background image
CONFIDENTIAL
CONFIDENTIAL
AMERICAN NATIONAL STANDARDS INSTITUTE
Report of Mail-In Audit of
Optics and Electro-Optics Standards Council
ANSI-Accredited Standards Developer
July-August 2006
background image
CONFIDENTIAL
CONFIDENTIAL
CONFIDENTIAL
CONFIDENTIAL
Note: This audit report and the information contained herein shall remain
confidential and shall not be disclosed to any person other than the auditee,
appropriate ANSI staff, the auditor, and, as appropriate, members of the reviewing
bodies (i.e., the Executive Standards Council and the ANSI Appeals Board). The
auditee may provide the audit information and reports received to whomever it
deems appropriate.
1.
Introduction
The authority for ANSI to audit ANSI-accredited standards developers is included in
clause 4.1.3 of the ANSI Essential Requirements: Due Process Requirements for
American National Standards (ANSI Essential Requirements). The purpose of an audit is
to determine whether there is any evidence of non-compliance with the criteria for
accreditation and to ascertain as far as possible if the procedures and practices of an
ANSI-accredited standards developer continue to be consistent with the current ANSI
Essential Requirements. When possible, in a separate report, the auditor will recommend
changes to the operation of the auditee that are intended to increase efficiency or
effectiveness.
The ANSI Auditing Policy and Procedures allow an auditee to provide all relevant
standards material to ANSI via the mail or electronically under circumstances approved
by the Director of the ANSI Standards Developer Audit Program. The audit will then be
performed without an on-site review of the developer's standards related documentation.
It was determined that the Optics and Electro-Optics Standards Council (OEOSC) was
eligible for a mail-in audit.
Dr. H. Glenn Ziegenfuss served as the auditor. A pre-audit telephone conference was
held on 11 July 2006 with Gene Kohlenberg, Executive Director, OEOSC; Glenn
Ziegenfuss, ANSI Auditor; and Jay Moskowitz, Director, ANSI Standards Developer
Audit Program. This provided an opportunity for questions and answers from both
parties. The mail-in audit was conducted during July and August 2006 at the location of
the auditor.
2.
Background
The Optics and Electro-Optics Standards Council (OEOSC) was formed in April 1993,
with participation by APOMA, COM, LEOMA, OSA, and SPIE. It has been serving as
the administrative sponsor and secretariat for the Accredited Standards Committee for
Optics and Electro-Optical Instruments (ASC OP) since its accreditation as an ANSI
Accredited Standards Committee on 23 February 2000. Some of the original sponsoring
organizations have discontinued their involvement, but the National Institute of Standards
and Technology has become a sponsor.
OEOSC has begun to provide training services for companies that want assistance in
testing their optical products optical surface appearance imperfections.
ASC OP sponsors two American National Standards, ANSI/OEOSC OP3.001-2001 and
ANSI/OEOSC OP1.002-2006. The first standard was developed using the Model
2
background image
CONFIDENTIAL
CONFIDENTIAL
CONFIDENTIAL
CONFIDENTIAL
Procedures for an Accredited Standards Committee. The second standard was developed
using procedures that were adapted from the Model Procedures for an Accredited
Standards Committee.
3.
Scope of the Audit
The audit involved a review of the operations of OEOSC as related to standards
development and associated activities, including continuity of administrative oversight
and support of the standards activities. As it was determined by the Director, ANSI
Standards Developer Audit Program, that ASC OP qualified for a mail-in audit, all
available documentation concerning the development of their newly developed standard,
OEOSC OP1.002-2006, For optics and electro-optical instruments ­ Optical elements and
assemblies ­ Appearance imperfections, was reviewed. The previous audit reviewed the
development of their other standard.
This audit report, including the findings, is based solely on the standards and
documentation actually reviewed. The audit report should not be viewed or relied
upon as evidence of anything beyond the scope of the documentation reviewed. The
audit did not involve the accounting or financial aspects of OEOSC.
