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    Medical device supplier audit checklist

    Quality management system is the regulatory requirement for a medical device manufacturer, and it is foundation of the quality of a medical device manufacture. What’s the key points we need to check in the medical device manufacture audit?




    Quality Organization

    Is there a quality manual defining the company’s policies, objectives, and commitment to quality? (please attach copy)

    Does the manual describe the Quality Department and its relationship to the rest of the organization?

    Does the manual identify specific persons by title for the responsibility of each quality function?

    Have adequate resources, including trained personnel, been identified and assigned for management and performance of work and verification activities?

    Is there a Management Representative appointed by the company’s executive management with defined and written authority for the implementation and performance evaluation of the quality system?

    Are Management Reviews conducted at defined intervals to review the quality system to ensure the continuing suitability and effectiveness of the quality system?


    Quality System

    Are quality system procedures documented and maintained to ensure product conformance with specified requirements?

    Is the Quality Management System continually monitored and updated to remain current with industry practices and regulatory expectations?

    Are quality plans developed to ensure that activities associated with the design, material procurement, fabrication, inspection and release of product meet the requirements specified in the contract/purchase order?

    Does Quality Assurance participate in contract review to identify and evaluate quality requirements?

    Internal Audits

    Are there planned and executed internal audits to determine the effectiveness of the quality system?

    Are internal audits conducted by appropriately trained personnel who are independent of the activities and functions being audited?

    Are internal audit results reported to responsible personnel?

    Are corrective actions assigned accordingly and verified for effectiveness?

    Training

    Do qualifications for jobs affecting quality include identification of appropriate education, training needs, and experience?

    Is a documented training program in place to ensure adequate training for personnel in relation to their job function(s)?

    Are training records maintained?

    Purchasing Controls

    Are purchasing procedures documented and maintained to ensure purchased product conforms to specified requirements?

    Is there a documented procedure for the qualification, use, and monitoring of approved suppliers?

    Are suppliers required to send notification for approval of changes prior to implementation?

    Do purchasing documents contain adequate descriptions and specifications of products being ordered?

    Are contracts and purchase orders reviewed to ensure that customer requirements are clearly defined and achievable?

    Are records of contract/purchase order reviews maintained?

    Design Controls

    Are procedures documented and maintained to ensure product conformance through the control and verification of design?

    For each design and development activity, are plans prepared, documented, and maintained?

    Are risk analysis tools employed throughout the design process?

    Are formal, documented reviews of design results planned and conducted at appropriate stages of design?

    Are design verifications and validations performed at appropriate stages of design to ensure that the design outputs meet the requirements of documented design inputs?

    Are design changes and modifications identified, reviewed, and approved prior to their implementation?

    Are all records related to the design process maintained in a design history file (DHF)?

    Currently a supplier to CTC and using CTC Controlled Documents?

    Are Design Document revisions current with CTC DMR document revisions?

    Annual recertification of CTC Documents submitted to and approved by CTC?

    Change Control

    Is there a written procedure describing customer notification for review and approval of changes to material, components, the manufacturing process, equipment, location, cost and delivery?

    Is there a documented process for the creation, revision, approval, distribution, and obsolescence of procedures?

    Are documents and data reviewed for adequacy and approved by authorized personnel prior to release?

    Is there a document master list that identifies the current revision status of controlled documents?

    Are procedures readily available to users, with revised and obsolete documents being promptly removed to prevent unintended use?

    Are changes reviewed and approved by the same functions that performed the original review and approval?

    Are procedures documented and maintained for the identification and control of quality records?

    Are records maintained that demonstrate product conformance and effective operation of the quality system?

    Are quality records readily retrievable and stored in secure facilities that prevent damage, deterioration, and loss?

    Are electronic data backed up at appropriate intervals with backup media stored in secure facilities that prevent damage, deterioration, and loss?

    Are record retention periods defined & documented?

    Manufacturing Process Controls

    Do controlled procedures exist for manufacturing operations, describing process controls and specifications?

    Are line clearances performed and documented prior to manufacturing startup?

