Understanding TS 16949

                                  Chapter 16
                    Understanding TS 16949:2002

8.4 Analysis of Data
You shall:
• Determine, collect, and analyze appropriate data (from monitoring and measuring activities as well as other relevant sources) to:

• Demonstrate the suitability and effectiveness of your QMS and to identify opportunities to continually improve its effectiveness

• Analyze data to provide information relating to:
    Þ customer satisfaction
    Þ conformity to product requirements
    Þ characteristics and trends of processes and product (including opportunities for
      preventive action)
    Þ Suppliers

8.4.1 Analysis and use of data
• You shall compare trends in quality & operational performance with progress towards objectives, leading to action that:
     Þ Prioritizes and promptly solves customer-related problems
     Þ Determines key customer related trends to support status review, decision making and
      longer term planning
     Þ Enables an information system for timely reporting of product usage

Note: Compare data with competitor and/or appropriate benchmarks

Key Explanation Points and Tips:
Þ It is amazing how many organizations have wonderful systems for collecting data, but do a poor job in sorting, summarizing and presenting this data for decision-making. You must sort and summarize the data you collect into TGR and TGW (things gone right and things gone wrong) and present them separately. Management can then focus on continual improvement of TGR and take corrective action on TGW.

Þ You must collect and analyze QMS data that relate to the effectiveness and efficiency of products; services; QMS processes; production output; supplier performance; use of resources; cost of poor quality; customer satisfaction; etc. Do year over year trend analysis to determine longer-term progress, identify opportunities for further improvement or prioritize correction action for negative trends.

Þ Your process for data collection and analysis must address the type of data to be collected; how it should be sorted and classified (remember TGR and TGW); use of appropriate information systems and data gathering tools and techniques; assignment of responsibility and authority to review and act; competency and training in use of tools and data analysis; that the data is gathered, analyzed and acted upon on a timely basis. A summary of QMS performance data must be included in your periodic management review (see clause 5.6).

Þ Compare trends in quality and operational performance against your business plans; competitors and industry benchmarks, where practical. Focus on key customer-related trends to prioritize prompt solutions to problems; to determine longer-term planning for performance improvement; and to enhance customer satisfaction.

Þ Performance indicators to measure the effectiveness of processes for data collection and analysis may include - reduction in cycle time to gather and evaluate data; reduction in inaccurate and incomplete data; increase in improvement opportunities obtained from data analysis; etc.

8.5 Improvement
8.5.1 Continual Improvement
You shall continually improve the effectiveness of your QMS through the use of:
• Quality policy and quality objectives
• Audit results
• Analysis of data
• Corrective and preventive actions
• Management review

8.5.1 Continual Improvement
8.5.1.1 Continual Improvement of the Organization
You shall define a process for continual improvement (see examples in annex B of ISO 9004:2000)

8.5.1.2 Manufacturing Process Improvement
You shall continually focus on controlling & reducing variation in product characteristics & manufacturing process parameters

Note 1: Controlled characteristics are documented in the Control Plan

Note 2: Continual improvement is implemented once manufacturing processes are capable and stable or product characteristics are predictable and meet customer requirements

Key Explanation Points and Tips:
Þ The focus of this clause is on continual improvement of the QMS and not on product. Continual improvement of product is addressed in clause 5.6.3b. and 7.1a.

Þ Under ISO 9000:2000, continual improvement is defined as a recurring activity to increase the ability to fulfill requirements. The ‘ability to fulfill requirements’ refers to both conforming as well as nonconforming processes. Conforming processes can be further improved; and nonconforming processes must be improved by taking corrective action to prevent recurrence. Recurring activity refers to the quality improvements listed in clause 8.5.1 - quality policy and objectives; audit results; analyses of data; etc.

Þ TS 16949 takes a different stance. Continual improvement is only applicable to processes that are stable and capable (i.e. under control or conforming). It cannot be applied to nonconforming processes. Corrective action must first be taken to bring nonconforming (unstable or non-capable) processes under control, before any continual improvement can be done.

Þ The continual improvement process can be conducted by:

    Þ Significant breakthrough projects that either revise or improve existing processes or l
     lead to new processes. These are usually done by cross-functional teams outside
     routine operations.

    Þ Small-step ongoing improvement activities conducted by personnel within existing
     processes.

Use of continual improvement tools listed in clause 8.5.1, include:
    Þ Quality Policy - if you recall clause 5.1 required top management to establish the quality policy and clause 5.3.e required them to review it for continuing suitability. Changes in product, customer base, organization ownership, management, technology, QMS standards, etc., may require changes to your quality policy and objectives. As a tool for continual improvement, it requires top management to review and understand these changes; make changes, if necessary, to the quality policy and objectives and use these changes to continue further improvement of the QMS and customer satisfaction.

    Þ Audit Results - Results of product, process, process and QMS audits usually provide many opportunities to improve QMS effectiveness and efficiency. Opportunities may relate to communications; information systems; processes; controls; use of resources; technology; etc. The management representative must report these opportunities to top management as included as part of the management review agenda. They can also be reported and reviewed at regular operational meetings, etc.