The audit took into consideration the practices and actions, records, and reports of
OEOSC in implementing the operating procedures to comply with ANSI criteria, rules,
procedures, and requirements including, but not limited to, the following items:
· Criteria for Accreditation
· Due Process Requirements
· Criteria for Approval and Withdrawal of American National Standards
· Other ANSI Requirements
4.
Audit Objectives
The following audit objectives formed the basis of the audit:
· Based on the evidence reviewed, confirm adherence by OEOSC to the criteria
for accreditation.
· Based on the evidence reviewed, confirm that OEOSC procedures and
practices continue to be consistent with the approved procedures and with
current ANSI Requirements.
· Recommend changes in procedure when, in the opinion of the auditor, such
changes would result in more efficient or effective operations.
5.
Summary of Audit Results
The audit identified areas where activities are notable, as indicated in Section 8A of this
report. Under separate cover, suggestions for potential improvements in efficiency and
effectiveness are offered for consideration.
The audit reviewed the recommendations
from the regular audit of the Accredited Standards Committee for Optics and Electro-
3
background image
CONFIDENTIAL
CONFIDENTIAL
CONFIDENTIAL
CONFIDENTIAL
Optical Instruments (ASC OP), held in December 2001, and efforts made to address non-
compliances. The results of this review are contained in Section 8B of this report.
The
audit also identified several areas where the auditor believed certain findings and
recommendations were appropriate, as indicated in Sections 8C and 8D of this report.
6.
Conduct of the Audit
After initial preparation, including the completion of the pre-audit checklist by OEOSC,
the audit was conducted in three phases: an examination of records and documentation by
the auditor; development of audit findings, recommendations, and comments by the
auditor; and a post-audit conference with OEOSC staff.
7.
Examination of Records and Documents
OEOSC provided the auditor with a copy of the completed pre-audit questionnaire
(Attachment A), as well as documentation substantiating the responses. A review of the
pre-audit questionnaire and the accompanying documentation provided the following
general findings:
OEOSC, as an ANSI-accredited standards developer, has unique accredited procedures,
the ASC OP Procedures for the Development and Coordination of American National
Standards, dated 2 May 2005. The standards development process is as follows: The
procedures have been adapted and updated from Annex A of the ANSI Procedures for the
Development and Coordination of American National Standards. There are a few items
that are not consistent with the current edition of the ANSI Essential Requirements that
should be addressed. These items are as follows:
a) In 3.1 d) and e) there is a referral to 11.3 regarding interpretations. Clause
11.3 just refers back to 3.1. There should to be a policy included in the procedures or as a
separate document indicating whether and how OEOSC handles interpretations.
b) In 5.4 interest categories are mentioned in the very general sense, but they are
not listed nor are they defined. The interest categories should be included either in the
procedures or in a separate document along with definitions of those categories. In the
14 July 2006 edition of these procedures, this item has been addressed. These new
procedures have not been submitted to ANSI for approval.
c) In Section 6, subgroups are discussed, but their official role in developing
standards is not defined. If the subgroups are responsible for any standards, they need to
be defined and they need to comply with the rules for balance, voting, and all the other
rules for standards committees. If they are only advisory to the main committee, that
should be so stated. In the 14 July 2006 edition of these procedures, the item is
addressed. However, changing these groups to consensus bodies may cause additional
problems with balance and participation due to the relatively low number of participants.
The 14 July 2006 edition has not been submitted to ANSI for approval.
d) In 8.1, reasons are required for all negative or abstain votes. Consideration
should be given regarding providing reasons for personnel matters and perhaps have this
requirement deleted for those items.
4
background image
CONFIDENTIAL
CONFIDENTIAL
CONFIDENTIAL
CONFIDENTIAL
e) In 8.6, the procedures need to be revised to reflect that all objectors need to be
advised in writing regarding the disposition of their comments and they also need to be
advised in writing regarding their rights to appeal. In the 14 July 2006 edition of the
procedures the second item has been addressed, but the first item has not. These new
procedures have not been submitted to ANSI for approval.
f) In 9.2, the procedures should be revised to reflect that ANSI no longer requires
two copies of the standard. The list of items in this clause should be updated to reflect
the current edition of the ANSI Essential Requirements. In the 14 July 2006 edition of the
procedures, this item has been addressed. These new procedures have not been submitted
to ANSI for approval.
