QM 8.5 Production and service provision

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Quality Manual

8 – Operations
Section 8.5 Section Revision: A Revision Date: 3/30/2017
8.5 – Production and service provision
Approved By: Dave Zirkelbach Date: 3/30/2017

GENERAL POLICY

Product and process information and appropriate work instructions are established and are communicated to relevant personnel. Operations and production processes are monitored and controlled, and are validated where appropriate. Equipment used in distribution processing and for monitoring and measurement activities are maintained. Methods for product release and delivery are defined.

Materials, components, and parts are identified. When required, traceability of materials and processes is recorded and maintained. Inspection and test status of product is identified to ensure that only product that has passed the required inspections is dispatched.

Customer-supplied products, if ever maintained, are controlled in the same manner as are purchased products. If ever maintained, Customer-owned tools, equipment, software, or other property are marked to indicate ownership. Any Loss, damage, or unsuitability of a customer’s product is recorded and reported to the customer.

Appropriate handling, storage and preservation methods are implemented to prevent product damage or deterioration. Receipt and dispatch to and from storage areas are controlled. The condition of products in stock is regularly assessed.

PROCEDURAL POLICIES

1. Control of production and service provision

1.1 Product and process information

Product and process information required by process operators is communicated through the work order, electronic forms, or is included in work instructions.

1.2 Work instructions

1.2.1 Work instructions and workmanship standards may be in the form of electronic manuals, electronic procedures, or electronic instructions on forms. They instruct on how to carry out a process or perform an operation or task. The need for work instructions is evaluated on the basis of criticality, importance and complexity of the process; the ability to verify results of the process; operator qualifications; and history of quality problems associated with the process. Workmanship standards are provided when acceptability of the process output can only be determined by comparison with a standard sample.

1.4 Measuring and monitoring equipment

1.4.1 Requirements for measuring and monitoring equipment are determined by Executive Management and Quality Assurance. This is in accordance with process control and product verification programs defined in product realization planning.

1.4.2 Dee Electronics has established and maintains documented procedures to control, calibrate and maintain inspection, measuring and monitoring equipment it uses to demonstrate the conformance of product to the specified requirements. Measuring and Monitoring equipment is used in a manner which ensures that the measurement uncertainty is known and is consistent with the required measurement capability. Measuring and Monitoring equipment include (but are not limited to) scales, calipers, and wire processing equipment.

Control Procedure – Dee Electronics:

  • Selects appropriate Measuring and Monitoring equipment that is capable of the necessary accuracy and precision,
  • Identifies Measuring and Monitoring equipment and specifies frequency of checks,
  • Maintains calibration records for Measuring and Monitoring equipment,
  • Assesses the validity of previous inspection and test results when Measuring and Monitoring equipment is found to be out of calibration,
  • Provides suitable environmental conditions for calibrations, inspections and tests,
  • Safeguards Measuring and Monitoring equipment from damage, abuse and unauthorized adjustment.
  • A robust hiring process is in place to ensure Team Members are competent and require all specific qualifications per each individual task

1.5 Process monitoring and control

Dee Electronics has identified and planned the order fulfillment, distribution and servicing processes which directly affect quality, and ensures that these processes are carried out under controlled conditions. These controlled conditions include:

  • Documented procedures defining the manner of order fulfillment, distribution and servicing,
  • Use and availability of suitable equipment, and a suitable working environment,
  • Compliance with reference standards, codes, quality plans and/or documented procedures,
  • Monitoring and control of suitable process parameters and product characteristics,
  • Approval of processes, equipment, tools, and technology, as appropriate,
  • Criteria for workmanship, which is stipulated in the clearest practical manner,
  • Suitable maintenance of equipment to ensure continuing process capability,
  • Process Environment and performance,
  • Process Output

1.6 Product release and delivery

1.6.1 Products are released for delivery only after all specified activities have been satisfactorily completed and conformity of the product has been verified.

1.7 VALIDATION OF PROCESSES

1.7.1 Special processes

There are no special processes in use at Dee Electronics.

1.7.2 Validation

Dee Electronics validates any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring and measurement, and as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered.

2. Identification and traceability

2.1 Product identification

2.1.1 Where appropriate, documented procedures have been established and maintained for identifying the product by suitable means from receipt, during all stages of order fulfillment, and throughout product realization.

2.1.2 During all stages of receipt, putaway, and order fulfillment, products are identified by labels, or the labeled containers in which they are held.

2.2 Traceability

2.2.1 Dee Electronics maintains traceability under certain circumstances, as described in the written procedures, but traceability is not required of Dee Electronics by any other entity. Records of traceability are maintained in accordance with procedures.

2.3 Inspection status identification

2.3.1 The inspection and test status of product is identified by suitable means, which indicates the conformance or nonconformance of product with regard to inspection and tests performed. The identification of inspection and test status is maintained, as identified in the documented procedures, throughout the order fulfillment process to ensure that only product that has passed the required inspections and tests (or released under an authorized concession) is dispatched.

2.3.2 Distribution/Order fulfillment and Assembly personnel authorized to carry out inspections and testing are responsible for identifying product inspection status. All personnel handling products are responsible for maintaining the identification.

2.3.3 Incoming products that have passed the receiving inspection are moved to putaway staging areas/carts. Products that have not passed receiving inspection are moved to a Hold Area.

2.3.4 Status of an in-process inspection is identified by current location and labeling of product or assembly, as well as electronic verification records resulting from bar code scanning/computer verification or written records. Each subsequent step verifies the that previous step was completed correctly.

2.3.5 Products that pass the final inspection are placed in Shipping Process Carts/Pallets area that is designated and used only for this purpose. In addition, products passing final inspection have an electronic Ship Authorization Record.

