Understanding TS 16949

                                  Chapter 15
                    Understanding TS 16949:2002

8.2.3 Monitoring and Measurement of Processes
You shall:
• Apply suitable methods for monitoring, and where applicable, measurement of QMS processes (see 4.1)

• These methods shall demonstrate the ability of QMS processes to achieve planned results (see 4.1)

• If planned results are not achieved, take correction and corrective action to ensure product conformity

8.2.3.1 Monitoring and Measurement of Manufacturing Processes
• Perform process studies of all new manufacturing (including assembly and sequencing) processes) to verify process capability & to provide additional input for process control

• Document the results of process studies with specifications (where applicable) for production, measurement, test & maintenance instructions

• These documents shall include objectives for manufacturing process capability, reliability, maintainability & availability, as well as acceptance criteria

• Maintain manufacturing process capability or performance as specified by the customer part approval requirements

• Implement Control Plans & process flow diagram to ensure conformity to specified:
    Þ Measurement techniques,
    Þ Sampling plans,
    Þ Acceptance criteria and
    Þ Reaction plans when criteria not met

• Keep a record of significant process events such as tool change, machine repair, etc.

• Initiate reaction plans from the Control Plan, for characteristics that are either unstable or not statistically capable.

• These reaction plans shall include containment of product and 100% inspection, as appropriate. Then complete a corrective action plan indicating timing and assigned responsibilities to assure that the process becomes stable and capable. If required, review these plans with the customer and get their approval.

• Keep records of effective dates of process changes

Key Explanation Points and Tips:
Þ You must establish methods and indicators to monitor and measure your QMS processes (see clause 4.1e and 5.4.1) to demonstrate process capability to achieve planned results and identify opportunities to improve the process. Use your organizations cross-functional knowledge of customer requirements; product; technology; manufacturing processes; etc, to determine process monitoring and measuring indicators and controls. Monitoring and measurement may be done manually or by automated means.

Þ One way to identify useful measuring and monitoring methods is to review what problems could occur or have occurred within a particular process. Monitor and measure these occurrences and develop process controls (methods) to reduce or eliminate them. Problems (risks) can occur with any of the variables in a process - e.g. - materials; equipment; facility; methods; technology; personnel; computer hardware or software; etc. By using fishbone analysis or similar tools, you can develop very useful monitoring and measuring methods and process performance indicators.

Þ Correction refers to action taken to eliminate a detected nonconformity (see clause 8.3). Correction involves the containment, evaluation of the nonconformity and action that may result in rework; regrade; scrap; return of nonconforming material/work to supplier or outsourcer; or acceptance through a customer concession or deviation permit.

Þ Correction differs from corrective action (clause 8.5.2). Corrective action is action taken to eliminate the cause of a detected nonconformity to prevent recurrence; whereas correction does not address cause.

Þ You must monitor your manufacturing QMS processes, first to determine and establish capability of new processes to conform to requirements

Þ And secondly, to monitor these processes over time to verify ongoing stability and capability to meet requirements

Þ And thirdly to determine and achieve levels of continual improvement

Þ Use your APQP, FMEA, MSA and PPAP reference manuals for guidance in determining process monitoring and measuring indicators and controls. Also review specific measurement and monitoring requirements at OEM customer or IATF websites.

Þ The output of your manufacturing process design process (clause 7.3.3.2 and 7.3.2.2) must specify the manufacturing process capability, reliability, maintainability & availability indicators, as well as process approval acceptance criteria

Þ Your manufacturing process capability performance must conform to the capability documented in your PPAP submission or agreed with your customer in writing. You must keep records of this ongoing conformance to your customer requirements and use this information to identify opportunities to improve the process.

Þ The measurement techniques, sampling plans, acceptance criteria and reaction plans must be documented or referenced in your control plan. Managers responsible for corrective action must be promptly informed of product and process nonconformities (see clause 5.5.1.1). Also review specific sampling plan requirements at OEM customer or IATF websites.

Þ Where the customer is significantly affected by a process nonconformity or change, they must be notified. Corrective action plans as well as resulting updated/changed PPAP’s must be reviewed and approved by the customer, when so required. If in doubt, get clarification from the customer.

Þ Use your manufacturing design process (clause 7.3) and change control process (clause 7.1.4) to manage manufacturing process changes.

