Calibration System

Procedure
1.0 PURPOSE AND SCOPE
1.1 Purpose

1.1.1 The purpose of this procedure is to define the calibration, maintenance

and control of
measuring and test equipment used to determine acceptability of
materials/products at our Company (BC).
1.1.2 This procedure includes the process for conducting internal and
external calibration activities.
1.1.3 When customer or employee owned measuring and test equipment is
used to determine acceptability of materials/products shipped to BC
Customers, the measuring and test equipment shall be identified and
tracked in the same manner as BC owned measuring and test
equipment.

1.1.4 This procedures calls for the clear identification of all measuring and
test equipment used at BC to prevent unauthorized or mis-use
concerns.
1.2 Scope
This procedure shall apply to all measuring and test equipment used in
Receiving Inspection, production Assembly/Fabrication, Test and
Inspection, and Engineering Design.
2.0 APPLICABLE DOCUMENTS
The following documents are applicable to the extent specified herein:
Industrial/Commercial/Government Documents
ISO 9001 Quality Management System – Requirements
ISO/EC 17025 Laboratory Accreditation
BC Document(s)
BC-QAP-XXX Purchasing System
BC-QAP-XXX Supplier Evaluation and Approval/Disapproval
BC-QAP-XXX Receiving Inspection
BC-QAP-XXX Quality Records
BC-QAP-XXX Nonconforming Material System
BC-QAP-XXX Corrective Action System
BC-QAP-XXX Internal Audits
Form(s)
FORM Calibration Extension Request
FORM Internal Calibration and Maintenance Record
FORM Defect Report
FORM Calibration Status Report
3.0 GENERAL CALIBRATION INFORMATION

3.1 Responsibilities
3.1.1 Quality Assurance - is responsible for preparing, implementing
and maintaining this procedure. In addition, QA is assigned
Calibration Administration responsibilities as defined in this
procedure

3.1.2 Calibration Administrator/Operations - is responsible for

following the procedure defined in this document.
Receiving Inspection - is responsible for following the procedure
3.1.3 defined in this
document.
Receiving - is responsible for following the procedure defined in
3.1.4 this
document.

3.2 Receipt and Identification of New and Re-Calibrated Equipment

3.2.1 Upon receipt of new company owned Capital Equipment/Assets, the
Receiving Department assigns an Asset number. For equipment
provided by a customer, the Customer's Asset Number or other unique
number shall be used.

3.2.2 All measuring or test equipment (herein after called equipment) that
will be used for judging acceptability of product/material is then
process through Receiving Inspection per BC-QAP-XXX, Receiving
Inspection procedure upon receipt.

3.2.1.1 The Receiving Inspector will contact the Calibration Administrator

who will ensure that the equipment is acceptable and has supporting
documentation certifying the equipment is calibrated when specified
by the BC issued Purchase Order. If the Item requires Calibration, the
Calibration Administrator shall ensure that the equipment is identified
"Held for Calibration" and segregated from use until the Calibration
effort is completed.

3.2.1.2 If the equipment has been calibrated by a calibration service that BC

has determined meets the requirements of ISO 9001 or ISO 17025 with
the necessary NIST traceability, the certification will be accepted. If
not, the equipment will be calibrated before it is put into use.
3.2.1.3 Equipment received that is nonconforming (i.e. damaged, out of
spec., etc) shall be rejected and processed in accordance with
BC-PGP-3001, Receiving Inspection.

3.2.2 After acceptance by Receiving Inspection, the Calibration

Administrator will be contacted to ensure that the equipment is
assigned an Asset Number or unique tracking number (Customer,
Employee or Supplier owned equipment) which is used for the
Calibration Identification Number (CIN).

3.2.3 The equipment CIN or unique tracking number information and

Calibration Label shall be attached or marked onto the equipment or
its packaging material for identification purposes.

