DEC 2016

Published by ORTHOWORLD Inc., BONEZONE delivers strategic sourcing & product commercialization solutions to orthopaedic device company decision makers and their partners.

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72 BONEZONE • December 2016 QUALITY MANAGEMENT These details are important to remember if you want to build a solid bridge, on time. Start Building Now With the introductions of the new MDSAP (Medical Device Single Audit Program) and transitions to ISO 9001:2015 and ISO 13485:2016, certification bodies will be experiencing incredible, back-breaking burdens for apportioning certi- fication resources, both registrar-based and inspectorate-based (regulatory or notified body implementations), between now and the termination of the transition period in 2019. Starting March 1, 2019, any existing certification issued to ISO 13485:2003 will not be valid. Don't wait to start building if you want to ensure that you're certified on time. Don't Forget This Fine Print • Ensure that calibration and maintenance are defined and measured. • Risk must be incorporated into audit planning as you prepare for supplier audits. This can be a quantifiable value that allows the lead auditor to determine the frequency and type of audit for each supplier. • There is a methodology to check that training requirements and effectiveness of training should be comparable to the risk associated with the work. Essential Questions to Ask The process gap analysis for making changes should emphasize at least these starter point-type questions: • What is your internal process for change control? • Who are the competent team members for bridge-building duty? • What cross-functional group determines the significance of each change? • When do I get the Notified Body involved? • How do you document and generate objective evidence concerning changes? • What is the state of our Document Management? Additional Bridge Building Instructions • Additional requirements in design controls on consid- eration of usability, use of external standards, verifica- tion and validation master planning, explicit design transfer activities and maintaining design records, e.g. the Design History File (DHF). • Emphasis on complaint handling and reporting to regulatory authorities much like the requirements in 21 CFR, Part 820.198 and medical device reporting (MDR). • Planning and documenting corrective action and preventive action, and implementing corrective action without undue "lag" times. Yes, corrective and preventive actions must be tracked and reviewed for timeliness and, of course, effectiveness. Musing About Your Bridge Isn't the Answer You must have a plan to build a decent bridge. Without a plan, it could end up looking like a bunch of sticks and stones and muddy procedures that will wash away during the first rainstorm of business pressures, regulatory demands, diffi- cult audits and daily operations. Taking the boat to the Isle of 13485:2016 is only a quick fix, because you have no way of getting back if the boat sinks. Sturdy bridge building is the only way that you and your employees can traverse this structure over and over again. Processes must be linked, risk must be accounted for and people need training. This is not an osmotic occurrence but, in fact, the culmination of a detailed plan with timelines and competent resources. It has been a while since you built the last bridge. I know you can do it. Happy bridge building. John Gagliardi has had success over the past 45+ years in the medi- cal device and pharmaceutical industries because of his practical approach to process-orientation and business. He has been actively involved in research and development, quality assurance, training, operations, process architecture, FDA inspections and regulatory affairs. Mr. Gagliardi specializes in building systems in a compli- ant and business-ready manner. Mr. Gagliardi can be reached at JGAGL777@One.Net. MidWest Process Innovation, LLC

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