| Scope: This
Quality Manual describes the quality system to be used by Midwest
Precision Tool & Die (MPT&D) on all fabricated components,
assemblies and sub assemblies.
1.0 Management Responsibility Quality Policy: MPT&D
strives to be a leader in the precision machining industry by
consistently providing products meeting or exceeding customer
expectations in both Quality and delivery. The Quality System
provides existing customers with the highest levels of
satisfaction and offers potential customers the opportunity to
review the competence and confidence of MPT&D. Quality at MPT&D
extends to each and every individual, who are responsible for
maintaining the quality of their work and providing feedback to
constantly improve the overall Quality within MPT&D.
Management reviews this Quality Manual with all personnel and it
is available at any time for reference. The Quality Manual is
updated to reflect MPT&D's growth and adaptation to industry
requirements. Organization Management Representative - The Quality
Manager is responsible for implementing and maintaining the
Quality System in a fashion that complies with the standards
outlined in ISO 9001. He or she is also responsible for providing
feedback to Management on the performance of the Quality System,
as well as providing suggestions for improvement and ensuring that
the procedures provided are adhered to. Responsibilities
Management (comprised of President, Shop Manager, Quality Manager
and Office Manager)
- Provides direction and resources to initiate Quality System
- Reviews performance of Quality System
- Ensures Quality development parallels Business development
- Supports the Quality Manager in promoting the Quality System
Sales
- Provides feedback from Customers
- Maintains the link between the Customer and production
- Provides the Customer with accurate and current information
- Promotes MPT&D's Quality Policy Purchasing
- Tracks Supplier and Subcontractor performance
- Ensures the highest levels of quality on Purchased and
Subcontracted product
- Maintains sufficient levels of raw materials and tooling
Planning
- Plans production to provide the highest Quality product and
attain delivery dates
- Coordinates with Quality to implement procedures in
production when needed
- Utilizes feedback from Quality, Manufacturing and Sales to
optimize production
- Provides feedback to President to optimize the quoting
process Manufacturing
- Ensures Quality is upheld throughout the production
- Identifies and reports problems with equipment or process
- Provides feedback to Planners to optimize production
- Supports Quality in identifying and correcting problems
Quality
- Maintains and oversees the overall Quality System
- Investigates and assists in correcting any reported problems
- Supports Planning to incorporate Quality into production
- Provides feedback to continually improve the process
- Monitors product conformance at various stages in production
Management Review - Management reviews the Quality System no
less that once every year to ensure that the Quality System
supports the Quality Policy, parallels Business Development
and is in compliance with the standards outlined in ISO 9001.
- Results of these reviews are recorded and maintained per ISO
9001.
2.0 Quality System Statements: MPT&D's Quality
System is documented by means of the Quality Manual, written and
approved policies and procedures, approved process forms and
certificates traceable to National and International standards.
The Quality System is comprised of a collection of these written
procedures and documents and defines methods for use. Procedures
& Quality Plan - In order to successfully meet the overall
objectives of the Quality System, considerations are given to the
entire production. General procedures are in place outlining how
the production will be performed, including verification of
conformance after each sequence, methods of inspection and
acceptable practices of measurement for various sequences.
Procedures to check conformance are specific to each operation and
are documented and made available to all personnel. Verification
of conformance after each sequence is required and documented
through signoff on the job traveler. Training is provided and
internal certification is required on the interpretation of
Engineering drawings per ASME Y14.5M, 1982 & 1994, as well as
basic print reading. Personnel are trained and certified on all
equipment they will be assigned to. Each employee's file contains
all valid certifications. Operation of equipment without
certification is prohibited. Production specific Quality plans are
written to support any production with special sequences or
requirements. Conformance checks are established as well as
acceptable measurement equipment and practices. Criteria for
allowing production to begin, continue or cease is identified. All
documentation of conformance generated is retained per ISO 9001.
3.0 Contract Review Statements: Contracts between
Customers and MPT&D are finalized and clarified before
becoming binding contracts. The acceptance of a Customer Purchase
Order serves as the final contract. Review - All contracts are
reviewed prior to acceptance to ensure that specifications and
requirements are understood and agreed upon by both parties. MPT&D
also ensures, prior to acceptance, that the capability to produce
the components is available. Quotes are handled by the President
only. Change Order - Any amendments to a contract after is has
been accepted require a formal Change Order showing both Customer
and MPT&D approval. A Change Order may be requested by the
Customer for changes to a contract, or by MPT&D for cases such
as print errors. Procedures for the requirements and use of a
Change Order are defined. The amendments are communicated to all
affected sequences of the production via the Change Order. Records
- All documentation including quotes and Change Orders are
maintained per ISO 9001.
