Contents: 1) Product Warranty 2) Manufacturing Procedures, Purchasing Controls and Materials Selection 3) Packaging and Labeling
4) Storage and Delivery 5) Servicing and Record Storage 6) QMS:Modifications, Remakes, Complaints 7) Medical Device Reporting, Recalls and Materials Disposition 8) Registered Devices 9) Document Controls and Employee Training 10) Quality Audit 1) Warranty Information for Dentures, Partials (cast or acrylic), Night Guard, Sleep Appliance or other removable appliance manufactured or assembled by Thorn Ford Dental Laboratory, LLC;
One year warranty from the date of delivery to the prescribing Dentist TFDL will repair, free of charge, any break, crack or fracture of acrylic, or replace free of charge any tooth or clasp loss or breakage that is a result of a flaw in workmanship or material on new products. However, we will not reconstruct, repair, reline or replace the appliance, free of charge, due to any of the following: loss, discoloration, excessive wear (for example, excessive grinding of teeth), inappropriate use (for example, any use not prescribed by the dentist), neglect, abuse or the loss of fit or function due to ongoing dental treatment. Defects or damages resulting from any service adjustments or alterations of your appliance by someone other than Thorn Ford Dental Laboratory, LLC are excluded from coverage. Exceptions to the one year term are repairs or additions to pre-existing prostheses, and any product labeled transitional or temporary in nature. These will be warranted for 60 days from date of delivery to the prescribing Dentist.
Fixed Appliances including crowns, bridges, veneers implant abutments and bars; One year warranty from the date of delivery to the prescribing Dentist’s office. We will replace, free of charge, any break, crack or fracture, or any other failure that is a result of a flaw in workmanship or materials. Consideration for failures beyond one year may occur with agreement between the lab and clinic and may be prorated over a 5 year period.
TFDL has no direct responsibility to the patient, but works only by prescription of a licensed dentist, that dentist is considered the final user. Modification and remake policy is typically no fault, no charge within the warranty period. Regular maintenance such as replacement of nylon components is subject to fees.
2) Manufacturing Procedures, Purchasing Controls and Materials Selection TFDL adheres to material supplier and manufacturer recommended procedures and instructions for use whenever provided. These instructions are available at corresponding work areas and on raw material labeling. Instructions, techniques and procedures are also available in the Instructions and Procedures (I&P) file box located in the main office, and electronic copies filed on the reception computer. The files are divided by production department, with a sections for equipment and policy documents.
When no supplier can provide instructions for a process, step instructions will be written by the technician most experienced in that procedure, dated, and a copy saved in the I&P file.
Material and suppliers are chosen for the best qualities offered, when applicable, from the following attributes;
1)Patient contact materials are FDA / ADA approved for dental use (possess premarket notification 510(k)) 2)competitive price 3)reliable delivery method 4)company is already an approved vendor 5)instructions for use and technical support available 6)MSDS documents provided 7)long term product support likely 8)ability to deliver on demand 9) Two competing suppliers for important products assure uninterrupted supply, when possible and economically feasible.
Suppliers will be held to the following quality standards; 1) Materials arrive more than 3 months before expiration date. 2 )Materials arriving with packaging sealed and intact 3)Materials consistently perform as described on instructions for use 4) Complaints resulting in Corrective action have not been repeatedly attributed to deficiencies in the material.
Each approved supplier will have an individual assessment form that will be reapproved annually for use, based on the parameters in the previous section. The key attributes and quality benchmarks that the supplier possesses will be initialed on the Supplier Approval form. Any negative experiences with the supplier such as missed shipments, mixed product, expired materials, or a failure related to any of the aspects for which the supplier was chosen will be noted on the lower section of the form. The master Supplier List and Supplier Approval forms will be filed under Policy Documents in the Instructions and Procedures file box in the upstairs office. Suppliers specific to OSA appliances will also have current copies filed in the appliance specific binders.
If a supplier has no negative experiences noted at each annual review no further inquiry is performed. Suppliers who have violated primary terms of their approval must be notified in writing of the known deficiency, and no further purchases occur until a satisfactory written response is received and attached to the supplier approval form detailing a change in process, materials or personnel on behalf of the supplier to correct the issue. Once reinstated, the next review should focus on the correction done, verifying that no further problems occurred.