OEOSC sponsors two ANSI-approved standards. The organization staff member
responsible for the maintenance of OEOSC's American National Standards is Mr. Gene
Kohlenberg, Executive Director.
Internationally, OEOSC is responsible for the TAG activities for ISO TC 172, Optics and
photonics. They participate in the standards development activities of this ISO
committee and propose OEOSC standards for adoption as ISO standards. They also
consider ISO TC 172 standards for adoption as American National Standards, but none
has been adopted to date.
Nationally, OEOSC does not have any formal relationships with other standards
developers, but members of OEOSC are members of other organizations, specifically
ASTM International committees.
The staff of OEOSC does not participate on the ANSI Organization Member Forum or
any other ANSI committee.
Since there is only one staff member in OEOSC, training consists of this person
monitoring the ANSI web site and other ANSI media for information on standards and
the requirements for American National Standards.
There was no project management mechanism provided in the data provided to track the
standards for OEOSC. Since they only have two standards, the auditor considers it
impractical to develop a system to track the standards.
For the most part, OEOSC provides information in electronic form to its consensus
bodies and to ANSI. In the beginning of the development of this standard some items
were handled in paper, but at the end of the process everything appears to have been
handled electronically.
OEOSC does not really have a Standards Interpretation Policy. It is mentioned in clause
11.3 of their Procedures for the Development and Coordination of American National
Optical Standards, but does not provide any detail on the mechanism for handling the
interpretations. According to OEOSC, no interpretations have been received in the past
year.
OEOSC has a Records Retention Policy. It is contained in Clause 14 of their Procedures
for the Development and Coordination of American National Optical Standards. It is in
5
background image
CONFIDENTIAL
CONFIDENTIAL
CONFIDENTIAL
CONFIDENTIAL
compliance with the minimum requirements of the current edition of the ANSI Essential
Requirements.
OEOSC has a Metric Policy. It is contained in Clause 16 of their Procedures for the
Development and Coordination of American National Optical Standards. It states that
the International System of Units (SI) is the preferred system for units of measure. In the
standard audited, metric units are used throughout without US customary units.
OEOSC does not have a Commercial Terms and Conditions Policy. A review of the
standard revealed that there were no commercial terms and conditions in the standard. In
the 14 July 2006 edition of their procedures, a new Section 18 has been added stating that
OEOSC will comply with the ANSI Essential Requirements regarding Commercial Terms
and Conditions. These new procedures have not been submitted to ANSI for approval.
OEOSC does not have a Patent Policy and reports that no patent issues have been raised
or identified. In the 14 July 2006 edition of their procedures, a new Section 17 has been
added stating that OEOSC will comply with the ANSI Patent Policy. These new
procedures have not been submitted to ANSI for approval.
According to the records at ANSI, the 2002 and 2003 Compliance Forms were not
submitted prior to the initiation of this audit. They were submitted during the conduct of
this audit.
The auditor reviewed the questionnaire completed by OEOSC (Attachment A), as well as
documentation substantiating the responses. All of the documentation necessary to
complete this audit was available.
The auditor emphasized the following specific areas in the examination of OEOSC
documentation:
A. Review of Documentation Indicating Evidence of Consensus and Due Process.
The auditor reviewed OEOSC OP1.002-2006, For optics and electro-optical
instruments ­ Optical elements and assemblies ­ Appearance imperfections.
A PINS form was submitted on 25 April 2002 with the title, "Optics and electro-optical
instruments ­ Optical elements and cemented subassemblies surface imperfection." A
revised PINS form was submitted on 14 December 2002 with the revised title, "Optics
and electro-optical instruments ­ Optical elements and assemblies ­ Appearance
imperfections." Both were completed correctly and in timely fashion.
