1. Healthcare

Mil-I-45208
Inspection System
Policy Manual
Author: Randy Cantu
Form #422A, Rec. “N/C”
Printed
01/01/2010
Policy No.:
QPM-001
Approved By:
Inspection System Manual
Contact List
Vince Ngam – PRESIDENT
PH: 1-800-613-8560
FX: (714) 543-3030
EMAIL: [email protected]
General Manager: Vince Ngam
PH: (714) 675-3395
FX: (714) 543-3030
Dan Salazar – Quality Manager
PH: (714) 852-2395
FX: (714) 543-3030
EMAIL:[email protected]
QUALITY CONTROL
PH: (714) 675-3395
FX: (714) 543-3030
Author: Dan Salazar
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Table of Contents
Contact List
P.
2
Table of Contents
P.
3
1.0 – Scope
1.1 – General
1.2 – Application
P.
P.
P.
4
4
4
2.0 – Normative Reference
P.
4
3.1 – Inspection System Requirements
3.1.1 – Management Responsibility
3.1.2 – Communication
3.1.3 – Customer Communication
P.
P.
P.
P.
6
6
9
9
3.2 – Documentation, Records and Corrective Action.
3.2.1 – General Requirements
3.2.2 – Documentation Requirements
3.2.3 – Records
P.
P.
P.
P.
10
10
11
12
3.3 – Measuring and Test Equipment
3.3.1 – Control of Monitoring and Measurement Devices
3.3.2 – Process Controls
P.
P.
P.
16
16
17
3.4 – Indication of Inspection Status
3.4.1– Identification and Traceability
P.
P.
18
18
– Government/Customer – Furnished Material
3.5.2 – Control of Customer Property
3.5.3 – Preservation of Product
P.
P.
P.
20
20
20
3.6 – Nonconforming Material
3.6.1 – Control of Nonconforming Product
P.
P.
22
22
3.7 – Qualified Products
P.
24
3.8 – Sampling Inspection
P.
25
3.9 – Inspection Provisions
3.9.1 – Inspection Process Overview
P.
P.
26
26
3.10 – Government/Customer Inspection at Subcontractor or Vendor Fac.
3.10.1 - Government/Customer Inspection Requirements
3.10.2 – Purchasing Documents
3.10.3 – Reference Data
P.
P.
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27
27
28
3.11 – Receiving Inspection
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Author: Dan Salazar
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3.12 – Government/Customer Evaluation
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Attachment ‘A’ – “Khom Asset List”
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Author: Dan Salazar
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3.11.1 – Verification of Purchased Product
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1.0 – Scope
1.1 – General
Khom machining promotes a planned, systematic, process approach for the development, implementation and
continuous improvement of its Quality Management System so as to enhance and improve customer satisfaction by
determining and then meeting or exceeding our customers and/or Government/Customer requirements.
Khom machining has a tradition of quality and service that began in 1998 and continues to thrive. Our
commitment to quality has kept us at the forefront of the machining world. Our equipment and
experienced staff allows us to meet or exceed the customer’s specifications. Our expertise in the
machining process enables us to deliver quality on time, defense, medical, automotive, commercial,
hydraulic, and many others. We have all types of services. Essentially, a one stop shop for metal finishing
and precision manufacturing. Khom machining is capable of prototype, short run, long run as well as high
volume production.
Our mission is to provide a high quality product on time, at a fair price and excellent customer service.
Please review our website www. for our capabilities and/or call us or email us for more information.
1.2 – Application
A Quality Policy Manual, that describes the policies and companywide control systems for the Quality
Management System The Planning, development and implementation of the Quality Management
System meets the requirements of Mil-STD-45208.
2.0 – Normative Reference
2.1
The extent and management of the Quality Management System and supporting manuals, procedures,
work instruction, objectives, documentation and records are based on the requirements identified in MIL-I45208A – Military Specification, Inspection System Requirements, limited only by the size of the
Company Facility, Customer and Government/Customer Requirements as may be imposed, as well as
the training needs of our employees and the complexity of the processes and objectives undertaken by
the Company.
The following documents are identified as ‘Reference Documents’ to this manual, whose revision control
is the latest approved version available…
MIL-I-45208A – Military Specification, Inspection System Requirements
ISO 9000 – Quality Management Systems – Fundamentals and Vocabulary
ISO 10012 – Measurement Mgt. Systems – Req’s for Meas. Processes and Meas. Equipment
ISO 19011 – Guidelines for Quality and/or Environmental Mgt. Systems Auditing
ISO/TR 10013 – Guidelines for Quality Management Systems Documentation
ISO 17025 – General Requirements for the Competence of Testing and Calibration Laboratories
2.1.1.1
For the purpose of this Inspection System Policy Manual and all supporting documentation, the terms
and definitions given in ISO 9000 apply to this manual and supporting documentation and records.
Author: Dan Salazar
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3. Inspection System Requirements
3.1 Management Responsibility
Khom machining tech shall provide and maintain an inspection system which will assure that all supplies
and services submitted to the Government/Customer for acceptance conform to contract requirements
whether manufactured or processed by the contractor, or procured from subcontractors or vendors.
We shall perform or have performed the inspections and tests required to substantiate product
conformance to drawing specifications and contract requirements.
And shall also perform or have performed all inspections and tests otherwise required by the contract.
.
..
.
Our inspection system is documented, and is available for review by the Government/Customer
Representative prior to the initiation of production and throughout the life of the contract. The.
.
Government/Customer at its option may furnish written notice of the acceptability or non-acceptability of.
the inspection system.
We. shall notify the Government/Customer Representative in writing of any change to the inspection
system.
The inspection system revision, or a proposed revision shall be disapproved if such changes thereto
would result in nonconforming product.
