Re: 16949 - internal lab scope -post good example please!
It all depends on the industry you're in and the accuracy required. May want to clarify this for the group. We are in the metal fab business and have fairly liberal tolerances, so we can afford to generalize where others may not be able to.
I'm not sure if our lab scope is "good", but we have not any issue with internal or 3rd party audits. I've removed names to protect the innocent
This would be a good opportunity for experienced eyes to offer some feedback for improvement.
Laboratory Scope
POLICY:
The laboratory policy for XYZ Company states that all testing required is to the customer’s specifications and TS16949 requirements.
1. Laboratory personnel:
Training for laboratory personnel is accomplished and maintained through appropriate education, previous experience, skills, and training. This is to assure all laboratory personnel are competent, and aware of results of their actions on job performance. Training for all Laboratory personnel is documented in the ABRA software maintained in the Human Resources Department.
2. Laboratory Product/Gage Identification and Testing:
Samples, materials, etc. used for customer sample approval, are clearly identified, logged in, and inspected as required by work instruction QUA-31-AR. For inspection guidelines, refer to work instructionsQUA-31-AR and QA-116-AR, which details the approval/ rejection process. Proper notification is given to the individuals in charge as to the status of the item.
Sample parts are stored in a rack near the lab to protect against damage and ensure dimensional integrity.
Gages are generally calibrated at the time of receipt; however, if gages are to be stored for a period of time before calibration is complete, they will be stored in an area to prevent theft, damage, tampering, or use.
Inspection equipment is uniquely identified and those identification numbers are referenced in all maintenance, calibration, and use of those gages.
3. Laboratory Process Control:
Cleanliness of the area and equipment is accomplished through daily activities.
The environment is monitored and the controls are appropriate for our laboratory based on the calibration standards and the accuracy required. Temperature or humidity does not affect the integrity of parts or equipment in our laboratory.
4. Laboratory Testing and Calibration Methods:
1. Dimensional testing: Initial sample or in-process inspection for customer parts.
2. Spot-weld “coupon peel” testing: Process which peels welded material to reveal the weld penetration size. Coupons of the same material are used to prevent destroying part.
3. Weld etch tests: As customer requires. Test which verifies the weld penetration of standard mig/tig welding. These tests are performed in accordance to AWS Welding Standard D1.1
4. In-house calibration of basic test equipment: Standard gages used for production monitoring are calibrated per the required procedures. Masters are calibrated by an outside source to maintain traceability to N.I.S.T.
5. Certification of fixtures: All internal and external production fixtures are dimensionally verified and error-proofed prior to the first production build and after revision change (if applicable).
6. Calibration of welding instruments: A load bank is used to verify the documented weld settings to the actual output of the machines.
5. Evaluation of Tests
Dimensional evaluation is accomplished by a variety of equipment and measuring tools such as but are not limited to the following:
A. Coordinate Measuring Machine
B. Height gages
C. Micrometers
D. Calipers
E. Weld inspection instruments
F. Radius gages
G. Thread Gages
H. Fabrivision
I. SPC data (variable and attribute)
J. Tape Measures
K. Scales
L. Check Fixtures
M. Protractors
Laboratory work instructions, customer specifications, and our Customer Parts Approval Requirements Book accomplish all instructions for the dimensional checks. This book is under document control to assure all testing remains to the latest revised documents.
6. Equipment listing
All gages and measuring equipment used in our Laboratory is listed in the gage control software. Records are available for review.
7. Methods and Standards
Calibration intervals for each in-house measurement instrument or standard shall be established from the history of gage types. Calibration methods and standards are accomplished through work instructions, procedures, and using master gages which are traceable to N.I.S.T. standards.
In-house calibration is accomplished by using master gages which are traceable to N.I.S.T. Calibration masters include, but are not limited to the following:
A. Gage blocks
B. Angle Blocks
C. Bench Micrometer
D. Thread Wires
E. Coordinate Measuring Machine
Work instructions, calibration procedures, and reference to various calibration standards (such as ISO/IEC 17025) direct proper approach to in-house calibration.
Accredited Laboratories: Commercial/independent laboratory facilities that we use for calibration of the laboratory equipment will be accredited laboratory facilities.
STATISTICAL PROCESS CONTROL:
All statistical controls are based on customer specific requirements and as referenced in the Statistical Process Control Reference Manual. MSA studies are performed on families of gages to review the stability, linearity, and bias of each type of gage.