The first BSR-8 form was submitted but there was no copy in the documentation. The
initial public review was incorrectly listed in the 2 July 2004 issue of Standards Action
under the PINS section (see Attachment B). ANSI acknowledged the error (see
Attachment C) and it was re-listed in the 23 July 2004 issue of Standards Action for a
period of 60 days and a comment deadline of 21 September 2004 (see Attachment D). A
second BSR-8 form was submitted on 28 November 2005 after having addressed a
number of comments from ANSI staff on their first BSR-9 form. A single page of
changes to the document was included. The BSR-8 form was completed correctly. It
6
background image
CONFIDENTIAL
CONFIDENTIAL
CONFIDENTIAL
CONFIDENTIAL
was submitted after the consensus ballot was complete. A second public review
announcement for OEOSC OP1.002-2006 appeared in the 9 December 2005 issue of
Standards Action with a thirty-day comment deadline of 8 January 2006.
An initial BSR-9 form was submitted, on 25 October 2004 (see Attachment E), but ANSI
staff returned it with a request for clarification on several items (see Attachment F).
There were several problems with the responses on the form, but it did show a balanced
consensus body with four producers, three users, and five general interest members. A
second BSR-9 form was submitted, but it was also returned for additional information
(see Attachment G). There was no copy of this form in the documentation. The revised
form was submitted on 3 March 2006 (see Attachment H). During the audit, OEOSC
located an email message forwarding the revised form with the consensus body ballot
results to the members of the consensus body. The revised form was completed correctly
and included a complete consensus body listing including interest categories. However,
the consensus body was completely different from what was listed on the first BSR-9
form (nine producers, five general interest, and no users). The three users were now
listed as producers. There was also no documentation to explain as to whether the
members changed their interest category or whether the first BSR-9 form was in error.
The second BSR-9 form was submitted within one year of the close of the second public
review period.
ANSI provided a notice of final approval on 7 March 2006 and the announcement was
included in the 17 March 2006 issue of Standards Action.
B. Review of Documentation Indicating the Disposition of Views and Objections
There was a total of five ballots issued: 23 November 2003, 29 December 2003,
4 November 2004, 29 January 2005, and 12 July 2005. None of the ballots could be
considered recirculation ballots since they were all reissued because of an insufficient
response or they were rewritten due to comments submitted on the previous ballot. All of
the ballots were issued for a thirty-day period. Each included the issue date and the due
date. Reminder letters were sent about ten days before the end of the balloting period and
in some cases again right before the end of the ballot due date.
All of the comments and negatives were circulated to the members of the consensus
body, but the members were not asked to reaffirm or change their votes. Technically, this
was not a recirculation ballot, but instead the document was revised and sent out for
ballot again. Some of this reballoting appeared to be a reaction to the ANSI response to
the first BSR-9 form that was submitted and returned for clarification. After the last
ballot there were no negatives and only editorial comments to resolve. Since there were
no objectors, there were no notifications of rights to appeal sent.
Two public reviews were held. One was after the first two ballots and the second was
after the last ballot.
7
background image
CONFIDENTIAL
CONFIDENTIAL
CONFIDENTIAL
CONFIDENTIAL
The minutes (see Attachment I) of the 21 January 2006 meeting of the OEOSC
Committee on this standard discussed several changes that would be incorporated in the
next revision.
C. Balance and Interest Categories of Consensus Body
The auditor noted that there was no representation in the user interest category and an
participation fee. The participation fee is based on the number of employees at the
member's company. Apparently, the fee can be waived if the member teaches a course
related to the standard. There is nothing in the procedures regarding the waiver policy.
Nno one has been removed from the consensus body involuntarily.
OEOSC included documentation showing how they try to attract members of the US
TAG to ISO TC 172, Optics and Photonics, but there was little information documenting
any outreach efforts for the OEOSC domestic standards activity. There was a
considerable amount of correspondence showing how new memberships are processed,
and one indication that a potential member from Pakistan was discouraged from joining
(see Attachment J). There does not appear to be any restriction in the OEOSC procedures
regarding participants from other countries.