3.1.1 – Management Commitment Policy
3.1.1.2 – Responsibility and Authority (Continued)
3.1.1.2.1 The general processes and lines of communication are illustrated in the Organization Chart. A more
specific definition for those responsibilities of the various positions of responsibility is described below,
(but not limited to)…
3.1.1.2 – Responsibility and Authority (Continued)
3.1.1.2.2 The Senior Executive of Operations is Mr. Vince Ngym (President/CEO).
3.1.1.2.3 The general processes and lines of communication are illustrated in the Organization Chart. A more
specific definition for those responsibilities of the various positions of responsibility is, (but are not limited
to)…
Author: Dan Salazar
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A)
President/CEO:
I)
II)
III)
IV)
V)
VI)
VII)
VIII)
IX)
X)
XI)
Planning, developing and establishing policy and objectives for the company.
Establishes, determines and reviews for relevance the Quality Policy and objectives.
Communicates policy, customer requirements and quality objectives to the
management of the company.
Performs objective Quality Audits of the Quality Assurance Department, focus of this
audit is Quality Assurance’s ability to perform objective Quality Audits of product.
Review reports and financial statements to determine progress towards attaining the
goals and objectives of the company and our customers.
Reviews Reports to monitor and make necessary decisions to assure the financial
well being of the company.
Authorizes the issuance of resources required to achieve planned results.
Is designated the Authority and Responsibilities of Chief Financial Officer.
Oversees the Financial wellness of its entirety.
Reviews and approves the companies or persons who provide the company with the
following services: Legal representation, Financial/Accounting, Insurance, etc.
The President in addition to his/her regular duties is granted additional authority to…
 Establish, implement and maintain the Quality Management System and those
actions necessary to achieve planned results.
 Report on the performance of the Quality System to Executive Management for
review and as a basis of improvement.
 Ensure the integrity of the Quality Management System and its Objectives at times of
implementation and revision.
 Identify Quality Problems.
 Initiate, recommend, provide for and verify the implementation of effective solutions
and preventative actions as may be required for continuous improvement.
 Act as Program Manager and facilitator of the Quality Management System.
 Develop and implement (at relevant functions and levels) objectives, procedures,
control plans, work instructions and other practices as may be required to promote an
effective Quality Assurance Management Program.
 Aid in the determination of Customer Requirements & Participate in Engineering
Design reviews of product prior to manufacture.
 Ensure the promotion of customer awareness requirements throughout the
organization.
 Communicate with and act as Company/Customer liaison in quality matters.
 Communicate with and request data from customers, suppliers, agencies, internal
departments and other company level managers concerning quality matters.
 Act as Management Representative on matters concerning Government/Customer or
Other Type Requirements implementation and Quality Management System
integration and integrity.
 The Development, Review and Implementation of Formal Training and Training
Practices in Quality Management System Specifics and Theory.
Author: Dan Salazar
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3.1.1.2 – Responsibility and Authority (Continued)
3.1.1.2. A – Management Representative
3.1.1.2. A.1
The designation ‘QMS Management Representative’ and those responsibilities affiliated with the
designation are allocated to the President, whose responsibilities encompass development and review of
the Quality Policy Manual, Quality System Procedures, Supporting Work Instructions and other Records
and Forms Development and Control.
3.1.1.2. A.2
Designated Individuals and Their Specific Authorities and Responsibilities, as required to
effectively function in accordance with Governing Specifications are identified in the fore mentioned
documents (QPM, QSP’s & W/I’s).
3.1.1.2. A.3 Regardless of other responsibilities the QMS Management Representative primary function is afforded
the organizational freedom to ensure that the Quality Management Systems, Planning and Reviews are
conducted with the aim of identifying customer requirements and to resolve matters pertaining to quality,
thus ensuring the enhancement of customer satisfaction and process’s performance. This function is
performed in such a manner, so as, the development and implementation, is concurrent with the
requirements as set forth in Mil-I-45208.
B)
General Manager:
I)
II)
III)
IV)
V)
VI)
VII)
VIII)
IX)
X)
Reports directly to the President and is responsible for the overall effectiveness of the
Facility and Department Wellness therein.
Reviews the status, effectiveness and improvement of the Quality Management
System.
Other responsibilities include the planning, development and implementation (at
relevant functions and levels) of organizational policies and objectives.
Authorizes the issuance of resources required to achieve planned results.
Reports directly to the President and whose responsibilities include directing the
following activities, Accounting, Payroll, Marketing, Sales, Purchasing,
Manufacturing, Quality Assurance Objectives, Human Resources and Customer
Service.
His/her particular concern will be with the determination of inspection methodology
for the purpose of product review and conformity determination as well as Inspection
Department throughput.
Reviews the status, effectiveness and improvement of the Quality Management
System.
The General Manager is directly responsible for those activities concerning the
determination of Customer Requirements, Planning, as well as the Design and
Development of product to achieve planned results and enhance customer
satisfaction.
Other responsibilities include the planning, development, training (of employees) and
implementation (at relevant functions and levels) of organizational policies and
objectives.
Authorizes the issuance of and maintenance, resources required to achieve planned
results.
Author: Dan Salazar
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XI) Authorizes the issuance of resources required to achieve planned results.
XII) Reports directly to the President and is responsible for the overall effectiveness of
the Accounting, Payroll, Marketing and Sales activities.
XIII) Aids in the Planning, developing and establishing policy and objectives for the
company.
XIV) Establishes, determines and reviews for relevance the Quality Policy and objectives.
Communicates policy, customer requirements and quality objectives to the
management of the company.
XV) Daily electronic communications control and maintenance.
3.1.1.2 – Responsibility and Authority (Continued)
3.1.1.2.A – Management Representative
XVI) Reports directly to the President and is primarily responsible for those activities
concerning the Purchasing, Storage, Scheduling, Forecasting, Processing and
Delivery of product and other essential resources required for the achievement of
planned results and the smooth flow of product through the entire manufacture
process.
C) Production Manager:
I)
Reports directly to the General Manager and is primarily responsible for those activities
concerning the manufacture and processing of product at the component level. This direction
of activities should be planned to ensure results and that those processes used are
accomplished in an efficient and timely manner through delivery to the customer.
II) Other responsibilities include the planning, development, training (of employees) and
implementation of policies and objectives.
III) Reports directly to the General Manager and is primarily responsible for those activities
concerning Product Manufacture Scheduling and production manufacture departmental
review, analysis and reporting.
