What is NIOSH 42 CFR Part 84 Compliance & Who Needs To Comply?
What is NIOSH 42 CFR Part 84 Compliance?
In June 1995, the National Institute for Occupational Safety and Health (NIOSH) updated and modernized the Federal regulation for certifying air-purifying particulate respirators [42 CFR Part 84]. The respirators certified under this new regulation are tested under much more demanding conditions, and they provide increased worker protection. These new respirators also provide significant cost savings: Estimates indicate that the health care industry alone will save millions of dollars as a result of this new generation of practical and efficient respirators.
Who needs to comply with NIOSH 42 CFR Part 84?
A company, corporation, association, or other organization that designs, manufactures, assembles, or controls the assembly of a respirator and who seeks to obtain a certificate of approval from NIOSH for such respirator whether it is N, R or P with an efficiency of 95 percent, 99 percent or 99.97 percent need to perform tests and create submittal packages that are specific for the approval. Testing, quality control, and other requirements under 42 CFR Part 84 are intended to ensure that respirators supplied to U.S. workers provide effective protection when properly employed within a complete respiratory protection program, as specified under MSHA and OSHA regulations.
What are the documents included in a NIOSH Compliance Application?
- A complete written description of the respirator for which approval is requested together with drawings (titled, numbered, and dated with revision dates & details) and specifications (and lists thereof) showing full details of construction of the respirator and of the materials used
- A proposed plan for quality control which meets the minimum requirements
- A statement that the respirator has been pretested by the applicant
- A statement that the respirator and component parts submitted for approval are either prototypes, or made on regular production tooling, with no operation included which will not be incorporated in regular production processing
How does LuitBiz DMS & QMS help you become NIOSH 42 CFR Part 84 compliant?
Rule
What it means
How LuitBiz DMS & QMS helps
42 C.F.R. § 84.41 (a)(2), (b)-(i); 42 C.F.R § 84.61(a): Design and Development
The manufacturer must maintain all of the records generated during the design and development process including design inputs, design outputs, including drawings, classification of defects, and incoming, in-process, and final inspections, typically found in the PQP and appropriate reviews and approvals of the design and development process, including both verification and validation
All documents and records can be easily maintained in different folders like "In-Process Test Results", "Design Documents" etc that can be created in LuitBiz DMS & QMS with suitable access controls. Additionally, tagging templayes can be created to enter user defined meta data like document / drawing number, test date, testing agency, etc and then documents can be retrieved based on these metadata.
42 C.F.R 84.41 (a)(2): Control of Documents and Data
The manufacturer must ensure that any data collection system is controlled to prevent unintentional alteration or deletion.
In LuitBiz DMS only authorized group leaders can delete data and that too after 2 levels of deletion request / permission.
In LuitBiz QMS only quality managers can control document requests, approvals and distribution.
42 C.F.R 84.41 (a)(4): Control of Purchasing
The manufacturer must have a process to identify qualified suppliers (with initial approval and periodic evaluations), communicate material and/or component requirements to suppliers and receive and review all incoming materials or components from suppliers.
In LuitBiz DMS, users can create "Supplier Control" tagging templates to enter meta data for supplier approval and evaluation and also store and retrieve all supplier documents including invoices and purchase orders with just one click.
In LuitBiz QMS, quality department can create supplier qualification forms that can be filled up and approved by designated users before adding suppliers to their system.
42 C.F.R 84.33 (b), (e)-(g); 42 C.F.R 84.41 (a)(5): Product Identification and Traceability
The manufacturer must have a procedure to identify raw materials used within the production process, properly label all respirators and respirator components, track, or trace, the essential components of the respirator and properly identify the finished respirator and required major subassemblies with a lot number, serial number, and/or manufacture date
In LuitBiz DMS product documents can be tagged with values of their lot number, product label, manufacturing date, approval date etc and thus these documents can be easily retrieved
In LuitBiz QMS, quality department can raw material qualification forms that can be filled up and approved by designated users to track respirator components, and identify the finished respirator and required major subassemblies with a lot number, serial number, and/or manufacture date.
