Understanding TS 16949

                                  Chapter 13
                    Understanding TS 16949:2002

7.5.2 Validation of Processes for Production and Service Provision
Validate any production or service provision processes where:
Þ The resulting output cannot be verified by subsequent monitoring or measurement
Þ Where process deficiencies become apparent only after the product is in use or the
   service has been delivered.

• Validation shall demonstrate the ability of these processes to achieve planned results
• Establish controls for these processes, including, as applicable:
a) Criteria for review and approval
b) Approval of equipment and qualification of personnel
c) Use of specified methods and procedures
d) Requirements for records
e) Revalidation

7.5.2.1 Validation of production processes - Supplemental
• Apply the requirements of 7.5.2 to all processes for production & service provision

Key Explanation Points and Tips:
Þ Validation is usually required where product quality cannot be verified without damaging or destroying the product, e.g. some types of welding, heat-treating; electroplating, rust-proofing, etc. In such instances, the quality of these activities may only be discovered after use. This would generally not be acceptable due to safety (e.g. weld) or aesthetic (evidence of rust or dullness of chrome) reasons.

ÞI n such cases, validation involves conducting capability studies using a combination of resources - technology, equipment; materials; environment; competent personnel; and production and testing methods that consistently result in a quality product or service. Document the specific procedures; methods; and combination of resources that achieve this capability, and keep records of ongoing studies to show that you are maintaining this capability. Validation may also require customer approval of the process (See PPAP clause 7.3.6.3).

Þ You must keep appropriate records of process validation showing both the achievement of planned results as well as the ongoing maintenance of such capability (see PPAP clause 7.3.6.3).

Þ If you change any part of the proven process capability (e.g. materials, equipment or personnel, etc.), you must revalidate (re-prove) the changed process. It is up to each organization to determine what combination of resources and methods will provide the required consistent quality product or service. Include as appropriate, validation controls in your control plans. You may need to re-PPAP your product and process.

Þ Performance indicators to measure the effectiveness of processes that validate production processes may include reduction in - defect rates, PPM’s (defective parts per million); validation cycle time; revalidations; etc.

7.5.3 Identification and traceability
Þ You shall
• Where appropriate, identify product by suitable means throughout product realization
• Identify the status of product with respect to monitoring and measurement requirements
• Control and record the unique identification of the product, (where traceability is a
    requirement).

Note: Configuration management is a means for maintaining identification and traceability in some industry sectors.

Note: You cannot use location of product as an indicator of inspection and test status, unless inherently obvious such as material in an automated production transfer process. Alternatives are permitted if status is clearly identified, documented and achieves the designated purpose.

7.5.3.1 Identification and Traceability - Supplemental
• The words “Where appropriate” in 7.5.3 does not apply to the automotive sector

Key Explanation Points and Tips:
Þ There are three distinct control requirements specified here.

Þ Product identification - means knowing the identity of (yours or customer supplied) product from - incoming receipt of materials; raw material storage; use in production; work in progress; finished product storage; and delivery of product to the customer. Product identification can be controlled using physical and electronic methods.

Þ Product status - means knowing the quality status (good or bad) of materials and product through each of the above stages. Product status can be controlled using physical and electronic methods.

Þ Unique Product Identification - is not a mandatory requirement under ISO 9001, unless contractually required by customers. For the automotive or aerospace or pharmaceutical industry, unique product identification is mandatory for safety, regulatory and risk management reasons. This usually involves keeping detailed records for - material; equipment; personnel; processes; production; inspection and test details, etc., for individual products or production batches. Review specific requirements for identification and traceability at OEM customer or IATF websites.

Þ These records help to trouble-shoot product and process problems; resolve customer complaints; and enables continual improvement of product and process. In many instances, it also reduces cost, risk and use of resources by narrowing the problem down to a specific cause or instance. Depending on the product, the OEM may specify the degree of unique identification and traceability required.

Þ While this clause does not call for a specific documented procedure, these controls may be included in your product realization processes through your product control plans; work instructions and other specific documentation. Examples of product identification and test status include physical tags, bar code labels linked to computer records; MRP systems tracking specific production runs/lots; automated production transfer processes, etc.

Þ Performance indicators (to measure the effectiveness of processes that control identification and traceability) may include - reduction in identification errors and omissions; product quality status errors and omissions; and traceability errors and omissions.

