04 200011 01e
2010-01-14
: Microscan 04-200011 04-200011 aboutus_pdf
Open the PDF directly: View PDF 
.
Page Count: 7
Form 05-000034 Rev. K
Revision Record (only the last 25 records are listed in this page. See Doc. History for more information):
Rev. Description By Date Checked
A Initial Release E.W. 10-1-99
B Changes in requirements N.A. 2/13/01
C Change Section A-3, DCR#13987 C.B. 12/19/05 Linda Dove
D Update DCR#14336 C.B. 7/26/06 Linda Dove
E Update and clarify DCR#15226 C.B. 5/9/08 R. Mustard
Notes:
It is the user’s responsibility to ensure that this document is the current revision.
All Quality Management System documents are maintained on the Document Control publicread drive.
For approval signatures and detail information on changes see the DCR forms located in “Hist” folders located on the Document
Control drive in the drawings folder.
Component Qualification Procedure
ORIGINATOR Eric Wash DATE: 10/1/99
Size Doc. # Rev.
A 04-200011-01 E
Component Qualification Procedure 04-200011-01 Rev. E
Page 2 of 7
Contents
PURPOSE ......................................................................................................... 2
SCOPE .............................................................................................................. 2
REFERENCES .................................................................................................. 2
PROCEDURE.................................................................................................... 2
SECTION A. COMPONENT QUALIFICATION PROCESS ....................................... 2
SECTION B. COMPONENT DOCK TO STOCK PROCESS..................................... 4
SECTION C. COMPONENT DE-CERTIFICATION PROCESS.................................. 4
SECTION D. QUALITY RECORDS – COMPONENT QUALIFICATION REPORTS ......5
TABLE 1 – COMPONENT QUALIFICATION LEVELS....................................6
FLOWCHART – COMPONENT QUALIFICATION PROCESS........................ 7
Purpose
The purpose of this procedure is to provide a common qualification methodology that applies to all purchased custom
inventory components for Microscan Systems, Inc. It shall be used in parallel with the Supplier Quality Management
Program.
Scope
This procedure applies to all custom inventory components of Microscan Systems, Inc.
References
04-200009 Supplier Quality Management Procedure
04-200010 First Article Inspection Procedure
04-110014 ECN Procedure
04-210004 Process Capability Procedure
04-000024 Corrective/Preventive Action Request Procedure
Procedure
Section A. Component Qualification Process
Responsibility Action
Quality, Purchasing,
Engineering
A-1 New parts shall be released at “Engineering (E)” or “No Inspection
Required (NIR)” Status based on the Quality Engineer's review (See New
Part Number Request Procedure). These are the only two qualification
levels available for new parts. The proper qualification level is chosen
based primarily on the part classification:
Custom parts: parts manufactured entirely per Microscan design.
Component Qualification Procedure 04-200011-01 Rev. E
Page 3 of 7
Spec-controlled parts: parts wish some specifications controlled by
Microscan (e.g., power supplies, motors)
Source-controlled parts: standard off-the-shelf components
Custom and spec-controlled parts are generally released as qualification
level E, while source-controlled parts generally do not have inspection
requirements, and are released as NIR. In each case, the appropriate
status shall be determined by the Quality Engineer.
Component Qualification Levels: Engineering (E), Pending First Article
(PFA), Approved (A), Dock to Stock (DTS), No Inspection Required (NIR)
and Obsolete (OBS) (See Table 1 for Detail).
Quality Engineer A-2 Parts classified as NIR will not have any inspection requirements. This
status will be noted in Visual and the Purchased Part Quality Database.
Quality Engineer A-3 For parts classified as E, Quality to provide information to Engineering on
supplier selection, as necessary and available.
Purchasing A-4 If required by Engineering, engineering parts may be ordered for
engineering evaluation and prototyping purposes. Quality will provide
inspection support to engineering to aid in the evaluation of the parts.
Quality, Engineering,
Purchasing
A-5 Drawing Review with supplier. A review should be conducted with the
supplier to assure all requirements can and will be met. Key
characteristics should be identified. Changes to drawings shall be
requested via the ECN procedure.
Quality Assurance A-6 Upon completion of a drawing review with the supplier, the component's
qualification level shall be promoted to Pending First Article (PFA).
Also, parts that have been changed through the ECN process (new dash
numbers) enter this process here and are reverted to PFA status
regardless of their previous status.
The status shall be recorded in the Visual Manufacturing database and the
Purchased Part Quality Database (PPQD).
Quality Assurance A-7 Production First Article Inspection. First article inspection will be performed
on the component in accordance with the First Article Inspection
Procedure.
Quality, Engineering A-8 Perform reliability or other testing required by the quality plan. This
reliability testing, or at least preliminary testing, may be required prior to
approval for certain components such as motors. On other components,
testing may be completed after component approval. This decision will be
made by the Quality Engineer.
Quality A-9 Upon first article inspection approval, component is promoted to
“Approved (A)” Status. “Approved (A)” Status shall continue to require
Receiving Inspection. The Approved status shall be recorded in the Visual
Manufacturing database and the Purchased Part Quality Database
(PPQD).
Quality A-10 Data on key characteristics from the first production shipment made may
be requested by the Quality Engineer depending upon the criticality of the
component and its key characteristics. Alternatively, data collected from
engineering shipments may also be used. If such data is obtained, it will
be evaluated for process capability and the information used to take any
necessary actions on the process or design.