IV) Supervision of the Shipping and Receiving activities and personnel.
V) Customer Service activities and subsequent actions and reporting.
VI) WIP control and follow up activities.
VII) Other responsibilities include the planning, development, training (of employees) and
implementation of policies and objectives as may be applicable.
VIII) Reports directly to the General Manager and is primarily responsible for those activities
concerning the Product Realization Planning both In-puts and Out-puts in accordance with
Approved Procedures.
IX) Update and Maintenance of Manufacture Data Base.
X) Design and development of Manufacture Methodology and is Technical Liaison for
Manufacturing.
D) Manufacturing Lead:
I)
Reports directly to the Production Manager and is primarily responsible for those
activities concerning the production and assemblage of product and sub-assemblies.
Author: Dan Salazar
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This direction of activities should be planned to ensure results, and that those
processes used are accomplished in an efficient and timely manner through delivery
to the customer.
II) Other responsibilities include the planning, development, training (of employees) and
implementation of policies and objectives
III) Oversees the Tool Crib and activities.
3.1.2 – Communication
3.1.1.3.1 The general processes and lines of communication are illustrated in the Organization Chart. For a more
specific definition for those lines of communication, responsibilities of the various positions of
responsibility, reference Sect. 3.1.1.2 - Responsibility and Authority, and 7.2.3 - Customer
Communication of this Manual.
3.1.3 – Customer Communication
3.1.3.1
Khom Machining has planned, developed and implemented those procedures necessary for effective
communication(s) relating to the customer and product desired.
3.1.3 – Customer Communication (Continued)
3.1.3.2
These communications include (but are not limited to) Customer inquiries, Product Information, Contacts,
Contracts or Order Handling, Commitments to Perform Work, Amendments, Customer Feedback as well
as Customer Complaints, Advisory or Government/Customer Requirements or Notices.
3.1.3.3
Pertinent records developed from these conversations are maintained.
Author: Dan Salazar
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3.2
Documentation, Records and Corrective Action.
3.2.1
Inspection and Testing Documentation
Inspection and testing shall be prescribed by clear, complete and current instructions.
The instructions shall assure inspection and test of materials, work in process and completed articles as
required by the item specification and the contract.
In addition, criteria for approval and rejection of product shall be included.
3.2.1.1– Determination of Requirements Related to the Product
3.2.1.1.1
Khom Machining Tech has planned, developed and implemented procedures
necessary for the planning, determination and identification of those requirements as designated by
governing statutory and Government/Customer agencies as well as those specified by the customer,
encompassing pre to post-delivery activities .
3.2.1.2
Where known, ‘O.E.M., has taken into consideration those requirements as designated
by governing statutory and Government/Customer agencies (where applicable), and as a manufacturer,
those requirements not stated by the customer, but are necessary for a products intended use.
3.2.1.3
‘We, shall determine and implement any additional internal quality and organizational
requirements as necessary to achieve product realization.
3.2.2.1– Review of Requirements Related to Product
3.2.2.1.1
Kham Machining Tech has planned, developed and implemented procedures necessary for
the review, prior to its commitment to supply product to the customer, of those requirements identified as
related to the customer and product desired.
3.2.2.1.2
a)
b)
c)
d)
e)
f)
documented.
These procedures ensure that …
Product and Government/Customer requirements are adequately defined and documented.
Contract and order requirements that differ from those previously expressed are resolved.
The Organization has the ability to meet those requirements as defined.
Identified Risks (e.g., new technology, short delivery time scale) have been evaluated.
Customer-specific requirements are identified and conformance verified.
Changes/Amendments to Purchase Orders/Contracts, Drawings or Specifications are verified and
3.2.2.1.3 Purchase Order/Contract amendments are reviewed and approved through a similar process.
3.2.2.1.4 Records of these reviews and the actions taken thereof are developed and maintained.
3.2.2.1.5 When the customer provides no documented statement of requirement, Customer Requirements are
identified and confirmed prior to acceptance of the Purchase Order/Contract.
Author: Dan Salazar
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3.2.2.1.6
Changes/Amendments to Purchase Orders/Contracts, drawings or specifications are verified and
documented, the relevant documents revised and appropriate personnel are notified of the approved
changes in requirement.
3.2.2.1.7
Records of these Purchase Order/Contract reviews, as well as those reviews for amendment to the
same and others are developed and maintained.
Author: Dan Salazar
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3.2.3 Records
Khom Machining Tech. shall maintain adequate records of all inspection and tests.
The records shall indicate the nature and number of observations made, the number and type of
deficiencies found, the quantities approved and rejected and the nature of corrective action taken as
appropriate.
3.2.3.1
QC Inspector reviews History Records for completeness and if acceptable to requirements, initials and
dates and files records in the Device History File and maintains.
If the Document Package is non-conforming to requirements will identify the non-conformities on the files
manila folder and forwards to the General Manager for review.
3.2.3.2
President requires the correction if all history records prior to their closure and retention.
3.2.3.3
QC Inspector shall develop and Maintain (within the Configuration Control File) all Approved Inspection
Reports (Form 824 A - Inspection Report) in accordance with those Instructions described in Form 824 A
- Inspection Report Release.
3.2.3.4
Verifies the accuracy, require the correction of and or accept all Inspection Reports developed for use
Upon acceptance of the Inspection Report shall identify his/her approval for release by stamping the
lower Right Corner of the Form 824 A - Inspection Report, and return to Doc. Control for control.
3.2.3. A - Receiving Inspection
3.2.3. A.1 Ship/Rec Clerk Verifies Receipt of Material, logs receipt of material and ensures its proper storage
according to material control procedures.
3.2.3. A.2 At each stage of the production process, inspects material, under controlled circumstance, for
conformance to requirements as defined in Traveler and records the results of such inspections.
3.2.3. A.3 If materials and documentation are found to be conforming, Completes, Stamps, and Dates all applicable
Documentation and Records in accordance with this and other supporting Procedures and Instruction.
Upon detection of a product nonconformance, completes a withholding Report as per QSP 830 – Control
of Nonconforming Product ensuring the reason and quantities of nonconforming materials are identified,
segregated and controlled appropriately.