2.3.6 Products that fail any inspections or tests are moved to identified Hold Areas. Whenever a nonconforming product is identified, the nonconformity is documented using a Corrective Action Report (CAR/RMA) Form.

3. Property belonging to customers or external providers

3.1 Receiving

3.1.1 Customer-supplied products (or personal data) are received and inspected following the same procedure that applies to purchased products, i.e. In the event the supplied products fail receiving inspection, or are not suitable for any other reason, the customer is contacted and a record is created in the Incoming Inspection log, along with a Corrective Action.

3.2 Marking, storage, and handling

3.2.1 Marking, storage, handling, and preservation of customer supplied products or personal data follow the same procedures that apply to purchased products.

3.2.2 Customer-owned tooling and returnable packaging are permanently marked so that ownership of each item is visually apparent.

3.2.3 Customer’s software, documents, and other intellectual property are protected to the same extent as would internal Dee Electronics’ documents of similar content, unless there are contractual requirements for special measure to protect customer’s intellectual property.

3.3 Special requirements

3.3.1 When specified in a contract, special handling instructions from customers will take precedent over the company’s standard procedures.

3.4 Loss or damage

3.4.1 Customers are contacted in the event of loss, damage, deterioration, or unsuitability of their products or personal data.

4. Preservation

4.1 Product handling and preservation

4.1.1 Dee Electronics provides methods of handling product in order to maintain conformity to requirements and prevent damage or deterioration.

4.2 Storage

4.2.1 Dee Electronics uses designated storage areas to prevent damage and deterioration of product, pending use or delivery. Appropriate methods are stipulated for authorizing receipt to and dispatch from such areas. In order to detect deterioration, the condition of product held in stock is assessed at appropriate intervals.

4.2.2 Products with limited shelf life are assessed via Cycle counting assessment. Products are rotated in the stockroom to ensure that the oldest product is used first.

4.2.3 Product stockroom areas are controlled using an inventory management system. The system can report available in stock quantities, product location, and turn-over times. The system is used to optimize and minimize inventory levels.

4.3 Packaging and labeling

4.3.1 Primary packaging are boxes, bags or other packaging in which products are presented to the end users.

4.3.2 Secondary packaging, if applicable, are cardboard boxes, pallets, or other additional packaging intended to contain and protect products for shipping and transportation.

4.3.3 Dee Electronics controls packing, packaging and marking processes (including materials used) to the extent necessary to ensure conformance to specified requirements.

4.3.4 Packing/Shipping department is responsible for selecting secondary packaging and labeling. The materials selected are compatible with requirements of commonly used carriers and for intended means of delivery (ground, sea, air). Any customer specific packaging instructions are documented in our system Customer Master Special Handling instructions, and are viewed at several points during our order fulfillment process, including Final Authorization.

4.4 Shipping and delivery

4.4.1 Shipping of products is initiated by the customer order. The order identifies the shipping address, shipping due date, products to be shipped, handling requirements, and transportation mode or carrier. Before products are dispatched, the order fulfillment process controls verify that the shipment contains the same products and quantities as specified in the customer order, and that customer requirements and/or carrier requirements are met. Only order lines that have been Final Ship Authorized and signed off by the shipping department personnel can be loaded for shipment.

5. Post-delivery activities

DEE performs the following pre- and post-delivery activities, as required:

  1. Periodic review of On-time Delivery Performance and Quality of Delivery Performance,
  2. Review of client requirements, conveyed in Purchase Orders, Verbal Request, Supply Agreements/Contracts, and Policies,
  3. Review of Client feedback received via email, via on-site visit, etc…
  4. Risk assessment, PFMEA, CTQ (Critical to Quality) identification and development of inspection plan, error-proofing, and proactive mitigation of potential quality/failure issues,
  5. Warranty execution, subject to the terms agreed upon with each client,
  6. General support requirements by client request, which can include but not limited to: providing samples, evaluating cost savings alternatives, VAVE ideas, coordination of technical support by component material factory staff, assisting with required documentation, etc…

6. Control of changes

DEE reviews and controls changes for production or service provision to ensure conformity with requirements.

  • The Client Revision Level is verified upon receipt of their purchase order in various ways depending on the client and their specific methodology of managing revisions.  If there is a change, DEE will inquire with client if a First Article Approval process should be initiated.
  • If we are informed of a change by DEE’s supplier (DEE proactively sends out inquiries to suppliers periodically asking if there have been any changes to material, production plant, design, etc… in the past or planned for the future), DEE will notify our client to determine how they would like to deal with the change.  If proceeding with the change, then a new revision level is identified and a First Article Approval process initiated.
  • DEE periodically and proactively asks our clients to verify that the revision level we are showing as the latest one is in fact the correct latest one, and if not, request an updated drawing or specification to review.  If there is a change, DEE will inquire with client if a First Article Approval process should be initiated.
  • If a supplier notifies DEE of a significant change in their ability to meet DEE’s requested due date, DEE proactively communicates with client about what delivery date options we have so that client and DEE work out a mutually acceptable due date or action plan to address any shortfall, and updates our systems accordingly.
  • If a client’s demand changes significantly (either via a Purchase Order due date change, Purchase order Qty change, or Forecast change), DEE is monitoring these changes and when there is a substantial change, contacts the client to discuss if the change was intended or not.  If the change was intended, DEE works with the client on an action plan that is mutually agreeable to address the change in demand, and updates our systems accordingly.
  • If DEE’s client indicates there will be a Revision change in the future, DEE initiates First Article Approval procedure for the new revision.
  • If DEE is going to change a supplier manufacturer of a component or is going to change the material, production location, tooling used, etc… DEE will submit a Request for Change communication to our client for review.  Based on that review and approval, DEE will initiate a First Article Approval procedure.

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