Safety Program
  • Emergency Action Plan
  • Investigation of Work-related Injuries and Illnesses
  • Method of Enforcement of Safety Rules
  • Compliance with State-specific OSHA plan as applicable

FDA Compliance

Did You Know:

  • FDA regulates dental laboratories
  • Dental labs that outsource to foreign labs must register with FDA
  • FDA has a right to inspect all dental labs
  • All dental labs should have a documented quality system
  • CAPA (Corrective Action) is required and helps you reduce remakes
  • If you manufacture sleep apnea devices or anti-snoring devices, then you must register with FDA
  • A contract manufacturer must register and pay an annual fee to FDA
  • You must formally evaluate your vendors and subcontractors for compliance to regulatory requirements
  • You must be able to trace your patient contact materials in the event of recall
  • You must conduct an internal audit of your quality system at least annually
  • You must document all complaints from dental clients
  • You must implement an effective corrective action process for complaints
  • You must comply with FDA to become DAMAS certified

A Quality System Must Cover:

  • Review of Non-conforming product
  • Assignment of Management Responsibility
  • Corrective and Prevention Action procedures
  • Defining of Purchasing Controls
  • Control of Labeling and Packaging
  • Identification and Traceability of Patient Contact Materials
  • Handling, Storage, Distribution & Installation of materials and finished items
  • Production and Process Controls
  • Records retention and control
  • Documented Final Quality Control

How To Reduce Waste In Your Lab

  1. Develop preventive maintenance schedules for all equipment critical to the manufacturing process as required by FDA and DAMAS by using SafeLink's Quality System documentation.
  2. Document repair records and review the records regularly to determine if equipment should be retired and replaced - another requirement by FDA and DAMAS as shown in SafeLink's Quality System documentation.
  3. If equipment requires calibration ensure that it is properly calibrated as required by FDA and DAMAS as shown in SafeLink's Quality System documentation.
  4. Keep areas where equipment is located clean and free of debris as required by FDA, DAMAS, and OSHA. Use SafeLink's Quality System documentation and Health and Safety materials.
  5. Train workers on proper use of the equipment and provide operating instructions at point of use as required by FDA and DAMAS as shown in SafeLink's Quality System documentation.

Contact Safelink Consulting

Call 1.800.330.6003 for more informaiton or use the form below to get in touch.

Get In Touch

SafeLink helps clients meet day-to-day safety requirements set forth by OSHA, as well as develop and maintain quality assurance systems required by the FDA. Contact us to find out what we can do for you.

About Safelink Consulting

SafeLink presenters are nationally recognized for providing workshops and seminars to diverse audiences. Through onsite visits, seminars, and Webinars SafeLink’s presenters have successfully trained thousands of our clients’ employees on safety and quality management.

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    Cumming, GA 30040 USA
  • Phone: (770) 205-6745
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    Saturday - Sunday: Closed
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