Thorn Ford Dental Laboratory Manufacturing Procedures and ...



Thorn Ford Dental Laboratory LLCManufacturing Procedures and Quality Controls2018.5Author; Loren M Ford. This document is the exclusive property of Loren M Ford, prepared for application by Thorn Ford Dental Laboratory LLCNo other use or duplication is allowed except by written and signed permission.Contents:1)Product Warranty2)Manufacturing Procedures, Purchasing Controls and Materials Selection 3)Packaging and Labeling4)Storage and Delivery5)Servicing and Record Storage6)QMS: Modifications, Remakes, Complaints7)Medical Device Reporting, Recalls and Materials Disposition8)Registered Devices9)Document Controls and Employee Training10)Quality Audit1) a) Warranty Information for dentures, partial dentures, night guards, sleep appliances and other removable appliances manufactured or assembled by Thorn Ford Dental Laboratory, LLC;B) 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. Specifically, immediate acrylic RPD’s, Essix retainers, resin C&B, and acrylic repairs of existing products not under warranty. These will be warranted for 60 days from date of delivery to the prescribing dentist.c) Fixed prosthetics 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, materials or design choices made by TFDL. Consideration for failures beyond one year may occur with agreement between the lab and clinic and may be prorated over a period of up to 5 years.d) 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 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 file box located in the main office, and electronic copies filed on the reception computer. The files are divided by production department, with sections for equipment and policy documents. This file box also contains master policy documents relating to production and compliance with outside agencies as well as retired documents for reference. When no manufacturer instructions are available for a process, process instructions will be written by an experienced technician, signed, dated, and a copy saved in the I&P file.B) Material and suppliers are chosen for the best qualities offered, when applicable, from the following attributes;1) Patient contact materials are FDA 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 key products to assure available supply. c) Suppliers will be held to the following quality standards; 1) Materials arrive more than 3 months before expiration date. This is noted when checking off product received on the supply order form. 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. d) 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 assessment will be undertaken by staff trained on the QMS system during the first quarter of the year. 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. A master Supplier List is attached to the current Approved Supplier forms which lists all current supplier names and contact information. Attached to that page is a list of all patient contact materials used by TFDL, each one naming all suppliers from whom that material or service may be obtained, ordered as preferred first, then secondary. The preferred provider is the one which is the closest to fulfilling the key attributes. There can be more than one secondary. These documents are clipped together and 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. E )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; outgoing removable products are packaged in a sealed plastic bag with water. 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, ID stickers 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. b) 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. Gate code 56681, unit # CO-233, padlock code 2732. 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 a) 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. The prescription must be followed, or subsequent permission must be obtained for necessary deviation.b) 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.c) Non-Conforming Product; an unfinished 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, and there is measurable waste of labor or material. 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. The product deemed non-conforming will be left in the case pan until the reworked case is completed and ready for quality control inspection for design reference. At that time the unfit product will be discarded in a solid waste receptacle before the case is approved for release and delivered to the front office for packaging. d) NCP reports will be reviewed quarterly for repeated similar events by the General Manager. The review will be documented on a Non-Conforming Product Log form and filed in the same folder. If a consistent problem is corroborated by 3 or more of the same type of event in the same year, a Corrective Action process will begin resulting in a report that may introduce changes 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.e) 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 and are customized for one patient. 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.f) 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 deemed defective 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.g) 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. h) Returned products are custom made for the patient using irreversible processes. Returned cannot be reused for any other patient. The exception to this is precious alloys which may be melted down and re-mingled with new alloy of the same type and origin. i) A Remake is a correction, modified or reconstructed, that is made 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. J) 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 and be verified by that clinic as being a valid claim, or directly from the patient.k) 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.l) 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 DispositionRecalls; a) 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 that should already be in progress will continue for a recall group. A product recall could be triggered by a single event if it is determined to be reportable, as in a significant health risk or a reportable event. See “Reportable Recall” below. b) If a material or component is recalled from a supplier, 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. c)Reportable Complaint and Recall definition and trigger; the event could be a reaction to materials that requires medical attention, soft tissue abrasion or swallowing of hazardous object related to the use of a medical device. 