Number range CHAPTER

*Draft*

Standard Administrative Procedures

July 1996

Please submit comments and suggestions to:

Georgia L. Harris

NIST Office of Weights and Measures

Bldg 820, Rm 232

Gaithersburg, MD 20899

FAX: 301/926-0647

Acknowledgment:

The NIST Office of Weights and Measures expresses appreciation to the
State of Minnesota for providing copies of its Standard Administrative
Procedures and Standard Laboratory Procedures.

**Table of Contents**

Standard Administrative Procedure 1\
Protection of Client Confidentiality and Proprietary Rights 1

> Figure 1 SAP 1 Flowchart 2

Standard Administrative Procedure 2\
Impartial Service 3

Standard Administrative Procedure 3\
Contract Review 4

> Figure 2 SAP 3 Flowchart 5

Standard Administrative Procedure 4\
Handling Calibration and Test Items 6

> Figure 3 SAP 4 Flowchart 8

Standard Administrative Procedure 5\
Scheduling 10

> Figure 4 SAP 5 Flowchart 14

Standard Administrative Procedure 6\
Document Control 15

> Figure 5 SAP 6 Flowchart 18
>
> Form 1 Document Review 19

Standard Administrative Procedure 7\
Data Management 20

Standard Administrative Procedure 8\
Preparation of Calibration and Test Reports 23

Standard Administrative Procedure 9\
Audits and Reviews 28

> Table 1 Audit Summary 32

Standard Administrative Procedure 10\
Software Quality Assurance 33

Standard Administrative Procedure 11Purchase and Evaluation of Supplies
and Services 37

> Form 3 Supplier Evaluation 39
>
> Form 4 List of Acceptable Suppliers 40

Standard Administrative Procedure 12\
Corrective Action and Complaint Resolution 41

> Figure 6 SAP 12 Flowchart 45

Standard Administrative Procedure 13\
Laboratory Maintenance 46

Standard Administrative Procedure 14\
Laboratory and Data Security 49

Standard Administrative Procedure 15\
Departure from Documented Policies and Procedures 53

> Form 5 Deviation Request Form 54

Standard Administrative Procedure 16\
Staff Training 55

Standard Administrative Procedure 17\
Recall Procedure 58

> Figure 7 SAP 17 Flowchart 60

**Standard Administrative Procedure 1**

**Protection of Client Confidentiality and Proprietary Rights**

1.  **Introduction**

This is the laboratory procedure for protection of client
confidentiality and proprietary rights. The laboratory will use the
system outlined in this standard administrative procedure to protect
client confidentiality and proprietary rights to the extent allowed by
law. All laboratory data and records are considered official public
record according to State Statute. The laboratory will not release
records except in accordance with official request procedures.

2.  **Purpose**

Protection of client confidentiality and proprietary rights is an
accreditation requirement as well as a legal concern; however, legal
requirements take precedence over accreditation criteria.

3.  **Responsibility and Authority**

The Laboratory Supervisor has direct responsibility to ensure that 1)
all requests for client information (other than requests from the
client) are presented properly in writing and 2) reports or other
information are not disseminated without following procedures described
here with proper authorization given.

4.  **Operations**

    1.  The following information is considered confidential or
        proprietary and will not be released without proper request and
        authorization:

        1.  information regarding submission of specific test items for
            calibration or numbers of items submitted;

        2.  test artifact condition of receipt, test or calibration data
            and results, calibration or test reports, or any adjustment
            data;

        3.  proprietary artifact design information;

        4.  client names, addresses, and contacts; and

        5.  any other questionable information or data issued to a
            specific client.

    2.  All telephone, facsimile, or e-mail requests for information
        listed in this procedure as confidential or proprietary will be
        refused. Requestor will be asked to present his request in
        writing, on official letterhead of the organization making the
        request, to the director stating specific questions or requests
        along with reason or justification for such requests.

    3.  Formal requests will be given to the Division legal staff for
        review against State requirements. A status letter will be sent
        to the requestor pending legal review.

        1.  An official letter of denial from the director will be sent
            to the requestor in the event that requests do not meet
            State requirements.

        2.  SEQ WPCAPTION \\\* MERGEFORMAT **SAP 1 Flowchart**An
            official letter from the director detailing the requested
            information will be sent to the requestor by certified mail,
            return receipt requested, along with any required copies of
            laboratory records if the request meets State requirements.

**Standard Administrative Procedure 2**

**Impartial Service**

1.  **Introduction**

This is the laboratory policy/procedure to ensure that clients received
impartial service. The laboratory will follow the policies outlined in
this standard administrative procedure to ensure that all clients
receive fair and equal treatment.

2.  **Purpose**

The laboratory is a government agency entrusted with public service
responsibilities. It is of the utmost importance to deliver fair,
unbiased, impartial service to calibration clients to ensure that the
integrity of the laboratory remains unquestioned.

3.  **Responsibility and Authority**

The Laboratory Supervisor will ensure that all procedures and process
used in the laboratory accord fair and equitable treatment to all
clients.

4.  **Operations**

    1.  The following policy guidelines and procedures will be strictly
        adhered to:

        1.  All submissions for test and calibration will be received
            and logged according to the laboratory handling and tracking
            procedure and scheduling procedure.

        2.  Calibration items will not receive preferential treatment
            with regard to customer status, calibration type, schedule,
            or fees charged of the customer, except as noted in the
            scheduling procedure.

        3.  Laboratory staff may not accept gratuities, gifts, or other
            special treatment in lieu of modifying laboratory policies.

    2.  All other State policies regarding laboratory operation with
        regarding to maintaining an unbiased position will be
        highlighted in a policy handbook as available.

**Standard Administrative Procedure 3**

**Contract Review**

1.  **Introduction**

This is the laboratory procedure for contract review. The laboratory
will follow this standard administrative procedure to ensure that
requests for test and calibration are properly documented by the
customer and that the laboratory delivers the expected calibration and
report.

2.  **Purpose**

Laboratory customers expect a given service when they request a test or
calibration and often use language that is unclear as to the specific
test or calibration they are requesting.

Laboratory staff must evaluate each request for calibration to ensure
that the proper standards, equipment, and trained staff perform the test
or calibration. Laboratory staff must also prepare specific reports
based on customer requests and needs.

3.  **Responsibility and Authority**

    1.  The laboratory technical manager or trained metrologist will
        ensure the following, in consultation with the customer as
        needed:

        1.  evaluate each request for calibration to ensure that it is
            properly documented;

        2.  assign specific staff to use specific procedures that will
            clearly identify standards and equipment; and

        3.  determine the appropriate type of report for the test or
            calibration.

    2.  The laboratory quality manager will randomly review the
        paperwork for the contract review process to ensure that these
        steps are being followed by the technical manager and by
        technical staff assigned to the test or calibration.
        Discrepancies will be detailed according to SAP 7 on Audits and
        Reviews.

4.  **Operations**

    1.  The laboratory receives requests for calibration in writing
        (often through a purchase order), by telephone, or by submission
        of test/calibration items without accompanying paperwork.

    2.  Laboratory staff review the request and complete a laboratory
        work order according to SAP 4, Handling Calibration and Test
        Items. The form indicates whether appropriate paperwork was
        submitted. If appropriate paperwork was not submitted, staff
        indicate whether this is a repeat calibration which the customer
        was satisfied with or if the customer was contacted directly (by
        telephone, facsimile, e-mail, or mail) to agree to the type of
        test that will be conducted.

    3.  The laboratory quality manager will randomly select work orders
        during technical audits to ensure that proper contract review
        has been completed.

SEQ WPCAPTION \\\* MERGEFORMAT **SAP 3 Flowchart**

**Standard Administrative Procedure 4**

**Handling Calibration and Test Items**

1.  **Introduction**

This procedure describes the management and tracking of artifacts
submitted for calibration. A laboratory log documents the assigned work
order number, status and location of each artifact, or group of
artifacts. Each artifact, or group of artifacts, is assigned a work
order which is circulated with the artifact during its stay in the
laboratory.

2.  **Purpose**

The handling and tracking system will ensure that services are provided
on schedule, allow the metrology laboratory staff to provide customers
with up-to-date information on the status of artifacts and help prevent
loss, accidental damage, incorrect return of artifacts, or theft of
artifacts.

3.  **Responsibility and Authority**

Trained metrology staff manage the tracking system. Metrology laboratory
staff provide accurate tracking information by making entries in the
laboratory log, and completing and attaching work orders to all
artifacts, or groups of artifacts. All entries are sufficiently detailed
so that anyone with familiarity with the laboratory operation can
evaluate the identification and calibration status of any customer item.

4.  **Operations**

    1.  Artifacts are submitted and received.

> Customers and Weights and Measures Division Investigators submit
> artifacts for calibration. The artifacts are received, logged, stored,
> calibrated, and returned according to the following procedures:

1.  All artifacts are tracked through the laboratory log. The log
    contains the following information about each artifact, or group of
    artifacts, submitted for calibration:

    1.  State test number(s) assigned to this artifact or group of
        artifacts;

    2.  Name of the company or individual, contact, address and phone
        number;

    3.  Source (i.e. whether the artifacts were submitted by the Weights
        and Measures Division, a registered placing-in-service agent, or
        other customer);

    4.  Description of the artifacts that includes the following
        information:

        1.  Quantity included in the group of artifacts;

        2.  Denominations, values, or range of values of the artifacts;

        3.  Manufacturer of the artifacts;

        4.  Any flaws, damage, or irregularities noticed when the
            artifacts were received.

    5.  Additional descriptive information (if needed). Additional
        information must be written on an attachment that includes the
        state test number. The attachment must be stapled to the log;

    6.  Location where the artifacts are stored;

    7.  Date the artifacts were received from the customer, and the
        initials of the receiving metrologist;

    8.  Calibration date, and the initials of the calibrating
        metrologist;

    9.  Date the artifacts were shipped or returned to the customer, and
        the initials of the metrologist who shipped or returned them.

    10. The receiving metrologist assigns a state test number, and
        enters the number into the laboratory log under the heading
        "State Test Number."

        1.  The state test number is taken from one of the pre-numbered
            inspection report forms issued to the metrology laboratory
            by the Weights and Measures Division Billing Clerk.

        2.  The pre-numbered inspection report form is placed in the
            vertical wall file in the metrology laboratory office. The
            slots in the wall file correspond to storage locations A, B,
            C, and D.

    11. The metrologist completes a work order and attaches it to the
        artifact or group of artifacts.

    12. The metrologist enters the customer identity and description of
        the artifacts into the laboratory log under the headings
        "submitted by", "source", and "description".

    13. The metrologist places the artifacts in a secure storage area
        (A, B, C, or D) and notes the location in the laboratory log
        (see Section 4.1.1.5) under "storage location".

    14. The metrologist checks the vertical wall file in the metrology
        laboratory office to ensure that the pre-numbered inspection
        report was placed in the slot that corresponds to the storage
        location.

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2.  Artifacts are stored.

> The metrology laboratory has four storage areas designated as A, B, C,
> and D. Areas A, B, and C are subdivided into numbered locations.
> Artifacts are assigned to these shelves. Artifact storage locations
> (letter and number) are recorded in the laboratory log.

1.  Storage area A is located in the small mass laboratory.

2.  Storage area B is located in the large mass laboratory.

3.  Storage area C is located in the small volume laboratory.

4.  Storage area D is located in the large volume laboratory.

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3.  Artifacts are calibrated.

