Appendix
C:
Mandatory requirements for OSHA recognition of third-party validation
organizations for the PSDI standard
This Appendix
prescribes mandatory requirements and procedures for OSHA recognition
of third-party validation organizations to validate employer and manufacturer
certifications that their equipment and practices meet the requirements
of the PSDI standard. The scope of the Appendix includes the three
categories of certification/validation required by the PSDI standard:
Design Certification/Validation, Installation Certification/Validation,
and Annual Recertification/Revalidation.
If further detailing of these provisions will assist the validation
organization or OSHA in this activity, this detailing will be done
through appropriate OSHA Program Directives.
I. Procedure
for OSHA Recognition of Validation Organizations
A. Applications
1. Eligibility.
a. Any person
or organization considering itself capable of conducting a PSDI-related
third-party validation function may apply for OSHA recognition.
b. However, in determining eligibility for a foreign-based third-party
validation organization, OSHA shall take into consideration whether
there is reciprocity of treatment by the foreign government after
consultation with relevant U.S. government agencies.
2. Content
of application.
a. The application
shall identify the scope of the validation activity for which
the applicant wishes to be recognized, based on one of the following
alternatives:
(1) Design
Certification/Validation, Installation Certification/Validation,
and Annual Recertification/Revalidation;
(2) Design Certification/Validation only; or
(3) Installation/Certification/Validation and Annual Recertification/Revalidation.
b. The application
shall provide information demonstrating that it and any validating
laboratory utilized meet the qualifications set forth in section
II of this Appendix.
c. The applicant shall provide information demonstrating that
it and any validating laboratory utilized meet the program requirements
set forth in section III of this Appendix.
d. The applicant shall identify the test methods it or the validating
laboratory will use to test or judge the components and operations
of the PSDI safety system required to be tested by the PSDI standard
and Appendix A, and shall specify the
reasons the test methods are appropriate.
e. The applicant may include whatever enclosures, attachments,
or exhibits the applicant deems appropriate. The application need
not be submitted on a Federal form.
f. The applicant shall certify that the information submitted
is accurate.
3. Filing office
location.
The application
shall be filed with:
PSDI Certification/Validation Program
Office of Variance Determination
Occupational Safety and Health Administration
U.S. Department of Labor
Room N3653
200 Constitution Avenue NW
Washington, DC 20210.
4. Amendments
and withdrawals.
a. An application
may be revised by an applicant at any time prior to the completion
of the final staff recommendation.
b. An application may be withdrawn by an applicant, without prejudice,
at any time prior to the final decision bY the Assistant Secretary
in paragraph I.B.8.b.(4) of this Appendix.
B. Review
and Decision Process
1. Acceptance
and field inspection. All applications submitted will be accepted
by OSHA, and their receipt acknowledged in writing. After receipt
of an application, OSHA may request additional information if it
believes information relevant to the requirements for recognition
have been omitted. OSHA may inspect the facilities of the third-party
validation organization and any validating laboratory, and while
there shall review any additional documentation underlying the application.
A report shall be made of each field inspection.
2. Requirements for recognition. The requirements for OSHA recognition
of a third-party validation organization for the PSDI standard are
that the program has fulfilled the requirements of section II of
this Appendix for qualifications and of section III of this Appendix
for program requirements, and the program has identified appropriate
test and analysis methods to meet the requirements of the PSDI standard
and Appendix A.
3. Preliminary approval. If, after review of the application, any
additional information, and the inspection report, the applicant
and any validating laboratory appear to have met the requirements
for recognition, a written recommendation shall be submitted by
the responsible OSHA personnel to the Assistant Secretary to approve
the application with a supporting explanation.
4. Preliminary disapproval. If, after review of the application,
additional information, and inspection report, the applicant does
not appear to have met the requirements for recognition, the Director
of the PSDI certification/validation program shall notify the applicant
in writing, listing the specific requirements of this Appendix which
the applicant has not met, and the reasons.
5. Revision of application. After receipt of a notification of preliminary
disapproval the applicant may submit revised application for further
review by OSHA pursuant to subsection I.B. of this Appendix or any
request that the original application be submitted to the Assistant
Secretary with a statement of reasons supplied by the applicant
as to why the application should be approved.
6. Preliminary decision by Assistant Secretary.
a. The Assistant
Secretary, or a special designee for this purpose, will make a
preliminary decision whether the applicant has met the requirements
for recognition based on the completed application file and the
written staff recommendation, as well as the statement of reasons
by the applicant if there is a recommendation of disapproval.
b. This preliminary decision will be sent to the applicant and
subsequently published in the FEDERAL REGISTER.
