SafeLink Consulting Blog

What Role Does Your Quality System Play in this COVID-19 World?

Written by Mary Bartlett | Feb 9, 2021 9:40:14 PM

The answer is “A very important one”. Some are referring to this stage of our business lives in having to deal with the challenges of a pandemic as “disruptive change”. I’m sure many of you agree with that terminology as this pandemic has caused business owners to rethink not only their safety program but how they are doing business. A lesson that business owners have learned during this pandemic is that there is a value in being agile and having the ability to adjust quickly. Some points to consider for dealing with the current disruptive change is: (1) ability to respond to change instantly and effectively, (2) engagement of employees in the change process, and (3) adaptability of the business.

 

Your business’ vision and mission should drive the course you will take to deliver your product. However, your Quality System is the platform that can be used to respond, engage, and adapt to most business challenges. Let’s look at how to use the components of your Quality System with those three topics to ensure your business can remain viable.

Respond to Change

Any change in the day-to-day routine in a business creates disruption. How the business reacts to that change determines how it will be received and accepted by the workforce and customers. COVID-19 has shown that our supply chains can be disrupted which can impede our ability to do business.

A Quality System documents the processes and procedures that are used daily to produce your product or service. A routine should be in place to review these processes and procedures as changes in your business model occur. COVID-19 has certainly changed how these processes and procedures are not only performed, but also new processes and procedures may have been introduced into your business. An example would be the 3D printing of face shields or testing swabs. A business that manages its Quality System will have systems in place to move quickly through the phases of introducing the production of a new product. That includes perhaps finding new suppliers and qualifying them, complying with applicable regulations such as the FDA, marketing these products, and conducting hazard assessments to determine if this production requires enhancement of the business’ health and safety program.

Engage your Employees

For the most part, disruption causes anxiety in the workforce. Encourage your workforce to engage in the process of evaluating how the change affects your business. Provide an atmosphere where there is trust and employees can openly share their ideas.

An effective Quality System requires a team approach and contains a procedure for evaluation. Use this procedure to ensure that all components of your business are included in activities designed to address the disruption. The manufacture of a new product typically affects the entire organization so engaging employees from all components of the business aids in a faster determination if the business can adapt to the change.

Adapt to Change

 The current disruption is being brought about by the COVID-19 pandemic. Businesses that are still in business have had to become innovative in order to protect their workforce and continue in business. For many businesses, these changes may not be temporary. They may have shaped an entire new way of doing business and/or introduced a new product to be offered. Leaders may be finding themselves in a different role from traditional leadership. To share a quote from a recent article in the ASQ magazine by Henry J. Lindborg: “Organizations can’t stop at bringing the best people in; they also must bring the best out of every person”. Use your current talent to help adapt to change.

Your Quality System includes a Mission Statement. Take this time of change to review that statement and determine if you are meeting your mission. If your business model has changed, then your Mission Statement may also need to be changed. At least annually, evaluate if you are meeting your Mission.

In Summary

Take a good look at your Quality System and use it to help you get through the COVID-19 disruption. Ensure that your organization has the ability to respond to future changes instantly and effectively, engage your employees in the change process, and adapt to the world of disruptions.

Contact us

Have questions about your dental lab quality system or need FDA compliance assistance? Contact us to learn more about how we can help your business. 

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Learn more about what SafeLink Consulting can do to help your business with compliance services, including safety compliance, to meet OSHA training requirements and quality system consulting to meet FDA compliance.  SafeLink Consulting assists businesses with workplace safety training, infection control training, HIPAA training online, quality systems, assessments, audits, due diligence, and more.

Industries include:

Dentistry compliance - assisting the dental practice with meeting requirements for OSHA, HIPAA, EPA, and CDC guidelines, patient safety and employee health & safety

Dental Laboratory compliance - assisting the dental lab with meeting requirements for OSHA, FDA, and CDC guidelines, employee health & safety, plus FDA requirements for lab manufacturing custom implant abutment /gmp for medical device manufacturers

Medical Device Manufacturers compliance - assisting with meeting OSHA compliance & FDA requirements, GMP - good manufacturing practices

General Industry compliance - assisting with OSHA compliance and FDA compliance as it pertains to the specific business

Beverage Industry compliance - assisting beverage businesses such as the craft brewery, winery, cidery, distillery, vintner with meeting OSHA compliance, health & safety, FDA requirements / GMP - Good Manufacturing Practices.