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Letter to All Respirator Manufacturers
April 7, 2005
SUBJECT: |
Clarification of Supplier and Subcontractor Relationships |
Background
National Institute for Occupational Safety and Health (NIOSH or the
Institute) approval holders have established relationships with suppliers
and subcontractors who are manufacturing components or subassemblies
for approved respirator configurations. A growing number of approval
holders wish to ship NIOSH-approved respirators directly from a subcontractor
to distribution centers or customers, and replacement parts directly
to a repair center. The Institute has identified two possible approval
holder relationships with suppliers and subcontractors. Listed below
are the responsibilities and requirements NIOSH has established for these
relationships.
Definitions
Approval Holder: The party of record
to whom certificates of approval have been issued. The approval holder
maintains responsibility for, and control of, product design, performance,
configuration management, manufacture, quality, and support.
Supplier: A supplier produces components or subassemblies
under their own quality system for delivery to the approval holder. The
approval holder confirms the acceptability of incoming goods by accepting
a Certificate of Compliance and inspecting incoming goods to ensure compliance
with all product design, performance, and quality assurance criteria
(drawings and engineering control). The approval holder releases the
product for distribution and sale.
Subcontractor: The approval holder may authorize a
subcontractor to release NIOSH-approved respirators directly from their
facility for distribution and sale, or to release components and subassemblies
directly to an authorized repair center. The approval holder maintains
responsibility for, and control of, product design, performance, configuration
management, manufacture, quality, and support by maintaining influence
over , and active involvement in , the subcontractor’s quality
system. As such, the subcontractor’s facility is considered to
be a manufacturing site for the approval holder.
Subcontractor Relationship Responsibilities
The approval documentation on file at NIOSH must demonstrate that the
following criteria have been met for NIOSH recognition of a subcontractor.
- As with all other NIOSH approvals, the approval holder maintains
responsibility for all aspects of the approval: control over product
drawings, material specifications, parts lists, and manufacturing
processes; control over the requirements for final inspection and testing;
and approval of any changes to the above.
- The approval holder must assure that a subcontractor has demonstrated
the ability to supply product that consistently meets the established
release criteria, and has adequate quality systems and procedures
in place to assure product quality on an ongoing basis.
- The approval holder must establish and maintain active involvement
and influence over subcontractor quality systems. This can be demonstrated
in many different ways. One example of this involvement and influence
can be exhibited by participating in the subcontractor’s management
reviews (as defined by ISO 9001, 2000, section 5.6) required by the
subcontractor’s Quality System. A second example is participation
in the subcontractor’s Material Review Board.
- The approval holder’s methods for maintaining active involvement
and influence over their subcontractor’s quality system needs
to be documented in a plan or procedure that suits the individual
situation and manufacturing complexity of the secured goods. This
plan or procedure must be formally submitted to NIOSH.
- The approval holder will maintain copies of subcontractor quality
records that demonstrate compliance with NIOSH performance requirements.
It is important to assure that, in the event of a broken relationship,
both the Approval Holder and NIOSH have continued access to those
records.
- All submissions related to the approval must be made by an authorized
representative of the approval holder. The subcontractor’s Quality
Manual and related quality system documents must represent how the
approval holder establishes and maintains active involvement and influence
over the subcontractor’s quality system. This information must
be specifically indicated and documented as part of a Quality Assurance
Application. As with all Quality Manuals, a process must be established
and followed for ongoing resubmission of the Quality Manual and related
quality system documents in the event of significant changes, and
on a periodic basis, per NIOSH requirements.
- All subcontractor relationships must be listed as an approval holder’s
manufacturing site, with a designated point of contact, on the
NIOSH Standard Application Form (SAF) for direct shipment from the
subcontractor to be acceptable under the NIOSH Approval.
- All manufacturing sites for NIOSH-approved products, including subcontractor
facilities, will be audited by NIOSH on a regular basis. The
Institute will not contact the subcontractor directly, but will always
work through the approval holder’s designated representative
for the specific manufacturing site.
Sincerely yours,
![Heinz W. Ahlers signature](https://webarchive.library.unt.edu/eot2008/20090122021152im_/http://www.cdc.gov/niosh/npptl/images/ahlers_sig.gif)
Heinz W. Ahlers
Acting Chief, Respirator Branch
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