    1.  A metrologist checks the work schedule to find the next
        assignment. The metrologist removes the artifacts from storage
        (if the artifacts are stored in storage area A, B, or C, the
        metrologist takes an "In Calibration" marker and places it in
        the position where the artifacts were stored). The metrologist
        proceeds to the calibration process.

    2.  Upon completing calibration, the metrologist notes the
        calibration date, and the metrologist's initials, in the
        laboratory log under the heading "Tested".

    3.  The metrologist returns the artifacts to the storage area from
        which they were taken (and, in the case of storage areas A, B,
        and C, places the "In Calibration" marker on the cabinet door).

    4.  The metrologist completes all of the test documentation,
        including the pre-numbered inspection report, and gives the
        documents to the Technical Manager for review.

    5.  The Technical Manager reviews and signs the calibration report
        if it is complete and correct.

    6.  The metrologist forwards the calibration report to
        administrative staff for copying, filing, customer notification,
        and shipping.

4.  Artifacts are returned to the customers

    1.  Metrology staff arrange shipping or return of the artifacts.

    2.  Artifacts are removed from storage at the time they are shipped
        or returned to the customer's representative.

    3.  The metrologist who supervises shipping of the artifacts enters
        and initials the date in the laboratory log under the heading
        "Returned".

5.  Multiple delivery dates

> In some cases, a single customer may submit several artifacts, or
> groups of artifacts, as part of one large calibration project that may
> extend over several days. A single state test number is assigned to
> all of the artifacts received as part of the project, unless there are
> more artifacts than lines on the numbered report. In that case
> additional numbered reports may be used.

1.  As each artifact in the project is calibrated, the calibrating
    metrologist will:

    1.  Return the completed artifact to its original storage location;

    2.  Complete a test report for the artifacts calibrated in each
        phase of the project;

    3.  Give the original calibration report to the Technical Manager
        for review;

    4.  Update the laboratory log as each phase of the project is
        completed.

2.  As each phase of the project is completed, the metrologist consults
    the original work order specifications and:

    1.  Ships or returns the calibrated articles to the customer; or,

    2.  Holds the calibrated artifacts until the entire project is
        completed.

SEQ WPCAPTION \\\* MERGEFORMAT **SAP 4 Flowchart**

**Standard Administrative Procedure 5**

**Scheduling**

1.  **Introduction**

This is the metrology laboratory policy and procedure for scheduling
tests. The metrologists maintain a work schedule that accommodates work
requests from customers, allows sufficient time for standards
surveillance and instrument monitoring, and provides annual calibration
for the standards and equipment used by the Weights and Measures
Division field staff.

2.  **Purpose**

Effective scheduling is necessary to ensure efficient use of the
metrology staff and laboratory resources. Effective scheduling of the
laboratory workload provides timely service to customers, and ensures
that the laboratory staff will have sufficient time for instrument
monitoring and laboratory standards surveillance. Effective scheduling
promotes good measurement services, and reduces unnecessary deadline
pressures that may lead to safety problems and shortcuts in procedures.

3.  **Responsibility and Authority**

All metrologists have responsibility for scheduling work and are
authorized to accept and schedule work orders within the parameters set
by this policy. The Laboratory Supervisor has the authority to change
the work schedule upon consultation with laboratory staff as needed.

4.  **Operations**

    1.  Service Goal

> The metrology laboratory will attempt to schedule all work requests so
> that the work can be completed within 15 days once the artifacts are
> received.

2.  Desk calendar (laboratory may implement 4.2 or 4.3 or both)

> A desk/wall calendar is maintained as the primary instrument for
> accepting and scheduling work orders. The calendar is available to
> staff members at all times.

3.  Electronic calendar

> The metrologists will update, maintain and print an electronic
> calendar that is posted for all staff to use. The electronic calendar
> is an instrument for recording whether a work order is received, and
> when the order is completed.

4.  Scheduling

    1.  Customer work requests received via telephone. The metrologist
        who receives a work request by telephone must:

        1.  Check the desk calendar to find the available dates and
            times;

        2.  Determine the nature of the work request and the amount of
            time required;

        3.  Discuss the available dates and times with the customer and
            set a mutually agreeable date and time;

        4.  Enter the work order on the desk calendar at the agreed upon
            date.

    2.  Customer work requests received by fax or mail. The metrologist
        who receives a work request by fax or mail must:

        1.  Check the desk calendar to find the available dates and
            times;

        2.  Determine the nature of the work request and the amount of
            time required. If the request is not clear, the metrologist
            must call the customer and request additional information;

        3.  Enter the work order on the desk calendar;

        4.  Notify the customer by telephone, fax or mail. The notice to
            the customer must include the date that the work will be
            completed.

    3.  Internal surveillance and monitoring. The Quality Manager, with
        the Laboratory Supervisor, must schedule surveillance and
        monitoring on the following:

        1.  Standards;

        2.  Processes;

        3.  Equipment;

        4.  Round robins.

    4.  Weights and Measures Division field equipment. The metrologists
        schedule calibration services for Weights and Measures Division
        field equipment.

        1.  In the first week of each month, the metrologist identifies
            Weights and Measures Division field inspectors who have
            equipment that was calibrated 11 months earlier.

        2.  The metrologist contacts the appropriate Regional Supervisor
            and sets a calibration date for the inspectors. The date
            must be set to ensure that the field equipment will be
            calibrated within 12 months of the previous calibration
            date.

        3.  The metrologist asks the appropriate Regional Supervisor to
            notify the inspectors of the equipment calibration date.

5.  Project Status

> The metrologists transfer data from the desk calendar to the
> electronic calendar. The log sheet is used to inform the metrology
> laboratory staff about the status of all work requests, including
> arrival date, test date and departure date of artifact(s). The
> electronic calendar is used to:

1.  Indicate that a work assignment has been completed;

2.  Indicate when a work order has not been delivered to the metrology
    laboratory on time.

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6.  Work order information

    1.  Customer work orders

> Each customer work order received and listed on the calendar must
> include the following information. The information must be obtained
> from the customer and entered on the desk calendar:

1.  Company Name;

2.  Contact Person;

3.  Telephone Number;

4.  Description of items to be calibrated:

    1.  Denominations;

    2.  Quantity;

    3.  Class (weights);

    4.  Descriptive information.

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2.  Surveillance and monitoring

> Each standards surveillance or instrument monitoring project listed on
> the calendar must include the description of work to be performed.

3.  Weights and Measures Division field equipment

> Each Weights and Measures Division field equipment calibration project
> listed on the calendar must include the following information:

1.  Inspector to whom the equipment is assigned.

2.  Description of the items to be calibrated.

    1.  Denominations;

    2.  Quantity;

    3.  Class (weights);

    4.  Descriptive information.

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7.  Scheduling priority

> The Laboratory, as required by State Statutes, Section xxx.xx provides
> calibration services to all companies and individuals that request
> services. When sufficient staff time is available to complete all work
> requests, the requests will be placed on the schedule in the order in
> which they were received. Occasionally, a large volume of work
> requests are received, and sufficient staff time may not be available
> to complete work on all of the requests within 15 days. In these
> cases, the metrologists follow this order of priority to prevent
> scheduling conflicts:

1.  Standards surveillance and instrument monitoring projects.

2.  Requests for emergency service, where a company must receive
    calibration services in order to:

    1.  Fulfill a requirement for a contract with a government agency or
        with another company;

    2.  Meet requirements to market a product or service;

3.  Weights and Measures Division field equipment that is due for
    calibration (i.e. last calibration was 12 months previous).

4.  Field equipment, operated by a registered placing-in-service agent,
    that is due for calibration (i.e. last calibration was 12 months
    previous).

5.  All other scheduled work requests.

6.  All work received without an scheduled appointment.

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8.  Unscheduled work requests

> The Metrology Laboratory will occasionally receive work orders that
> have not been scheduled. The metrologists place these work orders on
> the schedule calendar at the earliest possible date, without delaying
> the completion of scheduled work orders. When the unscheduled work is
> completed, the metrologists notify the company or person by telephone
> to point out that better service and faster turn-around times are
> available if work is scheduled in advance.

SEQ WPCAPTION \\\* MERGEFORMAT **SAP 5 Flowchart**

**Standard Administrative Procedure 6**

**Document Control**

1.  **Introduction**

This is the metrology laboratory procedure for document control.
Controlled documents include:

1.  Standard administrative procedures;

2.  Good laboratory procedures;

3.  Good measurement practices;

4.  Standard operating procedures;

5.  Statistical process control charts;

6.  All data collection forms and reporting forms are controlled by
    their inclusion in the standard procedures and charts listed in 1.1
    above.

NOTE: The document control of the laboratory quality manual is integral
to the quality manual. Items identified above that are included in NIST
Handbook 145 are not part of the laboratory document control system
except as modified by the laboratory.

2.  **Purpose**

The metrology laboratory controls documents to ensure that the
laboratory has uniform and consistent procedures for all calibrations
and tests performed in the laboratory, laboratory staff consistently use
the correct procedures to perform calibrations and tests and that
reports sent to customers are uniformly clear, consistent, and
understandable.

3.  **Responsibility and Authority**

Responsibility and authority for document review and control are
distributed according to the type of document. Following, are the
categories of documents that must be reviewed and signed, and the names
and titles of the responsible persons:

1.  Standard administrative procedures must be reviewed by the
    Laboratory Supervisor;

2.  Good laboratory practices, good measurement practices, standard
    operating procedures and associated forms must be reviewed and
    signed by the Technical Manager of the metrology laboratory;

3.  Statistical process control charts and forms must be reviewed and
    signed by the Quality Manager for the metrology laboratory.

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4.  **Operations**

    1.  Document review system

> All documents and forms must be reviewed annually, or more often if a
> need for change is identified by a metrology laboratory staff member.
> The following questions must be addressed and answered for each
> document and form reviewed:

1.  Has the National Institute of Standards and Technology recommended
    any changes to a standard document or form?

2.  Have there been any changes in laboratory equipment which will
    require corresponding changes in a document or form?

3.  Have metrology laboratory staff members suggested any changes to a
    document or form?

4.  Have metrology laboratory customers requested any changes to a
    document or form?

5.  How frequently has the document or form been used in the last year?

6.  Can this document or form be combined with another document or form?

7.  Can this document or form be eliminated?

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2.  Document identification system

> In order to ensure that documents are not changed without review, and
> to ensure that the correct documents are used in the metrology
> laboratory, the following information must be included in each
> document and form:

1.  An accurate descriptive title at the top of each document or form;

2.  An up-to-date revision number, located in the footer at the bottom
    of each document or form;

3.  The date that the document was last revised, located in the footer
    at the bottom of each document or form;

4.  A unique form number, located in the footer at the bottom of each
    document.

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3.  Document review and revision process

    1.  Annual review.

        1.  Each controlled document and form must be reviewed each
            year.

        2.  For the annual review process, the Laboratory Supervisor or
            designee will:

            1.  Schedule the document and form review sessions;

            2.  Schedule the calibration and testing workload to ensure
                that the staff will have sufficient time to complete the
                review process;

            3.  In May of each year, notify the metrology laboratory
                staff of dates for the upcoming review sessions in July;

            4.  Schedule staff leave requests to ensure that the entire
                metrology laboratory staff will be present for the
                review sessions.