4.0 Design Control Statement : Design is primarily
limited to the optimizing of existing customer designs and is not
fully ISO compliant at this time.
5.0 Document Control Statement: All documents at MPT&D
pertaining to the Quality System are controlled through electronic
media. Job Bossā software is used for the quoting, production and
manufacturing process, as well as sub contract work, purchasing
and shipping. All procedures, policies and controlled forms used
throughout the Quality System are maintained through a database
software. Access levels are controlled and both systems are on a
network to provide availability to all employees. Electronic media
is regularly backed up. Hard copy forms, such as faxed Change
Orders, prints, certification data, etc. are maintained in secure,
locking file cabinets. Document Approval and Issue - Controlled
documents are reviewed and approved prior to release or issue. A
list of all active documents providing revision information is
also maintained per ISO 9001. Controlled documents are either
located in or near the areas affected in the document, or a
network terminal is available to view the documents. Obsolete or
previous revisions are removed and marked, and only current
revisions are available for viewing on the network. All previous
revisions are maintained on the network as well, but are not
available for viewing. Document Changes - Any changes to
controlled documents are approved through the same process as the
original document. Justification of the change is provided to the
approvers. Specifics of the change are recorded on an attached
revisions page.
6.0 Purchasing Statements: MPT&D utilizes only the
highest quality Suppliers and Subcontractors. The diverse
backgrounds of the employees of MPT&D provide a large source
of referrals. Associates in the Tool & Die Industry are
another valuable resource for choosing and evaluating Suppliers
and Subcontractors. Recommendations by both employees and
associates are weighed heavily in the selection and only
reputable, industry known Suppliers and Subcontractors are used.
Evaluation of Subcontractors - Suppliers and Subcontractors are
chosen and utilized based on their ability to meet delivery
schedules and provide acceptable levels of quality. The Purchasing
Agent selects candidates and reviews them with Management before
using their services or products. The quality of the product or
service provided is closely monitored upon receipt. Suppliers or
Subcontractors not meeting expected quality levels or delivery
times are dismissed immediately. Job Bossā provides a means for
tracking Supplier and Subcontractor performance. Customer
specified Suppliers and/or Subcontractors are utilized when
requested. Quality or traceability documentation is acquired and
retained when required by the customer. Purchasing Data - Job Bossā
has full purchasing capability. Purchase orders are generated
containing all pertinent information to the order. Special
instructions or qualification information is documented on the
P.O. The software is in database format, providing a wide range of
configurations for viewing data contained on the P.O. The Job
number for which the P.O. has been generated is entered on the
P.O. to provide direct traceability upon receipt of the product.
Verification of Subcontracted Product - MPT&D verifies that
all subcontracted product conforms to customer specifications
before using the product. Subcontracted product is verified using
the same methods and procedures as if the product had been
produced internally. Subcontracted product is not receipted in
until Inspection is complete. Customers reserve the right to
verify subcontracted product. Customer verification does not
exempt MPT&D from performing standard verification nor from
providing acceptable final product.
7.0 Customer Supplied Product Statements: Customer
supplied materials or products for use in the production process
are reviewed upon receipt for quantity and quality. Any lost or
damaged product is documented and reported to the Customer. The
materials are marked with the Job number and routed to the
appropriate area. Components provided that are used in assemblies
are treated in the same manner. Unacceptable Customer supplied
materials will not be used without the approval of the Customer.
8.0 Product Identification and Traceability Statements: Production
traceability is controlled using Job Bossā. Job numbers are
assigned identifying all products on that job. When the job is
generated, Job Bossā creates a traveler that has a unique bar
code for each sequence of that job. Personnel scan the traveler
with a bar code scanner, entering progress on each sequence. Data
can be downloaded at anytime to provide up to the minute progress
on all sequences of a job. The location and status of each job is
tracked and monitored through this system. Product Identification
- For productions that have larger quantities of product, lot
numbers are assigned to provide closer monitoring of the product.
Mated items in an assembly product are identified by alpha
characters to ensure matched components are not intermixed.
