Document Number: / SP-8.5 Rev. 2
Approved By: / Randy Wombacher
Revision Details: / Controlled Document Revision Record
8.5.1 CONTROL OF PRODUCTION AND SERVICE PROVISION
Wacom implements production and service provision under controlled conditions.
Controlled conditions include, as applicable:
a) the availability of documented information that defines;
1. the characteristics of the products to be produced, the services to be
provided, or the activities to be performed;
2. the results to be achieved;
b) the availability and use of suitable monitoring and measuring resources;
c) the implementation of monitoring and measurement activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services, have been met;
d) the use of suitable infrastructure and environment for the operation of processes;
e) the appointment of competent persons, including any required qualification;
f) the validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement;
g) the implementation of actions to prevent human error;
h) the implementation of release, delivery and post-delivery activities.
8.5.2 IDENTIFICATION AND TRACEABILITY
Wacom use suitable means to identify outputs when it is necessary to ensure the conformity of products and services.
Wacom identifies the status of outputs with respect to monitoring and measurement requirements throughout production and service provision.
All parts and materials are identified upon receipt by means of supplier packing lists.
After receipt and while stored in the stockroom parts are identified by an attached label, storage bin label, or other suitable means including markings directly on the material.
Product identification is maintained throughout the production and inspection stages by use of job traveler papers assigned to the products the job number in Epicor.
Any product that does not meet requirements or the quality plan at any stage from receipt through delivery is subject to the Nonconforming Product process.
Wacom controls the unique identification of the outputs when traceability is a requirement, and retains the documented information necessary to enable traceability.
Traceability is provided where requested in advance of customer order and is ensured through:
a) Certificates of conformance for specific grades of Clear Fused Quartz.
b) The identification and recording of all products and raw materials (including lot numbers) within a specific contract being recorded using the serial numbers and/or lot numbers functions within the Epicor database, and/or serial number logs.
8.5.3 PROPERTY BELONGING TO CUSTOMERS OR EXTERNAL PROVIDERS
Wacom exercises care with property belonging to customers or external providers while it is under the Wacom’s control or being used by Wacom.
Wacom identifies, verifies, protects and safeguards customers’ or external providers’ property provided for use or incorporation into the products and services.
When the property of a customer or external provider is lost, damaged or otherwise found to be unsuitable for use, Wacom reports this to the customer or external provider and retains documented information on what has occurred in Epicor or the Action Log and reports to the customer (usually through email).
The main example of customer property is finished product owned by the customer and sent to us for repair or modification.
In general:
a) All customer-supplied product is reviewed upon receipt to verify the customer and Wacom agree as to what product is and what modifications are required.
b) Adequate storage and maintenance procedures are established for customer-supplied product, and are slightly different than regular product where required.
c) All customer-supplied product is inspected prior to work being performed regarding damage, quantity, and necessary documentation.
d) All customer-supplied product is identified during all stages of production in the same fashion as regular product.
e) Customer supplied product not meeting requirements is quarantined and the customer is informed; their product is either returned or scrapped, and records are kept of non-conforming product and customer correspondence.
NOTE A customer’s or external provider’s property can include materials, components, tools and equipment, premises, intellectual property and personal data.
8.5.4 PRESERVATION
Wacom preserves the outputs during production and service provision, to the extent necessary to ensure conformity to requirements.
NOTE Preservation can include identification, handling, contamination control, packaging, storage, transmission or transportation, and protection.
· Product moves through the facility in carts or hand carried.
· Tooling is stored in cabinets in the Mill room. Plant Engineer is responsible if there is any kind of change; will get with customer to get their okay and use a sheet / checklist to document the change. Tools are not stacked to protect them from damage.
· Shelf life material is used and maintained within cabinets and at necessary work stations.
· Documentation that ships with the product is protected/maintained in a folder prior to shipping.
8.5.5 POST-DELIVERY ACTIVITIES
Wacom meets requirements for post-delivery activities associated with the products and services.
Wacom Quartz does not provide post-delivery activities at this time with the exception of processing customer returns.
NOTE Post-delivery activities can include actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal.
8.5.6 CONTROL OF CHANGES
Wacom reviews and controls changes for production or service provision, to the extent necessary to ensure continuing conformity with requirements.
Wacom retains documented information describing the results of the review of changes, the person(s) authorizing the change, and any necessary actions arising from the review.
Personnel approved Authorizations Matrix can make changes as listed on Matrix. Initial and Date on paper copies, if electronically it will be kept track of in Epicor.
Note for Printed Copies: If this document was printed, please be aware that the most current information is on-line on the server and revisions to this procedure may be made after this record was printed.
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