        3.  Each controlled document will be reviewed according to the
            criteria in paragraph 4.1, above.

        4.  If the staff agree that a change is needed, the Laboratory
            Supervisor directs the person responsible for the document
            (see paragraphs 3.1 through 3.4 above) to prepare a draft of
            the document or form, including the suggested change, for
            the next weekly staff meeting.

        5.  The Laboratory Supervisor implements the document and
            removes all previous revisions after the following criteria
            have been met:

            1.  If the draft meets all of the criteria in sections 4.1
                and 4.2 above;

            2.  If the staff agree to accept the draft;

            3.  When the person responsible for the document (see
                paragraphs 3.1 through 3.4 above) has signed and
                approved the document.

    2.  Intermediate reviews.

        1.  Any controlled document or form may be reviewed during any
            weekly meeting of the metrology laboratory staff.

        2.  The Laboratory Supervisor will ask the laboratory staff, at
            each staff meeting, if anyone has discovered a problem or
            need for change in any controlled document or form.

        3.  If the staff agree that a change is needed, the Laboratory
            Supervisor directs the person responsible for the document
            (see paragraphs 3.1 through 3.4 above) to prepare a draft of
            the document or form, including the suggested change, for
            the next weekly staff meeting.

        4.  The Laboratory Supervisor implements the document and
            removes all previous revisions after the following criteria
            have been met:

            1.  If the draft meets all of the criteria in sections 4.1
                and 4.2 above

            2.  If the staff agree to accept the draft

            3.  When the person responsible for the document (see
                paragraphs 3.1 through 3.4 above) has signed and
                approved the document

4.  Implementing revised documents

> To implement revised versions of controlled documents and forms, the
> Laboratory Supervisor:

1.  Places the revised document, including any forms that are part of
    the document, in the appropriate laboratory manual;

2.  Removes the complete previous revision of the document from the
    laboratory manual and any other locations where documents may be
    used;

3.  Stores the previous revision in the document archive;

4.  Provides a supply of revised data collection or reporting forms for
    use in the metrology laboratory;

5.  Removes and recycles the existing supply of the previous revision of
    the form.

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5.  Document archive

    1.  The Laboratory Supervisor maintains an archive of all previous
        revisions of controlled documents and forms filed in the
        following order:

        1.  By form number;

        2.  By revision level for each form number.

    2.  The Laboratory Supervisor will maintain the controlled document
        and form archive indefinitely.

**SEQ WPCAPTION \\\* MERGEFORMAT SAP 6 Flowchart**

Form 1 Document Review

+-----------------------------------------------------------------------+
| **Document Review**                                                   |
+-----------------------------------------------------------------------+
| Date:                                                                 |
+-----------------------------------------------------------------------+
| Document Title:                                                       |
+-----------------------------------------------------------------------+
| Document Number:                                                      |
+-----------------------------------------------------------------------+
| **Review Questions:**                                                 |
+-----------------------------------------------------------------------+
| 1\. Has the National Institute of Standards and Technology            |
| recommended any changes to a standard document or form? Yes No        |
+-----------------------------------------------------------------------+
| 2\. Have there been any changes in laboratory equipment which will    |
| require corresponding changes in a document or form? Yes No           |
+-----------------------------------------------------------------------+
| Explain if yes                                                        |
+-----------------------------------------------------------------------+
|                                                                       |
+-----------------------------------------------------------------------+
| 3\. Have metrology laboratory staff members suggested any changes to  |
| a document or form?                                                   |
|                                                                       |
| Yes No                                                                |
+-----------------------------------------------------------------------+
| Explain if yes                                                        |
+-----------------------------------------------------------------------+
|                                                                       |
+-----------------------------------------------------------------------+
| 4\. Have metrology laboratory customers requested any changes to a    |
| document or form?                                                     |
|                                                                       |
| Yes No                                                                |
+-----------------------------------------------------------------------+
| Explain if yes                                                        |
+-----------------------------------------------------------------------+
|                                                                       |
+-----------------------------------------------------------------------+
| 5\. How frequently has the document or form been used in the last     |
| year?                                                                 |
+-----------------------------------------------------------------------+
| 6\. Can this document or form be combined with another document or    |
| form? Yes No                                                          |
+-----------------------------------------------------------------------+
| Explain if yes                                                        |
+-----------------------------------------------------------------------+
| 7\. Can this document or form be eliminated? Yes No                   |
+-----------------------------------------------------------------------+
| 8\. Do staff agree on the need for a change? Yes No                   |
+-----------------------------------------------------------------------+
| Staff assigned if yes:                                                |
+-----------------------------------------------------------------------+
| Revision date of approval/implementation per section 4.4:             |
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**Standard Administrative Procedure 7**

**Data Management**

1.  **Introduction**

This is the metrology laboratory policy for data management. The
metrology laboratory will use the data management system outlined in
this SAP to maintain records of standards control, process control and
quality control, and of the calibrations and tests performed by the
laboratory. The data management system includes filed paper copies of
documents and digital information stored on a computer hard disk drive.
All records are secured.

2.  **Purpose**

Proper data management aids in maintaining quality standards, managing
customer records, and scheduling metrology laboratory operations.

3.  **Responsibility and Authority**

    1.  The Laboratory Supervisor will review and maintain:

        1.  Work order records;

        2.  Standard Administrative Procedures (SAPs);

        3.  Instrument status records;

        4.  Training records;

        5.  Artifact and calibration records;

        6.  Scheduling calendars and records;

        7.  A file of customer complaints received by the metrology
            laboratory.

    2.  The Technical Manager will review and maintain:

        1.  SOPs and Round Robin records;

        2.  GLPs and GMPs;

        3.  Statistical Process Control Charts.

    3.  The Quality Manager will review:

        1.  SOPs;

        2.  and maintain all audit records and Statistical Process
            Control Charts.

    4.  The Weights and Measures Division MIS Coordinator (or suitably
        trained metrologist) will:

        1.  Assist the metrology laboratory staff in the design,
            installation, and maintenance of the computerized records
            system;

        2.  Perform regular backups of metrology laboratory records and
            data, and ensure safe storage of backup tapes;

        3.  Restore files from tape as requested by metrology laboratory
            staff.

    5.  Metrology Laboratory Staff will perform routine filing tasks and
        update computerized records as directed by the Technical
        Manager, the Laboratory Supervisor, or the Quality Manager.

4.  **Operations**

    1.  Files \-- Paper Copies.

        1.  The metrology laboratory maintains paper copies of:

> Quality System Manual
>
> Operations Manual
>
> Standard Administrative Procedures
>
> Standard Operating Procedures
>
> Standard Laboratory Practices
>
> Calibration Data
>
> State Test Reports
>
> Laboratory Log
>
> Statistical Process Control Data

2.  These records are kept in controlled file drawers that can be
    accessed only by metrology laboratory staff, and the Weights and
    Measures Division Director.

3.  Records will be kept for a minimum of seven years unless otherwise
    noted in the appropriate SAP.

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2.  Files \-- Computer Hard Disk Drive.

    1.  The metrology laboratory maintains electronic copies of:

> Quality System Manual
>
> Operations Manual
>
> Standard Administrative Procedures
>
> Standard Operating Procedures
>
> Standard Laboratory Practices
>
> Calibration Reports
>
> State Test Reports
>
> Statistical Process Control Data

2.  The electronic records are maintained on a hard disk drive that can
    be accessed only by the metrology laboratory staff, the MIS
    Coordinator, and the Weights and Measures Division Director.

3.  Formats follow accepted templates. Templates use:

    1.  Times New Roman (12 pt) for body text, unless otherwise noted in
        the corresponding SAP;

    2.  Times New Roman (14 pt) and Times New Roman (16 pt) for title
        text;

    3.  Times New Roman (10 pt) for footers and pagination.

4.  Monday through Friday of each week, the MIS Coordinator performs a
    hard disk drive backup to tape. The tapes are stored by the MIS
    Coordinator. If the MIS coordinator is absent, the backup is
    performed by the Weights and Measures Division Director.

**Standard Administrative Procedure 8**

**Preparation of Calibration and Test Reports**

1.  **Introduction**

This is the Metrology Laboratory procedure for preparing calibration
reports and test reports. Test reports are the only permanent written
records of the services provided by metrology laboratory. To the
customer, test reports represent the services they receive. It is
imperative that these items satisfy customer needs and expectations, and
reflect the high quality of service provided by the metrology
laboratory.

2.  **Purpose**

In order to provide uniform and understandable information to the
customer, the content of the test reports produced by the metrology
laboratory must comply with ANSI/NCSL Z540-1-1994 (ISO/IEC Guide 25).
They must be prepared with care to ensure that they accurately convey
all information pertaining to the calibration or test. Carefully
prepared test reports must contain all the necessary information to
justify the test results. The test report must be generated from the
information collected on standardized data sheets specific to each SOP.
The calibration report may include narrative information for special
calibrations.

3.  **Responsibility and authority**

The Technical Manager has primary responsibility for the content and
accuracy of calibration and test reports. The Quality Manager is
responsible for ensuring that the reports comply with the metrology
laboratory quality system and with ANSI/NCSL Z540-1-1994 (ISO/IEC Guide
25). The Technical Manager has authority to edit and modify all reports.

4.  **Operations**

Each calibration report or report of test must contain essential
information about the metrology laboratory, the customer, and the
calibrations or tests performed by the metrology laboratory.

1.  Required test report contents:

    1.  The report title, as follows:

        1.  "Calibration Report\"; or,

        2.  "Report of Test\".

    2.  The name and address of the metrology laboratory, as follows:

    3.  Customer identification and contact information:

        1.  Name;

        2.  Address;

        3.  Contact person (if the customer gives a contact name);

        4.  Telephone number;

        5.  Purchase order number (if the customer gives a number).

    4.  Description and unambiguous identification of the artifacts to
        be calibrated:

        1.  Model number (if a model number is available);

        2.  Serial number (if a serial number is available);

        3.  Manufacturer name (if a name is available).

    5.  Characterization and condition of the artifacts:

        1.  Poor - the artifact displays very significant wear or other
            degradation that will greatly reduce effectiveness as a
            standard;

        2.  Fair - the artifact displays significant wear or other
            degradation;

        3.  Good - the artifact displays some wear or other degradation;

        4.  Excellent - the artifact displays little wear or other
            degradation;

        5.  New - the artifact displays no wear or other degradation;

        6.  Contaminated - the artifact displays contamination (include
            a description of the contamination);

        7.  Other - include a description of any other condition which
            may effect the integrity of the standard.

    6.  Required dates:

        1.  Date that the artifacts were received;

        2.  Calibration date;

        3.  Date that the report is produced and signed.

    7.  Identification of the operating procedure used for the
        calibration or test:

        1.  The name and number of the Standard Operating Procedure used
            for the calibration or test; or,

        2.  A description of a non-standard operating procedure used for
            the calibration or test. If a non-standard procedure is
            requested by the customer (or required for an unusual
            artifact or instrument) the Technical Manager will establish
            the procedure and confirm acceptance with the client. A
            non-standard procedure will be concisely documented and
            described in the calibration report.

    8.  Deviations from standard methods

> Deviations from, additions to, or exclusions from the standard method
> must be noted on the report.

9.  Test or calibration results

> The Metrology Laboratory does not employ sampling procedures. All
> artifacts submitted by a customer must be calibrated or tested, and
> the results noted on the report.

10. Other relevant information

> Any information, such as an environmental condition relevant to a
> specific calibration, must be noted on the report.

