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Quality Manual

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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Last modified: October 20, 2006