Mitigating Risk Through Quality Assurance Policies


In today's ever-evolving regulatory world, it is critical for medical instrument companies to develop guidelines that will comply with continually-changing regulatory requirements.  How can companies and employees stay abreast of all the complexities and moving parts to achieve compliance? Having a protocol in place is essential. Here are five QA components to take into consideration when creating policies and procedures. 

Defining Characteristics to Implement a Quality Policy

QA_puzzle_pieces.pngIn a recent article by MED DEVICE ONLINE, Marcelo Trevino and Thomas Bento weigh in on quality policies and best practices for developing them.  Trevino and Bento state, "A quality policy is cross-functionally developed by management and quality experts to express the organization’s quality objectives. The policy’s purpose is to express the acceptable level of quality for the organization, and to outline the standards applicable to specific departments."

Trevino and Bento recognize several characteristics that should be considered when defining a quality policy. These practices can be adhered to even as compliance requirements change. Click here to read the complete original article.

5 Quality Assurance Components to Consider when Creating Procedures

1. Clarity
Identify and describe objectives that are expressly understood and easy for employees to remember.

2. Longevity
Create a stable plan that can endure industry and market trends.

3. Challenge
Implement continuous improvement plans that engage and provoke employees to further quality throughout the company.

4. Simplicity
The policy should be easily understood and general enough to encompass all of the organization's interests.

5. Inspiration
Motivate employees to follow, utilize and improve the quality policy. 

Once the quality policy is put in place, the work is not done.  The policy must be continually monitored to analyze the effectiveness of the objectives. Continuous improvement plans should be an integral part of QA policies. As the corporation develops and grows, so do objectives and goals. It is important to implement a risk management program into the quality policy so that new and changing risk factors are always analyzed. As Trevino and Bento state, "Risk management provides the initial risk-analysis needed to make good decisions, establish elements of an organization, or meet the requirements of sound project planning." 

KMC Systems is focused on quality assurance and regulatory compliance in every aspect of instrument development, design and manufacturing. KMC operates an FDA-inspected site and undergoes numerous industry audits every year. Our robust, FDA-compliant, automated software system has been customized over the years to continually comply to regulatory requirements with confidence and proven success.

Discover KMC's standards of quality assurance and regulatory compliance by visiting our quality assurance web page. To preview a list of industry best practices, click below and download the medical device quality assurance tip Sheet.

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Read the blog: The Role of Quality Assurance in Medical Device Design 

Topics: medical device quality assurance, medical manufacturing quality management