7. Public review
and comment period.
a. The Federal
Register notice of preliminary decision will provide a period
of not less than 60 calendar days for the written comments on
the applicant’s fulfillment of the requirements for recognition.
The application, supporting documents, staff recommendation, statement
of applicant’s reasons, and any comments received, will
be available for public inspection in the OSHA Docket Office.
b. If the preliminary decision is in favor of recognition, a member
of the public, or if the preliminary decision is against recognition,
the applicant may request a public hearing by the close of the
comment period, if it supplies detailed reasons and evidence challenging
the basis of the Assistant Secretary’s preliminary decision
and justifying the need for a public hearing to bring out evidence
which could not be effectively supplied through written submissions.
8. Final decision
by Assistant Secretary
a. Without
hearing. If there are no valid requests for a hearing, based on
the application, supporting documents, staff recommendation, evidence
and public comment, the Assistant Secretary shall issue the final
decision (including reasons) of the Department of Labor on whether
the applicant has demonstrated by a preponderance of the evidence
that it meets the requirements for recognition.
b. After hearing. If there is a valid request for a hearing pursuant
to paragraph I.B.7.b. of this Appendix, the following procedures
will be used:
(1) The
Assistant Secretary will issue a notice of hearing before an
administrative law judge of the Department of Labor pursuant
to the rules specified in 29 CFR Part 1905, Subpart C.
(2) After the hearing, pursuant to Subpart C, the administrative
law judge shall issue a decision (including reasons) based on
the application, the supporting documentation, the staff recommendation,
the public comments and the evidence submitted during the hearing
(the record), stating whether it has been demonstrated, based
on a preponderance of evidence, that the applicant meets the
requirements for recognition. If no exceptions are filed, this
is the final decision of the Department of Labor.
(3) Upon issuance of the decision, any party to the hearing
may file exceptions within 20 days pursuant to subpart C. If
exceptions are filed, the administrative law judge shall forward
the decision, exceptions and record to the assistant secretary
for the final decision on the application.
(4) The Assistant Secretary shall review the record, the decision
by the administrative law judge, and the exceptions. based on
this, the assistant secretary shall issue the final decision
(including reasons) of the department of labor stating whether
the applicant has demonstrated by a preponderance of evidence
that it meets the requirements for recognition.
c. Publication.
a notification of the final decision shall be published in the
FEDERAL REGISTER.
C. Terms and Conditions of Recognition, Renewal and Revocation
1. The following terms and conditions shall be part of every recognition:
a. The recognition of any validation organization will be evidenced
by a letter of recognition from OSHA. the letter will provide
the specific details of the scope of the OSHA recognition as well
as any conditions imposed by OSHA, including any Federal monitoring
requirements.
b. The recognition of each validation organization will be valid
for five years, unless terminated before or renewed after the
expiration of the period. The dates of the period of recognition
will be stated in the recognition letter.
c. The recognized validation organization shall continue to satisfy
all the requirements of this appendix and the letter of recognition
during the period of recognition.
2. A recognized validation organization may change a test method
of the PSDI safety system certification/validation program by notifying
the Assistant Secretary of the change, certifying that the revised
method will be at least as effective as the prior method, and providing
the supporting data upon which its conclusions are based.
3. A recognized validation organization may renew its recognition
by filing a renewal request at the address in paragraph I.A.3. of
this Appendix, above, not less than 180 calendar days, nor more
than one year, before the expiration date of its current recognition.
When a recognized validation organization has filed such a renewal
request, its current recognition will not expire until a final decision
has been made on the request. The renewal request will be processed
in accordance with subsection I.B. of this Appendix, above, except
that a reinspection is not required but may be performed by OSHA.
A hearing will be granted to an objecting member of the public if
evidence of failure to meet the requirements of this Appendix is
supplied to OSHA.
4. A recognized validation organization may apply to OSHA for an
expansion of its current recognition to cover other categories of
PSDI certification/validation in addition to those included in the
current recognition. The application for expansion will be acted
upon and processed by OSHA in accordance with subsection I.B. of
this Appendix, subject to the possible reinspection exception. If
the validation organization has been recognized for more than one
year, meets the requirements for expansion of recognition, and there
is no evidence that the recognized validation organization has not
been following the requirements of this Appendix and the letter
of recognition, an expansion will normally be granted. A hearing
will be granted to an objecting member of the public only if evidence
of failure to meet the requirements of this Appendix is supplied
to OSHA.
