The International Standards Organization believes in continual improvement. They have listened to the "voices of the QS-9000 universe" who have told them what is broken. QS-9000 has not produced significant improvement in the supply base due to the lack of effective implementation and monitoring. Would you believe organizations hired Registrars who did not take their job seriously? Audits of Registrars discovered some alarming trends:

They did not use control plans as reference documents during audits

They were not aware of customer specific requirements

They did not use the required checklist

Their audit findings did not reference the specific requirement, nor describe the failure to meet the specific requirement, nor a description of specific evidence that was observed

They did not address personnel training, especially OJT records

They did not audit client management

They did not discover client unreported changes to the product, process, or material

They did not view the QMS as a total system

The new Standard is being administered by the International Automotive Oversight Board (IAOB) that has adopted repair measures. The IAOB get well plan includes:

A new, beefed up, Registrar auditor re-training program prior to release for auditing

Publication of the new calibration Rules of Registration to the ISO/TS scheme.

Maintain a central database with audit schedules, results of audits, and auditor qualifications to take corrective action measures should the Registrar not be proactive.

Schedule a site review of the Registrar should supplier performance measures go bad to determine how the Registrar permitted it to happen.

So the first step in continual improvement is to expect Registrars to take their job seriously and to be calibrated in such a manner that their performance measuring and monitoring can be effective.

The next steps address some root causes why QS-9000 was ineffective over time.

QS focused on product, assuming the processes were robust enough to make long runs of product fit for customer use. Well, the processes were not effective and corrective action was not taken.

Nor was there an incentive to plan better, integrate better, to effectively monitor, and to take timely corrective action with a bias for prevention. ISO/TS now requires all suppliers to have a procedure for Manufacturing Process Design using the tools and methods of Product Design and Development. These tools are: specifications, process flow chart/layout, process FMEA, control plan, work instructions, acceptance criteria, data for quality, reliability, maintainability and measurability, and methods of rapid detection and feedback for nonconformities.

Additionally, Registrars are being instructed to test for Customer Orientated Processes (COPs). Internal Auditing is beefed up by requiring formal audits of the Quality Management System, a Manufacturing Process audit for each process to test for effectiveness, a scheduled Product Audit at various stages to verify conformity. Now, the Registrar will test for the effectiveness of these new internal audits.

Additionally, ISO/TS requires the validation of processes for production (7.5.2) which means some internal auditor needs to be assigned to test that the processes have the ability to achieve planned results or write a nonconformance.

Additionally, Section 8.2.1.1 Customer Satisfaction-Supplemental where "the organization shall monitor the performance of manufacturing processes to demonstrate compliance with customer requirements for product quality and efficiency of the process."

Still additionally, Section 8.2.3.1, Monitoring and measurement of manufacturing processes establishes criteria for how and when it’s done.

In summary, the get well plan is to focus on the processes that realize the product.

QS focused on having the audit trail document as proof of conformity. There was little attention paid to the task doer’s role in supporting quality assurance. Now, the Standard is more humanistic by using ISO-9001:2000‘s section regarding competence, awareness and training (6.2.2 d), organizations need to show how they ensure its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of quality objectives.

ISO/TS goes even further by requiring a process to motivate employees to achieve quality objectives, to make continual improvements, and to create an environment to promote innovation. There shall be a process to measure the extent to which its personnel are aware of their role for quality assurance. (NOTE: there are effective employee recognition program concepts available with a bias for low administration and reward costs.)

The get well plan is to involve the people capital better.

Ineffective management of suppliers who may or may not have ISO or QS registration. Ineffective supplier PPAP warrants, unreported changes in product, process, or material that set the stage for problems. Heck, they are using the same set of ineffective Registrars too.

Now ISO-9001:2000 has analysis of data (8.4 d) where data needs to be generated as a result of monitoring and measurement of suppliers. ISO/TS identifies supplier monitoring if there is a delivered product quality issue, if there are customer disruptions including field returns, if there are delivery schedule problems, and if there are customer notifications of quality or delivery issues. The assumption here is suppliers are expected to provide timely problem analysis, possible corrective action, and evidence of their monitoring of their manufacturing processes.

The get well plan is to formally measure and monitor (NOTE: key and under performing) suppliers with the expectation to achieve effective, timely, corrective and preventive action or to exercise Business Management System controls like payment delays or holds, stop sole sourcing agreements, and eventual PO movement to other sources.

QS, with ISO-9000:1994, had a series of Elements for compliance. They were evolved over time and brought better controls for their time. Now, using ISO-9001:2000 as its base, ISO/TS 16949 takes an enterprise view for quality assurance management. The only exclusion permitted is Design and Development for those that do not design.

Now, there is a requirement to set measurable quality objectives at relevant functions and levels within the organization. ISO/TS further requires the definition of measurement and their inclusion into the business plan. A note in ISO/TS seeks objectives to be achievable within a defined time period. Objectives now must be monitored in the Management Review Meetings via trend analysis to determine continual improvement is being achieved. The assumption here is poor trends mean formal corrective actions are launched.

The get well plan is to harmonize the Quality Management System with the Business Management System.

Is ISO/TS 16949 better? Yes, by plan, because it addresses the broken parts of its predecessor to close existing performance gaps in implementation and monitoring.