42 C.F.R 84.41 (a)(5), (7); 42 C.F.R 84.42 (c): Control of Production Processes
The manufacturer must have adequate documentation to ensure that the manufacturing process is consistently performed and followed, including any procedures for the setup of assembly or testing devices, assembly processes, and inspection procedures.
In LuitBiz DMS & QMS the complete documentation process for all manufacturing documents can be centrally managed along with the differenr versions of the documents for easy access and retrieval
42 C.F.R 84.41 (a)(4)-(6): Inspection and Test
The manufacturer must have a process to identify, review, and approve any incoming, in-process, and/or final inspections & ensure that inspection records provide sufficient detail to facilitate the identification of the lot and sample size, inspections performed, data collected, and the acceptance criteria. Additionally, manufacturer should also document the locations where performance inspections take place, when multiple inspection sites are used and properly maintain inspection records for time periods deemed appropriate to product life
In LuitBiz DMS & QMS all review process workflows can be designed and documents can be tagged with appropriate meta data for easy access and retrieval
42 C.F.R 84.41 (a)(3): Control of Equipment
The manufacturer must maintain all equipment calibration & status records for the equipments used during the production process
In LuitBiz DMS & QMS all equipment data can be stored in a separate folder with requisite access and tagged with calibration values for easy retrieval.
42 C.F.R 84.41 (a)(4),(5): Inspection and Test Status and the Control of Nonconforming Product
The manufacturer must have a process to identify the product’s acceptance status and also a process for the final disposition of a nonconforming product
In LuitBiz DMS & QMS process workflows can be defined and the acceptance status of the products can be entered as keywords meta data for easy retrieval.
42 C.F.R 84.41 (a)(7): Corrective Actions
The manufacturer must maintain all corrective action records.
In LuitBiz DMS all CAPA records and customer complant redressal records can be easily stored and retrieved in separate folders
In LuitBiz QMS all quality department can design their CAPA and customer complant redressal forms that can be filled and approved by the designated users and implemented.
42 C.F.R 84.41 (a)(5): Inventory and Handling Controls
The manufacturer must have a process to prevent the damage of all raw materials, in-process components, and finished NIOSH products.
In LuitBiz DMS & QMS all inventory and handling records can be easily stored and retrieved in separate folders
42 C.F.R 84.43 (a): Quality Records
The manufacturer must establish the retention time for all records, as appropriate.
In LuitBiz DMS it is possible to define retention periods of different records and documents based on NIOSH compliance requirements
42 C.F.R 84.41(a)(7): Internal Audits
The manufacturer must establish a schedule for internal audits and maintain the records for internal audits. The internal audit program must cover the entire quality system, including the approved quality plan.
In LuitBiz DMS & QMS it is possible to define the entire quality plan as a master document and attach the internal audits for these plans as "Related Documents" and retrieve them easily.
42 C.F.R 84.41 (a)(7): Training
The manufacturer must have a procedure to train and monitor personnel, which includes ensuring only authorized personnel assemble, test, and inspect a NIOSH-approved product
All training records and training materials can be stored and easily retrieved using LuitBiz DMS
All training related forms and records can be designed, approved and implemented using LuitBiz QMS
42 C.F.R 84.40; 42 C.F.R 84.41 (a)(7); 42 C.F.R 84.42: Quality Management
The manufacturer must have a process to review the quality system and ensure that management reviews the internal audit records
In LuitBiz DMS & QMS workflow templates can be designed to ensure that documents and quality forms follow a quality process with adequate approval levels and ensure that all internal audits are reviewed by the management
42 C.F.R 84.41 (a)(7): Organizational Structure
The manufacturer must establish an organizational structure to identify those positions responsible for fulfilling the requirements of the quality control plan
The organizational structure and company documents can be stored in LuitBiz DMS & QMS is separate folders with requisite access control