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  • 1.  QMS Implementation

    This message was posted by a user wishing to remain anonymous
    Posted 25-Oct-2022 11:11
    This message was posted by a user wishing to remain anonymous

    I need to implement a QMS at a new facility that does not have any SOPs in place.  Can anyone offer me guidance on which elements I should implement first? I work in an FDA regulated environment and want to be prepared in case of an unexpected audit. If I can show progress and a timeline for full implementation, I'm hoping that will show an auditor we are moving in the right direction.


  • 2.  RE: QMS Implementation

    Posted 25-Oct-2022 12:30

    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 Requirements
    Production
    Design Control
    Supplier Management, Purchasing, and Acceptance
    Distribution, Installation, and Servicing
    Medical Device Reporting
    Corrections and Removals
    Statistical Techniques

    To 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 effective
    N/A     Not applicable to the QMS
    OBS    The document is obsolete
    QUE    The document is in the writing queue
    RVW   The document is under review
    STR     The document is being written
    REV    An effective document is being updated

    Using 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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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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  • 3.  RE: QMS Implementation

    This message was posted by a user wishing to remain anonymous
    Posted 01-Nov-2022 08:43
    This message was posted by a user wishing to remain anonymous

    Thank you for your response. It has been very helpful. I appreciate your time.


  • 4.  RE: QMS Implementation

    Posted 26-Oct-2022 01:36
    In view of New facility and No SOP in place -  Facility Set up , required resources , man power, SME, expert, offices , well defined Organogram to be in place first.

    1) First have to classified your documents in Policy , directives , SOP and work instruction. Priority to be given for preparation of Quality manual ( May refer WHO guide) , then quality directives , quality Policy and then SOP.
    2) Design site master files , Validation master plan , approved drawings ,( You ma take help from approved thired party suppliers and contractores).
    3) Start preparation of SOP based on Quality Policy as - SOP for sop prepartion , documents preparation and control SOP, QMS SOP( change control, deviation , OOS, CAPA, trend managemnt, managemnt review , risk mamnagement ICH Q8,Q9,Q10), quality agreemant and contract with thired part service and supplier. This is I recommand as facility is new - Non commertialised. SOP for validation, qualification , calibration , maintence.
    4) Parallaly you may take support of third part supplier.
    5) Phase for facility and equipment /instrumnet qualification /validation.
    6) Parallely laboratory setup if available then basic test monitoring STP, Method validation , analytical method transfer and verification SOP. Mean while you ma take support of contract laboratory based on supplier / service provider qualification SOP.

    All the SOP / validation and qualification protocols should have basic track and trace mechnism for implemented QMS documents.

    based on periodic review and operational requiment you may go ahead for quality policy/directive/SOP/Work instruction upgradation based on need which is case to case basis.

    once the product launch at site then tech transfer, process validation , stability management, APQR , etc SOP/Protocols can be impelmented.

    Thanks and regards 
    Sanket Shah
    Quality Auditor.

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    [SANKET] [SHAH] [ REGIONAL MANAGER]
    [QA AUDITOR]
    [ABBOTT]
    [MUMBAI] [MAHARASHTRA]
    [INDIA]
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