3.2.4 When the equipment is exempt from calibration, the equipment will be
marked, tagged, or labeled with "Calibration Not Required" or
“Reference Only”. Defective or out-of-calibration items shall be red
tagged or identified/stored in a manner that makes it clear the items
are not calibrated and shall not be used for conducting test and
inspections on service or products. The item may be painted/marked
or labeled with a Yellow color when labeling or tagging is not practical
(environment or size issues) to indicate for Reference Only/Calibration
Not Required, or red tagged or stored in a clearly posted area to
prevent use all together.

3.2.5 Personal equipment used for judging material/product

acceptability during receiving inspection, inspection, test or
engineering design activities is subjected to the same calibration
and control requirements as detailed in this procedure.

4.0 CALIBRATION REQUIREMENTS

4.1 Control of Calibrated Equipment

4.1.1 All measuring and test equipment that is used to judge acceptability of
materials/products shall be calibrated and traceable to standard(s)
with NIST traceability. The equipment information is entered into the
Calibration Status Report (FORM) excel spreadsheet. Once entered,
the equipment is tracked using the Calibration Status Report (recall)
list by the Calibration Administrator. The following information is enter
into the Part Information screen:

a) Part Number
 b) Model Number
c) Manufactures Name
d) Serial Number
e) Work Center Location
f) Calibration Label Type
g) Calibration Frequency (interval)
h) Equipment Status
i) Service Code
j) Comments

4.1.1.1 Once the equipment successfully completes its calibration

requirements, the Calibration Administrator updates the Calibration
Status Report (FORM) excel spreadsheet. When it is necessary to
prepare a modified Calibration Status Report list for a batch of
equipment placed in the service or production work area, the list shall
contain the same information as the Calibration Status Report (FORM)
plus be dated and approved by the person preparing and maintaining
the list. See Figure 1 - Calibration Documentation Photo(s).

4.1.2 All test equipment that requires periodic calibration will have a label
attached to it per Paragraph 6.0 – "Labels" by the Calibration
Administrator or his/her assigned personnel that shows the following
information:

a. Date of last calibration approval

b. By whom calibrated it or Calibration Administrator Name
c. When next calibration is due
d. Calibration Identification Number (CIN) (Asset Number)

4.1.2.1 If the calibrated Item is small and is normally stored in a protective

box/case/etc., the label containing the above information may be
placed on the Item’s packaging/container. In addition, the Item shall
be marked/tagged/engraved/labeled/etc. with the CIN number that
matches the CIN number on the label placed on the
packaging/container. The CIN number may also be engraved or
permanently marked/tagged onto the asset for tracking and long with
a "Calibrated" sticker that includes the Issued By, Date and Due Date
information.

4.1.2.2 See paragraph 6.1, Labels for typical calibration system labels used.

4.1.3 The Calibration Administrator will maintain a Calibration Status Report

(recall listing). This report will be published as required and identifies all
items due for calibration. Each department assigned calibration
equipment is distributed a copy of the Calibration Status Report and is
 responsible to ensure that all equipment is collected and returned to the
Calibration Administrator for re-calibration. The Department assigned
the Calibrated equipment shall deliver the equipment to the Receiving
Inspection or Calibration Administrator for processing. Each department
supervisor/management person is responsible for reviewing calibrated
and non-calibrated equipment in their area and notifying the Calibration
Administrator if any equipment needs to be added to the Calibration
Status Report.
4.1.3.1 User functions shall use equipment that contains a current calibration
label or Calibration Extension Request approved by the Calibration
Administrator when accepting products/materials for ship to customers.
4.1.4 Departments not complying with this requirement will be reported to
Quality Assurance for corrective action in accordance with BC-QAP-XXX,
Corrective Action(s) System.
4.1.5 All calibration expired equipment removed or not physically removed
from the work area, shall be identified by the using department to
prevent unauthorized use. Typical identification methods include
tagging/labeling as "Out of Calibration" or "Do Not Use - Requires
Calibration".
4.1.6 Any equipment whose accuracy is suspect or found to be functioning
improperly will be tagged/labeled with the deficiency and "Out of
Calibration" or "Do Not Use - Requires Calibration". Any comments or
notes attached to the equipment shall be initialed/signed and dated by
the person recording the information. The Item is delivered to or
removed from the area by the Calibration Administrator for service as
required.
4.1.7 Equipment requiring repair or calibration will be identified, segregated
and held by the Calibration Administrator until pick-up by the
calibration service, or rework/repaired and re-calibrated internally by
BC.

