Relationship Advice on Valentine’s Day: Quality Assurance—In a Respirator, That IsPosted on by
On this Valentine’s Day, what lessons can respirator manufacturers learn from Liz Taylor, Larry King, Lana Turner, and Mickey Rooney? Why, the importance of quality assurance, of course. All of these celebs were married eight times—for Liz and Larry, they actually tied the knot twice with the same person—but their repeated unluckiness in love tells us that no matter how successful one is at starting a relationship, it might not stand up when put to a true, rigorous test of quality assurance.
Let’s run with this romantic analogy for a bit to briefly demonstrate how NIOSH reviews the quality assurance (QA) system under which respirators are manufactured. It’s our way of playing matchmaker and ensuring that a manufacturer seeking the NIOSH stamp of approval on a respirator makes for a worthy significant other.
The Screening Process
To keep things simple, let’s focus here on circumstances in which NIOSH has never even met a particular manufacturer before (kind of a “blind date” situation—things are different if we’ve already had a few successful outings together). In that case, NIOSH is certainly going to need to check out the necessary credentials. For prospective respirator approval holders, this means they must first do their homework (i.e., visit the links in the next section and carefully study the full application procedures) and meet specialized criteria before even submitting an application. These criteria include assembling detailed documentation, establishing and implementing a QA system for the product, demonstrating the ability to make the respirator, and formally requesting a three-digit manufacturer code from NIOSH. After assigning this code, NIOSH uses it to track all future application information and correspondence related to approval requests for this specific respirator.
Collectively, these materials serve as the equivalent of a draft of a user profile being prepped for a dating site. Hey, NIOSH has very high standards and requires accurate information for a candidate to make it through the QA screening process. And although we don’t need a “glossy glamour headshot” up front, we do require evidence of the location of the manufacturing site and the implementation of a QA system used for current production. This information will be inspected in greater detail and validated later upon submission of the first approval application. For a prospective respirator approval holder to be a serious contender whose product could be chosen, NIOSH requires all of this preparation even before the application is submitted.
The Application (Oh, Those Checklists)
Ever been sucked in by one of those magazine questionnaires (“Is it true love?”; “Will your relationship last?”) or filled out a detailed checklist to determine your personality type as part of your quest for a perfect match? The NIOSH QA respirator approval program checklist is something like that, but this internal checklist includes over 200 criteria.
After an applicant successfully completes the pre-application evaluation process, secures a manufacturer code, pays the $200 application fee (yup, perfect matches aren’t always free), and NIOSH receives the application and the respirator hardware, then the application will be reviewed by NIOSH for conformity and completeness.
To help manufacturers navigate the substantial complexities of this process, NIOSH provides them with different Standard Application Procedures based on the type of respirator that they’re manufacturing, and the content provided by prospective manufacturers in their Standard Application Procedures is matched against NIOSH’s internal respirator approval checklist mentioned above. Here’s where applicants need to supply such materials as an assembly matrix, detailed engineering drawings, test samples, user instructions, and a quality assurance system that includes a product-specific quality control plan. This is the equivalent of NIOSH checking out the family pedigree, including whether or not the applicant is using “relatives” (i.e., subcontractors—who are held to the same standards) to supply some or all of the respirator components. Again, as a well-established and trusted QA steward, NIOSH provides guidance for quality control plans that can help applicants to be successful in navigating the approval process prior to submitting an approval request, but the better acquainted applicants are with NIOSH guidance and the Standard Application Procedures, the more effective the process will be for both of us.
Quality Assurance Review
Finally, NIOSH conducts a QA review to evaluate the applicant’s quality control system, ensure the caliber of the production process, and check that there are clearly defined inspection procedures in place, in accordance with the highly detailed standards set forth in 42 CFR Part 84. In looking over this regulation, which numbers more than 300 sections and subparts, applicants discover that a QA review is both extensive and intensive, and it’s definitely not for the faint of heart.
The QA review for first-time applicants even includes a site visit (time to “meet in person for that first date,” so to speak) so that NIOSH can fact check the material provided in the Standard Application Procedures and verify details including the procedures for purchasing and accepting raw materials to be used in production, the in-process and final inspections, the procedures to monitor and train personnel, and a recording of the acceptable quality level—which indicates the percentage of defects that can be acceptable for any particular respirator characteristic. And when any part of the QA review reveals inaccuracies, inadequacies, or issues that need to be reconciled, then NIOSH will provide the applicant with a list of deficiencies that must be addressed to move forward (indeed, we do believe in second chances unless the problem is insurmountable) or decide that it’s time to part ways, depending on the seriousness of the issues (yes, NIOSH can end the date at any time if things turn sour).
In sum, from a QA point of view, NIOSH is looking for the complete package. Only prospective respirator manufacturers with complete application packages, well-vetted processes, quality assurance components, and acceptable configurations for fully assembled respirators can pass NIOSH’s rigorous review. Our ultimate aim is to provide quality assurance to both manufacturers and users. When manufacturers produce a NIOSH-approved respirator and they continue to follow the standards inherent to a QA review beyond the approval process, users can be assured that the respirator will protect them as advertised from exposures to chemicals, biological agents, and infectious diseases at work. Since NIOSH-approved respirators are used by millions of workers, we pride ourselves in building and maintaining lasting relationships with worthy respirator manufacturers. To achieve that relationship goal, a NIOSH quality assurance review is the key to wholehearted success.
Joseph Schall, MA, is a Health Communications Specialist in the NIOSH National Personal Protective Technology Laboratory.
Rhonda Sheets, BA, is a Quality Assurance Specialist in the NIOSH National Personal Protective Technology Laboratory.
Jaclyn Krah Cichowicz, MA, is a Health Communications Specialist in the NIOSH National Personal Protective Technology Laboratory.