    Þ Other Audits - Besides product, process and QMS audits, you might find it very productive to conduct financial; health and safety; environmental; technology; product profitability; social responsibility; information and communication systems audits. You will be amazed at what you will find and improvement opportunities you will uncover.

    Þ In using ‘analyses of data’ as a tool for continual improvement, use the TGR and TGW approach discussed in clause 8.4 to classify your data for decision-making.

    ÞExamples of situations which might lead to improvement projects include: machine set-up, die change, machine changeover times; cycle time; scrap; non value-added use of floor space; variation in product characteristics and process parameters; less than 100% first run capability; process averages not centered on target values; testing requirements not justified by accumulated results; waste of labor and materials; difficult manufacture, assembly and installation of product; excessive handling and storage; etc.

    Þ Other tools that are often used to continually improve, include: capability studies; design of experiments; evaluation procedure; quality control chart system; risk analysis; SPC; supplier evaluation; test and measurement technology; theory of constraints; overall equipment effectiveness; parts per million (ppm) to achieve zero defects; value analysis; benchmarking; analysis of motion/ergonomics and error-proofing. Ensure that personnel applying these tools are competent and trained.

    Þ Use SPC, new material, tooling, equipment or technology to control and reduce variation in product characteristics and process parameters. Document improvements in drawings, FMEA, control plans, work instructions, etc., and update PPAP.

Þ Performance indicators to measure the effectiveness of the continual improvement process may include - quality objectives being met sooner than planned;; achieving and exceeding business and quality objectives; improved efficiency in use of resources; cost reduction; improved product quality; increased Cpk’s; etc.

8.5.2 Corrective Action
You shall
• Take action to eliminate the cause of nonconformities in order to prevent their recurrence

• Take action appropriate to the effects of the nonconformities encountered

• Define requirements in a documented procedure to:
    a) review nonconformities (including customer complaints)
    b) determine the causes of nonconformities
    c) evaluate the need for action to ensure that nonconformities do not re-occur.
    d) determine and implement corrective action needed
    e) record the results of actions taken
    f) review corrective action taken

8.5.2.1 Problem Solving
• You shall have a defined process for problem solving leading to root cause identification & elimination. Use customer prescribed problem-solving format, where available

8.5.2.2 Error-proofing
• You shall use error-proofing methods in your corrective action process

8.5.2.3 Corrective Action Impact
• You shall apply the corrective action and controls you implemented to eliminate the cause of nonconformity, to other similar products & processes.

8.5.2.4 Rejected Products test/analysis
You shall:
• Analyze parts rejected by customers plant, engineering facilities and dealerships
• Initiate corrective action to prevent recurrence
• Minimize the cycle time of this process
• Keep records of these analyses and make them available to customers on request

Note: Cycle time for product analysis should be consistent with determining root cause, corrective action and monitoring effectiveness of implementation

Key Explanation Points and Tips:
Þ Corrective action is action taken to eliminate the cause of a detected nonconformity to prevent recurrence, whereas preventive action is action taken to eliminate the cause of a potential nonconformity or other undesirable situation, to prevent occurrence.

Þ You must have a documented procedure for your corrective action process which must address the following control requirements:

Þ Identify detected nonconformities that relate to your - products; QMS processes; resources; suppliers and outsourced work; product shipped to customers; customer complaints; cost of quality reports; and TGR (things gone wrong) reports.

Þ Define your process for identifying and using appropriate problem-solving tools to determine the underlying root cause(s) of the nonconformity Use the customer prescribed problem-solving format (e.g. 8D form), where available. Review specific tools, methods and requirements at OEM customer or IATF websites.

Þ Problem-solving tools may include - analysis of failure mode; capability studies; correlation diagrams; data collection; fishbone diagram (Ishikawa diagram); FMEA review; histograms; Pareto analysis; probability charts; stratification of data; graphic representations; etc. Ensure that personnel applying these tools are competent and trained.

Þ Do a Pareto analysis of the root causes of all your corrective actions by type, process, product, etc to prioritize problem-solving resources and applying lessons learned. Also, consider doing a Pareto analysis of cost of poor quality data to prioritize corrective action. Top management understand dollars a whole lot more than numbers!

Þ Actions taken to eliminate the cause of nonconformity must flow from your problem-solving activity. Actions may involve changes to product, process, resources, documentation, controls, etc or any combination of these. Conduct tests to determine whether these actions have indeed eliminated the cause(s) of the nonconformity and prevented recurrence. You must keep appropriate records of these actions and follow-up activities

Þ You must monitor your corrective action records on an ongoing basis, for any recurrence of the nonconformity, you took corrective action on. If you found that the problem has occurred again, then perhaps your analysis of root cause may have been incorrect or incomplete.

Þ Apply successful corrective action solutions to other similar products, processes and sites where there may be the potential for the same nonconformity to occur. Use error-proofing methods across similar products, processes and sites, wherever cost effective and feasible, to prevent recurrence or avoid occurrence of nonconformity.