4.1.8 The Calibration Administrator maintains the Calibration Status Report

with necessary information (i.e. Equipment Status or Comments block
on the Part Information screen) of all equipment forwarded to the
calibration service for accountability purposes.

4.1.9 The Calibration Administrator will update the Calibration Status Report
(recall list) status as the equipment is calibrated internally or returned
from the calibration service using the Calibration Status Report (FORM)
excel spreadsheet. All items returned from the external calibration
service shall be routed through the Receiving Inspection area and held
for the calibration Administrator for review and records updating.
4.1.10 If equipment requires extensive repair, the repair cost will be
reviewed by the responsible department supervisor/manager to
determine if the cost justifies the repair. Un-repairable equipment will
be dispositioned in the same manner.
4.1.11 Internal calibration personnel or the calibration service will report all
out of tolerance conditions to the Calibration Administrator. Quality
Assurance will evaluate all out of tolerance conditions to determine
degree of significance and take appropriate action. In general, an out
of tolerance condition of more than 10% of the specified operating
tolerance will be considered significant. The out of tolerance
parameter will be evaluated in conjunction with how the equipment is
used in the actual test environment to determine potential impact on
product quality. If a significant out of tolerance condition could have
affected performance of equipment delivered to a customer, the
customer will be so notified. See paragraph 5.1, Nonconforming
Material.
4.1.12 The Calibration Administrator will notify the using Department
promptly when the equipment is available for reissue.

4.1.13 The environment in which the test equipment is used shall be controlled
in such a manner that measurement accuracy remains within tolerance.
This includes temperature, humidity and overall cleanliness. Each
operator is responsible for proper handling and maintenance of
equipment under use in order to maintain the continued accuracy of the
equipment.

4.1.14 All equipment and facilities used for receiving inspection, inspection
and test activities will be made available to the Customer
representative for needs to be added to the Calibration Status Report.

4.2 Calibrating Activity Approval and Requirements

4.2.1 All calibration subcontractors are evaluated and approved in
accordance with BC-QAP-XXX, Purchasing and BC-QAP-XXX, Supplier
Evaluation and Approval/Disapproval. Each Calibration subcontractors
is considered a Type 1 Supplier and shall be re-approved annually by
Purchasing and Quality Assurance.

4.2.2 The calibration service shall furnish a calibration record and/or a

certificate for the equipment calibrated to assure that established
schedules and procedures are followed to maintain the accuracy of
the equipment and supporting standards. The records and/or
certificates will be filed in the QA Calibration Records file by CIN/Asset
Number and made available for review by authorized Customer
personnel.
The Calibration Certificate provided by a Subcontractor shall include or
provide the following information:
a) Equipment/Instrument Description (i.e. part number/model/serial
number/CIN, etc.)
b) Subcontractors Equipment Standard(s) used identification, NIST
number and calibration expiration date. When the subcontractor is ISO
9001 or ISO 17025, it is acceptable for the Subcontractor to submit the
equipment standards used identification and process method or
equipment ID number assigned to conduct the calibration
c)New assigned Calibration expiration date
d)Subcontractor written approval and date

Example:
Equipment Part Number NIST No. or
Used Subcontractor
Equip./Method ID
to Perform Calibration Expiration Date No. (*)
HP12345 07/09/10 123456778

( When the Subcontractor is not an ISO 9001 or ISO 17025

registered company and does not provide an NIST traceable
number for the standards used, BC shall obtain a copy of the
Calibration Certificate for the standard(s) used to verify traceability
and correct information. This information is filed with the
subcontractors provided Calibration Certificate.