5. A recognized validation organization may voluntarily terminate
its recognition, either in its entirety or with respect to any area
covered in its recognition, by giving written notice to OSHA at
any time. The written notice shall indicate the termination date.
A validation organization may not terminate its installation certification
and recertification validation functions earlier than either one
year from the date of the written notice, or the date on which another
recognized validation organization is able to perform the validation
of installation certification and recertification.
6.
a. OSHA may revoke its recognition of a validation organization
if its program either has failed to continue to satisfy the requirements
of this Appendix or its letter of recognition, has not been performing
the validation functions required by the PSDI standard and Appendix
A, or has misrepresented itself in its applications. Before
proposing to revoke recognition, the Agency will notify the recognized
validation organization of the basis of the proposed revocation
and will allow rebuttal or correction of the alleged deficiencies.
If the deficiencies are not corrected, OSHA may revoke recognition,
effective in 60 days, unless the validation organization requests
a hearing within that time.
b. If a hearing is requested, it shall be held before an administrative
law judge of the Department of Labor pursuant to the rules specified
in 29 CFR Part 1905, Subpart C.
c. The parties shall be OSHA and the recognized validation organization.
The decision shall be made pursuant to the procedures specified
in paragraphs I.B.8.b.(2) through (4) of this Appendix except
that the burden of proof shall be on OSHA to demonstrate by a
preponderance of the evidence that the recognition should be revoked
because the validation organization either is not meeting the
requirements for recognition, has not been performing the validation
functions required by the PSDI standard and Appendix
A, or has misrepresented itself in its applications.
D. Provisions of OSHA Recognition
Each recognized third-party validation organization and its validating
laboratories shall:
1. Allow OSHA to conduct unscheduled reviews or on-site audits of
it or the validating laboratories on matters relevant to PSDI, and
cooperate in the conduct of these reviews and audits;
2. Agree to terms and conditions established by OSHA in the grant
of recognition on matters such as exchange of data, submission of
accident reports, and assistance in studies for improving PSDI or
the certification/validation process.
II.
Qualifications
The third-party validation organization, the validating laboratory,
and the employees of each shall meet the requirements set forth in
this section of this Appendix.
A. Experience of Validation Organization
1. The third-party validation organization shall have legal authority
to perform certification/validation activities.
2. The validation organization shall demonstrate competence and
experience in either power press design, manufacture or use, or
testing, quality control or certification/validation of equipment
comparable to power presses and associated control systems.
3. The validation organization shall demonstrate a capability for
selecting, reviewing, and/or validating appropriate standards and
test methods to be used for validating the certification of PSDI
safety systems, as well as for reviewing judgements on the safety
of PSDI safety systems and their conformance with the requirements
of this section.
4. The validating organization may utilize the competence, experience,
and capability of its employees to demonstrate this competence,
experience and capability.
B. Independence of Validation Organization
1. The validation organization shall demonstrate that:
a. It is financially capable to conduct the work;
b. It is free of direct influence or control by manufacturers,
suppliers, vendors, representatives of employers and employees,
and employer or employee organizations; and
c. Its employees are secure from discharge resulting from pressures
from manufacturers, suppliers, vendors, employers or employee
representatives.
2. A validation organization may be considered independent even
if it has ties with manufacturers, employers or employee representatives
if these ties are with at least two of these three groups; it has
a board of directors (or equivalent leadership responsibilities
for the certification/validation activities) which includes representatives
of the three groups; and it has a binding commitment of funding
for a period of three years or more.
C. Validating Laboratory
The validation organization’s laboratory (which organizationally
may be a part of the third-party validation organization):
1. Shall have legal authority to perform the validation of certification;
2. Shall be free of operational control and influence of manufacturers,
suppliers, vendors, employers, or employee representatives that
would impair its integrity of performance; and
3. Shall not engage in the design, manufacture, sale, promotion,
or use of the certified equipment.
D. Facilities and Equipment
The validation organization’s validating laboratory shall have
available all testing facilities and necessary test and inspection
equipment relevant to the validation of the certification of PSDI
safety systems, installations and operations.
E. Personnel
The validation organization and the validating laboratory shall be
adequately staffed by personnel who are qualified by technical training
and/or experience to conduct the validation of the certification of
PSDI safety systems.