3.2.3. A.4 Reviews and Dispositions all Nonconforming Materials and Reports in accordance with QSP 830 –
Control of Nonconforming Product
3.2.3. B – First Piece Inspection
Author: Dan Salazar
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3.2.3.B.1 The Production Set-Up person shall measure, record and submit for Set-up Inspection, a representative
sample of product, a completed “Form 824 A - Inspection Report” with all applicable dimensional and
Traveler Sequence Information recorded and within applicable tolerances and no less than 3 sequential
parts to the Inspection Department for Measurement Validation.
The Traveler (Form 753 A - Manufacturing Job Traveler) is the most important of all Production
Documents used during the manufacturing process. It lists all of the Operation Instruction and Customer
Quality Requirements to be followed during the Product realization Effort.
DOES NOT ACCEPT AN OPERATON UNLESS THE PREVIOUS OPERATON HAS BEEN
COMPLETED AND ACCEPTED, Or MANAGEMENT AUTHORIZATION HAS BEEN GRANTED FOR
CONSECUTIVE MANUFACTURE OF SUBSEQUENT TRAVELER SEQUENCES.
For times when Consecutive Manufacture of Product on Multiple Machines, copies of Original Traveler
shall be made and kept with the product assigned to that separated materials run, noting such
Authorizations on Both/All Applicable Traveler Copies. Copies of the Traveler are not considered valid
unless the inspection approvals contained on the Original Traveler are transferred by the Quality
Representative who originally approved the operation (or the QA
3.2.3. B.2 This operation can only be performed when the Original Traveler is made available and the Inspection
Approvals validated.
The Inspector performing the re-stamping of the Traveler will place the newer stamps and present date
alongside the Original Approval Stamp.
3.2.3. B.3 The Quality Inspector shall perform Set-Up Inspection Verification (First Article), by mechanically verifying
and documenting the results of all applicable Drawing dimensions as may be applicable to that specific
Traveler Sequence Operation in accordance with this and other applicable PFD Policy, Procedure and
Instruction.
The dimensions to be checked shall be listed on the previously developed "Form 824 A - Inspection
Report” (Network Address: J:\1st Article\Part Number) as Identified in the Traveler Sequence Instruction
for that Specific Traveler Sequence. Unless specific methods or tools are listed on the Traveler, the
inspector may use discretionary judgment on the choice of tools.
The Inspector shall validate and record all applicable product features and attributes for that Set-up
Sample of product(s) in accordance with the Drawing, Traveler and Inspection Report Instruction. The
Range of each Sequence Dimension shall be logged at the time of validation for review and subsequent
Set-up Part Sample Analysis.
When the Drawing Requirements Inspection of the submitted samples yields acceptable results, the
inspector shall complete the ‘Form 824 A - Inspection Report' and Form 753 A - Manufacturing Job
Traveler Release Instruction accordingly.
All of the dimensions, which are to be monitored during production, shall be identified for Operator
verification. Pre-developed Inspection Reports forms are available on the Computer and are available for
use, in so long that the Revision of the Product matches that as listed on the report. The Measurement
Author: Dan Salazar
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Ranges for each Drawing Dimension shall be recorded in accordance with “Form 824 A - Inspection
Report Release”.
Upon acceptance of the Samples Dimensional Variables and Attributes, the Inspector shall Stamp, Sign
and Date the appropriate Traveler "Form 753 A - Job Traveler” Sequence Approval Blank (Ref. Form 753
A - Manufacturing Job Traveler Release, Seq 36 through 39).
The "Traveler" (for reasons concerning traceability) is the official "Quality Record" and must be complete
for all previous operations before a new set up can be approved (except on Traveler where simultaneous
operations are required and Authorized by Management).
The receipt and validation of the Raw Material must be accepted and the P.O. Number transferred to the
appropriate sequence on the "Traveler".
3.2.3. C – First Piece Inspection (Continued)
3.2.3. C.1 Upon completion of the Set-up Inspection Review and Appropriate Documentation, the Traveler Package
is returned to the Machine for Operator use in the manufacture of the product and a representative
sample is saved on the In-process Inspection Job Board for future reference. The sample part shall be
returned to the manufacture lot prior to transfer to the next Job Traveler manufacture sequence for further
processing.
If the Set-Up parts are found to Non-conforming to requirements, the Suspect product are to be identified
and processed in accordance with QSP 830 - Control of Nonconforming Product. The Set-up Records
noted accordingly and returned to the Set-up person for Machine Adjustment.
3.2.3. D – In-process Inspection
3.2.3. D.1 Setup Person Performs in process Inspection validation in accordance with QSP 824 - Monitoring &
Measurement of Product and specific instruction received at the beginning of the Machine Operation
Authorization.
3.2.3. D.2 QC Inspector. Performs in process Inspection validation in accordance with QSP 824 - Monitoring &
Measurement of Product and specific instruction as identified on the Form 824 A – Inspection Report.
3.2.3. D.3 General Manager: May elect to perform Statistical Process Review in accordance with QSP 840 Analysis of Data
3.2.3. E – Final Inspection
3.2.3. E.1 QC Inspector Verifies Accuracy of Shipping Documentation, ensuring the Delivery documents contains
the following:
Verify that all operations on the Traveler have been performed and accepted.
Author: Dan Salazar
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Reviews the Network Directory "J:\Quality Engineer (Year)\NCMR (Year)” and check under NCMR
No/Part No./Cust Name (Date), to determine if there are any Open or Closed NCMR’s against that
Product Lot. To be shipped.
If there are Closed/Dispositioned NCMR’s against the Product in question, the Inspector shall review the
Product to ensure that all Non-conformances Identified are not present/been repeated on that Product Lot
awaiting shipping release.
If there are open NCMRs, the Device Traveler and all supporting documentation shall be forwarded to the
Quality Assurance Manager for MRB dispositioning per QSP 830 - Control of Nonconforming Product.