4.2.3 The Calibration Administrator shall file the certificate of calibration

from the subcontractor in the QA Calibration Records file by CIN/Asset
number folder. When the supplier (new purchased items) or
calibration subcontractor assigns their own calibration tracking
number to the equipment, the calibration Administrator shall record
the BC assigned CIN/Asset Number onto the supplier/subcontractor
provided certification and initial/sign and date the recorded
information in order to provide proper certification traceability.

4.2.4 The calibration service will provide an adequate means of protecting

the equipment from deterioration during storage and transportation.

4.3 Calibration Intervals

4.3.1 The Calibration Administrator will determine calibration intervals
based on stability, purpose and degree of usage of each piece of
equipment.
4.3.2 New equipment for which there exists no calibration history will be
initially calibrated at the manufacturer's recommended interval. If not
specified, a one (1) year calibration interval will be used and can be
adjusted by the Calibration Administrator as required based on the
performance of the item.

4.3.2.1 Secondary standards such as gauge blocks, pin gauges,

mechanical measurement and chemical/material standards that
are retained and stored in a protective manner by the Calibration
Administrator are typically assigned a 2 to 10 year calibration
interval as determined appropriate by the Calibration
Administrator.

4.3.3 The adequacy of calibration intervals will be evaluated as the

equipment is calibrated internally or returned from the calibration
service based on the out of tolerance data obtained during
calibration. Equipment that requires no, or minimal, adjustments
during the previous two calibration periods may have its calibration
interval extended at the discretion of the Calibration Administrator.
The equipment initial Calibration Frequency (interval) may be
adjusted by the Calibration Administrator, as warranted, by reviewing
other similar equipment calibration history data.

4.3.4 Equipment that consistently requires extensive adjustment will have

calibration intervals shortened as required to assure continued
accuracy. In these instances, an evaluation of the adequacy of the
equipment, the calibration procedures, and the test procedures will be
made to identify equipment that does not perform satisfactorily.

4.3.5 The equipment Calibration Record files will be kept up-to-date

reflecting current calibration intervals for each piece of equipment
using the Calibration Status Report (FORM ) excel spreadsheet.

4.3.6 The Calibration Administrator may extend the calibration due date of
equipment in emergency situations. The length of extension shall be
determined by the Calibration Administrator based on the complexity
of what is to be tested; and the risk of accepting something bad, or
rejecting something good. Calibration due date extensions will be
based on the results of previous calibrations reflecting satisfactory
stability plus its intended use. See Figure 2 – Calibration Extension
Request. The Calibration Extension Request form shall be placed with
the equipment's QA Calibration Records file by CIN/Asset Number and
a new Calibration Label with the updated information placed on the
equipment (old one is remove
4.3.6.1 For equipment with an extended calibration date, the Calibration
Administrator shall update the Calibration Status Report

4.3.7 When equipment is calibrated internally, the instruction or method is

issued as a separate BC-QAP-XXX, Quality Assurance Instruction.

4.3.8 When internal Calibrations occur and data is retained, the Calibration
Administrator shall record this data using the Internal Calibration
Record form for the applicable equipment CIN/Asset Number.

4.3.8.1 The calibration data may also be recorded as a memo providing

traceability to the item being calibrated. The memo shall include the
assigned CIN/Asset number, variable measurements made and
pass/fail requirements, calibration standard CIN/Asset number used
that is traceable to the NIST standard, method used for calibration,
new expiration date, and date and approval of person performing the
calibration.

4.4 Control of Subcontractors Calibration System

4.4.1 BC purchase orders issued to subcontractors performing
Calibration Services are annotated with the following typical
requirements:

"Calibration Services (Subcontractor)

The Subcontractor performing the BC Purchase Order for Calibration
Services shall maintain a Calibration System in accordance with ISO
9001 or ISO 17025. The Calibration standards shall be traceable to the
National Institute of Standards and Technology (NIST). The
Subcontractor shall maintain part number, serial number and/or
calibration ID number records for each calibration performed that
provide attribute or variable data, traceability to the instrument(s)
used to perform the calibration and traceability to NIST standards.