Þ Analyze and take corrective action on product rejected by your customer’s manufacturing plants, engineering facilities and dealerships. Minimize the cycle time for both - rejected product analysis and related corrective action.

Þ Keep appropriate records of all corrective action steps. Ensure timely completion of any open corrective action or be prepared to provide evidence to justify its continued open status. Make your corrective action records available on request to customers and provide a summary report for management review.

Þ All nonconformities may not necessarily result in corrective action. Evaluate the significance of nonconformities in terms of their impact on - operating costs; cost of nonconformity and its correction; frequency of occurrence; product performance; process capability; process variation; dependability; safety; regulatory requirements; affect on customers product and processes; any other risks; and customer satisfaction. Consider using cross-functional teams in such decision-making, including the involvement of your organizations designated customer representative (see clause 5.5.2.1).

Þ Performance indicators to measure the effectiveness of the corrective action process may include - reduction in cycle time for correction actions, problem re-occurrence, open corrective actions, cost of poor quality; and improvement in QMS productivity.

8.5.3 Preventive Action
You shall:
• Determine action to eliminate causes of potential nonconformities to prevent their occurrence

• Preventive action must be appropriate to the effects of the potential problems

• Define requirements in a documented procedure to:
   a) determine potential nonconformities and their causes
   b) evaluate the need for action to prevent occurrence of nonconformities
   c) determine and implement the needed action
   d) record the results of action taken
   e) review the preventive action taken

Key Explanation Points and Tips:
Þ Corrective action is action taken to eliminate the cause of a detected nonconformity to prevent recurrence, whereas preventive action is action taken to eliminate the cause of a potential nonconformity or other undesirable situation, to prevent occurrence.

Þ Sources of information for finding potential QMS nonconformities include - analyses of data (see clause 8.4); audit results; cost of quality reports; quality records; service reports; supplier performance; customer satisfaction feedback; FMEA’s; management review records; lessons learned from past experience; SPC charts and analyses.

Þ You must have a documented procedure for your preventive action process which must address basically all of the explanation points and tips covered under the corrective action process.

Þ While preventing potential QMS nonconformities is our focus for ISO 9000 and TS 16949, it might be very useful to think of preventive action in a wider context, i.e. the entire business. Think in terms of actions needed to prevent - loss of market share; loss of product profitability; loss due to lack of product diversity; loss of business opportunities due to lack of capacity, inadequate or older facilities, production equipment, technology or information systems; loss of key or competent personnel; inadequate business financing; inadequate staffing, etc.

Þ These issues may have far more serious consequences than QMS issues. Consider a process that involves developing a business plan covering these issues, based on - gathering relevant research data on these issues; use of appropriate risk evaluation and management methods; developing proactive strategies and action; monitoring and reviewing performance against the business plan. This would constitute the ultimate preventive action process.

Þ Consider using a Pareto analysis to organize and rank the dollar value impact of the data on the issues listed above in order to:
    Þ Determine the magnitude of risks and effects on the organization and
    Þ Prioritize preventive on these issues as they are all important and may need significant
     amounts of resources to address them.
    Þ Performance indicators to measure the effectiveness of the preventive action process
     may include - reduction in cycle time for preventive actions, problem re-occurrence,
     open preventive actions, costs; and improvement in QMS productivity.

                                                                        Annex A

Control Plan
A 1 Phases of the Control Plan
The Control Plan must cover three distinct phases as appropriate.

a) Prototype: a description of the dimensional measurements, material and performance tests that will take place during the building of the prototype. You must have a prototype Control Plan if required by the customer.

b) Pre-launch: a description of the dimensional measurements, material and performance tests that will take place after prototype and before full production. Pre-launch is defined as a production phase in the product realization process, which may be required after prototype build.

c) Production: documentation of product/process characteristics, process controls, tests and measurement systems that take place during mass production

Each part must have a Control Plan, but in many cases, family Control Plans may cover a number of similar parts produced using a common process. Control Plans are an output of the quality plan.

A 2 Elements of the Control Plan
You must develop a Control Plan that includes as a minimum, the following information:

a) General data
Þ Control plan number
Þ Issue date, and revision dat, if any
Þ Customer information (see customer requirements)
Þ Organization’s name/site designation
Þ Part number(s)
Þ Part name/designation
Þ Engineering change level
Þ Phase covered - (prototype; pre-launch or production)
Þ Key contact
Þ Part/process step number
Þ Process name/operation description

b) Product Control
Þ Product related special characteristics
Þ Other characteristics for control (number, process or product)
Þ Specification/tolerance

c) Process Control
Þ Process parameters
Þ Process-related special characteristics
Þ Machines, jigs, fixtures, tools for manufacturing

d) Methods
Þ Evaluation measurement technique
Þ Error-proofing
Þ Sample size and frequency
Þ Control method

e) Reaction Plan and Corrective Actions
Þ Reaction plan ( include or reference)
Þ Corrective action

                                                       The End