11. Uncertainty

> The report must include an uncertainty statement with the following
> information:

1.  A statement of the estimated expanded uncertainty of the calibration
    result;

2.  The method used to calculate the uncertainty;

3.  The confidence level associated with the calibration result.

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12. Signature

> Reports require two signatures. The metrologist responsible for the
> contents of a report must sign and submit the report to the Technical
> Manager or the Laboratory Supervisor for review. The Technical Manager
> or Laboratory Supervisor must review and sign the report.

13. Test results \-- application restriction

> The report must include a statement that the results apply only to the
> artifacts calibrated.

14. Limitations of use

> If an artifact (a thermometer, for example) is calibrated in only part
> of its range, or if only some artifacts in a group of artifacts (10
> out of 30 weights, for example) are calibrated, the report must
> include a statement that clearly explains that use of the artifact or
> artifacts is limited by the extent of the calibration performed.

15. Reports \-- restriction on reproduction

> The report must include a statement that the report must not be
> reproduced, except in full, without written approval from the
> metrology laboratory.

16. Traceability statement

> The report must include a traceability statement with the following
> information:

1.  The standards to which the calibrated artifacts are traceable;

2.  Information referring to the test number of the standards to which
    the artifacts are traceable (indicating that records are on file);

3.  The calibration or test methods used to ensure that the results are
    traceable.

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17. Accreditation number

> The report must include the metrology laboratory accreditation number
> if available.

2.  Test report design

    1.  Arrangement and presentation of the calibration data must allow
        for ease of use by the client.

    2.  The specific standard report format must be used for each
        calibration procedure.

3.  Typeface and font size

    1.  Test reports must use the Times New Roman typeface, font size
        12.

    2.  Test reports produced using the MASSCODE software program must
        use the Courier W1 typeface.

4.  Test report distribution, storage, and retention

    1.  A copy of the report must be distributed to the customer via
        mail, courier, or in person.

    2.  Each test report must be filed:

        1.  By the calendar year in which the report was produced;

        2.  Alphabetically by customer name within the calendar year
            group.

    3.  An original, signed, paper copy of each test report must be
        retained for a minimum of seven years.

5.  Corrections or amendments to reports

    1.  A report shall not be considered to have been issued, until it
        has left the metrology laboratory. Any change to a report before
        it leaves the laboratory will not be considered an amendment.

    2.  A report may be modified to correct a recorded error, omission,
        or action by the Metrology Laboratory. A report may be modified
        only according to the following criteria and restrictions:

        1.  The verbiage of a report may be corrected if the changes do
            not affect the numerical values provided;

        2.  Incorrect entries from the data sheet may be corrected under
            the Technical Manager's supervision;

        3.  Changes to numeric values are not allowed unless the
            artifacts are recalibrated;

        4.  After a report is corrected:

            1.  The report must be reviewed again by the Technical
                Manager;

            2.  The Technical Manager must send a corrected report to
                the customer;

            3.  The Technical Manager must attach a copy of the
                corrected report to the filed copy of the original
                report.

        5.  The corrections must be noted in the Corrective
            Action/Complaint record.

    3.  Amendments to reports, resulting from requests or changes made
        by the customer, may be made according to the following
        criteria:

        1.  A report may be changed if the technical validity of the
            calibration or test is maintained;

        2.  When a report is amended:

            1.  The report must be reviewed again by the Technical
                Manager;

            2.  The Technical Manager must send the amended report to
                the customer;

            3.  The Technical Manager must attach a copy of the amended
                report to the filed copy of the original report.

        3.  The original contract must be reviewed to determine if the
            contract was correctly followed.

**Standard Administrative Procedure 9**

**Audits and Reviews**

1.  **Introduction**

This is the metrology laboratory procedure for conducting internal
audits, and for cooperating in external audits. This is the only
procedure that the metrology laboratory will use to conduct audits or
cooperate with external auditors.

2.  **Purpose**

The purpose of this procedure is to ensure that the metrology laboratory
maintains a high level of service quality, and a high level of
compliance with laboratory procedures, by conducting regular internal
audits, and by cooperating with external audits, within the limits set
by the procedure.

3.  **Responsibility and authority**

    1.  The Quality Manager is authorized to operate a continuous
        internal audit program.

    2.  The Technical Manager is authorized to:

        1.  Respond to requests from customers for external audits;

        2.  Arrange external audits to be performed, at the discretion
            of the metrology laboratory, by recognized accreditation
            organizations;

        3.  Respond to requests, received through the Weights and
            Measures Division Director, for performance or financial
            audits conducted by the State Legislative Auditor.

4.  **Operations**

    1.  Internal audits

> The Quality Manager will organize and complete periodic and special
> audits as outlined below:

1.  A Quality System Audit will be conducted semiannually.

    1.  The Quality Manager will evaluate the Quality Manual and the
        Standard Administrative Procedures (SAPs) for compliance with
        ISO Guide 25 requirements.

    2.  The Quality Manager will then observe operations to determine
        compliance with the requirements of the Quality Manual and the
        SAPs.

    3.  The Quality Manager will meet with the Technical and Laboratory
        Supervisors to report the findings of the audit.

    4.  The Technical and Laboratory Supervisors will address the
        findings to the Quality Manager's satisfaction, and will
        implement any necessary changes before the next Quality System
        Audit.

    5.  The Quality Manager will make a written report of the audit
        results and distribute copies to the Technical and Laboratory
        Supervisors, and to the Weights and Measures Division Director.
        The Quality Manager will keep a copy of this report on file.

2.  A Technical System Audit will be conducted semiannually in the
    quarters when the Quality System Audit is not conducted.

    1.  The Quality Manager will evaluate the Standard Operating
        Procedures (SOPs) and the Standard Laboratory Procedures (SLPs)
        for compliance with the requirements of NIST Handbook 143, NIST
        Handbook 150, and the laboratory Quality Manual.

    2.  The Quality Manager will then observe operations to determine
        compliance with the requirements outlined in the SOPs and SLPs.

    3.  The Quality Manager will meet with the Technical and Laboratory
        Supervisors to report the findings of the audit.

    4.  The Technical and Laboratory Supervisors will address the
        findings to the Quality Manager's satisfaction, and will
        implement any necessary changes before the next Technical System
        Audit.

    5.  The Quality Manager report the audit results in writing to the
        Technical and Laboratory Supervisors, and to the Weights and
        Measures Division Director. The Quality Manager will maintain a
        copy of this report on file.

3.  A Safety Audit will be conducted annually.

    1.  The Quality Manager with work with the Weights and Measures
        Division Safety Coordinator to evaluate the SOPs, SAPs, and SLPs
        for compliance with safety requirements.

    2.  The Quality Manager and the Safety Coordinator will observe
        operations to determine compliance with the safety procedures
        outlined in the SOPs, SAPs, and SLPs.

    3.  The Quality Manager and the Safety Coordinator will meet with
        the Technical and Laboratory Supervisors to report the findings
        of the audit.

    4.  The Technical and Laboratory Supervisors will address the
        findings to the satisfaction of both the Quality Manager and the
        Safety Coordinator, and will implement any necessary changes
        within a reasonable time limit to be determined by the Safety
        Coordinator.

    5.  The Quality Manager will report the audit results, in writing,
        to the Technical and Laboratory Supervisors, the Safety
        Coordinator, and the Weights and Measures Division Director. The
        Quality Manager will maintain a copy of this report on file.

4.  A Special Internal Audit may be called at any time by the Weights
    and Measures Division Director, the Weights and Measures Division
    Safety Coordinator, or any of the Metrology Department's Staff if
    there is concern that some portion of the metrology system is
    generating discrepant results or unsafe conditions.

    1.  The Quality Manager will conduct the audit with assistance from
        the Safety Coordinator, if necessary.

    2.  The procedures for the audit will depend upon the nature of the
        discrepancy or condition, and will be determined by the Quality
        Manager at the time of the audit.

    3.  The Quality Manager will meet with the Technical and Laboratory
        Supervisors, the Safety Coordinator (if necessary), and the
        person who requested the special audit to report the findings of
        the audit.

    4.  The Technical and Laboratory Supervisors will address the
        findings to the satisfaction of the Quality Manager. They will
        implement any necessary changes within a reasonable time limit
        set by the Quality Manager.

    5.  The Quality Manager will report the audit results, in writing,
        to the Technical and Laboratory Supervisors, the Safety
        Coordinator (if necessary), and to the Weights and Measures
        Division Director. The Quality Manager will maintain a copy of
        this report on file.

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2.  External audits requested by laboratory customers

> The Metrology Laboratory will submit to audits requested by laboratory
> customers. The metrology laboratory will respond to the following
> audit requests with the following procedures:

1.  When the Technical Manager receives a written request from a
    customer for documents or information relating to metrology
    laboratory procedures, calibrations, or tests:

    1.  Write to the customer to acknowledge receipt of the request;

    2.  Review the customer's request and, if necessary, place a
        telephone call to the customer's representative to clarify any
        requested items that may not be clearly identified in the
        request;

    3.  Compile the requested information and send it to the customer
        within thirty days after receiving and clarifying the request.

2.  When the Technical Manager receives a formal written request for an
    on-site audit to be conducted by a customer's audit team:

    1.  Place a telephone call to the customer's representative and
        schedule a mutually agreeable date and duration for the audit,
        not more than forty-five days after the date of the request,
        unless the customer specifies a later date;

    2.  Write to the customer to acknowledge receipt of the customer's
        request, to confirm the audit date and duration, and to extend
        an invitation to the customer's audit team;

    3.  In the letter (required in 4.2.2.2 above), ask the customer's
        representative to provide written questions, a list of the
        documentation the audit will review, a complete description of
        the customer's audit criteria, and a deadline by which the
        requested information must be received;

    4.  When the requested information is received, assign metrology
        laboratory staff to an audit team that will work with the
        customer's audit team;

    5.  If the requested information is not received by the deadline,
        write to the customer and cancel the audit;

    6.  Assign audit preparation tasks and deadlines to ensure that the
        Metrology Laboratory will be fully prepared for the audit;

    7.  Meet with the customer's audit team and assist them in
        completing their audit as quickly and efficiently as possible;

    8.  Set a mutually agreeable deadline, in writing, for the
        customer's audit team to report their audit results;

    9.  Respond to any follow-up questions or requests the customer's
        audit team submits prior to the agreed upon deadline. Respond to
        follow-up questions and requests within five days after they are
        received;

    10. Receive and file the customer's audit report;

    11. Meet with the metrology laboratory staff and the Weights and
        Measures Division Director to decide whether to implement any
        suggestions in the auditor's report, or how to correct any
        problems that may have been discovered in the auditor's report;

    12. Implement any changes according to standard administrative
        procedures;

    13. Report the results to the Weights and Measures Division
        Director.

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3.  External audit by an accreditation organization

> The metrology laboratory may request an audit by an external
> accreditation organization. The Technical Manager must use the
> following procedure to make such a request, and to respond to the
> audit results:

1.  Select an appropriate accreditation organization;

2.  Determine the scope of the audit (by producing a list of laboratory
    procedures or operations that are to be audited);

3.  Receive permission from the Weights and Measures Division Director
    to request an external audit by the selected accreditation
    organization;

4.  Submit a formal written request for an audit to the selected
    accreditation organization;

5.  Place a follow-up telephone call to a representative of the
    accreditation organization to set a mutually agreeable date for the
    audit;

6.  Notify the metrology laboratory staff of the audit dates, and
    organize an audit team to assemble the necessary information and to
    work with the audit team from the accreditation organization;

