Understanding The ISO/TS 16949:2002 Standard 

7.6 Control of Monitoring and Measuring Devices (MMD)  

Determine what monitoring and measurement is required and what MMD devices are needed to provide evidence of product conformity (see 7.2.1) 

Establish processes to ensure that monitoring and measurement can be carried out and is in fact being carried out in a manner that is consistent with requirements.

When necessary to ensure valid results:

a)        Calibrate or verify MMD at specified intervals, or prior to use, against measurement standards that are traceable to national or international standards. Record the basis for calibration if no such standard exists. 

b)        Adjust or re-adjust MMD as necessary 

c)        Identify MMD so that its calibration status can be determined 

d)        Safeguard MMD from improper adjustments that would invalidate the measurement result 

e)        Protect MMD from damage and deterioration during handling, maintenance and storage 

Assess and record the validity of previous measuring results if when the MMD does not meet requirements

Take appropriate action on such MMD and any product affected 

Keep records of the calibration and verification of MMD’s 

Confirm the ability of computer software to satisfy the intended application, when it is used to measure and monitor to specified requirements.  Confirm this ability prior to initial use and reconfirm as necessary.

Note: See ISO 10012-1 and 10012-2 for guidance 

Note:   A number or other identifier traceable to the device calibration record     meets the intent of 7.6c.  

7.6.1  Measurement System Analysis 

Conduct statistical studies to analyze variation present in the results of each type of MMD that is referenced in the Control Plan.

Use analytical methods & acceptance criteria that: 

Conform to methods and criteria in customer reference (MSA) manuals Or use other methods, if approved by the customer 

7.6.2    Calibration/verification Records  

Keep records of the calibration or verification of company & employee owned MMD’s to show evidence of product conformity. These records shall include: 

Þ            MMD identification, including the measurement standard used to calibrate the MMD 

Þ            Revisions following engineering changes 

Þ            Any out-of-specification readings as received for calibration or verification 

Þ            An evaluation of the impact of the out-of-specification condition 

Þ            Statement of conformity to the specification after calibration or verification 

Þ            Notification to the customer if suspect product or material been shipped 

7.6.3   Laboratory Requirements 

7.6.3.1 Internal Laboratory  

In your QMS documentation, define the scope for your laboratory that includes: 

Þ      It’s capability to perform required inspection, test & calibration services 

Your laboratory shall specify & implement technical requirements that, as a minimum, include: 

Þ            Adequacy of laboratory procedures 

Þ            Competency of laboratory personnel 

Þ            Product testing 

Þ            Capability to perform these services correctly and be traceable to relevant process standards (such as ASTM, EN, etc,) 

Þ            Review of related quality records 

Note – your internal laboratory may be accredited to ISO/IEC 17025, but it is not mandatory. 

7.6.3.2 External/commercial/independent Labs  

Where you use an external, commercial or independent laboratory for inspection, test or calibration services, it shall have a defined laboratory scope that includes its capability to perform the inspection, test or calibration services you require. 

You shall obtain evidence that the external laboratory is: 

Þ            Accredited to ISO/IEC 17025 or national equivalent 

Þ            OR - that it is acceptable to the customer  

Note 1: Evidence of customer acceptance may include an audit by the customer or an audit by a customer-approved 2^nd party that the laboratory meets the intent of ISO/IEC 17025 

Note 2: The equipment manufacturer of a specific MMD, can perform its calibration, if a qualified laboratory is not available. In such cases, you shall ensure that clause 7.6.3.1 requirements are met. 

Key Explanation Points and Tips: 

Þ      Requirements for what needs to be measured (see clause 4.1c & e; 7.1c) and the acceptance criteria (see clause 7.2.1; 7.1c; 7.3.3c) may come from the customer, regulatory, industry and your own organization. Product realization planning (see clause 7.1) must determine the following – what specific product and process characteristics needs to be monitored and measured; the criteria for product acceptance; the type of monitoring and measurement device needed; frequency - at what stages of realization to do it; sample size; etc. 

Þ      You must then determine what MMD is appropriate for each measuring or monitoring requirement. Consideration must be given to the measurement capability (precision) of the MMD which may have to be several times greater than the tolerance criteria for product measurement. This would depend on the industry you are in and the criticality of end use for the product (e.g. the precision requirements for an engine block or for ball bearings may be much greater than say for cutting leather to cover a car seat). 

Þ      Personnel using MMD’s must have  competence and training in the use of MMD’s in terms of their function, range and precision of measurement, reliability, use and maintenance.  

Þ      MMD’s may include measurement and testing tools; equipment; hardware and software. They may be owned by your organization; your employees or the customer. MMD’s may be used to verify product as well as to measure process conformity (e.g. a temperature controller on an oven). Besides MMD’s used for product conformity, you may need to calibrate and control certain MMD’s used in related and peripheral processes such as production equipment; tooling; maintenance; etc. 

Þ      To ensure valid measurement and monitoring results, MMD’s must be controlled. A process is required, to control the selection; purchase; identification; status; calibration; use; verification or adjustment; use; handling; maintenance and storage; training; nonconforming MMD’s; calibration records; etc. Appropriate records need to be kept of the use of these controls.  

Þ      All MMD’s used for product verification must be capable of being calibrated, verified or both. Calibration is setting or correcting an MMD, usually by adjusting it to match or conform to a dependably known and traceable standard (e.g. adjusting a micrometer or caliper to conform to master blocks traceable to national standards).  

