C. M

Craig M. Jackson

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PROCESS FOR MAKING CHANGES IN WG1 QUALITY
SYSTEM PROCEDURES
Author: C. M.
Jackson
Date : 2006/01/24
Version : 2.1
Authorized :
JCTLM Executive
JCTLM WG1-
P-07
1/10
PROCESS FOR MAKING CHANGES IN WG1
QUALITY SYSTEM PROCEDURES
WG1 P-07
PRIMARY AUTHOR AUTHORIZED
NAME
CRAIG M. JACKSON
NAME 
JCTLM EXECUTIVE
FUNCTION
MEMBER/LEADER, JCTLM WG1
 PROCEDURES TEAM
FUNCTION
SIGNATURE SIGNATUREPROCESS FOR MAKING CHANGES IN WG1 QUALITY
SYSTEM PROCEDURES
Author: C. M.
Jackson
Date : 2006/01/24
Version : 2.1
Authorized :
JCTLM Executive
JCTLM WG1-
P-07
2/10
PROCESS FOR MAKING CHANGES IN WG1 QUALITY SYSTEM PROCEDURES
1.  Contents
PARAGRAPH TITLE PAGE
1. CONTENTS....................................................................................................... 2
2. PURPOSE......................................................................................................... 2
3. SCOPE.............................................................................................................. 2
4. ACRONYMS...................................................................................................... 2
5. DEFINITIONS.................................................................................................... 3
6. RESPONSIBILITIES AND AUTHORIZATIONS................................................ 3
7. PROCEDURE.................................................................................................... 3
8. RELATED DOCUMENTS.................................................................................. 7
9. ATTACHMENTS ............................................................................................... 7
10. REVISION HISTORY......................................................................................... 7
11. FLOWCHART ................................................................................................... 9
ATTACHMENT 1 PROCEDURE CHANGE REQUEST FORM................................ 10
2.  Purpose
The purpose of the WG1 Change Control Procedure is to describe the process by which
changes in WG1 procedures and procedure documents are initiated and tracked, and how
users of WG1 procedures are apprised of how adoption and implementation of suggested
changes occurs. 
It is the policy of JCTLM WG1 to make changes in its procedures and documents by a
transparent process using openly distributed procedure documents that can be known to all
interested parties.
The procedures provided in this Quality System document are those by which the changes
in WG1 procedures are made and placed in operation.
3.  Scope
The scope of this document is all procedures that describe the activities of JCTLM WG1.
4.  Acronyms
All acronyms employed in JCTLM Procedure Documents are given in the procedure
document WG1-P-00, Quality Policy and Definitions. Acronyms particularly relevant to this
document are repeated below.PROCESS FOR MAKING CHANGES IN WG1 QUALITY
SYSTEM PROCEDURES
Author: C. M.
Jackson
Date : 2006/01/24
Version : 2.1
Authorized :
JCTLM Executive
JCTLM WG1-
P-07
3/10
JCTLM...................Joint Committee for Traceability in Laboratory Medicine
WG1....................... Working Group 1 of the JCTLM; is responsible for identifying and
recommending for listing reference materials and reference
measurement methods/procedures.
WG1 Chair .............Leader of WG1, during some time periods the Chair position may be
held by more than a single individual to facilitate WG1 activities
CRM.......................Certified Reference Material
RMM......................Reference Measurement Method 
RMP .......................Reference Measurement Procedure, a particular implementation of
reference measurement method
RMM/P...................The concatenation of RMM and RMP for brevity in the WG1
5.  Definitions
All definitions employed in JCTLM Procedure Documents are given in the procedure
document WG1-P-00, Quality Policy and Definitions.
6.  Responsibilities and Authorizations
6.1. Proposal for changes in WG1 documents can be made by:
6.1.1.  The JCTLM Executive
6.1.2.  Members of any JCTLM Working Group or Review Team
6.1.3.  JCTLM members
6.1.4.  Nominators of CRMs and RMM/Ps for review by WG1
6.1.5.  Users of the lists of higher-order reference materials and reference
measurement methods/procedures
7.  Procedure 
Procedure for Proposing Changes to WG1 Documents
7.1. Changes in procedures and procedure documents can be proposed by any of the
groups or individuals identified in Section 6, above.