3.2.3. E.2 QC Inspector Validates and records all applicable product features and attributes for that Final Inspection
Sample of product(s) in accordance with the Drawing, Traveler and Inspection Report Instruction and WI 824
C - Final Inspection.
Upon acceptance of the Products Attributes and Variables, the Inspector shall complete the Device Travelers
Final Inspection Sequence Information, develop a Final Inspection Report, by transferring the Inspection
Measurement Results and Pertinent Information to a New Computer Generated Inspection Form, printing two
completed copies and Stamping as required per Form 824 A – Inspection Report Release and forwards to the
Shipping clerk for Packaging and Delivery.
Author: Dan Salazar
Form #422A, Rev. “N/C”
Printed
01/01/2010
Policy No.:
Approved By:
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3.2.3. F – Packaging Inspection
3.2.3. F.1 Ship Clerk Ensures that all documentation records are complete and accurate.
Packages Product as per QSP 750 - Production Provision and performs any special instruction as listed on
the For 753 a – Job Traveler.
Prepares copies of the Product and or Process Certifications (Material Test, Supplier Added Value Process
Certification and SPC charts) as may be required per customer or regulatory requirements to accompany the
Shipping Document Package.
3.2.3. F.2 General Manager Performs Final Shipping Inspection of Product Documentation and Product Packaging in
accordance with applicable Customer or Regulatory Requirements or PFD’s Standard Packaging Processes
(Package for Protection from Damage) and accepts as is or requests changes so as to ensure the protection
of product to requirements.
Ensures that all documentation records are complete and accurate and the Delivery documents contain the
following (at a minimum):
1) Part and revision numbers, revision numbers matches the traveler
2) If there is a difference between the 2 documents, discuss the matter with the Q.A.
Manager.
3) Listed quantities, along with Customers P.O.#, and the PFD Traveler Number and
Shipper Number. If any of these items are missing, return the document to the originator
of the document.
Signs and Stamps Final Inspection Sequence Information on the Form 753 A – Job Traveler and Dates
accordingly.
When all steps are completed, Signs, Stamps and Dates Certificate of Conformity accordingly and releases
the shipment to the shipping/receiving clerk for delivery.
3.2.3. F.3 Ship Clerk Arranges delivery of Product per M1 Instruction.
Makes appropriate Device History Record Copies of Quality Documentation and disperses records
accordingly to the Customer and PFD Quality Control Department.
3.2.3. F.4 Ship Clerk Forwards Approved Device Manufacture Record records to the Document Control Clerk for
Maintenance and retention.
Author: Dan Salazar
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3.2.4 Corrective Action
.We shall shall take prompt action to correct assignable conditions which have resulted or could result
in the submission to the Government/Customer of supplies and services which do not form to (1) the
Quality assurance provisions of the item specification, (2) inspections and tests required by the
Contract, and (3) other inspections and tests required to substantiate product conformance.
.
.
.
3.2.4.1 – Corrective Action
3.2.4.1.1‘ Develop, approved and implemented procedures to identify and control those actions taken to eliminate
. The cause of nonconformance in order to prevent its recurrence.
3.2.4.1.2
These corrective actions are appropriate to the effects of the nonconformities encountered.
3.2.4.1.3
These Documented procedures define the requirements for (but are not limited to just)…
A)
Reviewing nonconformities (including customer complaints).
B)
Determining the causes of nonconformities.
C)
Evaluating the need for action to ensure that nonconformities do not recur.
D)
Determining and implementing actions needed, including, if appropriate, updating
documentation.
E)
Recording the results of any investigation and of actions taken.
F)
Reviewing the corrective actions and its effectiveness.
G)
H)
Flow down of the corrective action requirement to a supplier, when it is determined
that the supplier is responsible for the root cause.
Specific actions where timely and/or effective corrective actions are not achieved
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3.3
Measuring and Test Equipment
Provide and maintain gages and other measuring and testing devices necessary to assure that supplies
conform to the technical requirements.
In order to assure continued accuracy, these devices shall be calibrated at established intervals against
certified standards which have known valid relationships to the National Institute of Standards and Tests
(NIST Traceable).
If production tooling, such as jigs, fixtures, templates, and patterns is used as a media of inspection, such
devices shall also be proved for accuracy at established intervals.
Calibration of inspection equipment shall be traceable to the National Institute of Standards and Tests
(NIST Traceable).
When required measuring and testing equipment shall be made available for use by the
Government/Customer Representative to determine conformance of product with contract requirements.
In addition, if conditions warrant, contractor’s personnel shall be made available for operation of such
devices and for verification of their accuracy and condition.
3.3.1 – Control of Monitoring and Measurement Devices
3.3.1.1
Khom Machining Tech, developed, approved and implemented procedures for the determination of
Monitoring and Measurement Methodology, Mechanisms, and activities needed to be undertaken in order
to provide objective evidence of product conformity to determined requirements.
3.3.1.2
These procedures define the activities implemented to ensure that monitoring and measurement
activities can be, and are, carried out in a manner that is consistent with the monitoring and measurement
requirements.
3.3.1.3
The organization maintain a register of these monitoring and measurement devices that defines the
process employed for their calibration, this definition includes details of equipment type, unique
identification, location, frequency of checks, check methodology and acceptance criteria
3.3.1.3 Where required and necessary to ensure valid results, measurement equipment is…
A)
Calibrated or verified at specified intervals, or prior to use, against measurement
standards traceable to International or National Standards. (Where no such standards
exist, the basis for and results of equipment verification is recorded).
B)
Adjusted or re-adjusted as necessary.
C)
Identified to enable the status to be determined.
D)
Safeguarded form adjustment that would invalidate the measurement result.
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E)
F)
Protected from damage and deterioration during handling, maintenance and
storage.
Be recalled to a defined method when requiring calibration
3.3.1.4 When equipment used in final product conformity verification has been determined to be in nonconformance
with requirements, Khom Machining Tech shall assess and record the validity of suspect previously
determined measurement results.
3.3.1 – Control of Monitoring and Measurement Devices (Continued)
3.3.1.5
‘Take appropriate action on equipment and/or product affected by nonconformance of measurement
device.