Þ      Verification is confirming that the MMD is meeting or performing to acceptable national measurement standards and does not involve any correction or adjustment (e.g. verifying a ruler or tape measure against a calibrated ruler that has been calibrated to a national standard). A ruler or tape measure is generally not capable of being calibrated and when it gets out of calibration its use must be discontinued.  

Þ      There are MMD’s that are capable of being both calibrated and verified (e.g. a CMM- coordinate measuring machine) and may require both to be done in specific situations based on frequency of use and criticality of measurement. This requirement also applies to the use of computer software whose calibration status must be established prior to initial use and reconfirmed (verified) at defined intervals.  

Þ      You must define the frequency and method of calibration for each type and level (shop floor; laboratory or standard) of MMD. Your calibration records must identify what standard you used for calibration and show traceability of the standards you use at your facility to national or international standards.  

Þ      In rare circumstances, national or international standards may not exist for calibrating a specific MMD. In such situations consider using industry, manufacturer or even your own organizational standard to validate the accuracy and reliability of your MMD. Consult with your customer if the contractual circumstances require it.   

Þ      Your control plan must define the measurement and monitoring required and the type of MMD needed for it, including the frequency of measurement and acceptance criteria. Use customer reference manuals, such as the Measurement Systems Analysis (MSA) manual, to conduct statistical studies on MMD’s referenced in your control plans. Ensure that personnel performing such statistical studies are trained and competent to do so. 

Þ      A multitude of software tools are available to manage and control MMD’s including all the record keeping details required by clause 7.6.2. There are many acceptable methods to identify MMD’s and their calibration status. The methods you select must consider the manufacturers recommendations; frequency of use; environment the MMD is used in; etc. 

Þ      Where an MMD is found to be out of calibration, you must take appropriate correction action to contain and re-verify the product affected, to the extent practical. This is in addition to containing, repair and recalibration of the defective MMD.  

Þ      Customer or internal engineering changes may result in a change in product measurement, requirements and/or the MMD to be used.  These changes would normally be reflected in your control plan. Ensure that your calibration process shows clear linkage to your process for change control (clause 7.1.4) and control plan (clause 7.5.1.1). 

Þ      The quality of measurement data is subject to variability related to the measuring device, the measuring process, the operator using the measuring device, the product being measured, the environment the measurements are made in, etc. The study and control of the statistical characteristics (bias, repeatability, reproducibility, stability and linearity) that measure these variables is called Measurement System Analysis (MSA).  

Þ      The TS 16949 standard requires that the MMD or category (verniers, calipers, etc.) of MMD referenced in product Control Plans be subject to statistical analysis. The analysis methods and acceptance criteria for the statistical characteristics referred to above must conform to automotive OEM - MSA reference manuals. Other methods and acceptance criteria may be used if approved by the customer. Also review specific MSA requirements at OEM customer or IATF websites. 

Þ      In many organizations, the internal laboratory may conduct more technical and comprehensive inspection, testing and calibration using more complex and sensitive equipment, methods and standards. You must have document the internal laboratory scope; You must also specify technical requirements for – adequacy of procedures; personnel training and competency; testing methods; traceability to relevant process standards; control of test specimens; records needed, etc.  

Þ      Your internal laboratory scope must specify the tests, evaluations and calibrations it is qualified to perform; provide a list of the equipment used to perform these activities; and a list of the methods, standards, etc., used. 

Þ      The procedures used in the laboratory could be established practices; MMD manufacturer’s reference or user manuals; industry standards, methods and practices; customer specified methods; and regulatory methods and practices. These procedures typically address testing methods and standards; identification and traceability; etc. The need to have a documented laboratory procedure or manual would depend on the scope and complexity of product testing and inspection. 

Þ      OEM customers may have specific competency and training requirements for laboratory personnel. Refer to OEM websites; IAOB reference material or contact your OEM customer for the latest requirements.  

Þ      If you use an external laboratory, you must have evidence that it is ISO/IEC 17025 (or national equivalent) accredited or acceptable to the customer. Ensure that the external laboratory’s ISO/IEC 17025 accreditation is not out of date and its scope includes the activities you have contracted it to perform. Also review specific external laboratory requirements at OEM customer or IATF websites. 

Þ      Clause 4.1f requires you to continually improve your processes. Consider using appropriate performance indicators such as the monthly trends in - the number of out of calibration MMD’s; or the number of MMD’s past their calibration due date; number of MMD’s being used and not controlled; etc. Use these indicators to tighten and improve the effectiveness of your MMD process. If you have significant laboratory activities, it might be useful to establish similar performance indicators to measure the effectiveness of laboratory controls. 

Þ      Clause 7.6 does not require a ‘documented’ procedure. However, you must identify and document all processes addressing this clause as part of your QMS (see clause 4.1). For these processes, you must also identify what specific documents, controls and resources are needed (see clause 4.2.1d. and 7.1b.). You could use a product quality plan; documented procedure or other combination of specific practices, procedures, documents and methods. Look at the risks related to your product, processes and resources in determining the extent of documented controls you need to have (also see clause 4.2.1 notes).  

Þ      Performance indicators (to measure the effectiveness of processes that control MMD’s) may include reduction - in MMD’s found past due for calibration and being used; reduction in damaged, uncontrolled and uncalibrated MMD’s being used; reduction in untrained personnel found using MMD’s; reduction in lost MMD’s; reduction in MMD’s found out of calibration; no uncertified external laboratories being used; etc.