7.2. Proposals for changes will be accepted, reviewed and if recommended, adopted on a
biannual basis. The date for making submissions is specified on the Procedure
Change Request Form, WG1-P-07-F-01 and can be found and downloaded from:
http://www.bipm.org/utils/en/doc/WG1-P-07-F-01.doc.
7.3. Proposals for changes are made by completing the Procedure Change Request Form
attached to this procedure. 
7.3.1.  All sections of the Procedure Change Request Form, WG1-P-07-F-01, must be
completed before it can be forwarded to the JCTLM Procedures Team by the
Secretariat.
7.3.1.1.   Authorized parties and reviewers are responsible for completing the
pertinent sections of the form as indicated on the form.PROCESS FOR MAKING CHANGES IN WG1 QUALITY
SYSTEM PROCEDURES
Author: C. M.
Jackson
Date : 2006/01/24
Version : 2.1
Authorized :
JCTLM Executive
JCTLM WG1-
P-07
4/10
7.3.1.2.   If any section of the Procedure Change Request Form is not applicable to a
proposed change, this must be stated in that section by the responsible
party.
7.3.1.3.   The reasons for a section of the Procedure Change Request Form deemed
to not be applicable must be given in writing in the inapplicable section.
7.3.2.  Completed Procedure Change Request Forms, WG1-P07-F01 are to be
submitted to the JCTLM Secretariat as attachments to email messages directed
to: jctlm@bipm.org
7.3.2.1.  The Secretariat will assign a document tracking number to the form
received at BIPM.
7.3.2.2.   Incomplete Procedure Change Request Forms will be returned to the
individual or organization submitting the form. 
7.3.2.3.   Unless the amended Procedure Change Request Forms with the omitted
sections completed are returned to the JCTLM Secretariat by the final
submission date specified on the form, the form will not be considered until
the subsequent biannual cycle unless deemed urgent by the WG1 Chair(s)
or the JCTLM Secretariat or Executive.
7.4. Completed Procedure Change Request Forms are forwarded by the JCTLM
Secretariat to the WG1 Chair(s).
7.5. The WG1 Chair(s) may at their discretion transfer the change forms to the WG1
Quality System Procedures Team Leader for initial review and subsequent
distribution to the Procedures Team of WG1.
Procedure for Reviewing and Recommending Changes to WG1 Documents
7.6. Proposals for changes are reviewed by the JCTLM Procedures Team Leader for
review category prioritization as follows:
7.6.1.  Are the proposed changes consistent with the JCTLM mission?
7.6.1.1.  Changes inconsistent with the objectives of JCTLM cannot be considered.
7.6.2.  Are the proposed changes concordant with the ISO standards used by JCTLM
in its activities?
7.6.2.1.   Changes inconsistent with the ISO standards cannot be considered except
under highly unusual circumstances.
7.6.3.  Are the proposed changes limited to clarification of wording without
substantive change in criteria or process?
7.6.3.1.   Changes that simplify or clarify wording within the WG1 procedure
documents may at the discretion of the WG1 Chair(s) be reviewed and a
revised procedure document substituted for the document with unclear
wording by the Secretariat. 
7.6.3.1.1.  Changes that simply clarify will be assigned revision numbers to
the right of the decimal point of the current revision number.PROCESS FOR MAKING CHANGES IN WG1 QUALITY
SYSTEM PROCEDURES
Author: C. M.
Jackson
Date : 2006/01/24
Version : 2.1
Authorized :
JCTLM Executive
JCTLM WG1-
P-07
5/10
7.6.4.  Is the proposed change related to a discrepancy between a definition given in a
procedure(s) and the ISO document on which the definition is based or from
which the definition has been taken?
7.6.4.1.   Proposed changes related to deviations from the ISO standards will be
reviewed by the Procedures Team and WG1RTs
7.6.4.2.  The rationale for such deviations and/or making changes to remove such
deviations will be recorded on the Procedure Change Request Form.
7.6.5.  Does the proposed change result in alteration in a criterion employed in review
or for decision making?
7.6.5.1.  Proposed changes that will alter a criterion used in the review and
recommendation processes of WG1 in a substantive way will be reviewed
by the Procedures Team and WG1RTS.
