calibration as a risk management strategy
TRANSCRIPT
Calibration as a Risk Management Strategy
www.alliancecalibration.com
Final Product
Component C
Component B
Component A
Non Conforming Part ?
How do you Know it won’t work?
It does not fit or function properly!
How did you make this determination?
You measured it or compared it to a standard.
How wide is
the blade?
Cut “fat”
Cut “skinny”
Blade Thickness
Operator Vision
Straightness of Cut
Measurement Uncertainty
The combination of all the contributors
Prevention
Quality Management System
Training
Defect Prevention
FMEA
Inspection/Calibration
Measurement
Audits
Testing
Internal Failures
Rework
Scrap
Crisis Management
External Failure
Product Recall
Customer Dissatisfaction
Reputation Damage
Cost of Quality
ISO 9001 Section 7.6
7.6 Control of Monitoring and Measuring Equipment
The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements.
The organization shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements.
ISO 9001 Section 7.6 7.6 Control of Monitoring and Measuring Equipment continued
Where necessary to ensure valid results, measuring equipment shall a) Be calibrated or verified, or both, at specified
intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded.
b) be adjusted or re-adjusted as necessary; c) have identification in order to determine its
calibration status d) be safeguarded from adjustments that would
invalidate the measurement result; e) be protected from damage and deterioration
during handling, maintenance and storage.
ISO 9001 Section 7.6 7.6 Control of Monitoring and Measuring Equipment continued
In addition, the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization shall take appropriate action on the equipment and any product affected. Records of the results of calibration shall be maintained.
Traceability
Product
Process
Calibration Laboratory
National Metrology Institute (NMI) National Primary Standards Laboratory Standards
International Bureau of Weights and Measures (BPIM)
What should I calibrate?
Any process that can contribute to customer expectations needs to examined.
Should I hire an outside company for all calibrations?
NO! If you have a properly trained staff and have master standards that have been calibrated and have evidence of traceability you can perform calibrations internally.
When should I consider using an outside service?
• No in-house expertise • Standards too expensive to maintain • Specialized equipment • Inadequate Document Control System •Perform a Risk Analysis
How do I Select a Calibration Company ?
ISO 17025 is the standard for calibration and testing laboratories
In order to become and maintain ISO 17025 accreditation an independent Third Party assessment must occur.
This assessment includes observation of technical competence.
Stating “compliance” or “adherence” to ISO 17025 is not the same as being accredited.
Accredited Calibration Laboratories will have a certificate of accreditation. Ask for it!
ISO 17025 accreditation means a Laboratory is competent to do all
my calibrations, Correct?
Absolutely Not!
In addition to the Certificate of Accreditation you need to ask for the Scope of Accreditation.
The Scope of Accreditation delineates by line item what measurement a company has demonstrated technical competence to perform.
Example: A company may be accredited to calibrate micrometers, but is not accredited to calibrate temperature.
Minimize your Risk!
Determine what needs
to be calibrated
In-house Calibration
Maintain proper Standards
External Calibration
Scope of Accreditation
Keep records
Examine Results
Determine Calibration Frequency
Reduce Internal
rework and scrap
Produce more product that
meets specification
Gain market shared share
based on quality work
Increase Profit!
Phil Wiseman
Alliance Calibration 11402 Reading Road Cincinnati, OH 45241
513-769-1200
www.alliancecalibration.com
Calibration as a Risk Management Strategy All the technical journals are abuzz with the changes to ISO 9001:2015. One significant paradigm shift is to a risk based management approach. Most companies already apply risk-based thinking in their planning process for organizational management. This article will take a very narrowly focused approach to a key aspect of Risk management: Calibration. SLIDE 2 The goal of every company is customer satisfaction. Reality is if your customers are not happy the long term odds of your business viability are slim. There might be an exception if you are the only manufacturer of a product that everyone must have. That is just not reasonable in the global market place. Slide 3 In order to effectively manage your risk you must know what your customers need and want and how to deliver that while maintaining a reasonable profit. If you use external suppliers you must communicate your customer expectations through the supply chain to ensure your risk is mitigated or managed as you produce your final product.