3) Packaging and Labeling; all outgoing removable products are packaged in a sealed plastic bag with water. All fixed cases are sterilized after final inspection in the department of origin and placed in a non-sterile plastic box with bottom padding. Products, along with related models indexes and other materials are packaged in a larger box labeled with the company name and phone number for delivery by courier or US Mail to the clinic of the prescribing Dentist. Boxes delivered by courier will have a delivery slip taped to the top with the clinic information and Patient ID exposed. If the case is to be mailed this slip is inside the package.
4) Storage and Delivery There is no long term storage of finished work or case materials since all items are manufactured by custom order. Work in progress that has been returned to the clinic for patient appointment will still have a case pan which contains all related material not needed by the Doctor for current process. These pans are filed alphabetically in cupboards in the front office. When the case returns for further work it is reunited with the correct pan. Case invoices remain open until the case is ready for final delivery at which time the invoice is finalized, printed and included in the package. All related materials are returned to the clinic.
In the greater North Seattle region cases are delivered by company courier. Outside the delivery area the preferred shipper is USPS. If overnight service is necessary FedEx is preferred.
5) Servicing and Record Storage
When a case is competed all physical materials are returned to the clinic or discarded. All paper documentation is scanned and saved to the patient’s permanent file, and the paper files are stapled and filed in boxes by case number. Files one year old or less are stored on site in the upstairs storage room on movable shelves. Older files are in long term storage, at SherLock public Storage in Bothell. Unit # CO-233. Case files are kept for 10 years. Files that are older or that have been scanned to record will be destroyed by shredding.
6) QMS: Modifications, Remakes, Complaints Quality management; a Product Performance Summary will be printed biannually from the Evident case reporting menu for product groups that show recurrent remake and modification trends. The information is reviewed and discussed by department leaders to identify corrections that will have a beneficial effect on production or the product. The ultimate safety and effectiveness of a custom dental appliance or prostheses is determined by the prescribing doctor, who has the right to request esthetic and functional elements as well as changes to the case plan without disclosing their purpose.
Management Review: It is not necessary to perform a formal management review process to assure top managers know what is being done in the compliance program, because the General Manager is the one who is responsible for conducting or directing all QMS activity.
Non-Conforming Product; a product is considered non-conforming when any step in the production process is flagged as being incorrectly done or not meeting set quality standards. The following system will be used to track waste and unacceptable work being done internally.
A product is considered non-conforming when any step in the production process must be repeated due to specifications not met. A half-page NCP form detailing the nature of the defect, date and signature of the technician will be completed included with the case documents until it is scanned with other case records at completion. The forms will be filed in the proper section of the QMS drawer for later review.
NCP reports will be reviewed quarterly for repeated similar events. If a consistent problem is corroborated by 3 or more of the same type of event in the same year, a Preventative Action report will be written that introduces change in process or new controls that will reduce or eliminate the incidence of non-conforming product being addressed. The report will become an addendum to the existing manufacturing process instructions, and will be dated with the date inclusion begins. Responsible technicians will sign off on the new instructions as having been educated about the substance of, and reason for the change in procedure.\
Returned or rejected products made with resins, plastics and ceramics have been custom formed for a patient by prescription. Products made from these materials cannot be re-introduced to the supply chain since they undergo irreversible processes. The exceptions to this are undamaged pre-manufactured metal components which may be sterilized and re-used, and precious alloys which may be melted down and re-mingled with new alloy of the same type.
Raw materials that do not perform to standards will also be documented with a NCP report. Materials that have are found to be defective will be disposed of or returned to the manufacturer within one week. Solids and powders may be placed in the trash, liquids should be handled as follows; disposal may constitute moving the affected materials to the expired materials cabinet in the tool room. Any containers that are not past expiration dates must be labeled as unusable and for what reason. Liquid chemicals must not be disposed in the trash, poured into the sink or left outside, but will be retained in the Expired Materials Cabinet.