3.3.1.6
Prior to initial use, the ability and use of, computer software used in the monitoring and measurement of
specified requirements is confirmed and reconfirmed to intended requirement as necessary.;
3.3.1.7
Records of the results of calibration and verification activities of measurement devices are recorded and
maintained.
3.3.2
Process Controls
Process control procedures shall be an integral part of the inspection system when such inspections are a
part of the specification or the contract.
3.3.2.1 – Monitoring and Measurement of Processes
3.3.2.1
‘Khom Machining Tech has developed, approved and implemented documented procedures for the
application of suitable/appropriate methods for the monitoring and, where applicable, measurement of the
Quality Management System and its processes.
3.3.2.2 These procedures and methods demonstrate the ability of the ‘QMS’ processes to achieve planned results
3.3.2.3 When planned process results are not achieved resulting in nonconformity any resulting products are
identified and controlled in accordance with sect 8.3 (of this Quality Policy Manual) unto appropriate and
effective corrective action(s) are developed and performed, as appropriate, to ensure conformity of the
process and any resulting product(s) to requirements or agreed upon arrangements.
Author: Dan Salazar
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3.4
Indication of Inspection Status
Khom Machining Tech. shall maintain a positive system for identifying the inspection status of supplies.
Identification may be accomplished by means of stamps, tags, routing cards, move tickets, tote box cards
or other control devices.
Such controls shall be of a design distinctly different from Government/Customer inspection identification.
3.4.1– Identification and Traceability
3.4.1.1
Documented procedures have been developed, approved and are maintained for the Identification, status and
traceability of product throughout the various stages of product realization, storage, delivery, installation,
servicing and configuration maintenance of the product (in order to identify any differences between the actual
configuration and the agreed configuration) ensuring that only product that has passed the required
inspections and test (or released under authorized concession) is dispatched, used or installed.
3.4.1.2
These procedures define the extent and type of identification and traceability, efforts, processes and those
records required.
3.4.1.3
Where required by device safety, function, regulation or customer requirement, these identification and
traceability records shall include (but are not limited to)…
I)
II)
III)
All Components thereof.
Materials Used.
Work Environment Conditions
3.4.1.4
When required by customer and/or is subsidiaries and partnerships, shall require itself, its distributors and its
agents to maintain records of the name and address of the shipping package consignee and the distribution
of medical devices in accordance with approved procedures, so as, to allow traceability, and that, such
records be available for inspection.
3.4.1.5
Documented procedures have been developed and implemented to ensure that medical devices returned
from a distributor or customer if is identified and distinguished from conforming product,
3.4.1.6
These processes take into consideration such factors as measurement and monitoring requirements.
3.4.1.7
Khom Machining Tech. has established and documented controls for acceptance authority media (e.g.,
stamps, electronic signatures, passwords), does the organization
3.4.1.8
Where required by contract, documented traceability procedures and records are maintained using unique
identification for individual product or batches.
3.4.1.9
According to the level of traceability required by contract, regulatory, or other established requirement has
implemented an identification and traceability system that provides for…
A)
Identification that is maintained throughout the product life.
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B)
All the products manufactured from the same batch of raw materials or from the
same manufacturing batch to be traced, as well as the destination (delivery, scrap) of
the same batch.
C)
For an Assembly, the identity of its components and those of the next higher
assembly to be traced (as required).
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3.4.1– Identification and Traceability (Continued)
D)
For a given product, a sequential record of its production (manufacture, assembly,
inspection) to be retrieved.
3.4.1.10 Sub-contractors are required to identify individual product or batches where traceability is required by
customer contract.
3.4.1.11 Authority for Product Identification and Traceability is delegated to the Quality Assurance Manager.
Author: Dan Salazar
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3.5 Government/Customer – Furnished Material
When material is furnished by the Government/Customer procedures shall include as minimum the
following:
(a) Examination upon receipt, consistent with practicability, to detect damage in transit;
(b) Inspection for completeness and proper type;
(c) Periodic inspection and precautions to assure adequate storage conditions and to
guard against damage from handling and deterioration during storage;
(d) Functional testing, either prior to or after installation, or both, as required by contract
to determine satisfactory operation;
(e) Identification and protection from improper use or disposition; and
(f) Verification of quantity.
3.5.1
Damaged Government/Customer -furnished Material
Khom Machining Tech. shall report to the Government/Customer Representative any
Government/Customer -furnished material found damaged, malfunctioning or otherwise unsuitable for use.
In the event of damage or malfunction during or after installation Khom Machining Tech shall determine and
record probable cause and necessity for withholding material from use.
3.5.2 – Control of Customer Property
3.5.2.1
Khom Machining Tech has planned, developed and implemented procedures necessary for the identification,
verification, protection and safeguarding of customer property while it is under our control.
3.5.2.2
These procedures ensure that the use of care is exercised in the handling of customer owned property.
3.5.2.3
Designated areas for customer property storage have been developed and are maintained.
3.5.2.4
Customer Property is evaluated at the time of receipt and reassessed periodically for suitability of use,
damage and deterioration.
3.5.2.5
3.5.2.6
Appropriate actions are taken as a result of these assessments.
If customer property is lost, damaged, or found to be unsuitable for intended use and will report (in a
manner concurrent to the company’s needs) to the customer the exact nature of the non-conformance.
3.5.2.7
Records of these evaluations and communications are developed and maintained.
3.5.3 – Preservation of Product
3.5.3.1
Documented procedures and/or Work Instruction have been planned, developed, approved and implemented
for the preservation of product conformity during internal processing unto delivery to the intended destination.
3.5.3.2
This preservation of product and product conformity includes (but is not limited to)…
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I) Identification, Marking and labeling, including safety warnings (See QPM-001, Ss.
7.5.3) within those areas of our control.
II)Handling and protection from identified sources of damage within those areas of our
control, as well as, special handling information for sensitive products.
III) Packaging as identified by review or by customer requirement.
IV) Storage, shelf life control and stock rotation within those areas of ‘our’ control.