7.  Respond to any pre-audit requests from the accreditation
    organization audit team (send documents and other information as
    requested);

8.  Schedule the metrology laboratory staff so that the entire staff
    will be available to answer questions, provide documents, and
    demonstrate procedures during the audit;

9.  Work with the accreditation organization audit team to set a
    deadline for completing the audit report;

10. Respond to any follow-up questions or information requests from the
    audit team;

11. Receive and file the audit report;

12. Meet with the metrology laboratory staff and the Weights and
    Measures Division Director to decide how to implement any
    suggestions in the auditor's report, and how to correct any problems
    that may have been discovered in the auditor's report;

13. Implement the changes according to standard administrative
    procedures;

14. Report the results to the Weights and Measures Division Director.

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4.  External audits by the State Legislative Auditor

> The metrology laboratory will respond to any request for a performance
> or financial audit by the State Legislative Auditor. Such requests
> will be passed to the metrology laboratory by the Weights and Measures
> Division Director. The Technical Manager will use the following
> procedure to respond to the audit request:

1.  Meet with the Weights and Measures Division Director, Finance
    Manager, and the audit team from the State Legislative Auditor's
    office to:

    1.  Determine the scope of the audit;

    2.  Receive requests for information;

    3.  Set a deadline for responding to the auditors' requests.

2.  Organize an audit response team to assemble the requested
    information within the deadlines set by the State Legislative
    Auditor;

3.  Provide the requested information to the Weights and Measures
    Division Director;

4.  Schedule the metrology laboratory staff to respond to any requests
    from the auditor for interviews or demonstrations;

5.  Respond to any follow-up information requests by providing the
    requested information to the Weights and Measures Division Director;

6.  Receive the audit report from the Weights and Measures Division
    Director;

7.  Discuss the report with the Division Director and the Finance
    Manager to determine how to implement any changes or suggestions;

8.  Implement changes according to the standard administrative
    procedures.

**Table 1 Audit Summary**

  ----------- ----------------- ------------------------- -------------------
  **Audit                                                 
  Summary**                                               

  Section     Audit type        Frequency                 Responsible Manager

  4.1.1       Quality System    Alternating Quarters      Quality Manager
              (QS)              (from TS)                 

  4.1.2       Technical System  Alternating Quarters      Quality Manager
              (TS)              (from QS)                 

  4.1.3       Safety            Annually                  Quality Manager

  4.1.4       Special Internal  As requested or needed    Quality Manager

  4.2.1       Customer          As requested              Technical Manager
              Requested                                   

  4.3         Accreditation     Determined by Accrediting Technical Manager
              On-site           Agency                    

  4.4         State Legislative As requested              Director, Technical
              Audit                                       Manager

                                                          
  ----------- ----------------- ------------------------- -------------------

**Standard Administrative Procedure 10**

**Software Quality Assurance**

1.  **Introduction**

This is the metrology laboratory procedure for protecting and validating
the accuracy of computer software. Software is classified as primary,
secondary, or tertiary, according to its potential for introducing
errors into calibration results. Each classification has an associated
validation and security protocol. Reference NCSL RP 13, Computer Systems
in Metrology.

2.  **Purpose**

The purpose of this procedure is to ensure that software does not
contribute errors or additional uncertainty to any measurement process
and to ensure that computer systems are adequately secure.

3.  **Responsibility and authority**

    1.  The Technical Manager will classify new software and validate
        the numerical and computational integrity of primary and
        secondary software. Validation records are maintained in the
        laboratory for primary software.

    2.  For primary software that does not have built in protections to
        prevent accidental changes during routine use, the Technical
        Manager and the MIS Coordinator will implement a system of
        templates, cell protection, read only access, or other security
        measures to protect the programming.

    3.  The MIS Coordinator will employ the following security measures
        to maintain the security of the disk partition where primary
        software resides:

        1.  Passwords to limit disk access. Only the metrology
            laboratory staff, the Weights and Measures Division
            Director; and the MIS Coordinator will have access to the
            disk;

        2.  Regular backups of the entire disk partition;

        3.  Restoration of software in the event of a disk failure.

    4.  The Quality Manager is authorized to ensure that this procedure
        is followed and that all software associated with a measurement
        result has been validated. The Quality Manager is responsible to
        validate, or arrange to have another metrologist validate, any
        primary or secondary software written by the Technical Manager.

4.  **Operations**

    1.  Computer Software \-- Classified

> Software is classified as primary, secondary, or tertiary, according
> to its potential for introducing errors into calibration results.

1.  Primary Software - Software that contributes numeric data to a
    calculation algorithm. The following primary software is used in the
    metrology laboratory:

  ------------------------ ------------------------------ ---------------------
  [Software]{.underline}   [Purpose]{.underline}          [Program
                                                          Source]{.underline}

  ------------------------ ------------------------------ ---------------------

  ------------------- ------------------------------ --------------------
  LAB WIZARD          Mass Calibration               NIST

  MASSCODE.DOS        Mass Calibration               NIST

  3-1WEIGH.W\*\*      Mass Calibration               NIST
  ------------------- ------------------------------ --------------------

  ------------------- ------------------------------ --------------------
  VolLPG              LPG Volume Calibration         NIST

  5GALGRAV            5 Gal Gravimetric Calibration  NIST

  VOLUME.W\*\*        Volume Calibration             NIST
  ------------------- ------------------------------ --------------------

1.  Primary software \-- exception

> Primary software does not include software that performs basic
> arithmetic procedures such as multiplication and division. Software
> that performs basic arithmetic procedures is indirectly validated
> through the validation of the primary and secondary programs in which
> it is utilized.

2.  Firmware \-- exception

> Firmware (algorithms or programming coded into the circuitry of a
> device or instrument, and provided with the device or instrument by
> the original manufacturer) is also excepted from the definition of
> primary software.

2.  Secondary Software

> Programming developed in the metrology laboratory that contributes
> numeric data to a calculation algorithm through a series of basic
> arithmetic procedures specified by the metrologist who designed the
> program. These basic calculations are performed by tertiary software
> that is indirectly validated through the validation of the secondary
> software. The possibility of error arises mainly from the
> metrologist's program itself. Examples include spontaneously written
> spreadsheets to calculate a mean, or standard deviation. These
> internally developed programs are not stored or listed.

3.  Tertiary Software

> Acquired software that is produced outside of the metrology
> laboratory, including:

1.  Software that does not contribute numeric data to a calculation
    algorithm;

2.  Software that performs such basic mathematical functions that its
    accuracy can be assumed and indirectly validated through the
    validation of the primary and secondary software in which it is
    utilized.

The following tertiary software is used in the metrology laboratory:

+--------------------+--------------------------+----------------------+
| [Sof               | [Purpose]{.underline}    | [Program             |
| tware]{.underline} |                          | Source]{.underline}  |
+--------------------+--------------------------+----------------------+
| Microsoft Word v   | Word processing          | Microsoft            |
| 6.0a               |                          |                      |
+--------------------+--------------------------+----------------------+
| Word Perfect 6.1   | Word processing          | Corel                |
+--------------------+--------------------------+----------------------+
| Microsoft Excel v  | Spreadsheet              | Microsoft            |
| 5.0                |                          |                      |
+--------------------+--------------------------+----------------------+
| Microsoft          | Presentation             | Microsoft            |
| PowerPoint v 4.0   |                          |                      |
+--------------------+--------------------------+----------------------+
| Lotus 1-2-3 v 3.1  | Spreadsheet              | Lotus                |
|                    |                          |                      |
| Quattro Pro        | Spreadsheet              | Corel                |
+--------------------+--------------------------+----------------------+
| Labview v 3.0      | Instrument Control and   | National Instruments |
|                    | Data Acquisition         |                      |
+--------------------+--------------------------+----------------------+
| Microsoft Windows  | Secondary Operating      | Microsoft            |
| v 3.1              | System                   |                      |
+--------------------+--------------------------+----------------------+
| IBM PC DOS v 6.1   | Operating System         | IBM                  |
+--------------------+--------------------------+----------------------+
| Math Cad v 4.0     | Calculation              | Math Soft            |
+--------------------+--------------------------+----------------------+

2.  Computer Software \-- Validation System

    1.  Primary Software

> Primary software is validated upon initial acceptance, and after any
> modification, or platform transfer. The validation procedure includes:

1.  Checking for data entry errors; and,

2.  Verifying the accuracy for all extremes using accepted standards
    such as recognized data sets; or,

3.  Verifying the accuracy for all extremes by hand calculation.
    Differences must be \<\< less than the uncertainty of the
    measurement process. The Technical Manager is responsible for
    determining what "\<\< less" means in each case.

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2.  Secondary Software

> Validation includes an examination of formulae, checking significant
> digits, and verifying cell or variable names. This validation is
> performed by:

1.  The Technical Manager validates secondary software written by
    laboratory staff.

2.  The Quality Manager validates secondary software written by the
    Technical Manager, or arranges to have the software validated by
    another metrologist (this may involve a third party metrologist from
    another organization).

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3.  Tertiary Software

    1.  Tertiary software that performs basic arithmetic functions is
        indirectly validated through the primary and secondary software
        in which it is utilized.

    2.  Tertiary software that does not contribute numerically is not
        validated because it does not contribute to measurement results

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3.  Computer Software \-- Security

    1.  Primary Software

> Upon successful validation, primary software is secured so that it
> cannot be altered without an intentional action by the Technical
> Manager. Software may be secured through compilation, cell protection,
> read only templates or other measures as deemed necessary by the
> Technical Manager and the MIS Coordinator. Current primary software is
> secured as follows:

  ------------------------ -------------------------------------------------
  [Software]{.underline}   

  LAB WIZARD               Compiled by NIST

  MASSCODE.DOS             Compiled by NIST

  3-1WEIGH.W\*\*           Cell protection, read only template

  5GALGRAV.W\*\*           Cell protection, read only template

  VolLPG.W\*               Cell protection, read only template

  Volume.W\*\*             Cell protection, read only template

  Vol40                    Cell protection, read only template

  Density                  Cell protection, read only template
  ------------------------ -------------------------------------------------

2.  Secondary Software

> Secondary software is not stored and therefore not secured.

3.  Tertiary Software

> Tertiary software is indirectly validated through the validation of
> any primary or secondary software which utilizes it.

**Standard Administrative Procedure 11**

**Purchase and Evaluation of Supplies and Services**

1.  **Introduction**

This is the metrology laboratory procedure for purchase, storage, and
evaluation of supplies and services. Obtaining products or services from
organizations registered to ISO 9000 or accredited to ISO Guide 25 is
recommended where possible; however, this is no guarantee of acceptable
quality. The laboratory inspects and evaluates products or services and
identifies any unique storage requirements when products are received or
returned.

2.  **Purpose**

It is imperative that supplies and services obtained by the laboratory
reflect the expected quality of service and that they do not adversely
contribute to the quality of measurement results.

3.  **Responsibility and Authority**

    1.  The Technical Manager is responsible for ensuring that suitable
        specifications are used to purchase supplies and services.