Returned work is separated into two categories, remakes and modifications. When entered into Evident, a remake invoice refers to the original invoice ID, and a fault field is required to be completed with fault and description of the problem, this is only used for a total remake of a case with no salvaged components except for undamaged, pre manufactured metal hardware. Remakes may be searched by calendar dates, by customer, or by complaint type. Modifications are not entered the same way, simply generate a new unrelated invoice under a modification product code. Data may be searched by any desired parameter by using Evident Case Reporting menu. Remakes and fall into 3 categories that require different levels of response; remake, complaint and reportable complaint.
Returned products are custom made for the patient using irreversible processes. Raw materials cannot, and must not be reused for general production. The exceptions to this are undamaged metal components which may be sterilized and re-used, and precious alloys which may be melted down and re-mingled with new alloy of the same type.
A Remake is a corrected, modified or reconstructed TFDL product that is modified or remade and returned to the clinic with successful delivery to the patient for the following reasons; for modification of fit, shade (color), doctor or patient esthetic or functional dissatisfaction, or changes in original request. The request could occur at time of delivery, or during the warranty period. TFDL makes exclusively custom appliances made to the design standard set by the customer and this activity is a normal part of the delivery process. Acceptable or unacceptable performance is determined by the prescribing dentist.
A Complaint means any communication that alleges, or any product is returned that exhibits deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution. In all complaint situations the product is returned to us for correction and redelivery following a new prescription. A complaint must come from the dental clinic customer of origin or be verified by that clinic as being a valid claim.
Complaint Handling: When a complaint occurs copies of the case files will be listed in chronological order on the Complaint Log in the QMS file drawer. A complaint may be presented written on a note or prescription, given verbally and documented by the employee taking the call, or given via e-mail. The General Manager (Loren F.) must be made aware of the communication of complaint, and must act upon the information by performing or directing an investigation, looking at all sources of information about the case, from the Evident case files including prescriptions and related documents and customer interview. Determination and subsequent corrective action for that case will be noted on the on a complaint file cover sheet for the case in the complaint file. Action that is taken following a complaint investigation must be summarized as an addendum to the manufacturing process instructions for the product or process in question.
For OSA appliances additional QMS policy statements are in the Policy section of the product specific binders. For OSA appliances the complaint files are listed on the lower half of the Device History Activity Log, which is attached to the Production Summary, grouped in the year of origin.
7) Medical Device Reporting, Recalls and Materials Disposition
Reportable Complaintdefinition and trigger; the event could be a reaction to materials that requires medical attention, soft tissue abrasion or swallowing of hazardous object. Hazardous is anything that has the potential to cause internal obstruction or injury. When a reportable event occurs as described above, all related documentation should be gathered into one file In the QMS file drawer and shared with all involved parties including the FDA.
Procedure for determining if an event meets he definition of reportable complaint; TFDL staff must report device-related deaths, serious injuries, and malfunctions to FDA whenever they become aware of information that reasonably suggests that a reportable event occurred (one of their devices has or may have caused or contributed to the event). When notice is given of a serious malfunction of an appliance resulting in serious injury or death either verbally, in writing or by e-mail, management will verify the information with the dental facility of origin. Loren F will complete and submit form 3500A to the eMDR within 21 days of becoming aware of an event. For events that require remedial action to prevent an unreasonable risk of substantial harm to the public health and other types of events designated by the FDA, Loren F will submit form 3500A within 5 days of becoming aware of the event. With 30 calendar, and 5 work day reports when device or device family is reported for the first time. Interim and annual updates are also required if any baseline information changes after initial submission using form 3417.
When And What To Report [§803.3(q)] Manufacturers must report all MDR reportable events to FDA on Form FDA 3500A. Each manufacturer shall review and evaluate all complaints to determine whether the complaint represents an event which is required to be reported to FDA. A separate Form 3500A is required for each device involved in a reportable event. A report is required when a manufacturer becomes aware of information that reasonably suggests that one of their marketed devices has or may have caused or contributed to a death, serious injury, or has malfunctioned and that the device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Serious injury/(Serious illness) [§803.3(aa) is an injury or illness that is life threatening, even if temporary in nature; results in permanent impairment of a body function or permanent damage to a body structure; or necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.
