1 LABORATORY SCOPE . The following is the SCOPE of activities, processes, personnel, control, etc. for the in- house LABORATORY capabilities at Champion Gasket and Rubber, Inc. 1. Personnel- All personnel making ANY judgment as to the status of parts, material, gauges, templates, etc. must be qualified (trained) and have appropriate experience with our LABORATORY requirements. a. This carries on to the use of specific measuring devices. Any employee that uses measuring devices at Champion Gasket and Rubber, Inc. must be trained in that respect. Employees who have not received explicit / formal training on the measuring devices, processes and LABORATORY SCOPE are not qualified to make LABORATORY judgments.
2 I. Education: No specific education requirement is applicable for LABORATORY personnel at this time ii. Formal Training: All LABORATORY employees must be formally trained in our LABORATORY procedures. This means verification of employee knowledge of requirements must be established. This is done through a written test. iii. Experience: LABORATORY tests are allocated to personnel based on their training performance and experience with the test(s) at hand. b. The Quality Assurance Manager and the Production Manager are responsible to ensure and enforce the LABORATORY personnel requirements.
3 Please see them for any further question in this area. 2. SCOPE - The dimensional testing of parts, material, templates and the like for conformance to a dimensional specification. a. This includes both the Metric and American Standard units of measure. The following equipment /. methods are used for this type of verification/inspection. Calipers Micrometers Precision Scales Radius gauges Mylar / StyreneTemplates Visual Inspection Please note that any other measuring tool not on the above list is NOT an approved IM & TE tool. 3. Calibration- All of the above-mentioned equipment must show the appropriate level of calibration as shown in the categories below.
4 GAUGE NAME TEST TYPE REQUIRED CALIBRATION FACILITY FREQUENCY. Caliper Certified Conformance Accredited Outside Lab Annual Caliper Capability In-house ( Champion ) Annual (As Req'd). Micrometer Certified Conformance Accredited Outside Lab Annual Micrometer Capability In-house ( Champion ) Annual (As Req'd). Precision Scales Certified Conformance Accredited Outside Lab Every Three Years Radius Gauges Certified Conformance Accredited Outside Lab Every Five Years Mylar / Styrene Templates Conformance In-house ( Champion ) Once (w/ periodic checks). a. A master list of all Inspection, Measuring & Test Equipment is kept by the Quality Assurance manager.
5 The last date of calibration, the gauge (serial) number, and the next calibration date are all documented on a label on the back of the above-mentioned measurement devices. Ensure that the gauge is calibrated for use before use. LAB SCOPE 2/26/01. * The gauges fabricated in-house are only required to be calibrated once due to the fact that there is an extremely low chance that the templates will change over time due to the nature of their physical properties combined with our relatively low usage. The template is however visually examined prior to each use. ** Precision Scales and Radius Gauges require less frequent calibration due to the fact that there is an extremely low chance that the gauges will change over time due to the nature of the nature of their physical properties combined with our relatively low usage.
6 The gauges are, however, visually examined prior to each use. 4. LABORATORY Process Control- Any form of LABORATORY analysis performed at Champion Gasket must be within our LABORATORY SCOPE of capabilities (see Item 2). a. All conditions must be adequate for initial, in-process, and final inspection being performed by operators. The production floor is a suitable environment for these inspection procedures. The following applies only to the LABORATORY inspection required for template checking b. Environmental Conditions must be adequate to perform the required LABORATORY task.
7 Currently environmental conditions are not a major element of our LABORATORY analysis, however these conditions are documented on the LABORATORY test sheet. The following are the environmental concerns that must be noted before inspection: i. Is the area of inspection at ambient room temperature? (Approximately 70 F). ii. Is the area of inspection reasonably free from dust or other possible contaminants? iii. If using a caliper / micrometer is the area free from possible electronic / magnetic interference? c. Personnel must be trained to perform LABORATORY tests (see item 1) The following are the personnel concerns that must be noted before inspection: i.
8 Is the employee trained to perform the LABORATORY analysis? ii. Have appropriate training/instructions been given to guide employee? d. All LABORATORY tests must be documented and records must be retained to show that the product /. gauge has been tested. The following are documentation concerns: i. Have the appropriate test records been provided ( lab inspection record). ii. Have all areas of all forms been completed in full? iii. Is the form applicable for the test being performed? ** Only after all of the above tasks have been verified may the template dimensional test commence 5.
9 Statistical Techniques- Appropriate statistical techniques are used to determine the repeatability and reliability of some gauges. The frequency of these studies is determined by how often the gauge is used. Calipers / Micrometers are the only measuring devices that we verify with statistics. A gauge Reliability and Repeatability or R&R Study is performed. See the calibration chart on the previous page for more information. LAB SCOPE 2/26/01.