All detective equipment that requires rework/repair (replacement of

materials) shall be in writing to and approved by BC prior to the
activity being performed. The Subcontractor shall retain all
replacement/defective materials removed from the item and send
them in a bag labeled as defective parts with the Item Calibrated back
to BC.

A Certificate of Calibration shall be issued with each item calibrated.

The certificate shall include the following minimum information:
a) Item P/N, Model, Description Being Calibrated
b) Traceability to NIST, or Subcontractors method (for ISO 9001
or ISO 17025 registered companies only)
c) Calibration Date
 d) Recommended Re-calibration Due Date (See BC PO
requirements, typically 1 year)
The Subcontractors Equipment P/N or Description, NIST Traceability
Number for each equipment used, and Calibration Expiration Date and
Approval signature from the person who is certifying the Certificate
information is true and accurate."

4.5 Rented/Leased or Loaned Equipment Control

4.5.1 Equipment Rented/Leased or Loaned to BC for the purposes of judging
final acceptance of material/products will be handled and tracked in
the same manner normal BC calibrated equipment.

4.5.2 All incoming rented/leased or loaned equipment must include a

calibration certificate traceable to NIST and calibration sticker with
at least 6 months remaining before expiration. If not, the
equipment will be returned to the provider or scheduled for re-
calibration by the Calibration Administrator.

4.5.3 Each rental/lease/loan service will be responsible for the calibration

and maintenance of the rented equipment, unless otherwise
specified by a BC issued purchase order. BC will observe calibration
intervals assigned to the equipment by the respective rental service.

4.6 In-Plant Calibration by Subcontractor

4.6.1 Quality Assurance may direct that the equipment calibration be
performed at BC by an approved calibration service. Such activity will
conform to the requirements stated in paragraph 4.0 of this
procedure. When calibration activities are performed by BC, BC is
considered the calibration service provider and is responsible for the
same activities as the external calibration service defined in this
document.

4.7 Definition for What Needs Calibration

4.7.1 Typically, there are many types and pieces of electronic or mechanical
measuring devices used in the areas of Assembly/Fabrication, Test,
Receiving Inspection, Inspection or Engineering Design. Not all these
items needed to be calibrated. The items that need to be calibrated
are those measurement devices that are used to final accept or
reject customer materials/products based on the Customer order
requirements.

4.7.2 When a Customer order defines specific variable or attribute

requirements, the Material/Product shall be inspected/tested to ensure
each requirement is met. When the “Final Inspection/Test” is
performed (Test or Quality Assurance), the proper measurement device
(10 times better accuracy) shall be selected to make the measurement.
The measurement device that is used to judge final acceptance of these
requirements shall be calibrated as stated in this document. When a
specific requirement
 must be verified at earlier assembly levels (because it can not be
measured at final inspection/test), the equipment used to make this
measurement shall also be calibrated.

4.7.3 Measurement equipment that are used at earlier fabrication levels

(that are not making final acceptance measurements) need not be
calibrated. In order to prevent rejection of acceptable product, Quality
Assurance shall define the means that shall be used to ensure that the
measurement device provides the right level of accuracy needed
without causing the company to be charged for external calibration
costs.

4.7.3.1 When similar measurement equipment are used, multiple

measurements from each piece of equipment shall be made using the
same source and the measurement results compared for differences.
When the differences are minimum based on the measurement type,
Quality Assurance may authorize this piece of equipment for passing
or failing product at earlier fabrication steps before Final
Inspection/Test.

4.7.4 Measurement equipment that is used to make relative

measurements (non-production analysis, line meters or pressure
gauges, etc.) and are not used to accept final product shall be
labeled “REFERENCE ONLY” or “CALIBRATION NOT REQUIRED”. The
item may be painted/marked/tagged Yellow in color when labeling is
not practical (environment or size issues) to indicate for Reference
Only.

4.8 Special Process Equipment/Tool/Fixture

4.8.1 When special equipment/tool/fixture is used during manufacturing to
perform fabrication processes (i.e. component lead forming, crimping,
drill hole locating, etc.), the equipment/tool/fixture shall be labeled
“Calibration Not Required”. When necessary to control these types of
equipment/tools/fixtures, Set-Up or First Article Inspection points are
established during the normal process flow by Quality Assurance.

