Pain is Weakness Leaving the Body! I love this old military mantra!  Or then there’s “No pain no gain!” Sometimes a little bit of pain goes a long way for ultimate success! We accept this mantra at Quality Audit Consulting (QAC)! We can help you get through your growing pains with a gap assessment for…

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NIOSH 42 CFR Part 84 provides the standards for the approval of N95 respiratory protective devices. The approval of N95 respiratory protective devices requires that there be a Quality Control Plan in place. Part 84.41 describes the Quality Control Plan.  One of the parts of the Quality Control Plan which must be in place in…

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N95 Respirator Test Requirements for NIOSH Submission NIOSH requires that N95 manufacturers follow the guidelines in the Code of Federal Regulations (CFR), 42 CFR Part 84. 42 CFR Part 84 provides the test procedures, requirements, and documentation needed to file an application with NIOSH Before respirators can be submitted to NIOSH for certification, manufacturer’s must…

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The FDA defines N95 Respirator as a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles.  The edges of the respirator should be designed to form a seal around the nose and mouth. Surgical N95 Respirators are commonly used in healthcare settings and are a subset…

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Quality System Requirements, N95 NIOSH Approved Respirators is required by the FDA.  FDA enforcement of normal requirements for Face Masks and N95 Respirators has relaxed during the COVID-19 Global Pandemic. On April 2020 (revised on May 2020) the FDA issued Guidance “Enforcement Policy for Face Masks and Respirators During the Corona Virus Disease (COVID-19) Public…

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The COVID-19 Pandemic has brought the issue of hand sanitizer requirements and their regulation to the national forefront.   Because of the public health emergency, the FDA has stated that they do not intend to take action against firms that prepare alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs…

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Travel has been restricted due to the Corona Virus and many companies have turned or will be turning to alternatives to complete their audit schedule.  Remote Auditing is one of the alternatives to re-scheduling an audit. So what are the essentials for a good remote audit? The FDA, as part of the Medical Device Single…

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Each year the FDA provides spreadsheets summarizing the areas of regulation cited in these observations at the following website:  FDA.gov  The spreadsheets are not a comprehensive listing of all observations but represent the a number of times it was cited as an observation on a FDA Form 483.     Top categories for 2018: #1 Quality…

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Metric Reporting

Metrics, This one word can cause many emotions, fear, trembling, excitement, or dread! I have experienced all of these emotions when it comes to metrics. That Pareto Chart ascending or descending in at a particular elevation or curve can have a profound effect upon us! The FDA has recognized the importance of Quality Management System…

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