    2.  The Quality Manager is responsible for ensuring that products
        and services meet designated specifications.

4.  **Operations**

    1.  The laboratory will use national or international specifications
        for standards where available and inspect the standards upon
        receipt to determine that standards meet specifications.
        Examples include:

        1.  Mass standards: OIML R 111 or ASTM E 617;

        2.  Mass field standards: NIST Handbook 105-1;

        3.  Volumetric field standards: NIST Handbook 105-2, 105-3; and

        4.  Thermometers: ASTM E 1 or NIST Handbook 105-6.

    2.  In addition to specifications, and if specifications are not
        available, the following criteria will be used in purchase
        considerations:

        1.  Accuracy, stability, contribution to measurement uncertainty
            (quality factor);

        2.  Familiarity with the product, word of mouth experience from
            other laboratories (quality factor);

        3.  Prior relationship with supplier, supplier's reputation, and
            commitment to customer satisfaction;

        4.  Availability of product, parts, or services.

    3.  Maintenance of records

> The laboratory will maintain purchase and warranty records and
> maintain performance history files. In situations where the quality of
> product or services are not adequate for the intended purpose, the
> laboratory will investigate the issue prior to additional purchases.

4.  List of acceptable suppliers

> The laboratory will maintain a list of acceptable suppliers for
> laboratory standards, equipment, supplies, and services where the
> quality of such products or services may affect the quality of the
> measurements. Each supplier will be evaluated initially and annually
> thereafter according to criteria in section 4.2.

5.  Examples of purchases affecting quality of measurement results

    1.  Laboratory supplies affecting measurement quality

        1.  Chemicals

        2.  Wipes

        3.  Weight handling equipment - gloves, forceps, filter paper

        4.  Meniscus reading tools, magnifiers

    2.  Standards

        1.  Weights

        2.  Volumetric

        3.  Thermometers

        4.  Barometers

        5.  Hygrometers

        6.  Tapes

    3.  Equipment

        1.  Balances

        2.  Water purification system

    4.  Services

        1.  Calibration of standards

        2.  Balance repair and/or maintenance

6.  Inspection prior to use

> All products and services are inspected or validated prior to use of
> equipment or supplies.

Form 3 Supplier Evaluation

  -----------------------------------------------------------------------
  **Supplier Evaluation**

  Date:

  Supplier:

  Supplier products:

  **Evaluation Questions:**

  Applicable specification Yes No

  Title of applicable specification:

  Supplier registration/accreditation:

  Accuracy, stability, uncertainty evaluation:

  Familiarity with product, word of mouth experience from other
  laboratories:

  Prior relationship, supplier reputation, commitment:

  Availability of products, parts, service:

  Other comments regarding supplier:

  Signature of responsible staff:
  -----------------------------------------------------------------------

**Form 4 List of Acceptable Suppliers**

  ---------------------- ------------------------ ------------------------
  Supplier               Product(s)               Acceptance Date

                                                  

                                                  

                                                  

                                                  

                                                  

                                                  

                                                  

                                                  

                                                  

                                                  

                                                  

                                                  

                                                  

                                                  

                                                  

                                                  

                                                  

                                                  

                                                  

                                                  

                                                  

                                                  
  ---------------------- ------------------------ ------------------------

**Standard Administrative Procedure 12**

**Corrective Action and Complaint Resolution**

1.  **Introduction**

This is the metrology laboratory procedure for resolving customer
complaints and for correcting errors discovered by the laboratory staff.
This procedure will be used to correct all errors and resolve all
customer complaints.

2.  **Purpose**

    1.  The purpose of the customer complaint resolution system is to
        ensure that:

        1.  All customer complaints are resolved quickly and
            effectively;

        2.  Metrology laboratory customers are satisfied with the
            services provided by the laboratory.

    2.  The purpose of the internal error correction system is to ensure
        that:

        1.  All errors discovered by the laboratory staff are corrected
            and prevented from occurring again;

        2.  Services provided to our customers are of the highest
            quality possible.

3.  **Responsibility and authority**

    1.  The Laboratory Supervisor:

        1.  Receives customer complaints;

        2.  Investigates customer complaints;

        3.  Takes corrective action to resolve customer complaints;

        4.  Initiates corrective recalls as outlined in SAP No. 17 if
            needed.

    2.  The Technical Manager:

        1.  Determines the source, magnitude, extent, and significance
            of all errors discovered and reported by the laboratory
            staff;

        2.  Determines whether a recall is necessary;

        3.  Instructs the Laboratory Supervisor to contact all affected
            customers in the event of a recall.

    3.  The Quality Manager:

        1.  Performs internal audits as outlined in SAP No. 09;

        2.  Informs the Technical and Laboratory Supervisors of any
            discrepancies or errors uncovered by these audits.

    4.  The Laboratory Supervisor, Technical Manager, and Quality
        Manager are responsible for maintaining a working environment
        that:

        1.  Encourages error discovery and correction;

        2.  Strongly supports error reporting, by all metrology
            laboratory staff members, without regard for the source of
            the error.

    5.  The entire metrology laboratory staff is responsible for
        reporting errors to the Technical Manager.

4.  **Operations**

    1.  Customer complaints \-- initial contact

> A metrologist who receives a customer complaint must request the
> following information:

1.  Company name;

2.  The name of the person making the complaint;

3.  The state test number;

4.  A telephone number for the contact person;

5.  A fax number;

6.  The nature of the complaint.

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2.  Customer complaints \-- resolution

> Below is a list of potential customer complaints and methods of
> resolution:

1.  When a work order has not been given timely placement on the
    metrology laboratory work schedule, the Laboratory Supervisor will:

    1.  If possible, reschedule the work for an earlier date within the
        parameters outlined in SAP 12;

    2.  If rescheduling is not possible, explain the metrology
        laboratory work load to the customer and assure the customer
        that the laboratory will complete the work as soon as possible.

2.  When the metrology laboratory has not completed work on time, the
    Laboratory Supervisor will:

    1.  Determine when the work was scheduled to be completed;

    2.  Determine whether the work was completed at the time promised to
        the customer;

    3.  If the work was delayed:

        1.  Determine the cause of the delay;

        2.  Explain the cause of the delay to the customer;

        3.  Take corrective action to prevent further problems.

3.  If the metrology laboratory failed to comply with the specifications
    in a work order, the Laboratory Supervisor will:

    1.  Review the work order;

    2.  Review all of the reports produced for the work order;

    3.  If the metrology laboratory failed to comply with the customer's
        specifications:

        1.  Ask the customer to re-submit the work order;

        2.  Re-schedule and complete the work as soon as possible;

        3.  Supervise the re-scheduled work to ensure that the metrology
            meets the customer's specifications;

        4.  Take corrective action to prevent future problems.

4.  If there are errors in reports produced by the metrology laboratory,
    the Laboratory Supervisor will:

    1.  Review reports to determine if errors were made;

    2.  If the metrology laboratory made an error:

        1.  Correct the error;

        2.  Provide a corrected copy of the report to the customer;

        3.  File a corrected copy of the report with the original test
            reports;

        4.  Determine the cause of the error;

        5.  Take corrective action to prevent future errors.

5.  When a customer reports a discrepancy between test results reported
    by the Minnesota metrology laboratory and results reported by
    another laboratory, the Technical Manager will:

    1.  Determine whether the differences in the reported values are
        within the uncertainty ranges reported by both laboratories;

    2.  If the differences in the reported values are within the
        uncertainty ranges, explain the measurement uncertainty concept
        to the customer;

    3.  If the differences in the reported values exceed the uncertainty
        ranges, and if the reason for the discrepancy is unclear,
        contact the other laboratory and discuss the discrepancy to
        determine the cause and possibly conduct an Interlaboratory
        Comparison;

    4.  If the cause of the discrepancy cannot be determined, ask the
        customer to re-submit the work order so that the test procedure
        can be reproduced.

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3.  Complaint file

> The Laboratory Supervisor will maintain a complaint file that includes
> that following information for each complaint received by the
> metrology laboratory:

1.  Complainant name;

2.  Date complaint was received;

3.  Nature of the complaint;

4.  Disposition of the complaint.

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4.  Internally discovered errors

    1.  Any member of the metrology laboratory staff who discovers an
        error must report the error to the Technical Manager.

    2.  Upon receiving a report of an error, the Technical Manager will:

        1.  Determine the source of the error as categorized below:

            1.  Human errors, such as an incorrect reading,
                transcription, or manual computation, are usually
                one-time errors that affect one artifact;

            2.  Procedure errors may be a long term problem that may
                affect many calibrations;

            3.  An instrument malfunction, or poor performance, may be a
                long term problem that may affect many calibrations.

        2.  Determine the time-frame within which the error occurred;

        3.  Determine the range of artifacts that may have been affected
            (for example, a specific equipment performance problem may
            only affect mass standards less than three grams);

        4.  Notify the Laboratory Supervisor of the error, and instruct
            the Laboratory Supervisor to research the metrology
            laboratory records to identify customers that may have been
            affected by the error;

        5.  Work with the metrology laboratory staff, Quality Manager
            and Laboratory Supervisor to correct the problem that led to
            the error.

    3.  Upon receiving notice of an error from the Technical Manager,
        the Laboratory Supervisor must:

        1.  Research the metrology laboratory records for all
            calibration and test records:

            1.  Produced during the time-frame the error is known to
                have occurred;

            2.  Produced by the staff member who is known to have made
                the error;

            3.  Produced using an instrument that is known to have
                caused the error;

            4.  Produced using an incorrect or inappropriate procedure.

        2.  Identify the customers and the artifacts affected by the
            errors;

        3.  Send one written notice to each customer affected by the
            error. The notice must include:

            1.  The identity of the artifacts affected by the error;

            2.  The magnitude and nature of the error;

            3.  A request to recall the artifacts for recalibration;

            4.  A statement that all recalibration services will be
                provided without charge;

            5.  A statement that it is the customer's option to decide
                whether to recalibrate.

        4.  If the written notice is returned as undeliverable, the
            Laboratory Supervisor must place a telephone call to the
            affected customer's representative (as identified on each
            calibration report);

        5.  Receive and schedule, as quickly as possible, all
            recalibration requests from customers affected by the error.

    4.  The Technical Manager must work with the Quality Manager, the
        Laboratory Supervisor, and the metrology laboratory staff to
        correct the error and prevent recurrences.

SEQ WPCAPTION \\\* MERGEFORMAT **SAP 12 Flowchart**

**Standard Administrative Procedure 13**

**Laboratory Maintenance**

1.  **Introduction**

This is the metrology laboratory policy and procedure for maintenance.
Cleanliness is a vital component of metrology laboratory operations.
Dust and dirt, that may enter the metrology laboratory environment from
any source, will increase measurement uncertainties, contaminate
standards, damage measurement instruments, adversely affect the health
and safety of the staff, and generally degrade the measurement
capabilities of the laboratory.

Cleaning responsibilities must be carried out by the metrology
laboratory staff. Cleaning by an untrained person could result in damage
to standards, instruments, or the laboratory environment.

2.  **Purpose**

The Metrology Laboratory cleaning and maintenance program has four main
purposes:

1.  To ensure that calibration and testing results are not affected by
    dust and dirt;

2.  To ensure that measurement instruments are not damaged, or their
    performance degraded, by dust and dirt;

3.  To maintain safe and healthful working conditions in the metrology
    laboratory and in the areas surrounding the laboratory;

4.  To maintain dust free conditions in the small mass calibration room
    by:

    1.  Regularly removing all dust and dirt within the small mass
        calibration room;

    2.  Regularly cleaning the areas surrounding the metrology
        laboratory to eliminate potential sources of dust and dirt
        incursion into the small mass calibration room.

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3.  **Responsibility and authority**

The Laboratory Supervisor is responsible for maintaining the metrology
laboratory and the areas surrounding the metrology laboratory. The
Laboratory Supervisor will assign cleaning responsibilities on a
rotating schedule to all laboratory staff. These cleaning assignments
will be listed on the metrology laboratory schedule.