There was no evidence in the documentation submitted that the consensus body list was
circulated to the members on an annual basis as required by their procedures. However,
OEOSC reported that they maintain the consensus body list on their web site which the
ExSC deems sufficient in lieu of distributing hardcopies of the roster.
According to the final BSR-9 form, the consensus body is seriously out of balance (see
Attachment G). There were nine producers and five general interest members, with no
users. As noted earlier in this report, this is a significant shift in membership from the
original BSR-9 form. The procedures call for reasonable balance, with no dominance
from a single interest category. With a substantial majority of the members in the
producer category, this is not in compliance with the ANSI Essential Requirements.
The standard is not a safety or safety related standard, but the balance requirements were
not met in either case.
The numerical consensus requirements were met even though there was a relatively high
number of not returned ballots.
D. Appeals
OEOSC has an Appeals Procedure. It is contained in Clause 12 of their Procedures for
the Development and Coordination of American National Optical Standards. The
procedure mirrors the one that was used previously in the ANSI Procedures for the
Development and Coordination of American National Standards, except that it has been
updated to reflect that the ExSC does not participate in creating the appeals panel. It
meets the minimum requirements of the ANSI Essential Requirements. OEOSC reported
that they have had no appeals since the last audit.
In 8.6 of their Procedures for the Development and Coordination of American National
Optical Standards, each objector is to be notified of their right to appeal. As noted in the
8
background image
CONFIDENTIAL
CONFIDENTIAL
CONFIDENTIAL
CONFIDENTIAL
section above regarding recommended changes to these procedures, OEOSC needs to add
"in writing" when notifying objectors of their right to appeal.
E. Compliance with ANSI Requirements for Publication and Maintenance of Standards
In reviewing OEOSC compliance with ANSI requirements for publication of standards,
the auditor notes that OEOSC arranges for publication of their American National
Standards. The American National Standards include on the cover the words "Approved
American National Standard" and the approved ANSI Logo. The date of ANSI approval
is included on the title page. A unique alphanumeric designation is used to identify their
American National Standards. For some unexplained reason, the title of the published
standard was slightly different than the title included on the corrected PINS form, the
BSR-8 form, and the BSR-9 form. It appears to be only a small grammatical difference.
The title of the published standard is "For optics and electro-optical instruments ­ Optical
elements and assemblies ­ Appearance imperfections."
OEOSC announces the availability of their standards on their web site at
www.optstd.org
.
The standards are available in either paper or electronic form. The standards are also
available through the ANSI Store.
In reviewing OEOSC compliance with ANSI requirements for maintenance of standards,
the auditor noted that this audit only covered their newly completed standard, and the
previous standard has not yet exceeded the five-year review period.
8.
Development of Audit Findings, Recommendations and Comments:
The auditor developed the following findings, recommendations, and comments:
A.
The auditor noted the following:
i)
The auditor noted that OEOSC encourages and promotes broad
participation of interested persons and organizations.
ii)
The auditor noted that OEOSC utilizes their web site (www.optstd.org) to
announce information for those who are interested and have access to the
web. The auditor believes that use of the web site increases the visibility
of the standards and potentially increases participation on the consensus
body.
iii)
The auditor noted that OEOSC makes a substantial effort to resolve all
comments and objections and to ensure that consensus is achieved. In
reviewing the actions taken, the auditor found that the consensus body was
willing to make substantive technical changes, even though the time for
approval of the standard was lengthened.
iv)
The auditor noted that OEOSC presently conducts the ANSI public review
after the conclusion of the consensus ballot and any attempts to resolve
objections. OEOSC staff indicated that the public review is held after the
conclusion of the consensus ballot because of the changes that are made to
the document as a result of the consensus ballots.
