I did a similar project for a client to implement the FDA regulations. I divided the project into phases based on the company history. They have been in business for twenty years and are well established. They make a general class of products for which one application is a medical device, but they did not realize it. The got a nastygram from FDA saying they had not registered and listed.The company owners are averse to documentation, so the project was to implement a minimal system with the least documentation. My target was no procedure or work instruction should be longer than three pages. For production, they used samples and not written work instructions. Where samples were not appropriate, we used work instructions with photographs. We did need to write test procedures.The phases I chose were:QMS Management RequirementsProductionDesign ControlSupplier Management, Purchasing, and AcceptanceDistribution, Installation, and ServicingMedical Device ReportingCorrections and RemovalsStatistical TechniquesTo track the project, I used an Excel workbook. The main worksheet lists the QSR clauses and allocates them to a phase. Some QSR clauses do not apply such as 820.75 Process Validation.For each document I created a numbering system with two or three letters to identify the type of document and three digits for the specific documents. The numbers are non-significant; this will great for my next project with them. SOP is a Standard Operating Procedure, WI is a Work Instruction, FRM is a form, etc.I put the identity of the document in the Excel worksheet in the same row as the QSR section and the phase. For example, training would have an SOP and some training forms.The workbook also had a status column with entries:EFF The document is effectiveN/A Not applicable to the QMSOBS The document is obsoleteQUE The document is in the writing queueRVW The document is under reviewSTR The document is being writtenREV An effective document is being updatedUsing the various phases and codes I built worksheets for metrics to track the status of the project. These allowed me to provide weekly reports to management.This company's medical device is marketed in the US only. Consequently, the project did not involve ISO 13485:2016.I infer that FDA will publish QMSR in 2023 Q1 with a one-year transition period. This will be a major implementation project since it means mapping QSR to QMSR, updating the documents, and training the affected people. The use of a nonsignificant numbering will help. We plan to reuse the tools to manage the new project.
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