Understanding The ISO/TS 16949:2002 Standard 

8.2.4 Monitoring and Measurement of Product  

You shall: 

Monitor and measure product characteristics to verify that product requirements have been met 

Carry this out at appropriate stages of product realization as per planned arrangements (see clause 7.1) 

Maintain evidence of conformity with acceptance criteria 

Keep records of person(s) authorizing release of product  

Do not release or delivery product until all planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority, and where applicable by the customer. 

Note:   Consider type of product characteristics, (when selecting product parameters to monitor conformity to internal and external requirements). These should lead to types of measurements, suitable means of measurement and capability & skills required,  

8.2.4.1 Layout Inspection 

You shall perform a layout inspection & functional verification for each product, to applicable customer engineering material & performance standards, as specified in the Control Plans. Keep results available for customer review 

8.2.4.2 Appearance Items 

For parts designated by the customer as appearance items, you shall provide: 

Appropriate resources including lighting for evaluation 

Masters for color, grain, gloss, metallic brilliance, texture, distinctiveness of image, as appropriate 

Maintenance & control of appearance masters & evaluation equipment 

Verification of the competence and qualifications of personnel performing appearance evaluations 

Key Explanation Points and Tips: 

Þ      to determine process monitoring and measuring indicators and controls. Monitoring and measurement may be done manually or by automated means. 

Þ      You must identify, monitor and measure product characteristics to verify conformity to requirements. Product characteristics may include - dimensional; functional; performance; reliability; durability; maintainability; life; cost; etc. We had previously established that requirements may come from your customer, your own organization, regulatory and industry sources. Also review specific product test and monitoring requirements at OEM customer or IATF websites. 

Þ      You must plan (see clause 7.1) – what product characteristic(s) to measure; type of measurements; what measurement device to use; how often to measure; sample size; acceptance criteria; and records needed - for each product or product type. Your planning must include all special and safety characteristics specified by the customer, your own organization, regulatory and industry sources. Also review specific sample size requirements at OEM customer or IATF websites. 

Þ      Use your APQP process (use product design, see clause 7.3.3 and 7.3.3.1); customer and applicable regulatory requirements; and cross-functional knowledge of - customer requirements, product technology, manufacturing processes; etc., to determine product acceptance criteria; types of measurement; related monitoring and measurement controls; and capability and skills required to perform these monitoring and measurement controls. 

Þ      Your control plan must define the stages that various monitoring and measurement controls will be carried out – incoming receipt of materials from suppliers or outsourced work; storage; internal production processes; finished product; packaging; at time of shipping; and post installation. 

Þ      Monitoring and measurement may be done by your personnel, subcontracted or outsourced labor or by the customer. You must ensure that all personnel performing monitoring and measurement of product are trained and competent.  

Þ      If you plan on releasing (during any stage of production) or shipping finished product, where all planned inspections and measurements to that stage have not been completed, ensure that you obtain prior written approval/waiver from a relevant internal authority or the customer (see clause 8.3.4). Where practical, consider completing all missed planned inspections and measurements before product delivery. 

Þ      Layout inspection is the complete measurement of all product dimensions shown on the design record. Refer to your specific customer requirements and PPAP reference manual for guidance on frequency and process for doing layout inspection and functional testing. Ensure you use the correct customer engineering material and performance standards for each product. Keep all records for customer review and/or submit for approval if required. Review specific layout requirements at OEM customer or IATF websites. 

Þ      Clarify (using your APQP process) up-front during contract negotiations or during design and development whether the product is designated as an ‘appearance item’. Resources for controlling appearance items may include - special equipment and supplies; lighting; environmentally controlled space or laboratory; competent and trained personnel; appearance standards or masters (provided by the customer; industry or developed by your own organization); use of special testing and measurement devices and their calibration; etc. 

Þ      Your process for ‘appearance items’ must define and control all of these variables as applicable. In the event of an ‘appearance item’ product nonconformity, clarify with your customer, the rules for repair and rework. Review specific appearance items requirements at OEM customer or IATF websites. 

Þ      Clause 8.2.4 does not require a ‘documented’ procedure. However, you must identify and document all product realization processes that may address this clause, as part of your QMS (see clause 4.1), e.g. receiving, production, shipping, etc.. For such processes, you must also identify what specific documents are needed (see clause 4.2.1d. and 7.1b.) for effective planning, operation and control.  

Þ      You could use a product control 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 product conformity - reduction in defect rates, PPM’s (defective parts per million), scrap rates, waste, rework; improvement in on time delivery (see clause 7.1a); product returns from customer; etc. 

Þ      Don’t overlook performance indicators to measure compliance with product related regulatory requirements – e.g., reduction in product test and product performance failures to regulatory or industry criteria.