4.  **Operations**

    1.  Levels of cleanliness \-- defined

> Three distinct levels of cleanliness are required for the metrology
> laboratory and the areas surrounding the metrology laboratory. These
> three levels are:

1.  The [LEVEL 1]{.underline} environment is a dust free, restricted
    access environment:

    1.  Access is restricted to prevent incursion of dust;

    2.  Loose papers, reports, manuals and reference documents must be
        removed upon completion of each calibration assignment;

    3.  At each scheduled cleaning event:

        1.  All surfaces and instruments must be thoroughly wiped with a
            damp cloth to remove dust;

        2.  The floor must be mopped (wet mop if Friday, else dry dust
            mop);

        3.  The adhesive-surfaced dust removal mat must be checked and
            replaced if necessary.

2.  The [LEVEL 2]{.underline} environment is a clean, limited access
    environment. At each scheduled cleaning event:

    1.  Dust must be removed from all surfaces;

    2.  Floors must be vacuumed;

    3.  Wastebaskets must be emptied;

    4.  Recycling containers must be emptied;

    5.  Loose papers must be put away or recycled;

    6.  Manuals and reference documents not in use must be reshelved.

3.  The [LEVEL 3]{.underline} environment includes clean, limited access
    and open access environments.

    1.  If dirt or dust is present in the calibration work area, the
        area must be cleaned and swept at the beginning of each
        calibration or test assignment.

    2.  At each scheduled cleaning event:

        1.  All floors must be swept;

        2.  Wastebaskets must be emptied;

        3.  Tools and other articles must be put away.

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2.  Levels of cleanliness \-- applied

> The Metrologists will maintain three distinct levels of cleanliness in
> the Metrology Laboratory and surrounding areas. The three levels of
> cleanliness (defined in section 4.1 above) will be applied to the
> Metrology Laboratory and surrounding areas as follows:

1.  A [LEVEL 1]{.underline} environment will be maintained in the small
    mass calibration room.

2.  A [LEVEL 2]{.underline} environment will be maintained in:

    1.  The small mass tolerance testing area;

    2.  The thermometry calibration area;

    3.  The metrology laboratory office area.

3.  A [LEVEL 3]{.underline} environment will be maintained in:

    1.  The large mass calibration and tolerance testing room;

    2.  The work room between the loading dock and large mass room;

    3.  The volume transfer calibration area;

    4.  The loading dock area outside the metrology laboratory office;

    5.  The storage and shipping room adjacent to the metrology
        laboratory office;

    6.  The garage area adjacent to the loading dock area.

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3.  Cleaning and maintenance schedule

> The Laboratory Supervisor will assign metrology laboratory staff
> members to clean the metrology laboratory and surrounding areas on
> Friday (on Thursday if staff work a 4-day week).

4.  Unscheduled maintenance

> When a calibration or testing assignment generates dust or dirt in the
> metrology laboratory, or in the areas surrounding the metrology
> laboratory, the metrologist who completed the assignment will clean
> the area according to the appropriate level of cleanliness defined in
> section 4.1. This maintenance task must be completed when the
> calibration or testing assignment is completed. The accumulated dust
> or dirt must not be left for the next scheduled cleaning day.

5.  Volume transfer calibration areas

> When a metrologist completes a volume transfer calibration assignment
> (in the volume calibration area inside or above the entrance to the
> petroleum laboratory) the metrologist will:

1.  Clean the volumetric prover platform, if used during the calibration
    or test;

2.  Clean the sink area and counter top if used during the calibration
    or test of a small volume test measure;

3.  Dry the loading dock floor below the volumetric prover platform;

4.  Dry the floor inside the entrance to the petroleum laboratory;

5.  Dry the surfaces of the volumetric provers used for the calibration
    or test.

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6.  Additional maintenance

> The Laboratory Supervisor will perform the following maintenance tasks
> at the intervals indicated with each task:

1.  Check the supply of clean gloves, lab coats, and lint-free cloth
    squares on the first working day of each month and submit a request
    to purchase any supplies that must be replenished.

2.  Charge the electric pallet mover each Friday at the end of the
    workday.

**Standard Administrative Procedure 14**

**Laboratory and Data Security**

1.  **Introduction**

This is the metrology laboratory policy for physical security and data
security. The Laboratory Supervisor will use this policy to ensure the
security of the metrology laboratory.

2.  **Purpose**

The purpose of the laboratory security procedure is to:

1.  Protect the state standards of mass, length, volume, temperature and
    density in order to:

    1.  Protect the validity of the original NIST calibrated values;

    2.  Protect the validity of all of the subsequent surveillance work
        performed on the standards;

    3.  Ensure that the standards are safe from:

        1.  Accidental damage or breakage;

        2.  Exposure to harmful environmental effects;

        3.  Theft or vandalism.

2.  Protect the instruments and equipment used in the metrology
    laboratory in order to:

    1.  Ensure the continuing validity of measurements produced with the
        instruments;

    2.  Ensure that there are no environmental or other factors which
        will degrade the validity of the control chart data produced and
        maintained for the instruments;

    3.  Ensure that the instruments are safe from;

        1.  Accidental damage or breakage;

            1.  Exposure to harmful environmental effects;

            2.  Theft or vandalism.

3.  Protect laboratory reports, records, documents and electronic data
    relating to:

    1.  Calibration and test data for all artifacts calibrated or tested
        in the metrology laboratory;

    2.  Standard procedure documents;

    3.  Statistical process control charts;

    4.  Archival data, reports, and procedure documents.

4.  Ensure the physical security of the metrology laboratory staff.

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3.  **Responsibility and authority**

    1.  The Laboratory Supervisor is responsible for the security of:

        1.  The state standards;

        2.  Laboratory instruments and equipment;

        3.  Laboratory records and electronic data;

        4.  The laboratory staff.

    2.  The Laboratory Supervisor is authorized to seek assistance from:

        1.  The Weights and Measures Division Director and Regional
            Supervisors for guidance and direction on security and
            safety issues;

        2.  The Division's Management Information Systems Coordinator to
            ensure the security of electronic data.

4.  **Operations**

The Laboratory Supervisor will implement procedures to provide a secure
working environment for the protection of the metrology laboratory
staff, standards, equipment, and documentation.

1.  Levels of security defined.

    1.  LEVEL 1 security means that access is restricted by a code lock
        or key operated lock. The doors to LEVEL 1 areas are locked at
        all times. Only the metrology laboratory staff and the Weights
        and Measures Division Director have access to the code or key to
        enter a LEVEL 1 area.

    2.  LEVEL 2 security means that access is restricted by a code lock.
        The doors to the LEVEL 2 area are locked at all times except
        when equipment is moved from one area to another. Only Weights
        and Measures staff stationed at this locations have access to
        the entry code for the LEVEL 2 area.

    3.  LEVEL 3 security means that access is limited. LEVEL 3 areas are
        locked except as noted below. Doors to a LEVEL 3 area are kept
        closed but not locked when they are not in use during normal
        working hours - 6:00 AM through 5:30 PM, Monday through Friday.
        During normal working hours, and when the areas are in use,
        LEVEL 3 areas can be accessed from the dock area (a LEVEL 4
        area).

    4.  LEVEL 4 security means that the area is open to the public
        during normal working hours - 6:00 AM through 5:30 PM, Monday
        through Friday. LEVEL 4 areas are locked at night. During normal
        working hours, LEVEL 4 areas can be accessed through the garage
        service door at the rear of the building, or through the front
        entrance to the Weights and Measures Division office.

2.  Laboratory security

    1.  The following areas are LEVEL 1 security areas:

        1.  The metrology laboratory office;

        2.  The small mass tolerance testing area;

        3.  The temperature calibration area;

        4.  The large volume calibration platform above the entrance to
            the petroleum laboratory.

    2.  The following areas are LEVEL 2 security areas:

        1.  The large mass calibration room. (The large mass room also
            has a key lock, allowing access by metrology and managerial
            staff only);

        2.  The length bench area;

        3.  The work room between the loading dock area and the large
            mass calibration room.

    3.  The following areas are LEVEL 3 security areas:

        1.  The shipping room adjacent to the metrology laboratory
            office;

        2.  The work room area where calibrations are performed with the
            5 gallon slicker plate measure.

    4.  The following areas are LEVEL 4 security areas:

        1.  The garage area and loading dock area;

        2.  The Weights and Measures Division office.

3.  Fire protection

    1.  All areas outside the small mass calibration room are protected
        by an automatic sprinkling system and warning system that meets
        State fire codes. The system was professionally installed when
        the building was constructed. It is maintained and regularly
        tested by the building owner in accordance with local fire
        codes.

    2.  The interior of the small mass calibration room is protected by
        an automatic Halon fire quenching and warning system that meets
        State fire codes. The system was professionally installed when
        the small mass calibration room was constructed inside the
        metrology laboratory. The system is professionally maintained
        and tested in accordance with local fire codes.

    3.  Portable fire extinguishers are located in the loading dock
        area, the shipping room, the small mass tolerance room, and the
        petroleum laboratory in accordance with local fire codes. The
        fire extinguishers are maintained in accordance with local fire
        codes.

4.  Environmental controls

    1.  The main HVAC system for the building maintains stable
        temperature and humidity in the:

        1.  Metrology laboratory office;

        2.  Small mass tolerance room between the laboratory office and
            the small mass calibration room;

        3.  Large mass room;

        4.  Workroom between the loading dock and the large mass room;

        5.  Shipping room;

        6.  Loading dock and garage areas.

    2.  Metrologists will prevent large temperature swings in the
        metrology laboratory and large mass calibration room when the
        overhead garage doors are opened by:

        1.  Closing the doors to the work room and the large mass
            calibration room;

        2.  Keeping the door to the metrology laboratory office, and the
            double air-lock door to the small mass calibration room
            closed at all times.

    3.  A separate HVAC system maintains the temperature and humidity
        within tightly controlled parameters in the small mass
        calibration room.

5.  Special security considerations

> The state standards and metrology laboratory records and data must be
> carefully handled, securely stored, and carefully maintained according
> to the following procedures:

1.  Handling and storage of the state standards

    1.  The state standards of mass, length, volume, and temperature
        must be handled according to Standard Operating Procedures.

    2.  Standards that are normally stored in a LEVEL 1 security area
        must never be left unattended when they have been removed from
        the area. Standards removed from a LEVEL 1 security area must be
        returned to a LEVEL 1 security area at any time when the
        metrologist using the standards will not have direct control and
        supervision of the standards.

    3.  All standards must be immediately returned to their designated
        secure storage areas when a metrologist completes a calibration
        or test assignment.

    4.  The primary one-kilogram mass standards, designated **P1**C and
        **P1**CC, are stored in a locked container in a locked cabinet
        in a LEVEL 1 security area.

2.  Secure storage of documents and paper records

    1.  Documents and records are maintained in the metrology laboratory
        office, a LEVEL 1 security area.

    2.  The door access code is known only to metrology staff and the
        Weights and Measures Division Director.

3.  Computer data security

    1.  Metrology laboratory files and data are stored within a single
        disk partition on a network server in the Weights and Measures
        Division office.