Quality A-11 Part quality will be monitored through receiving inspection and review of
Component Qualification Procedure 04-200011-01 Rev. E
Page 4 of 7
production defects. Unsatisfactory performance may lead to Supplier
Corrective Actions.
Section B. Component Dock to Stock Process.
Responsibility Action
Quality B-1 In order to promote a part to “Dock to Stock” status the following
requirements must be met.
Acceptable process capability (Cpk>1.3) across five consecutive
shipments. The shipments must come from distinct production lots from
approved suppliers.
Or
1. Demonstration by supplier of the existence of a process with adequate
process controls that ensure process stability and identify any process
instability prior to shipment to Microscan, if such circumstances should
arise. This final condition shall be demonstrated through supplier
documentation and/or Microscan audits of the supplier.
2. No receiving related “negative” incidents over past 12 months from a
single supplier.
3. No Service or field related “negative” incidents over past six months.
Completion of any required reliability tests, as defined in the parent
product’s Quality Plan.
B-2 These requirements will be shown to be met in a Component Qualification
Report prepared by the Quality Engineer and approved by the Quality
Manager.
Quality B-3 Upon successful completion of the above requirements, the part may be
promoted to “Dock to Stock” (DTS) status in the Visual
Manufacturing/Purchased Quality Database that will be denoted as
DTS/supplier name/CofC example: DTS/Gee Plus/CofC, if a certificate of
conformance is required. Receiving will ensure that part has the approved
Dock to Stock supplier and CofC is present if applicable. If shipment fails
to meet the set criteria than the shipment will be forwarded to QA
Receiving for Inspection.
Section C. Component De-Certification Process.
Responsibility Action
Quality C-1 It may be necessary to de-certify a part from “Dock to Stock” status based
on quality performance issues. Issues that may lead to de-certification
include supplier attributable major “negative” incident that impacts
Microscan Systems, Inc. Production Lines or Microscan Systems, Inc.
Customers.
Quality C-2 Quality Engineer will demote the part status from “Dock to Stock” to the
appropriate status in the Visual Manufacturing Database. Purchasing and
Supplier to be informed of change and a SCAR may be requested if
Component Qualification Procedure 04-200011-01 Rev. E
Page 5 of 7
appropriate.
Quality C-3 Unless otherwise stated, the part must complete the requirements in
Section A and B based on its qualification status in order to be promoted
back to “Dock to Stock” status.
Section D. Quality Records – Component Qualification Reports
Responsibility Action
Quality D-1 Collected: Quality Engineer to create and obtain approval.
D-2 Indexed/Filed: Receiving Inspection History Files by part number.
D-3 Storage: Receiving inspection area file cabinets. Electronically on
shared drive O://Public Read/QA/Component
Qualification
D-4 Access: Open to all Microscan employees, customers, and
designated parties.
D-5 Retention Time: Qualification Reports will be maintained for life of the
part.
D-6 Disposal: Qualification Reports will be disposed or recycled after
retention period.
Component Qualification Procedure 04-200011-01 Rev. E
Page 6 of 7
Table 1 – Component Qualification Levels
Qualification Level Description of Activity Requirements to Promote
Engineering (E) Engineering evaluation, components required for
engineering evaluation and prototype builds.
Engineering First Article Inspections
as required, Document review
completed with supplier, Qualification
Plan completed.
Pending First Article
(PFA)
Qualification for approval is in process. Component
requires Production First Article Inspection. Generally
used for pilot and pre-production builds.
Approved Production First Article and
any required reliability tests
Approved (A) First article meets drawing requirements.
Receiving Inspection is required in accordance with
the Quality Plan.
Full proof of ability to maintain stable
process at acceptable process
capability and completion of all
reliability testing
Dock to Stock (DTS) Inspection at Microscan Systems, Inc. has been
eliminated. Parts may be audited for verification
purposes.
N/A
No Inspection
Required (NIR)
Components that are typically “off the shelf” or “bin
stock.” (i.e. standard hardware, passive components,
etc…)
No inspection required. Receive
directly to stock.
Obsolete (OBS) Part is no longer used and drawing in document
control has been changed to obsolete.
N/A
Component Qualification Procedure 04-200011-01 Rev. E
Page 7 of 7
Flowchart – Component Qualification Process
Part Number
released
New part or
part change?
set status as NIR
(No Inspection
Required) in Visual
and PPQD
set status as E
(Engineering) in
Visual and PPQD
select supplier and
perform drawing
review with
supplier
set status as PFA
(Pending First
Article) in Visual
and PPQD
perform First
Article, and other
testing in Quality
Plan as needed
passed FA and
testing?
issue SCARs,
take action
set status as A
(Approved) in
Visual and PPQD
monitor quality
through receiving
and production
data
performance
acceptable?
issue SCARs, set
special inspection or
data requirements in
PPQD and POs,
disapprove if necessary
candidate for
Dock to Stock
(DTS)?
collect process
capability data, process
information, review
history
meets DTS
requirements?
set status to DTS
(Dock to Stock) in
Visual and PPQD
monitor quality
through receiving
and production
data
performance
acceptable?
change status to A
(Approved) in
Visual and PPQD
inspection
required?
issue SCARs, set
special inspection or
data requirements in
PPQD and POs,
disapprove if necessary
new part
yes
no
part
change
no
yes
no
yes
no
yes
yes
no
yes
work with supplier to
improve process,
remain in Approved
status, or move part to
another supplier
no