9.0 Process Control Production Plans: The planning of a
job begins at the initial quote. The flexibility of Job Bossā
allows the quote to act as the basis for planning of the entire
job. After reviewing the prints, equipment is chosen based on
criteria such as tolerance, finish, complexity and quantity. Times
are estimated based on the criteria listed above as well as the
equipment chosen. This information is entered into Job Bossā,
which assigns costs to each sequence and returns the quote. All
quoting is done by the President. Once the quote has been approved
for build, the job is passed to the Planners, where the job is
scheduled in the shop, programs are written and production is
begun. The Planners reserve the right to adjust the sequence as
long as the final cost is not affected. Planners will generate a
traveler using Job Bossā, set up notes for specific operations
and any special instructions for the job. This package of
information serves as the production plan. Planners will also
determine at this point, with the assistance of the Shop Manager
and/or Quality, any processes that require formal in-process
checks extending beyond the standard procedures. Production
Control - For productions that require conformance checks or
monitoring extending beyond the standard procedures, such as high
volume runs or high tolerance applications, parameters are
identified prior to the start of production. Procedures and
control forms for monitoring the process are written by Quality
and approved by Planning and the Shop Manager prior to startup.
For normal production, conformance is checked after each sequence,
per standard policy. Equipment Control - Equipment is maintained
on a regular PM schedule. Equipment requiring consideration for
environmental effects are maintained in separate rooms. Each area
is responsible for keeping the area orderly. Personnel - Where
special procedures are required, training is provided to all
affected employee's. Employee's are required to attend training in
ASME Y14.5M GD&T and required to pass a written exam.
10.0 Inspection & Testing Receiving Inspection:
Purchased product is subjected to incoming inspection prior to use
for production. Raw materials are verified for conformance to
specifications. Samples with testing documentation for raw
materials are retained when required. Manufactured or fabricated
product is inspected for conformance to specifications prior to
use in final product. Any premature or urgent release of material
for production is documented. In-Process Inspection - Formal
in-process checks are implemented on production runs that require
close monitoring of the process. Planning will identify these
processes during the generation of the production plan. Parameters
such as tolerance, quantity and the process(s) used are
considered. Guidelines exist for determining production runs
requiring formal in-process checks. These checks are designed by
Quality and approved by Planning and the Shop Manager prior to
starting the run. The procedures are documented and training is
provided to appropriate personnel. A first article may be required
prior to start up. On product not requiring specific in-process
inspections, each area is responsible for ensuring the product
complies to the production plan for that sequence before releasing
to the next sequence. The traveler must be signed showing
conformance before passing to the next sequence. This is also
accomplished via the bar code scanning to provide acceptance of
the sequence. Final Inspection - Inspection of product upon
completion is carried out by Quality according to documented
procedures. Any required incoming inspection of supplied product
as well as in-process inspections are verified for acceptance
prior to final release of product. The production plan is reviewed
and verified for completeness. Inspection Records - Final
inspection records, as well as any supplied product incoming
inspection records and in-process records are retained per ISO
9001. Final inspection records identify acceptance or rejectance
criteria. Rejected product is handled per nonconformance
procedures.
11.0 Control of Inspection & Measuring Equipment
Statements: Capability studies are performed on measurement
equipment to determine the allowable tolerances for which they can
be used. Equipment is chosen for inspections or tests based on
this information. All equipment used for inspection or conformance
to specifications is calibrated to National or International
standards at prescribed intervals. The procedures for calibration
of equipment are documented stating intervals, process, acceptance
criteria and non conformance procedures. Calibrated equipment is
labeled in a visible manner with date showing validity of the
calibration. All documentation of calibrations is retained.
Standards and equipment used for calibration are stored safely to
prevent tampering. A master list of all equipment showing
calibration status and validity dates is also maintained. For
equipment calibrated by outside sources, documentation of the
contractor's equipment showing traceability to National or
International standards is also retained.
12.0 Inspection Status Statements: The Inspection status
of product can be identified by the status of the job as tracked
using the bar code scans. When a sequence is completed, the
traveler is scanned and that sequence is then logged as complete.
This step also serves as the approval sign off stating that the
part is in conformance for any operations performed during that
sequence. Thus the Inspection status of the product is easily
traceable through Job Bossā.
13.0 Nonconforming Product Control Statements:
Nonconforming product is identified and/or removed from production
upon discovery. Product is immediately tagged to prevent it from
getting back into production. Written procedures exist to define
the process to be followed by operators who find non conformance's
during production. Non conformance's found at Final inspection are
segregated to ensure they are not shipped until a disposition has
been approved. In the unlikely event that a non conformance may
impact Customer due dates, the Customer will be notified.
Disposition - For non conformance's found during production,
operators may disposition the product if it is obviously beyond
repair, or if simple rework can bring the product back to
conformance. For more complex cases, the disposition is handled by
the Quality department along with the Shop Manager. Possible
dispositions include scrap, rework or use as is. Scrap - Product
that is dispositioned as scrap is replaced as required to fulfill
the contract. Planning must be notified of scrap dispositions in
order to schedule replacement product. Rework - Rework
dispositions require documented instructions detailing the rework
required to bring the product back to conformance. Planning is
notified of any Rework dispositions to schedule the rework. The
product must be inspected again upon completion to ensure the
product meets specifications. Use As Is - Product that is deemed
useable by the Customer may be accepted as Use As Is. This
requires formal approval documentation from the Customer prior to
release for shipment. It is the Customer's discretion to approve
or disapprove this disposition after being informed of the
discrepancies.