A malfunction [§803.3(m)] is a failure of the device to meet its performance specifications or otherwise perform as intended. Performance specifications include all claims made in the labeling for the device. A malfunction should be considered reportable if any one of the following is true: the chance of a death or serious injury occurring as a result of a recurrence of the malfunction is not remote; the consequences of the malfunction affect the device in a catastrophic manner that may lead to a death or serious injury; it causes the device to fail to perform its essential function and compromises the device's therapeutic, monitoring or diagnostic effectiveness which could cause or contribute to a death or serious injury, or other significant adverse device experiences
Reporters do not need to assess the likelihood that a malfunction will recur. The regulation presumes that the malfunction will recur. Furthermore, FDA believes that once a malfunction has caused or contributed to a death or serious injury, a presumption that the malfunction is likely to cause or contribute to a death or serious injury has been established. This presumption will continue until the malfunction has caused or contributed to no further deaths or serious injuries for two years, or the manufacturer can show, through valid data, that the likelihood of another death or serious injury as a result of the malfunction is remote.
Malfunctions are not reportable if they are not likely to result in a death, serious injury or other significant adverse event experience. A malfunction which is or can be corrected during routine service or device maintenance must be reported if the recurrence of the malfunction is likely to cause or contribute to a death or serious injury if it were to recur.
When NOT To Submit A Report [§803.22] FDA requires only one medical device report from the manufacturer if they become aware of information from multiple sources regarding the same patient and the same event. Also, for contract manufacturers, FDA would expect only one report from either the specifications developer or the contract manufacturer for one reportable event. Nevertheless, there must be a written agreement which identifies which party is responsible for completing Form 3500A.
In addition, FDA does not require that a manufacturer submit an MDR report: when the manufacturer determines that the information that they received is erroneous and a death or serious injury did not occur; or if they are not likely to result in a death, serious injury or other significant adverse event experience.
Where To Submit Reports [§803.12]All MDR reports should be submitted to eMDR:
eMDR utilizes the FDA Gateway, an agency-wide entry point for all electronic submissions, to receive electronic MDRs. The Gateway authenticates and validates electronic submissions and routes it to CDRH. See the Electronic Submissions Gateway site to register as a trading partner.
FDA's electronic submission tool—FDA eSubmitter—is a free downloadable program that enables program participants to electronically complete and submit MDR information using the MedWatch 3500A form. FDA eSubmitter provides the 3500A form in an electronic format. The FDA eSubmitter software provides:
Tools to save address and contact information
Product code searching
Patient and device problem code searching
Method, result, and conclusion code searching
The option to attach documents when additional information needs to be provided
A “missing data report” that ensures all required fields of the form are completed before submission to FDA. Once the report is completed with all the required fields, the files are “packaged for submission.” The package generates the 3500A form as a Health Level 7 (HL7) Individual Case Safety Report (ICSR) compliant XML document. By using FDA eSubmitter, participants generate a standard adverse event message effortlessly, without the need for special programming. (Sections IV and V provide more information on HL7 and ICSR.)
All electronic submissions to FDA must come through the ESG. You must purchase a digital certificate and register as a trading partner with FDA. Once registered, you can submit electronic MDRs via the ESG.
Recalls; When a Complaint Log comprises 25% or more complaints of the total appliances made in the same period a recall will be made of all undelivered product, and notice will be given to all clinics having received affected products with a list of all included patients by name or ID. The recall notice will include instructions, ranging from notification for the patient’s file in case problems arise, to immediate notice to return all product possible, depending on the severity of the problem and hazard to the patent. The Corrective Action process will continue for a recall group.
If a material is recalled from a manufacturer, the appliances manufactured incorporating the material or component in question will be identified in a search of the Evident Case Reporting menu and a patient list will be generated. Written notice will be sent to the clinics that delivered those appliances outlining required action stated in the recall notice. The affected cases that are returned will be invoiced as remakes, replacements or corrections will be performed when possible.
Unusable material disposal: Materials that have been recalled will be disposed of or returned to the manufacturer within one week. Disposal may constitute moving the affected materials to the expired materials cabinet in the tool room. Any containers here that are not past expiration dates must be labeled as unusable and for what reason.
8) Registered Devices TFDL currently makes the Silent Partner mandibular advancement device.