4.8.2 When the Assembly/Test operator or Quality Assurance finds

that the equipment/tool/fixture is incapable of producing the
needed result or is producing nonconforming material, the
equipment/tool/fixture shall be labeled “OUT OF CALIBRATION”
until repaired or proven to be fixed.
4.8.3 When determined by Quality Assurance that an
equipment/tool/fixture is critical to a specific process, Quality
Assurance may add the item to the normal Calibration System for
control and scheduled calibration purposes. The type of calibration
that shall be performed shall be defined by Quality Assurance.

4.8.4 When a Fabrication/Assembly/Inspection drawing aid is printed to scale

(i.e. 1:1) and is to be used for process control measurement purposes, the
aid's accuracy shall be checked using a calibrated instrument and
approved prior to usage. The aid shall be identified with
a part number and revision and Document Control identification number,
and contain or be stamped/labeled with the following typical
information:

Note:
1.Template is to Scale
2.Verify Lengths Prior to Use
Length Verified by: ______________ Date: _______
Template Accurate to: +/- _______

4.8.4.1 A record showing traceability to the CIN/Asset Number used to check the
aid is not required. Aids are not tracked using the Calibration Status
Report. Aids are removed from usage when destroyed or found not to be
effective by the area group leader/supervisor or Quality Assurance.
Configuration Management is responsible for issuing controlled copies of
drawing aids with part numbers and revisions, and removing obsolete
copies from use. See BC-QAP-XXX, Document Control for additional
information.

4.8.4.2 The area group leader or supervisor, inspector or Quality

Assurance shall verify the drawing aid's accuracy and approve
prior to use.

5.0 QUALITY ASSURANCE

5.1 Nonconforming Material

5.1.1 All product discrepancies shall be recorded using a Defect Report
(DR) form and submitted for disposition in accordance with BC-QAP-
XXX, Nonconforming Material System.

5.2 Audits
5.2.1 Quality Assurance shall be responsible for performing audits as scheduled
per BC-QAP-
XXX, Internal Audits.
6.0 CALIBRATION SYSTEM LABELS

6.1 Labels
6.1.1 The following are typical calibration system labels that are used to
support this
procedure. Calibration Identification Number is assigned by BC in
accordance with this
procedure. Actual visual appearance of the Calibration Labels may
vary for
subcontractors or suppliers of the labels:

CALIBRATED REFERENCE
Expiration
Date:______________ ONLY
Approval:_______
Date:________
(Use with Asset ID Tag )
CALIBRATION
CALIBRATED NOT REQUIRED
By:____________ Date: ________
Due: ____________________

(Use with Asset ID Tag )

OUT OF
CALIBRATED CALIBRATION
CIN No.:___________
Expiration Date:______________
Approval:_______ Date:_______

Note:
1) When a Subcontractor is used to perform Calibration Services, the
Subcontractor’s labels may be used if the label contains the
information specified in this procedure.
 Figure 1 – Calibration Extension Request

Calibration Extension Request

A - GENERAL

Originator Name: ________________________________ Date: ________________

To: Calibration Administrator/Quality Assurance Department

Calibration Identification No.: ________________ Current Expiration Date:

_____________________

Item Description: _______________________________ Location: _____________________________

B – REASON FOR EXTENTION

1) Equipment is involved in Product Testing/Inspection and Customer delivery
would be
impacted if taken out of service. Equipment is in good Working order.
2) Other: __________________________________________________________________
__________________________________________________________________

C – EXTENTION AUTHORIZATION JUSTIFICATION

1) The Item has no history of prior calibration accuracy problems.
2) The Item appears to be in good working order with no obvious physical damage
3) Other: _________________________________________________________________

D–EXTENTION REQUEST APPROVAL

Requested/Authorized New Expiration Date:

_______________

Extension Approved by Calibration Administrator: ____________________ Date:

_____________