3.5.3 – Preservation of Product (Continued)
V) Cleaning, Prevention, detection and removal of foreign objects (when required by
product specification and/or applicable regulations)
3.5.3.3
Documented procedures and/or Work Instruction have been planned, developed, approved and
implemented for the control of product with a limited shelf life or requiring special storage conditions.
3.5.3.4
Objective evidence and records of such control are developed and maintained in accordance with
approved procedures ensuring that documents required by the contract/order to accompany the product are
present at delivery and are protected against loss and deterioration.
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3.6 Nonconforming Material
Khom Machining Tech. shall establish and maintain an effective and positive system for controlling
nonconforming material, including procedures for the identification, segregation, presentation and
disposition of reworked or repaired supplies.
Repair of nonconforming supplies shall be in accordance with documented procedures acceptable to the
Government/Customer.
The acceptance of nonconforming supplies is the prerogative of and shall be as prescribed by the
Government/Customer.
All nonconforming supplies shall be positively identified to prevent use, shipment and intermingling with
conforming supplies.
Holding areas, mutually agreeable to the Government/Customer Representative, shall be provided by the
contractor.
3.6.1 – Control of Nonconforming Product
3.6.1.1
These procedures identify the controls, authorities and related responsibilities (as well as the process for
approving personnel making these decisions) for dealing with non-conforming product and ensure that such
product or devices are identified and controlled to prevent its unintended use or delivery.
3.6.1.2
These procedures identify the methods in which non-conforming shall be disposition of which are…
A)
By taking action to eliminate the detected nonconformity.
(Rework to approved requirements).
B)
Customer authorization for non-conforming product use as is, release or acceptance
under concession, when the product is produced to a customer design and the
nonconformity results in a departure from the contract/design requirements.
(Product is accepted under customer concession, only if regulatory requirements are also
met).
C)
By taking action (conspicuously and permanently marking, or positively controlling
until it’s physically rendered unusable) to preclude, its unintended use or application.
(Scrap in house or at supplier).
3.6.1.3
Approved Procedures ensure that prior to the rework/correction processing of product, or device, a review
of the adverse effects of rework/correction is performed and rework documentation is generated in the same
manner, and goes over the same authorization process, as the original work instruction.
3.6.1.4
Such procedures ensure that reworked/corrected product or devices are subjected to re-verification to
demonstrate conformity to requirements.
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3.6.1.5
When nonconforming product is detected after delivery or use has started,We shall take timely action for
the reporting and correction (appropriate to the effects or potential effects) of the nonconformity in accordance
with approved procedure, customer and regulatory requirements, this notification shall include a clear
description of the nonconformity, which includes as necessary parts affected, customer and/or organization
part numbers, quantity, and date(s) delivered.
3.6.1.6
In addition to any contract or regulatory authority reporting requirements, the quality management system
provides for timely reporting of delivered nonconforming product that may affect reliability or safety.
3.6.1 – Control of Nonconforming Product (Continued)
3.6.1.7
Records of the nature of nonconforming product, its disposition and actions taken, concessions obtained
and the identity of the person(s) authorizing concession, rework or use and release, are developed and
maintained in accordance with approved procedures.
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3.7
Qualified Products
The inclusion of a product on the Qualified Products List only signifies that at one time Precision
Grinding Company made a product which met Government/Customer specification requirements.
It is not intended to relieve Precision Grinding Co. of its responsibility for furnishing supplies that meet
all specification requirements or for performing specified inspections and tests for such material.
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3.8
Sampling Inspection
Sampling inspection procedures used by Khom Machining Tech. to determine quality conformance of
supplies shall be in accordance with ASQC - Zero Acceptance Number Sampling Plans or as stated
in the contract and shall be subject to approval by the Government/Customer .
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3.9 Inspection Provisions
Alternative inspection procedures and inspection equipment may be used by Khom Machining Tech.
when such procedures and equipment provide, as a minimum, the quality assurance required in the
contractual documents.
Prior to applying such alternative inspection procedures and inspection equipment, we shall describe
them in a written proposal and shall demonstrate for the approval of the Government/Customer
Representative that their effectiveness is equal to or better than the contractual quality assurance
procedure.
In cases of dispute as to whether certain procedures of inspection system provide equal assurance, the
procedures of this specification, the item specification and other contractual documents shall apply.
3.9.1 – Inspection Process Overview
3.9.1.1
to ensure customer satisfaction Khom Machining Tech’ has planned, developed, approved and
implemented the monitoring, measurement, analysis and improvement processes needed to (but not to
just)…
A)
Demonstrate conformity of the product or device.
B)
Ensure the conformity of the Quality Management System.
C)
Maintain and improve the Quality Management System.
D)
Review and Implement ‘Gained Experience’ from post production activities.
3.9.1.2
As required by customer or Government/Customer agency, this planning and implementation shall
include determination of applicable Monitoring and Measurement Methodology, Statistical Techniques
and Documented Procedures including their scope and use.
3.9.1.3
The President (or his delegate) is afforded the responsibility and authority to determine and
coordinate calibration activities within the Quality Management System, including those related to
Production Machine validation and verifications activities
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3.10
Government/Customer Inspection at Subcontractor or Vendor Facilities
The Government/Customer reserves the right to inspect at source supplies or services not manufactured
or performed within our facility.
Government/Customer inspection shall not constitute acceptance;
Nor shall it in any way replace contractor inspection or otherwise relieve of his responsibility to furnish an
acceptable end item.
When inspection at subcontractors’ plants is performed by the Government/Customer, such inspection
shall not be used as evidence of effective inspection by such subcontractors.
The purpose of this inspection is to assist the Government/Customer Representative at Khom Machining
or at Suppliers facility to determine the conformance of supplies or services with contract requirements.
It is understood, such inspections can only be requested by or under authorization of the
Government/Customer Representative.
3.10.1
Government/Customer Inspection Requirements
When Government/Customer inspection is required, Khom Machining Tech shall add to his purchasing
document the following statement:
“Government/Customer inspection is required prior to shipment from the customers’ plant. Upon receipt of
this order, promptly notify the Government/Customer Representative who normally services the
customers’ plant so that appropriate planning for Government/Customer inspection can be
accomplished.”