    2.  The disk partition is accessible only from computers operated
        by:

        1.  The metrology laboratory staff;

        2.  The Weights and Measures Division Director;

        3.  The Management Information Systems Coordinator.

    3.  A user name and user defined password are required to access the
        operating systems of the computers (listed in 4.5.3.2 above)
        that are mapped to the metrology laboratory disk partition on
        the network server.

    4.  Physical access to the computers used by the metrology
        laboratory staff is restricted. The computers are located in the
        metrology laboratory office, a LEVEL 1 security area.

**Standard Administrative Procedure 15**

**Departure from Documented Policies and Procedures**

1.  **Introduction**

This is the metrology laboratory policy for departure from documented
policies and procedures. The Laboratory Supervisor will use this policy
to ensure that policies and procedures are followed and updated as
needed. The laboratory will not deviate from documented policies and
procedures unless authorized.

2.  **Purpose**

The laboratory quality system and procedures have been developed and
implemented to ensure consistent quality of measurement results and good
laboratory practices. Deviation from laboratory policies and procedures
may contribute to measurement errors.

3.  **Responsibility and Authority**

    1.  The Technical Manager, Quality Manager, and Laboratory
        Supervisor must all evaluate possible consequences of requested
        departures and approve departures prior to their occurrence as
        follows:

        1.  The Technical Manager is responsible for evaluating the
            effect of deviations on measurement accuracy and
            traceability.

        2.  The Quality Manager is responsible for evaluating the
            potential impact on the quality system, including
            identifying deviations in other policies or procedures.

        3.  The Laboratory Supervisor is responsible for evaluating the
            impact on laboratory operations, staff safety, and customer
            expectations.

    2.  If a deviation occurs without prior approval, it will be
        recorded as an audit finding and treated as such.

4.  **Operations**

    1.  Any staff member requesting a deviation is responsible for
        obtaining authorization from laboratory managers using the
        Deviation Request Form.

    2.  The request is evaluated for whether or not policies or
        procedures should be changed if approval is granted.

    3.  The completed form is placed in the Deviations file for review
        during audits.

    4.  If all approvals are granted, the deviation may proceed.

**Form 5 Deviation Request Form**

  -----------------------------------------------------------------------
  **Deviation Request Form**

  Date:

  Requested deviation:

  Reason for deviation:

  **Evaluation Questions:**

  What is the impact of this request on accuracy and traceability of
  measurements and report?

  Approved: Yes No

  Signature of Technical Manager:

  What is the impact of this request on the quality system? Will this
  deviation affect other policies or procedures? If so, which ones?

  Approved: Yes No

  Signature of Quality Manager:

  What is the impact of this request on laboratory operations? Staff
  safety? Customer expectations?

  Approved: Yes No

  Signature of Technical Manager:

  Should a policy or procedure be changed as a result of this request?
  Yes No

  Describe proposed change if yes:

  Signature of staff requesting deviation:
  -----------------------------------------------------------------------

**Standard Administrative Procedure 16**

**Staff Training**

1.  **Introduction**

This is the metrology laboratory procedure for staff training. It is the
Weights and Measures Division Director's goal to have a highly trained
and effective staff in the metrology laboratory. The Laboratory
Supervisor has the full support of the Division Director to provide and
arrange high quality training for the entire staff of the metrology
laboratory.

2.  **Purpose**

A highly trained and effective staff will ensure that the metrology
laboratory will:

1.  Maintain its certifications and accreditations;

2.  Fulfill the Weights and Measures Division statutory mandate to
    provide high quality measurement services to its customers.

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3.  **Responsibility**

The Laboratory Supervisor is responsible for:

1.  Locating appropriate training opportunities for the metrology
    laboratory staff;

    1.  Assigning the staff to required training courses, including NIST
        metrology seminars;

    2.  Notifying the staff of optional training opportunities;

    3.  Encouraging the staff to take advantage of training
        opportunities.

2.  Receiving training requests from metrology laboratory staff members;

3.  Coordinating training activities with the Weights and Measures
    Division Training Coordinator;

4.  Ensuring that the metrology laboratory staff complete NIST metrology
    training, including NIST assigned Laboratory Audit Problems.

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4.  **Operations**

    1.  Types of training

> The Laboratory Supervisor must offer and arrange the following types
> of training for the metrology laboratory staff:

1.  Formal training that includes courses, seminars, and classroom
    training sessions presented by NIST/OWM, Regional MAP, NCWM, NCSL,
    universities, colleges, and other organizations offering academic,
    scientific, and professional development courses.

2.  On the job training on the quality system and procedures that
    includes:

    1.  Individual instruction;

    2.  Group discussion sessions;

    3.  Informal instructional sessions conducted by one member of the
        metrology laboratory staff to convey information from a formal
        training course;

    4.  Team working sessions conducted by one member of the metrology
        laboratory staff to demonstrate a procedure.

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2.  Training information sources

> The Laboratory Supervisor must read bulletins and newsletters from
> NIST, NCWM, NCSL, and other organizations to find appropriate training
> opportunities for the metrology laboratory staff.

3.  Training activities \-- coordination

> The Laboratory Supervisor must coordinate all training activities with
> the Weights and Measures Division Training Coordinator, as follows:

1.  Set training priorities and, if necessary, determine funding
    availability;

2.  Submit departmental training requests to the Training Coordinator
    for approval by the Training Coordinator, Division Director, and
    Department Personnel Manager;

3.  Submit out-of-state travel requests, if necessary, to the Training
    Coordinator for approval by the Division Director, Department
    Accounting Director, and Department Commissioner;

4.  Receive all necessary approvals for training;

5.  Ask the Training Coordinator to make travel arrangements, if
    necessary.

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4.  Supervision of training

> The Laboratory Supervisor must schedule and supervise training for the
> metrology laboratory staff as follows:

1.  Enroll staff members in training courses and seminars;

2.  Supervise completion of any course work assigned as part of the
    training course or seminar. This is particularly important in the
    case of NIST metrology training. For NIST metrology training, the
    Laboratory Supervisor must:

    1.  Impose a firm deadline to complete Laboratory Audit Problems
        following the NIST metrology training seminar;

    2.  Schedule sufficient time for a metrologist to work on the
        Laboratory Audit Problems during normal working hours, and to
        complete the problems by the deadline;

    3.  Work with the Technical Manager to act as advisors to a
        metrologist who is completing the Laboratory Audit Problems;

    4.  Ensure that the deadline is met, and that the completed
        Laboratory Audit Problems are submitted to NIST/OWM.

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5.  Training records

> The Laboratory Supervisor maintains records of all training completed
> by the metrology laboratory staff. The record includes a complete
> training log, and copies of diplomas or certificates, if available. A
> record is maintained for the following types of training:

1.  NIST/OWM metrology training;

2.  NIST special discipline training in the measurement of mass, volume,
    temperature, length, density, and other fields related to metrology;

3.  NIST/OWM training offered annually at the National Conference on
    Weights and Measures;

4.  Participation in Regional MAP seminars;

5.  Participation in other work-related seminars;

6.  Work-related academic training or courses;

7.  Professional developmental programs that may improve skills utilized
    in a laboratory;

8.  Undergraduate and graduate degrees, and other academic or
    work-related course work completed prior to employment with the
    metrology laboratory.

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6.  Minimum level of training required:

> In addition to the coursework required for employment as a Laboratory
> Metrologist or a Metrology Laboratory Manager, all metrology
> laboratory staff members must complete the following training courses
> and seminars:

1.  Quality Awareness Training - an overview of quality system
    requirements;

2.  NIST/OWM basic metrology training, including successful completion
    of the Laboratory Audit Problems;

3.  Annual participation, to the extent allowed by budget and travel
    limitations, in Regional MAP training and meetings.

**Standard Administrative Procedure 17**

**Recall Procedure**

1.  **Introduction**

This is the metrology laboratory procedure for recalling a calibrated
artifact when an error is discovered after the artifact is returned to
the customer. The metrology laboratory staff will use this procedure for
all recalls.

2.  **Purpose**

The purpose of the recall procedure is to correct errors when they are
discovered. This will be accomplished by:

1.  Informing customers when a calibration error is discovered;

2.  Working with customers to correct calibration errors made by the
    metrology laboratory.

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3.  **Responsibility and Authority**

    1.  The Laboratory Supervisor, Technical Manager, and Quality
        Manager are responsible for maintaining a working environment
        that:

        1.  Encourages error discovery and correction;

        2.  Strongly supports error reporting, by all metrology
            laboratory staff members, without regard for the source of
            the error.

    2.  The entire metrology laboratory staff is responsible for
        reporting errors to the Technical Manager.

    3.  The Technical Manager is responsible for:

        1.  Determining the magnitude, extent, and significance of all
            errors discovered and reported by the laboratory staff;

        2.  Determining whether a recall is necessary;

        3.  Determining the source of all reported errors;

        4.  Determining the time frame within which the error occurred;

        5.  Instructing the Laboratory Supervisor to search the
            calibration records for customers that may have been
            affected by the error.

    4.  The Laboratory Supervisor is responsible for:

        1.  Researching records to find customers that may have been
            affected by the error;

        2.  Contacting all affected customers to recall artifacts
            affected by the error;

        3.  Scheduling the metrology laboratory staff to correct errors
            on recalled artifacts.

4.  **Operations**

> When an error is discovered, it must be corrected as soon as possible.
> The following procedure will be used to correct errors:

1.  Any member of the metrology laboratory staff who discovers an error
    must report the error to the Technical Manager.

2.  Upon receiving a report of an error, the Technical Manager will:

    1.  Determine the source of the error:

        1.  Human errors, such as an incorrect reading, transcription,
            or manual computation, are usually one-time errors that
            affect one artifact;

        2.  Procedure errors may be a long term problem that may affect
            many calibrations;

        3.  An instrument malfunction, or poor performance, may be a
            long term problem that may affect many calibrations.

    2.  Determine the time-frame within which the error occurred;

    3.  Determine the range of artifacts that may have been affected
        (for example, a specific equipment performance problem may only
        affect mass standards less than three grams);

    4.  Notify the Laboratory Supervisor of the error, and instruct the
        Laboratory Supervisor to research the metrology laboratory
        records to identify customers that may have been affected by the
        error;

    5.  Work with the metrology laboratory staff, Quality Manager and
        Laboratory Supervisor to correct the problem that led to the
        error.

3.  Upon receiving notice of an error from the Technical Manager, the
    Laboratory Supervisor must:

    1.  Research the metrology laboratory records for all calibration
        and test records:

        1.  Produced during the time-frame the error is known to have
            occurred;

        2.  Produced by the staff member who is known to have made the
            error;

        3.  Produced using an instrument that is known to have caused
            the error;

        4.  Produced using an incorrect or inappropriate procedure.

    2.  Identify the customers and the artifacts affected by the errors;

    3.  Send one written notice to each customer affected by the error
        including:

        1.  The identity of the artifacts affected by the error;

        2.  The magnitude and nature of the error;

        3.  A request to recall the artifacts for recalibration;

        4.  A statement that all recalibration services will be provided
            without charge;

        5.  A statement that it is the customer's option to decide
            whether to recalibrate.

    4.  If the written notice is returned as undeliverable, the
        Laboratory Supervisor must place a telephone call to the
        affected customer's representative (as identified on each
        calibration report);

    5.  Receive and schedule, as quickly as possible, all recalibration
        requests from customers affected by the error;

    6.  Work with the metrology laboratory staff, Quality Manager and
        Technical Manager to correct the problem that led to the error.

SEQ WPCAPTION \\\* MERGEFORMAT **SAP 17 Flowchart**