Understanding The ISO/TS 16949:2002 Standard 

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 

8.5.1.1 Continual Improvement of the Organization 

l        You shall define a process for continual improvement (see examples in annex B of ISO 9004:2000) 

8.5.1.2 Manufacturing Process Improvement 

l        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 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.  

Þ      Examples 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.