9
background image
CONFIDENTIAL
CONFIDENTIAL
CONFIDENTIAL
CONFIDENTIAL
v)
The auditor noted that membership is not restricted on the basis of
technical qualifications. Participation is not conditional upon membership
in any organization.
vi)
The auditor noted that the interest category of participants is determined
through self-declaration.
vii)
The auditor noted that OEOSC has submitted a PINS form to ANSI when
the title of the standard changed.
viii)
The auditor noted that OEOSC submits ANSI PSA forms electronically,
thus reducing the potential for delays and errors.
ix)
The auditor noted that no appeals of the approval of the OEOSC standards
have been filed. The appeals process is outlined in Clause 12 of their
Procedures for the Development and Coordination of American National
Optical Standards.
x)
The auditor noted that OEOSC does not have any formal liaisons with
other standards developers as the standard is unique and there is no need
for harmonization or coordination.
xi)
The auditor noted that OEOSC actively participates in international
activity in the area of standardization, specifically in ISO TC 172, Optics
and Photonics.
xii)
The auditor noted that OEOSC American National Standards are available
as individual documents, in paper or electronically, and in the ANSI
Standards Store.
xiii)
The auditor noted that OEOSC provided a written statement during the
course of the audit that the ANSI Patent Policy found in clause 3.1 of the
ANSI Essential Requirements will be used as the OEOSC patent policy.
xiv)
The auditor noted that the completed OEOSC 2006 Compliance Form is
on file with ANSI.
xv)
The auditor noted that OEOSC has a Policy on Evidence of Compliance,
which is contained in Clause 14 of their Procedures for the Development
and Coordination of American National Optical Standards. It is in
compliance with the minimum requirements of the current edition of the
ANSI Essential Requirements, and is on file at ANSI.
xvi)
The auditor noted that OEOSC has a Metric Policy, which is contained in
Clause 16 of their Procedures for the Development and Coordination of
American National Optical Standards and is on file at ANSI. It states that
the International System of Units (SI) is the preferred system for the units
of measure.
xvii) The auditor noted that OEOSC has recently revised their operating
procedures. The auditor noted that many of the concerns raised in this
audit report are addressed in the proposed revision provided in the 14 July
10
background image
CONFIDENTIAL
CONFIDENTIAL
CONFIDENTIAL
CONFIDENTIAL
2006 edition. The auditor further noted OEOSC intends to submit the
final version to ANSI as soon as possible after this audit.
B.
The auditor reviewed the recommendations from the December 2001 regular audit
of OEOSC and observed the following:
i)
2001 Audit Recommendation
. The auditor recommends that, in
accordance with clause 1.2.6 of the ANSI Procedures, ASC OP submit a
PINS form at the initiation of the project to develop or revise an American
National Standard, rather than ten days prior to the submission of the
BSR-8 form (this was also six months after accreditation of the
committee). In the opinion of the auditor such initiation begins when the
project is approved by ASC OP. Registration of projects using the PINS
form is designed to provide a central databank of information relative to
voluntary national standards. It is useful for providing direct information
to all interested parties and is a key element in planning and coordination.
It is therefore crucial that submission of a PINS form be timely.
2006 Audit Finding. The auditor noted that the PINS form was submitted
soon after the project was approved. This item has been fully addressed.
ii)
2001 Audit Recommendation
. The auditor recommends that, in
accordance with clause A.8.1 of the ANSI Procedures, ASC OP issue a
ballot that includes the four options of Affirmative; Affirmative, with
comment; Negative, with reasons, and Abstain, with reasons. As noted in
Part 7 of this report, no actual ballot was issued to the members of the
consensus body.
2006 Audit Finding. The auditor noted that the ballots issued included
the options of yes; yes, with comments; no, with comments; and abstain,
with comments. This item has been fully addressed.
iii)
2001 Audit Recommendation. The auditor recommends that, in
accordance with clause A.8.1.3 of the ANSI Procedures, ASC OP issue a
ballot for a fixed period of six weeks. In reviewing the standard, the
auditor found that no actual letter ballot was issued, although all members
of the consensus body apparently did submit a final vote.