    Are inspections of first and last articles performed and documented at manufacturing startup and end?

    Are procedures in place for the identification and handling of raw materials, work in progress, and finished product?

    Are workmanship criteria developed, documented, and implemented?

    Is a bill of materials established for each product?

    Is there a documented procedure addressing the approval, verification, and validation of any changes?

    Are production records maintained and reviewed for compliance?

    Are procedures in place for maintaining facility and product cleanliness?

    Is there a documented preventive maintenance system ensuring that all maintenance activities are recorded and reviewed?

    If any environmental controls are applied during manufacturing, are associated records maintained?

    Process Validation

    Are written procedures in place for the qualification and validation of equipment and processes?

    Are written procedures in place for the validation of software, including software used as part of the quality management system??

    Are validation plans and specifications established with results of validation activities documented and reported?

    Have all processes been validated?

    Are changes to processes, equipment, and software validated prior to release?

    Inspection & Testing

    Are procedures documented and maintained for product inspection and testing to ensure specifications are met?

    Are sampling plans established for inspection and testing?

    Are purchased materials inspected or verified for conformance prior to use?

    Is in-process testing conducted in accordance with established procedures or quality plans that are based on customer requirements?

    Is the final product inspected and tested in accordance with established procedures or quality plans that are based on customer requirements?

    Are the results of all inspections, testing, and any related analyses documented and maintained in device history records?

    Is there a final review of all documentation related to production, inspection, and testing prior to final product release?

    Are written procedures in place for the identification and segregation of product by status (i.e. Accepted, Rejected, Quarantined, etc.)?

    Measuring & Test Equipment

    Are written procedures established for the control, calibration, and maintenance of equipment used for inspection, measuring, and testing?

    Is equipment calibrated at regular intervals with calibration covering the range of use?

    Is equipment uniquely identified to show the calibration status?

    Are calibrations traceable to the National Institute of Standards and Technology (NIST) or another nationally recognized standard?

    Are records of calibration activities and results maintained?

    Are procedures established for the assessment of product impact in the event that any equipment falls outside of specified limits?

    Is calibration performed internally or by a third party?

    Nonconforming Product

    Are written procedures established for the identification, documentation, evaluation, segregation, and disposition of nonconforming product?

    Is a documented procedure established for reprocessing or rework of nonconforming product?

    Has the responsibility for review and authority for disposition of nonconforming product been defined?

    Are records related to the investigation and disposition of nonconforming product maintained?

    Corrective & Preventive Action

    Have documented procedures been established for the implementation of corrective and preventive actions?

    Are procedures established for the effective handling and documentation of customer complaints?

    Are procedures established addressing the investigation, root cause analysis, and corrective action required for nonconformities related to product, process, and quality system?

    Do procedures for preventive action address the use of appropriate sources of information to detect, analyze, and eliminate potential causes of nonconformities?

    Are documented procedures in place addressing the implementation and effectiveness checks of corrective and preventive actions?

    Are records of corrective and preventive actions documented and maintained?

    Material Controls

    Are written procedures established for the receipt, handling, storage, labeling, packaging, and delivery of product?

    Are product handling, storage, and delivery methods developed to prevent damage and deterioration?

    Are labeling and packaging operations controlled to prevent mix-up?

    Is there an individual designated to review and proof labeling for accuracy?

    Are storage areas clearly identified with products appropriately segregated (such as incoming raw material or finished product, nonconforming product, usable stock)?

    Where required, is the storage environment controlled?

    Is traceability maintained on each lot of raw material to its applicable certification or test report?

    Are “First In / First Out” (FIFO) procedures maintained for stock control?

    Are procedures established for the control and handling of outdated/expired materials?

    Are unique identifiers assigned to incoming or in-process materials?

    Are lot numbers representing one homogenous production run assigned to final products?

    Are materials shipped with records identifying product, quantity, and conformance?

    Statistical Techniques

    Are statistical techniques used in establishing, controlling, and verifying process capability and product characteristics?

    Is the use of statistical tools documented?


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