The Silent Partner splints are made from lab sourced materials, complying with the design standard provided by Dr. Doneskey. The fixing hardware is provided by Dr. Doneskey, one set of parts for each case sent. All finished appliances are delivered back to Dr. Doneskey, who retains complete control over the final delivery to the patient. When the silent Partner is considered ready to market to other Dentists the cases will still return to the Doneskey clinic for inspection and packaging.
Establishment Registration & Device Listing
Thorn Ford Dental
Thorn Ford Dental Laboratory LLC9
device, anti-snoring - TAP 3 10
device, anti-snoring - Silent Partner 11
National association of Dental Laboratories interpretation of FDA requirements: 2010All dental laboratories (foreign and domestic) are required to comply with the FDA Quality System/Good Manufacturing Practices. Not all dental laboratories are required to register with the FDA. Only those that operate overseas, serve as the initial importer for a foreign laboratory, conduct repackaging services or manufacture sleep apnea/snoring and other certain orthodontic appliances are required to register.
The FDA has authority to inspect any dental laboratory manufacturing for the United States—registered or unregistered—in the United States or abroad.
9) Document Control and Employee Training Forms will be organized in a binder and stored in the reception area and managed by Kristin H. They will each be given a version ID on the header using year and numerical month for example; 2015.2 Copies of previous version shall be stored in a labeled section at the back of the binder.
Policy documents will be given similar version ID on the header using year and numerical month and shall be stored in the Policy Documents-Current file of the Manufacturing Procedures file box stored in the office bookshelf. This file will be managed by Loren F. Copies of previous versions of policy documents will be stored in a separate file named Policy Documents-Retired, in the same box. The master copy of each policy document will remain in the file, signed and dated with the day of deployment on the header, by the author. Multiple copies will be available for distribution.
At least annually the entire file will be reviewed by the company auditor as part of the Quality Audi. Once reviewed for accuracy the auditor will write a list of observations, sign and date the page, and attach it to the current copy of the TFFL Operating Procedures document which will remain in the file until it is retired and replaced.
Electronic versions and templates of forms will be stored on the desktop of Kristin’s pc, and the policy document files will be stored in file on Loren F’s PC.
Retired documents and forms will have an attached (stapled) ½ page cover sheet describing the changes implemented in the newer version. The cover sheet will be signed and dated by the person editing the document and when audited will be signed and dated again by the auditor if approved. Once this has occurred it will not need to be reviewed again.
Copies of newly created documents and forms will be provided to all employees who use or are affected by the paper, with a description given of the reasons for the change, new content pointed out and instructions for use.
Employee Training Policy; When a new policy, procedure, process or document requirement is assigned and explained in full detail to an employee for the first time the act will be documented on a Training & Mastery Log so the employee may accept responsibility for the task or procedure. By signing and dating the Log, the employee attests to understanding and being capable of applying the information.
10) Quality Audit: Required sections of the TFDL QMS will be audited annually by an employee who is otherwise uninvolved in daily implementation. The auditor will primarily review three parts of the program: Manufacturing Procedures Purchasing Controls and Material Selection; QMS- Modifications Remakes Complaints and Recalls; and Document Controls. Policy and documentation specific to sleep appliances will also be audited, including non-conforming product.
This includes sample reading patient histories, summary sheets and activity logs as well as resulting documents following complaints and corrective actions. The auditor will look for consistency between policy statements and actual use of the forms. The auditor will keep a log of inconsistencies and missing information on the Audit Log form, and note anything that does not seem clear from what has been written concerning the activity being tracked and the resulting data collected.
The auditor will then complete an Audit Log Cover Sheet listing suggestions for improvement of the system directly based on the problems and omissions noted on the audit log. The completed audit will be signed and dated by the auditor and filed in the Quality Audit section of the QMS file drawer. The audit will occur between April 1 and June 30, with enough time allowed to be completed by June 30
Copies of the audit will be given to the General Manager to review and implement by July 5th. At that time the auditor and manager will discuss the results recorded in the audit to review the suitability and effectiveness of the quality system to ensure that it satisfies the requirements of this part the established quality policy and objectives. The dates and results of quality system reviews shall be documented.
Additional Management review is not necessary because the General Manager performs or directs all QMS activity.