2006 Audit Finding. The auditor noted that the ballot period in their new
procedures is thirty days, or earlier if all ballots have been submitted. All
ballots were issued for thirty days. This item has been fully addressed.
iv)
2001 Audit Recommendation. The auditor recommends that ASC OP
substantiate all votes in writing, particularly in those instances where the
vote is obtained via email or other electronic means. The auditor noted
that in two instances ASC OP recorded votes from members of the
consensus body but there was no back-up documentation verifying the
vote. Accurate record-keeping of votes cast is essential in order to provide
evidence of consensus.
11
background image
CONFIDENTIAL
CONFIDENTIAL
CONFIDENTIAL
CONFIDENTIAL
2006 Audit Finding. The auditor noted that all ballots were in the
documentation and recorded properly. This item has been fully addressed.
v)
2001 Audit Recommendation. The auditor recommends that, in
accordance with clause A.8.7 of the ANSI Procedures, ASC OP report
final results of voting to the committee. The auditor found that the results
are reported only to
ANSI via the BSR-9 form. Methods of reporting can
include a written report or a report given at a meeting and so recorded in
the meeting minutes.
2006 Audit Finding. After a thorough review of all the documentation
submitted, the auditor was unable to find any evidence that the final voting
results were reported to the members of the consensus body. During the
audit, OEOSC located an email forwarded the final BSR-9 form and the
consensus body voting tally to the members of the consensus body. This
item has been addressed.
vi)
2001 Audit Recommendation. The auditor recommends that, in
accordance with clause 1.2.2 of the ANSI Procedures, ASC OP take
additional efforts to ensure that the committee is balanced and no interest
category is more than half of the total. The auditor reviewed the current
consensus body roster and found that there is only one producer, two
users, and four general interest members. In addition to being quite small,
there is a clear imbalance of members.
2006 Audit Finding. Although the balance situation has tilted in the
completely opposite direction, it is now out of balance with far too many
producers versus either of the other two interest categories. This area still
needs considerable effort and is not yet resolved.
vii)
2001 Audit Recommendation. The auditor recommends that, in
accordance with A.7.1 of the ANSI Model Procedures for Accredited
Standards Committees ASC OP ensure that meeting announcements are
made in ANSI's Standards Action. The auditor was unable to find
evidence that this was being done.
2006 Audit Finding. The auditor noted that OEOSC has made a
commendable effort in announcing meetings in Standards Action. There
was documentation showing announcements for seven meetings. This
item has been fully addressed.
viii)
2001 Audit Recommendation. The auditor recommends that, in
accordance with A5.5 of the Model Procedures for Accredited Standards
Committees ASC OP maintain and update the ASC OP membership list
and provide it to committee members at least once per year.
2006 Audit Finding. The auditor could find no evidence that the
membership list was being provided to the members on an annual basis.
During the audit, OEOSC reported that they intend to maintain the
membership roster on their web site. This item has not been addressed.
12
background image
CONFIDENTIAL
CONFIDENTIAL
CONFIDENTIAL
CONFIDENTIAL
C.
The auditor found areas of non-compliance. The following findings and
recommendations are made to address these non-compliances:
i)
The auditor recommends that, in accordance with clause 4.1.3 of the ANSI
Essential Requirements, OEOSC officially provide ANSI with their
current operating procedures and, if the changes are considered by the
ExSC to be substantive, the reaccreditation process shall be initiated. In
reviewing the 2 May 2005 edition of the Procedures for the Development
and Coordination of American National Optical Standards, the auditor
found that they are not in compliance with the current edition of the ANSI
Essential Requirements. The auditor also notes that these procedures were
submitted to ANSI almost one year later on 27 April 2006. The auditor
notes that several substantive changes have been proposed during the
course of this audit and are included in the 14 July 2006 version. The
auditor recommends that the new edition be completed after this audit and
submitted to ANSI in a timely manner. OEOSC is required by clause
4.1.3 of the ANSI Essential Requirements to notify ANSI of any changes
to procedures on record at ANSI. Further details regarding recommended
procedural changes are included in Section 7 of this report and in several
places in this section.