7.6.5.2.  The rationale for making changes to criteria that are used in the review and
recommendation process will be recorded on the Procedure Change Request
Form.
7.6.6.  Is the proposed change an alteration in the basic process described in the
procedure document?
7.6.6.1.  Proposed changes that will fundamentally alter the processes used in the
review and recommendation activities of WG1 in a substantive way will be
reviewed by the Procedures Team and WG1RTs.
7.6.6.2.  The rationale for making changes that will fundamentally alter the
processes used in the review and recommendation activities of WG1 will be
recorded on the Procedure Change Request Form.
7.7. After categorization of the substance of the submitted suggestion for change, as
described above, the procedures team leader will circulate the Procedure Change
Request Forms to the members of the Procedures Review Team for comments.
7.7.1.  The procedures team will query the members of the team for an indication of
whether the change discussions can be processed by email or conference call or
will require a face-to-face discussion prior to or in conjunction with a general
JCTLM meeting.
7.7.2.  All substantive changes, i.e., changes in criteria or process, will be discussed in
a face-to-face WG1 meeting prior to final approval of changes to the current
version of the procedure and submitting the revised procedure document(s) to the
JCTLM Executive Committee.
7.7.2.1.  Consensus acceptance will result in transfer of the procedures with the
recommended changes to the JCTLM Secretariat for subsequent forwarding
to the JCTLM Executive for review and approval.
7.7.3.  All non-substantive changes will be made without face-to-face discussions
using email discussions to achieve consensus of the revised document for
subsequent submission to the JCTLM WG1 members for full WG1 consensus. 
7.7.3.1.   If no response is received within one month of circulation of the proposed
changes, agreement will be assumed.PROCESS FOR MAKING CHANGES IN WG1 QUALITY
SYSTEM PROCEDURES
Author: C. M.
Jackson
Date : 2006/01/24
Version : 2.1
Authorized :
JCTLM Executive
JCTLM WG1-
P-07
6/10
7.7.4.   All changes for which unanimous consent is expressed will be made and the
changed documents submitted to the members of JCTLM working group for their
review and consent. 
7.7.4.1.   If no response is received within one month of circulation of the proposed
changes, agreement will be assumed.
7.7.5.  Any changes for which consensus is not obtained by electronic communication
will be discussed and consensus obtained at a WG1 meeting prior to the changes
put into effect.
Procedure for Evaluating, Adopting and Implementing Changes 
7.7.6.  Criteria employed in evaluating the proposed changes are as follows:
7.7.6.1.   Is the proposed change inconsistent with the mission of the JCTLM as
presented in the JCTLM Declaration of Cooperation 
7.7.6.2.  Would the change be incompatible with any ISO or other standard adopted
by JCTLM?
7.7.6.3.  Would the change alter the JCTLM review process to make it less
transparent?
7.7.6.4.  Would the change be likely to alter prior decisions and thus provoke re-
examination of earlier decisions to list or not list CRMs or RMM/Ps?
7.7.6.4.1.  If changes would alter prior decisions, the drafting of a “brief
report” that will address the consequences of such changes will be
initiated.
7.7.7.  The WG1 Quality System Procedures Team Leader will present proposed
substantive changes for discussion by the JCTLM WG1 at a general meeting of
WG1.
7.7.7.1.   Proposed changes will be discussed to obtain consensus regarding the
importance, appropriateness and impact of the changes should they be made
and a recommendation for the date for implementation. 
7.7.7.2.  Changes recommended by the consensus process will be forwarded by the
JCTLM Secretariat to the Executive for approval.
7.7.7.3.  All processed Change Request Forms will be kept by the Secretariat for
future reference.
7.7.7.4.  Date of implementation of changes will be specified by the JCTLM
Executive, but will normally not precede the next cycle for solicitation,
nomination and review by WG1RTs.
7.7.7.4.1.  Secretariat will post notice of change to the affected procedure and
the date of implementation on the JCTLM website.
7.7.8.  WG1RTs will be informed by their RTLs of the changes and the possible
effects of the changes on post-adoption reviewing of nominated CRMs and
RMM/Ps. PROCESS FOR MAKING CHANGES IN WG1 QUALITY
SYSTEM PROCEDURES
Author: C. M.