7.5.4 Customer Property
• Exercise care of customer property while under your control or being used
• Identify, verify, protect, and safeguard where provided for use or inclusion in your product
• Report to your customer, if their property is lost, damaged, or becomes unsuitable for use.
• Keep records of your control of customer property

Note: Includes customer owned returnable packaging and can include intellectual property

7.5.4.1 Customer owned production tooling
• Permanently mark customer owned tools, manufacturing & test equipment so that the ownership of each item can be visibly identified or determined.

Key Explanation Points and Tips:
Þ Customer property may include material; production equipment; tooling; measuring and test equipment; facilities; transport vehicles; returnable packaging; intellectual property (drawings, specifications or proprietary information); product returned for servicing under warranty, product sent for outsourced work; etc. Review specific requirements for customer property at OEM customer or IATF websites.

Þ All customer property is exposed to the risk of being damaged, lost, misused; misplaced; stolen, become unsuitable or obsolete for use. You must establish controls for each of these risks. Notify the customer in writing if their property is lost, damaged or otherwise found to be unsuitable (perishable past its shelf life, e.g. paint) for use.

Þ Control to minimize the risks to customer property include - inventory management; preservation and storage; identification, status and traceability indicators; maintenance; notification; traffic flow; authorized use; restricted access; etc. Marking customer property with a unique identification number that can be traced to a record that provides details of ownership is one of many acceptable controls.

Þ This clause requires records to be kept of customer property that is lost, damaged or otherwise found to be unsuitable for use. This implies tracking the storage and use of and quality status, of customer property.

Þ While this clause does not call for a specific documented procedure, these controls may be included in your product realization processes through your product control plans; work instructions and other specific documentation. Many of the controls needed for clause 7.5.3 Identification and traceability and clause 7.5.5 Preservation of product apply to customer property. The processes, controls and documentation for these other clauses could be expanded to include customer property.

Þ Performance indicators (to measure the effectiveness of processes that control customer property) may include - reduction in identification errors and omissions; loss due to damage or unsuitability; scrap; rejects; etc., as well as increased customer property turnover rates.

7.5.5 Preservation of Product
• Preserve the conformity of product during internal processing and delivery to the intended
destination
• Preservation shall include identification, handling, packaging, storage, and protection.
• Preservation shall also apply to the constituent parts of the product.

7.5.5.1 Storage & inventory
• Assess stock condition at appropriate planned intervals, in order to detect deterioration.
• Use a inventory management system to optimize inventory turns and assure stock
rotation such as ‘first in first out’ (FIFO).
• Control obsolete stock in a manner similar to the control of nonconforming product

Key Explanation Points and Tips:
Þ All raw materials, work in progress; finished product; supplies; customer provided materials or product; product sent for outsourced work; etc, are subject to risk of being damaged, lost, misused; misplaced; stolen, become unsuitable (perishable) or obsolete (past shelf life) for use. This could occur during receipt, handling; storage; use in production; transportation to the customer; etc.

Þ Controls include - inventory cycle counts; stock rotation methods such as FIFO; just in time; tracking shelf life; MRP systems for tracking requirements and usage; special, controls for restricted access; handling and storage of hazardous materials, climate and environment; identification, status and traceability indicators; maintenance procedures; bar codes; training; use of special equipment for handling; etc. Also review specific requirements for preservation and storage at OEM customer or IATF websites.

Þ While this clause does not call for a specific documented procedure, these controls may be included in your product realization processes through your product control plans; work instructions and other specific documentation. Many of the controls needed for clause 7.5.3 Identification and traceability apply to preservation of product.

Þ Performance indicators (to measure the effectiveness of processes that control preservation of product) may include - reduction in identification errors and omissions; rejects; waste; scrap; etc., and increase in inventory turnover and material/product availability; and product safety.

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:
ÞMMD identification, including the measurement standard used to calibrate the MMD
ÞRevisions following engineering changes
ÞAny out-of-specification readings as received for calibration or verification
ÞAn evaluation of the impact of the out-of-specification condition
ÞStatement of conformity to the specification after calibration or verification
ÞNotification 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, i
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:
    ÞAccredited to ISO/IEC 17025 or national equivalent
    ÞOR - 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.