3.10.2
Purchasing Documents
When, under authorization of the Government/Customer Representative copies of the purchasing
document are to be furnished directly by the subcontractor or vendor to the Government/Customer
Representative at his facility rather than through Government/Customer channels, Khom Machining Tech
shall add to his purchasing document a statement substantially as follows:
“On receipt of this order, promptly furnish a copy to the Government/Customer Representative who
normally services the customers plant or, if none, to the nearest Army, Navy, Air Force, or Defense
Supply Agency inspection office. In the event the representative or office cannot be located, our
purchasing agent should be notified immediately.”
3.10.2.1 – Purchasing Information
3.10.2.2 Khom Machining Tech ensures the adequacy of specified purchase requirements prior to their
communication to the supplier, these requirements include (but are not limited to)…
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3.10
A)
Requirements for the approval of product, procedure, processing and equipment.
B)
Requirements for the approval of personnel (when required).
C)
And, Quality Management System requirements.
Government/Customer Inspection at Subcontractor or Vendor Facilities
(Continued)
3.10.2.2 – Purchasing Information (Continued)
D)
The name or other positive identification, and applicable issues of specifications,
drawings, process requirements, inspection instructions and other relevant technical
data.
E)
Requirements for design, test, examination, inspection and related instructions for
acceptance by the organization.
F)
Requirements for test specimens (e.g., production method, number, storage
conditions) for design approval, inspection, investigation or auditing.
G)
I)
II)
Requirements relative to…
Supplier notification to organization of nonconforming product, and
Arrangements for organization approval of supplier nonconforming
material.
H)
Requirements for the supplier to notify the organization of changes in product and/or
process definition and, where required, obtain organizational approval.
I)
Right of access by the organization, their customer, and Government/Customer
authorities to all facilities involved in the order and to all applicable records, and,
J)
Requirements for the supplier to flow down to sub-tier suppliers the applicable
requirements in the purchasing documents, including key characteristics where required.
3.10.2.3 In accordance with approved procedures, to the extent required for the traceability of Product or
Processing, Khom Machining Tech develops and maintains such relevant purchasing information in the
form of documents and records as may be required.
3.10.3
Reference Data
All documents and referenced data for purchases applying to a Government/Customer contract shall be
available for review by the Government/Customer Representative to determine compliance with the
requirements for the control of such purchases.
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Copies of purchasing documents required for Government/Customer inspection purposes shall be
furnished in accordance with the instructions of the Government/Customer Representative.
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3.11
Receiving Inspection
Subcontracted or purchased supplies shall be subjected to inspection after receipt, as necessary, to
assure conformance to contract requirements.
Khom Machining Tech. shall report to the Government/Customer Representative any nonconformance
found on Government/Customer sourced-inspected supplies and shall require his supplier to coordinate
with his Government/Customer Representative on corrective action.
3.11.1 – Verification of Purchased Product
3.11.1.1 For the purposes of verification of purchased materials or processing, ‘Khom Machining Tech has
developed and implemented approved procedures identifying those activities (inspection as well as
others) necessary for ensuring that purchased product meets specified purchasing requirements.
3.11.1.2
These verification activities include (when applicable)…
A) Obtaining objective evidence of the quality of the product from suppliers (e.g.,
accompanying documentation, certificates of conformity, test reports, statistical records,
process control)
B) Inspection and audit at supplier's premises.
C) The review of the required documentation.
D) The inspection of product upon receipt.
E) The delegation of verification to the supplier certification.
3.11.1.3
Purchased products controlled from use or further processing until it has been verified as conforming
to specified requirements.
3.11.1.4
Documented provisions been developed and implemented for the release of purchased product under
positive recall controls.
3.11.1.5
When it is determined acceptable to requirements; ‘PGC’ Receiving Inspection may choose to utilize
test reports to verify purchased product, however; acceptance of materials or certifications can only occur
after the data in those reports is found acceptable to applicable specifications.
3.11.1.6
The periodic validation of random test reports for raw material by qualified independent sources.
3.11.1.7
‘Khom Machining Tech’ does not delegate verification activities to suppliers.
3.11.1.8
Where Khom Machining Tech’ intends to perform verification of product or services at the suppliers
premises, ‘PGC” shall state the intended verification arrangements and methodology of product release in
the purchasing information communicated to the vendor.
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3.11.1.9
When specified in the contract, the customer or the customer's representative afforded the right to
verify at the supplier's premises and/or the Khom Machining Tech premises that subcontract, the
conformity of product to specified requirements.
3.11.1.10
Verification by the customer shall not be used by Khom Machining Tech evidence for 'Effective
Control of Quality' by the supplier, and so, shall not absolve of the responsibility to provide acceptable
product, nor shall it preclude subsequent rejection by the customer.
3.11.1 – Verification of Purchased Product (Continued)
3.11.1.11
Records of Verification of Product are developed and maintained in accordance with approved
procedures.
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3.12
Government/Customer Evaluation
Our inspection system and supplies generated by the system shall be subject to evaluation and
verification inspection by the Government/Customer representative to determine its effectiveness in
supporting the quality requirements established in the detail specification, drawings and contract and as
prescribed herein.
Related Procedures:
Not Applicable
References
ASQC – Zero Acceptance Number Sampling Plans: Table 1A
MIL-I-45208, MIL-I-45208
Author: Dan Salazar
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Inspection System Manual
Attachment ‘A’
Khom Machining Tech
Identified Services
and
Asset List
CNC FADAL 3016 MACHINES (3X)
ROTARY TABLE FOR 4 AXIS
METAL CUTTING BAND SAW
COMPRESSOR MODEL 2475
DRILL PRESS
GRINDERS (2X)
HEIGHT GAGE
CALIPERS (5X)
MICROMETER(3X)
SET OF PIN GAGE .011-.800
SURFACE TABLE (2X)
( To Revise C-Ref. Matrix – Insert Object – From File )
Author: Dan Salazar
Form #422A, Rev. “N/C”
QPM-001
Rev. No:
Page:
Joe Dokovic
A
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