Slide 4 So what does calibration have to do with any of this? Everything is manufactured to a tolerance. A + or – some measurement so that component parts fit together. Controls such as Temperature, Pressure and/or Force are also measurements that can affect final product conformance. Imagine you need a 1 inch diameter rod to fit a part. How close to 1 inch does it need to be? Is 1 ¼ inches good enough? Is 1.00001 inch necessary? This is the +or- we mentioned above. A part arrives and it does not fit or perform properly. What is the first thing you do? Measure it with a device such as a ruler, caliper, micrometer, etc. SLIDE 5 and SLIDE 6 You are cutting a piece of wood. Do you saw it on the line? Cut it “skinny” or “fat”?
How wide is the saw blade? What is the final measurement of the cut wood? How do you know if it is the correct length?
Imagine the chaos if everyone had their own interpretation of what an inch is! In order to reduce the chaos and manage the uncertainty standards must exist. We need an agreed upon standard so that we know what an inch is. Would you be frustrated if every gas station had their own interpretation of a gallon. At four dollars a gallon I personally want to know I got my gallon’s worth. SLIDE 7 Enter Calibration. Calibration is the comparison to a known physical standard. Our global marketplace dictates International Standards to facilitate commerce across geographical borders. An integral piece to this concept is internationally recognized standards for comparison. Standards are extremely expensive to maintain and most companies could not afford to send their instruments to NIST or the UK or wherever the physical standard is located. Likewise, the weeks or months waiting for the instruments to return would be cost prohibitive. These economic constraints are mitigated by using an accredited calibration company that can provide an unbroken chain of traceability to the standard. SLIDE 8- COST OF QUALITY Each link in the traceability chain contributes to the + or- we discussed previously. The sum of all the +’s and –‘s is referred to as measurement uncertainty. The smaller the measurement uncertainty the better confidence you have in the measurement. Would you want to measure a 1 inch block with a yard stick ±1/4inch or a comparator ±0.0001 inch? Your product tolerance makes that determination for you. Now that we have had a rudimentary discussion of calibration, why does any of this matter to your process or product? One company makes lids and another company makes cups. Does anybody care that they fit together? Ask anyone that has ever had a leaky cup/lid and they will say yes. SLIDE 9 10 11 12 13 ISO 9001 Section 7.6 requires a calibration program be in place. You can view this as a cost or revenue center. A properly executed calibration program will reduce internal rework and reduce external customer rejections. The more product you make that meets customer’s requirements the more profit you will make.
What should I calibrate? Any process that can contribute to customer
expectations needs to be examined. Does this mean you must a hire a calibration company for every device that is used for measurement. No. If you have a properly trained staff and have master standards that have been calibrated you can perform calibrations internally. It can become cost prohibitive to maintain all the necessary calibration standards internally so a cost benefits analysis should be done. SLIDE 17 How do I select a calibration company? An international standard ISO 17025 exists for calibration and testing. In order to become and maintain ISO 17025 accreditation independent third party assessment must occur. This independent assessment includes observation of technical competence. It is common for companies to say they are compliant with ISO 17025. This is not the same as being accredited. Automotive standard TS 16949 requires ISO 17025 accredited calibration. A key risk management component of ISO 17025 is the unbroken chain of traceability back to the standard. SLIDE 18 ISO 17025 accreditation does not mean a calibration company is competent for all calibrations. Accreditation bodies issue a scope of accreditation that delineates by line item what measurement a company has demonstrated technical competence to perform and the scope will also list the best measurement uncertainty they have demonstrated. The end user needs to read this document to determine if the calibration company can meet your specific needs. Reduce your risk by doing the following:
• Determine what needs to be calibrated. • Evaluate in–house expertise for calibration. • Maintain the proper standards for calibration • Select an external calibration laboratory if appropriate. • Examine external laboratory’s Scope of Accreditation • Maintain records of calibration results • Analyze records to determine calibration frequency • Use calibration to reduce internal rework and scrap • Produce more product that meets specification • Gain market share based on quality work
Phil Wiseman is COO of Alliance Calibration in Cincinnati, Ohio. He earned a B.S. degree in Chemical Physics from Centre College in Danville, KY and holds certifications from ASQ as Certified Manager of Quality/Organizational Excellence and Certified Quality Auditor.