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Do you have your year-end quality management checklist ready?
October 25, 2018

Before we get to all the challenges that await us as quality professionals in 2019, now’s the time to take a cold hard look at the to-do list for the remainder of 2018. Why? Well, if you stack up the people on your staff using up their vacation allowance, the relatively dead week around Thanksgiving, and the increasing trend toward year-end holiday shutdowns, you’re looking at less time than you think to get things done this year.

Here’s a few places where you don’t want to be caught flat-footed:

Supplier Audits

Now’s the time to review your supplier audit schedule and verify it’s being executed as per your procedure. If you find you’re short-handed or need more flexibility, call Cannon Quality Group. We have 10+ years of experience in organizing and executing supplier audits. Take a look at some of the testimonials we’ve received here. We’ll do our best to get a date on the supplier’s calendar for this year, but the sooner you get started, the better the chances are. Also bear in mind that travel costs tend to escalate the closer we get to the holidays.

Internal Audits

If a Q4 internal audit is on your calendar, now’s the time to lock it down. Please note that Cannon Quality Group performs many internal audits for our clients every year. We’re happy to work with you in developing the audit agenda and making sure the audit complies with your procedures and fulfills your requirements. We are responsive, and hold ourselves accountable for client satisfaction.

Management Reviews

Your procedures spell out the frequency of quality management reviews, and chances are you may need to execute on a review yet this year. Since the review is designed to evaluate the progress and continual improvement of your Quality Management System, it’s critically important to deploy the proper amount of resources in preparing for it by gathering the appropriate data and creating the necessary graphs, charts, and other displays of that data. You’ll want to make sure you have the right people attending the review, and to give them prep materials well in advance to ensure a successful meeting. Cannon Quality Group can assist in all these activities and support your Management Representative throughout the process. The key is for the organization to decide what needs to be done to improve the system further. That might even include streamlining overly burdensome procedures!

Apart from these activities, don’t forget routine administrative tasks like your FDA registration renewal. The U.S. Food and Drug Administration (FDA) requires that all registered medical device and drug facilities renew their FDA registration between October 1 and December 31, 2018.

Everyone wants to look forward to year-end as a time to relax and reflect on accomplishments. By creating your year-end plan today, you’ll help make your holiday season a great time to recharge for the challenging year ahead.

 

About us: Cannon Quality Group strives to be “the change in Quality” and to lower the cost of innovation in medical device development by offering creative solutions to everyday quality management challenges, such as Shared Supplier Audits, MedTech workshop and shared workspace memberships, and off-the-shelf audit reports at start-up friendly terms and conditions. Visit us today at www.cannonqualitygroup.com

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