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. D) Reportable Recall; TFDL will submit a written report to FDA of any correction or recall of a device within 10-working days of initiating such correction or removal to reduce a risk to health posed by the device or to remedy a violation of the act caused by the device which may present a risk to health. The report will include the name address and telephone number of the manufacturer, and the name, title, address, and telephone number of the person responsible for conducting the device correction or removal. Also the brand name and the common name of the device and the intended use of the device. Also included will be the premarket notification number, premarket approval number and the device listing number. As well as the establishment registration number. And the unique device identifier (UDI) that appears on the device label or on the device package, or the device identifier.e) Write a description of the event(s) giving rise to the information reported and the corrective or removal actions that have been and are expected to be taken. Include the following: Any illness or injuries that have occurred with use of the device. If applicable, include the medical device report numbers. The total number of devices manufactured or distributed subject to the correction or removal. The date of manufacture or distribution and the device's expiration date or expected life. A copy of all communications regarding the correction or removal and the names and addresses of all recipients of the communications. If any required information is not immediately available, a statement as to why it is not available and when it will be submitted. The recall report is sent in letter form to the local FDA office labeled “attention coordinator”, in accordance with 21CFR806.f) If, after submitting a report under this part, TFDL determines that the same correction or removal should be extended to additional lots or batches of the same device, we shall within 10-working days of initiating the extension of the correction or removal, amend the report by submitting an amendment citing the original report number. A report submitted by a TFDL does not necessarily reflect a conclusion that the report or information constitutes an admission that the device caused or contributed to a death or serious injury. g) 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. Documentation of the verified notification must be filed with any existing complaint documentation and the whole file is moved to a new folder in the same drawer labeled “Reported Events”. That documentation may be printed e-mails, copies of prescriptions, letters, or a written log of a phone conversation. Any of these must be signed and dated by the acting General Manager acknowledging the date the notice was received. Any subsequent action, new information or periodic reporting concerning the event will be added to this file. The information in the file must be retained for 10 years. h) Once internal documentation and verification has been done, Loren F will complete and submit form 3500A to the eMDR within 21 days. Interim and annual updates are also required if any baseline information changes after initial submission. Within 30 calendar days of the receipt of information that is new or not known at the time of initial submission a supplemental report must be made. The options for preparing and transmitting a supplement or follow-up report are the same as those for initial reports.? Include the initial report number and state that the type of submission is a follow-up report. ?Limit additional entries to those where you need to update previously provided information.? For example, if patient age and sex are unchanged do not include them.? If you are updating or correcting the model number, provide the corrected information only.?If FDA requests additional information for an MDR under 21 CFR 803.15, you are encouraged to submit the response electronically. ?i)A manufacturer responding to an FDA request for additional information, using the 3500A format, should enter the initial report number, indicate in Block H2 that the type of follow-up is a “Response to FDA Request,” and provide the requested information in Block H10/11, Additional Manufacturer Narrative.? Any discrete data elements should also be reported in Block H10/11. You may submit the letter you received as an attachment to the submission. j) 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.k) 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.l) 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 experiencesm) 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.n) 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.o) 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. 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.p) Where To Submit Reports [§803.12] All MDR reports should be submitted to 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 informationProduct code searchingPatient and device problem code searchingMethod, result, and conclusion code searchingThe option to attach documents when additional information needs to be providedA “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.q) 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.Sample registration:Establishment Registration & Device ListingThorn Ford Dental New Search6 EstablishmentName78 Registration NumberCurrentRegistration YrThorn Ford Dental Laboratory LLC9 WA/USA 3005866789 2015 device, anti-snoring - TAP 3 10Manufacturer device, anti-snoring - Silent Partner 11Contract Manufacturer ?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. b) 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 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, Kristin W. Once reviewed for accuracy and currency Kristin will sign and date the master copy which will remain in the file until it is retired and replaced.c) 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.d) Retired documents and forms will have an attached (stapled) ? 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.e) 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.f) 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 of the information.10) Quality Audit: a) 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. b) 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 inconsistences 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 annual Quality Audit will look at any open Corrective and Preventative Actions and render an independent opinion as to the results or status of the Action.c) The auditor will then complete an Audit Log Cover Sheet listing suggestion 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 31. 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 of direct involvement of our management in reporting and production.d) When applicable, the audit notes recommending change to a process will be summarized one a Process Addendum form which describes the nature and purpose of the change, with a date of inclusion, signed by the technician responsible for the affected phase of production indicating understanding and acceptance of the pliance policy question: Does Medical Device reporting only pertain to registered medical devices, or to all dental devices, appliances and prosthetics we offer?Actions Calendar:January and June; Device History summaries SilPar 5aFebruary; Supplier assessment. (Between January and end of March) 2dReview NCP report activity, January and June 6dThermometer CalibrationSeal Replacement, ErkopressQuality Audit 2nd quarter, April-June 10cApril and September; Update CAPA reports SilPar7LEnd of document ................
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