Jackson
Date : 2006/01/24
Version : 2.1
Authorized :
JCTLM Executive
JCTLM WG1-
P-07
7/10
7.7.8.1.   The consequences of the changes for any given RT will be discussed by
general email communication or by conference call between the RTL and
RT members.  This mechanism will be used as training for RT members. 
8.  Related documents
JCTLM Preamble Website: http://www.bipm.org/utils/en/pdf/Preamble.pdf
JCTLM WG1-P-00 Quality Policy and Definitions
JCTLM WG1-P-01 Outline of JCTLM Procedures for Evaluating Certified Reference
Materials and Reference Measurement Methods/Procedures to be
Listed As Being of Higher Metrological Order 
JCTLM WG1-P-02 Process for Requesting and Accepting Nominations for Certified
Reference Materials (CRMs) and Reference Measurement
Methods/Procedures (RMM/Ps)
JCTLM WG1-P-03 Process for Review and Approval of Nominated Certified
Reference Materials (CRMs) and Reference Measurement
Methods/Procedures (RMM/Ps)
JCTLM WG1-P-04A Process for Comparing Certified Values of the Same Measurand in
Multiple Certified Reference Materials (CRMs)
JCTLM WG1-P-04B Process for the Demonstration of the Extent of Equivalence of
Multiple Reference Measurement Methods/Procedures (RMM/Ps)
for the Same Nominal Measurand
JCTLM WG1-P-05 Process for Consensus Review of Recommendations from WG1
Review Teams and Communicating the Recommendations to the
JCTLM Secretariat
JCTLM WG1-P-06 Application, Nomination and Approval for Membership on WG1
Review Teams 
JCTLM WG1-P-08 Process for Creating, Restructuring and Retiring WG1 Review
Teams 
JCTLM WG1-P-09 Process for Appealing Decisions of the JCTLM Executive
9.  Attachments
JCTLM WG1 Procedure Change Request Form, WG1-P-07-F-01
10.  Revision History
Version number Date of
Issue/Review
Summary of change
1.0 11/15/2005 Initial draft of  JCTLM Change Control ProcedurePROCESS FOR MAKING CHANGES IN WG1 QUALITY
SYSTEM PROCEDURES
Author: C. M.
Jackson
Date : 2006/01/24
Version : 2.1
Authorized :
JCTLM Executive
JCTLM WG1-
P-07
8/10
2.1 24/01/2006 Minor text correctionsPROCESS FOR MAKING CHANGES IN WG1 QUALITY
SYSTEM PROCEDURES
Author: C. M.
Jackson
Date : 2006/01/24
Version : 2.1
Authorized :
JCTLM Executive
JCTLM WG1-
P-07
9/10
11.  Flowchart
PROCESS FOR MAKING CHANGES IN
WG1 QUALITY SYSTEM PROCEDURES
WG1-P-07
Form Transferred to
WG1 Quality System Team for
Review & Recommendations
Submit Change to WG1RTs for Circulation and
Comment before Annual WG1 Meeting
(by Email, FAX, etc.)
Is Change
Consistent with JCTLM Mission
and Concordant with Normative
Standards?
Recommend Change(s) Be Made by WG1 QS
RTL and Revised Procedure Presented to WG1
WG1-P-05
Is Change
Acceptable?
No
Yes
WG1 Chair(s) Receive Change
Form
Does Change
Clarify or Improve
Process?
WG1 Quality System Team
Revises Proposed Change
Can
Change be
Improved?
Yes
Yes
No
No
Yes
No
Recommend Change Not Be Made
WG1-P-05
Revised procedure documents are transferred according to
WG1-P-05 to the Secretariat for posting on the JCTLM WebsitePROCESS FOR MAKING CHANGES IN WG1 QUALITY
SYSTEM PROCEDURES
Author: C. M.
Jackson
Date : 2006/01/24
Version : 2.1
Authorized :
JCTLM Executive
JCTLM WG1-
P-07
10/10
Attachment 1 JCTLM WG1 Procedure Change Request Form

1/10 PROCESS FOR MAKING CHANGES IN WG1 QUALITY

http://www.bipm.org/utils/en/pdf/WG1-P-07.pdf

1/10 PROCESS FOR MAKING CHANGES IN WG1 QUALITY

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