1. The validation organization shall assign overall responsibility
for the validation of PSDI certification to an Administrative Director.
Minimum requirements for this position are a Bachelor’s degree
and five years professional experience, at least one of which shall
have been in responsible charge of a function in the areas of power
press design or manufacture or a broad range of power press use,
or in the areas of testing, quality control, or certification/validation
of equipment comparable to power presses or their associated control
systems.
2. The validating laboratory, if a separate organization from the
validation organization, shall assign technical responsibility for
the validation of PSDI certification to a Technical Director. Minimum
requirements for this position are a Bachelor’s degree in
a Technical field and five years of professional experience, at
least one of which shall have been in responsible charge of a function
in the area of testing, quality control or certification/validation
of equipment comparable to power presses or their associated control
systems.
3. If the validation organization and the validating laboratory
are the same organization, the administrative and technical responsibilities
may be combined In a single position, with minimum requirements
as described in E.1. and 2. for the combined position.
4. The validation organization and validating laboratory shall have
adequate administrative and technical staffs to conduct the validation
of the certification of PSDI safety systems.
F. Certification/Validation Mark or Logo
1. The validation organization or the validating laboratory shall
own a registered certification/validation mark or logo.
2. The mark or logo shall be suitable for incorporation into the
label required by paragraph (h)(11)(iii) of this section.
III. Program
Requirements
A. Test
and Certification/Validation Procedures
1. The validation
organization and/or validating laboratory shall have established
written procedures for test and certification/validation of PSDI
safety systems. The procedures shall be based on pertinent OSHA
standards and test methods, or other publicly available standards
and test methods generally recognized as appropriate in the field,
such as national consensus standards or published standards of professional
societies or trade associations.
2. The written procedures for test and certification/validation
of PSDI systems, and the standards and test methods on which they
are based, shall be reproducible and be available to OSHA and to
the public upon request.
B. Test
Reports
1. A test report
shall be prepared for each PSDI safety system that is tested. The
test report shall be signed by a technical staff representative
and the Technical Director.
2. The test report shall include the following:
a. Name of
manufacturer and catalog or model number of each subsystem or
major component.
b. Identification and description of test methods or procedures
used. (This may be through reference to published sources which
describe the test methods or procedures used.)
c. Results of all tests performed.
d. All safety distance calculations.
3. A copy of
the test report shall be maintained on file at the validation organization
and/or validating laboratory, and shall be available to OSHA upon
request.
C. Certification/Validation
Reports
1. A certification/validation
report shall for which the certification is validated. The certification/validation
report shall be signed by the Administrative Director and the Technical
Director.
2. The certification/validation report shall include the following:
a. Name of
manufacturer and catalog or model number of each subsystem or
major component.
b. Results of all tests which serve as the basis for the certification.
c. All safety distance calculations.
d. Statement that the safety system conforms with all requirements
of the PSDI standard and Appendix A.
3. A copy of
the certification/validation report shall be maintained on file
at the validation organization and/or validating laboratory, and
shall be available to the public upon request.
4. A copy of the certification/validation report shall be submitted
to OSHA within 30 days of its completion.
D. Publications
System
The validation organization shall make available upon request a list
of PSDI safety systems which have been certified/validated by the
program.
E. Follow-up
Activities
1. The validation
organization or validating laboratory shall have a follow-up system
for inspecting or testing manufacturer’s production of design
certified/validated PSDI safety system components and subassemblies
where deemed appropriate by the validation organization.
2. The validation organization shall notify the appropriate product
manufacturer(s) of any reports from employers of point of operation
injuries which occur while a press is operated in a PSDI mode.
F. Records
The validation organization or validating laboratory shall maintain
a record of each certification/validation of a PSDI safety system,
including manufacturer and/or employer certification documentation,
test and working data, test report, certification/validation report,
any follow-up inspections or testing, and reports of equipment failures,
any reports of accidents involving the equipment, and any other pertinent
information. These records shall be available for inspection by OSHA
and OSHA State Plan offices.
G. Dispute
Resolution Procedures
1. The validation
organization shall have a reasonable written procedure for acknowledging
and processing appeals or complaints from program participants (manufacturers,
producers, suppliers, vendors and employers) as well as other interested
parties (employees or their representatives, safety personnel, government
agencies, etc.), concerning certification or validation.
2. The validation organization may charge any complainant the reasonable
charge for repeating tests needed for the resolution of disputes.
[53 FR 8361, Mar. 14, 1988]
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