14.0 Corrective Action Statements: Corrective action is
crucial to the continuous improvement of Quality and to uphold the
statements set forth in the Quality Policy. Corrective action
includes investigation of non conformities found internally or as
reported by the Customer. Any internal personnel can request a
corrective action. Corrective Action - When a corrective action is
requested either internally or stemming from a Customer reported
non conformity or complaint, it will be handled by the Quality
personnel. An investigation into the cause of the non conformity
will be conducted with the help of Planning, the Shop Manager
and/or Manufacturing personnel. Upon determining the root cause of
the non conformity, the corrective action required to prevent
repeat occurrences will be determined. The details of the initial
occurrence are documented, as well as the corrective action the
was determined. Sign off by Quality and a representative of any
affected areas provides approval of the corrective action.
Communication of the corrective action to all affected areas will
be carried out by Quality and/or the Shop Manager. All records are
retained per ISO 9001.
15.0 Handling, Storage, Packaging and Delivery Statements:
Each sequence is responsible for the appropriate handling of
product during production while in that area. Storage - Raw
materials are stored by material and size. The materials are
clearly identified and marked by size, as well as the racks in
which they reside. Raw material storage is very orderly and well
marked. Only materials that have been verified upon receipt are
placed in racks. Unknown materials are treated as scrap and not
allowed in storage racks. Storage of product after completion, but
prior to shipment is handled by Quality, in a limited access area.
Product is clearly identified including Final inspection status.
Surplus product extending beyond the ordered quantities is clearly
labeled with the part number and revision, treated with the
appropriate preservative and placed into inventory. The quantity
and all pertinent information is entered into an Inventory
database. Packaging - Any special packing instructions are
included in the production plan. Standard packing instructions are
defined where specific instructions are not defined. Product is
wrapped and packaged to prevent damage during normal shipping and
handling. All packages are clearly marked with part number,
quantity and revision level. Copies of any documentation
pertaining to the order are included, such as Change Orders,
Inspection reports or certification documents. Delivery - Job Bossā
is capable of generating packing slips that contain all pertinent
information. Complete traceability is available through the
packing slip number. The standard carrier is Corporate Express.
For overnight or express deliveries, Federal Express or U.P.S. is
used.
16.0 Quality Record Control Statements: Documentation
and procedures used within the Quality System are fully
maintained. The proper handling of these documents and procedures
is defined and adhered to. These records provide evidence of
conformance to the Quality System and verify the integrity of
product. Sign off's and approvals are evident where applicable.
Quality Records - Inspection documents, including acceptance
documents of raw materials and sub contracted product, where
applicable, are retained in such as manner to make them readily
available. Other documentation such as procedures defining
in-process inspection, corrective actions, deviation
authorizations, change orders or special handling instructions are
retained where applicable. All records are retained in a suitable
environment to prevent damage or loss. Electronic media is
routinely backed up.
17.0 Internal Quality Audits Statements: Quality audits
are performed on at least a yearly basis to verify that the
systems outlined in this Quality Manual and as set forth by the
Quality System are in compliance. Audits are planned and based on
importance. The audits are performed by personnel independent of
the area being audited. Results of the audit are clearly defined
and documented and provided to Management for review. Management
addresses non compliance issues and, working with personnel
responsible for the area, assigns corrective action. Upon
completion of the corrective action, a follow-up audit is
performed to verify that the area has been brought back to
compliance. All records and documents of audits are retained per
ISO 9001.
18.0 Training Statements: MPT&D works on the
Toolmaker/Apprentice program where Apprentices work along side
skilled Toolmakers. Each area has developed a training regimen on
the equipment contained in that area. All personnel in that
department who will be using the equipment are required to pass a
written knowledge check before being allowed to operate the
equipment. The knowledge checks are developed by the senior
operators of the equipment. Successful completion of the training
and knowledge check serves as certification for the operation of
equipment. These documents are maintained in the employee's file.
Personnel are also required to complete a course in basic print
reading and ASME Y14.5M Geometric Dimensioning and Tolerancing (GD&T).
The course is given to the 1982 standard with 1994 updates and
revisions. A written exam is given on the 1982 standards and a
computer based training with knowledge check is given on the 1994
updates and revisions. These records are also maintained.
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