Þ Performance indicators are not needed for this clause as it provides direction for the application of monitoring and measurement performance indicators for all QMS processes. However the output of monitoring and measurement methods used within each QMS process provides useful performance indicators for determining the effective implementation and maintenance of QMS processes. Review the performance indicators within each process covered this far.

Þ Performance indicators to measure process effectiveness and efficiency include - productivity; reduction of cycle time, waste, errors, omissions and failures; asset utilization rates (downtime, turnover), etc.

Þ Don’t overlook performance indicators to measure compliance with process related regulatory requirements - e.g., reduction in health and safety incident/violation rates; reduction in regulatory reporting violations, etc.

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.

8.3 Control of Nonconforming Product
You shall:
• Identify and control nonconforming product to prevent its unintended use or delivery

• Have a documented procedure to define the controls and related responsibilities and authorities to deal with nonconforming product. Nonconforming product must be dealt with in one or more of the following ways:
    a) take action to eliminate the nonconformity
    b) authorize its use, release, acceptance (under concession) by a relevant authority or
        where applicable by the customer
    c) take action to preclude its original intended use or application

• Maintain records of the nature of the nonconformity and any subsequent actions (and concessions obtained)

• Re-verify corrected product to show conformity to requirements

• When nonconforming product is detected after delivery or use has started, take action appropriate to the effects (or potential effects) of the nonconformity.

8.3.1 Control of N/C product - Supplemental
You shall classify unidentified or suspect product as nonconforming product

8.3.2 Control of reworked product
Rework instructions including re-inspection requirements shall be accessible & used by appropriate personnel

8.3.3 Customer Information
Notify customers promptly if nonconforming product has been shipped

8.3.4 Customer Waiver
• When your product or manufacturing process is different from that currently approved, then you shall obtain a customer concession or deviation permit prior to further processing.

• Keep a record of expiry date & quantity authorized by each concession or permit

• Revert back to compliance with the original or superceding specification, when the customer authorization expires

• Properly identify each container of material shipped on an authorization. This also applies to purchased product

•Approve any requests from your suppliers before submission to your customers

Key Explanation Points and Tips:
Þ Nonconforming product is defined as product that does not conform to customer requirements; applicable regulatory requirements or your own organization requirements. The definition may also apply to nonconforming processes and services. Nonconformities may relate to suppliers and outsourced work; your own organizational activities or product shipped to customers. Also review specific nonconforming product requirements at OEM customer or IATF websites.

Þ The controls under clause focus on eliminating the nonconformity, but not the cause. Eliminating the cause is addressed under clause 8.5.2. Your documented procedure for nonconforming product must include controls and responsibilities to - identify; contain it,(i.e. prevent further processing or use); keep records of the nature and other details of the nonconformity; notify appropriate personnel (see clause 5.5.1.1) and customers, where appropriate; evaluate what disposition action needs to be taken; carry out timely disposition; determine policies for release for further processing or shipment to the customer; obtain customer concessions and deviation permits; rework and re-verification; waivers and approvals of supplier materials, etc.

Þ Product or material found with no identification or its quality status is not known, must be treated as nonconforming product and controlled by the above procedure.

Þ If you find that nonconforming product has been shipped, without a customer concession, notify the customer immediately and use your procedure, to effectively contain and resolve the situation to your customer’s satisfaction. Where required, use the customer prescribed form for recording and controlling nonconforming product.

Þ An authorization refers to written permission (number or code) to ship or manufacture nonconforming product. The permission is usually very specific about product, quantity and time frame during which nonconforming product can be shipped. The authorization number or code must identify each container shipped under the authorization.

Þ A concession authorization allows you to ship nonconforming product, under controlled conditions. A deviation authorization allows you to manufacture product different from the original specification, under controlled conditions. Also review specific waiver requirements at OEM customer or IATF websites.

Þ Ensure that all rework has evidence of re-inspection after the rework has been done and that the personnel doing the rework and re-inspection have been trained (keep records of training) and are using the rework instructions.

Þ All customer-oriented processes (see clause 4.1) must show the interaction with your process for nonconforming product.

Þ Performance indicators to measure the effectiveness of control of nonconforming product may include - reduction in cycle time to evaluate and dispose of nonconforming product; reduced errors in preventing unintended use or delivery; improved alternate use of nonconforming product and cost recovery; etc.