| by Cathryn Girard
There is a great deal of material discussing ISO/TS 16949, and with the expiration of QS-9000 certificates approaching, now is a good time to revisit this technical specification.
Having observed and listened to suppliers during training and consulting engagements, I believe that the reluctance to implement an ISO/TS 16949 quality management system is the result of a misperception. Many automotive suppliers believe that if the organization has only a QS-9000 certificate without an underlying QMS, then registration to ISO/TS 16949 is easy. There are two fundamental problems with this idea. First, it assumes that the QS-9000 system is robust and has been effectively audited. Second, it assumes that reorganizing QS-9000 documents will allow the QMS to meet the requirements of ISO/TS 16949 and customers.
A long professional relationship with suppliers has shown me that the challenge for suppliers is not necessarily transitioning from QS-9000 to ISO/TS 16949 but transitioning from an element-based, document-driven system to a process-based, data- and performance-driven system. When managers understand
this, the scope of the transition becomes more realistic.
At this point in the automotive industry’s transition, many global tier one suppliers have implemented and achieved registration to ISO/TS 16949. However, most of these plans were coordinated from the corporate level and took up to two years to accomplish. I have seen several of these 18-24 month plans adjusted to provide additional time to ensure success.
The companies that are targeted for this discussion are small and midsize tier one and tier two organizations. Many of these organizations have not assigned responsibility for the transition nor identified the proc-ess owners needed for the process approach to implementation.
The transition begins with assigning responsibility and accountability for
the QMS. Typically with QS-9000 the person responsible for the implementation was the quality manager. ISO/TS 16949 has a significantly different view of the responsibility for defining, implementing, maintaining, monitoring and reviewing the QMS. The technical standard requires that top management and process owners be intimately involved with the QMS.
The effect of the roles of management in the process is a significant change in the audit scenario. The role of top management is spelled out in Section 5 of the specification. A quick read of the requirements reveals that each of the six clauses begins, “Top management shall...” These requirements cannot be delegated.
It’s clear that the objective of the management responsibility requirements in Section 5 is to clearly reinforce the idea that QMS planning and performance is the responsibility of top management, not the quality manager. Correspondingly, the associated evidence to support management’s commitment needs to be provided in an audit.
In conversations with auditors, I have verified that 20 to 30 percent of an initial audit is typically conducted with top managers. The audit starts with management requirements for a very good reason: If the QMS hasn’t been effectively planned by top management--including properly allocating resources--the potential success of the QMS in reducing variation is compromised.
Auditors need to assess if top management has properly identified the organization’s customers and customer requirements. The scope of customers must include both internal customer requirements--most often derived from business or strategic planning--and external
customer requirements. Once these requirements have been identified, the questions for top management follow logically:
 Has top management defined policies and objectives that are aligned with customer requirements? Examples could include cost objectives to meet internal customer requirements and on-time delivery to meet external customer requirements. It’s very important
to understand that these objectives must have defined goals and targets, and be measurable. The lack of goals for objectives is a common problem.
Is there evidence that planning has facilitated the proper allocation of resources? Does the human resources department have adequate planning, and do its goals and performance align with the QMS? Regarding infrastructure recourses, do facilities and equipment meet customer requirements?
Does management review and respond to the performance of the QMS? Auditors should ensure that the QMS is reviewed at appropriate intervals. If the QMS is performing poorly, it should be reviewed often. If the QMS is performing well, it can be reviewed less frequently.
Auditors should also consider management’s response to the process. Processes that don’t meet requirements and objectives are, by definition, in corrective action. Corrective action requires the identification of cause. Hence, the primary response issue is, does management provide for corrective action that addresses the mitigation of the cause of nonconformance or risk in the QMS? As a secondary issue, are processes considered for continual improvement when objectives and requirements are met?
A critical facet in assigning roles and responsibilities for implementation of the QMS relates to the identification of process owners. The specification requires the identification of a management representative. This representative has specific duties, including communicating the quality policy and reporting
the performance of the QMS to management.
The transition from a QS-9000 quality department-owned system to an effective QMS for ISO/TS 16949 can only occur once the issue of responsibility is decided.
A QMS typically involves product-realization processes such as customer-oriented processes (COPS), which include APQP, manufacturing and shipping; management processes (MOPS), which involve business planning and management review; and support processes (SOPS) such as human resources and IT. It’s unreasonable to expect the management representative to define, monitor and maintain all of these categories. It’s also unreasonable to expect that the quality manager will have the necessary knowledge of all processes to ensure that they’re effective and continually being improved.
In an effective QMS, the design engineering manager, for example, “owns” the process for product design, and the human resource manager “owns” the human resources and training processes. This means that process owners must know and understand the requirements and techniques necessary to define, document, monitor and review internal processes. After the processes have been defined, the process owners need to ensure that there is effective communication and accessibility to the documents needed for effective process performance.
To achieve QMS performance and conformance with customer-specific requirements, the system must be addressed
with a pragmatic approach, ensuring that the roles of top management are fulfilled and that process owners are given responsibility and authority.
After the initial consideration regarding responsibility has been made, the next issue is planning for the transition. Prior to this planning, the organization’s top managers and process owners should be trained. It may become apparent that there is a “chicken and egg” dilemma here. How do you know what the processes are before you begin the development of the ISO/TS 16949 QMS? With a little research, it’s easy to determine typical processes. Additionally, the International Automotive Task Force has identified 10 typical COPS present in supplier organizations. The transition leader may need to have prior training to ensure that the right people are trained throughout the organization.
The next critical activity is a gap analysis, which is intended to identify and document the deficiencies that need to be addressed before the organization is prepared to meet the requirements of ISO/TS 16949. The gap analysis, rather than simply reporting on action items necessary to allow a QS-9000 quality system to meet the requirements of the technical standard, also identifies weaknesses in the existing system.
A proficient analyst will be able to provide a concise report of the findings and recommendations in the gap analysis. The gap analysis should be used for two purposes. The first is to develop an implementation timeline. The second is to assign responsibility and allocate resources.
With the transition deadline looming in December 2006, many automotive suppliers are confronting milestones on the road to certification. A supplier’s transition planning must provide for a stage-one readiness review audit, three months of data and a complete internal audit. These requirements mean that suppliers need to start planning now.
Compounding the effect of the timing constraints is the finite number of available third-party audit days. The issue is not so much the total number of audit days available from all registrars, but rather the demand for preferred auditors from a limited number of registrar organizations. Having to opt for unfamiliar auditors or auditors with backgrounds in dissimilar processes could change the audit.
When planning to transition an organization from QS-9000 to ISO/TS 16949, there are two critical initial considerations: the assignment of roles and responsibilities, and the development of an implementation timeline. When these two issues are effectively addressed, the transition can be managed successfully. Success can be measured both in terms of achieving certification and providing value to the organization by reducing variation.
Cathryn Girard is the COO of Integritas Business Systems. She has trained and consulted with automotive manufacturers and their suppliers for more than 15 years. She is a certified QS-9000 and ISO/TS 16949 lead auditor. Girard designed and developed Integritas’ FormVision software application, which is used to document and manage the new program development process (APQP). She is a senior member of ASQ and has been its Automotive Division’s vice chair, executive secretary, treasurer and conference chair.
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