ii)
The auditor recommends that, in accordance with clauses 3.0 and 3.5 of
the ANSI Essential Requirements, OEOSC document the Standards
Interpretation Policy and provide ANSI with a copy. The primary purpose
for providing an Interpretation Policy is to protect the accredited OEOSC
from liability resulting from incorrect or improper interpretations. The
establishment of a formal method by which interpretations are offered
diminishes this risk of liability. The auditor considers the current
information in clauses 3.1 d), 3.1 e), and 11.3, to be inadequate. Further
details are contained in Section 7 of this report.
iii)
The auditor recommends that, in accordance with clauses 3.0 and 3.1 of
the ANSI Essential Requirements, OEOSC either develop a patent policy
or adopt clause 3.1 of the ANSI Essential Requirements as the OEOSC
policy. The auditor notes that OEOSC has included a proposal in the
14 July 2006 edition of the Procedures for the Development and
Coordination of American National Optical Standards. These new
procedures should be submitted to ANSI for approval.
iv)
The auditor recommends that, in accordance with clauses 3.0 and 3.2 of
the ANSI Essential Requirements, OEOSC document the Commercial
Terms and Conditions Policy and provide ANSI with a copy. The auditor
notes that OEOSC has included a proposal in the 14 July 2006 edition of
the Procedures for the Development and Coordination of American
National Optical Standards. These new procedures should be submitted to
ANSI for approval. Further details are contained in Section 7 of this
report.
13
background image
CONFIDENTIAL
CONFIDENTIAL
CONFIDENTIAL
CONFIDENTIAL
v)
The auditor recommends that, in accordance with clause 5.1 of the
Procedures for the Development and Coordination of American National
Optical Standards, OEOSC take formal action to add to the membership of
the consensus body, document such action, and advise the consensus
body, as required by the operating procedures. The auditor found that in
the case of one applicant from Pakistan, OEOSC is not handling
membership requests in accordance with the accredited procedures.
Further details are contained in Section 7C of this report.
vi)
The auditor recommends that, in accordance with clauses 1.2, 1.3, 2.2, 2.3,
and 3.3 of the ANSI Essential Requirements, OEOSC keep accurate
records of membership changes. The auditor noted that the consensus
body changed significantly for this standard from the original BSR-9 form
that was submitted to ANSI to the final BSR-9 form that was submitted.
There was no documentation indicating what occurred to justify such a
change in membership. Adequate monitoring of balance and participation
requires an accurate and up-to-date list of members of the consensus body
and associated membership records. Further details are contained in
Sections 7A and 7C of this report.
vii)
The auditor recommends that, in accordance with clauses 1.2, 1.3, 2.2, and
2.3 of the ANSI Essential Requirements and Clause 2 of the Procedures for
the Development and Coordination of American National Optical
Standards, OEOSC take additional efforts to ensure that the consensus
body is balanced and no interest category is more than a majority of the
total. The auditor noted clause 2.3 recommends that no single interest
category constitutes a majority of the membership of a consensus body
dealing with other than safety-related standards. The auditor found that
the current consensus body roster appears to be seriously out of balance.
Specifically, the final BSR-9 form indicates that there were nine producers
and five general interest members with no users. Furthermore,
a)
The auditor suggests that OEOSC make additional efforts to
encourage additional membership and suspend those members who
are not actively participating.
Further details are contained in Section 7C of this report.
viii)
The auditor recommends that the non-compliances listed in this audit
report be reviewed at the next scheduled audit to verify that corrective
action was taken.
9.
Post Audit Conference
The findings, recommendations, and comments were discussed during a post audit
teleconference call that was held on 25 October 2006. Those who participated were Gene
Kohlenberg, Executive Director, OEOSC; Glenn Ziegenfuss, ANSI Auditor; and Jay
Moskowitz, Director, ANSI Standards Developer Audit Program.
14
background image
CONFIDENTIAL
CONFIDENTIAL
CONFIDENTIAL
CONFIDENTIAL
Finally, the auditor would like to express appreciation for the cooperation extended by
the OEOSC staff, which helped significantly in expediting the audit process, enabled the
audit to be effective, and provided an opportunity for discussions benefiting ANSI as well
as OEOSC.
15