ISO 9001: 2000 Quality Management System Design

13.3 Team Leaders

It is also customary for the stewards to assign cross-functional teams to handle the more broad reaching requirements that touch several operational areas. The leader for such a group is sometimes called the team leader and for more complex activities can hold the title of program or project manager. Their responsibility is to ensure that specific cross-functional programs are effectively managed. Such programs include the following:

• ISO 9000 management representative: usually the quality-assurance manager, if such a position exists. Often found to be the president or head of operations when the QA function is not formally designated. Lower level employees are sometimes used with a dotted line authority to the top manager. (They are often responsible for 4.1: General Requirements and 4.2: Documentation Requirements using action teams as support groups. Responsibility includes the coordination of the total QMS creation process through the certification audit.)

• CAPA manager: usually the quality-assurance manager if the function exists, and if it does not it is usually shared by several managers (e.g., the customer service manager stewards the customer complaints activities). Refer to Clauses 5.2: Customer Focus and 8.5: Improvement of the Standard.

• Total audits manager: usually led by the QA manager if the function exists, otherwise stewarded by another manager (e.g., controller, head of operations, director of safety). Refer to Clause 8.2.2: Internal Audit. This clause has again been written myopically. For a far more productive approach to the audit, it should include first-, second-, and third-party audits, not just first-party audits. For example, one of the most useful audits is your customer's second-party audit of either you or your subcontractors.

• Training manager: usually performed by the human-resources manager if that function exists, and, if not, it can be shared by all local area managers (e.g., all department heads are responsible for the training and documentation of their staffs). Refer to Clause 6.2: Human Resources.

These assignments can take many forms, but a possible distribution of responsibility in a design and manufacturing facility is demonstrated in Table 13.3. An effort has been made in the table to evenly distribute the stewardship responsibilities among top management. Unfortunately, it often happens that operations and quality assurance end up with an inordinate level of activity compared to the other departments. This type of situation is to be avoided when possible, as everyone in the company is usually already over-loaded. Appendix A is a convenient way to catalog both the stewardship and team leader/project assignments.

13.3.1 Cross-Functional Team Organization

Table 13.3 demonstrated how the sections and clauses of the Standard can be generated by means of stewards and cross-functional teams. Although team establishment and organization is not an obvious dynamic, there is nothing mystical about this approach, and each organization should structure their teams in a way that best fits their purpose. We have found it helpful when design and manufacturing teams form as shown in Table 13.4. The teams dealt with their appropriate clauses and SHALLS within the Standard's sections indicated. For additional detail, refer to Appendix A. Have some fun with the team names. They run all over the place from the Charlie's in honor of their leader, to Tool Time, for obvious reasons, and Enthusiasts for possible political reasons, and Road Runners to resolve poor vendor performance—and the reports even have baby pictures of the members. Team organization is replete with fanciful names such as the use of executive steering committees and area champions. Impressive action team awards and plaques are used to create the ownership required in response to the tremendous efforts put out by the teams. The results in bottom-line dollars saved are quite remarkable and over 5 to 10 years can be in the billions of dollars for multibillion dollar companies ^[2].

13.3.2 Organizations Without Explicit Design or QualityAssurance Functions

For those organizations without an explicit design or quality-assurance department, both the Giants and the Seers Teams would be led by the manufacturing manager. The Giants would focus on process and product engineering themes that, although they do not include design, still require engineering discipline.

In this case, the Standard requires that we discuss clearly in the manual why Section 7.3: Design and Development is not required. Our prescriptive response would be something like this:

7.3 Design and development exclusion: The Excellent Corporation does not design and develop its products but receives this information in the form of a manufacturing release package from its customers. The manufacturing release includes the bill of materials, printed wiring board layouts, engineering change orders, and test procedures. Engineering support services are then provided by Excellent in the form of manufacturing engineering that includes both process and product engineers under the direction of the vice president of operations. Excellent is required to obtain authorization from its customers for any changes that affect form, fit, function, reliability, safety, or other regulatory or statutory requirements. The process related to manufacturing engineering is contained in the document entitled "Manufacturing Engineering Procedures."

13.3.3 Team Effectiveness

Figure 13.1 illustrates the need for cross-functional teams in the effective implementation of the Standard so that the quality improvement team (QIT) can effectively integrate the functional areas of corrective action, preventive action, customer complaints, and nonconforming product. For example, the QIT could consist of members from QA, engineering, manufacturing, customer service, and finance. The several interactive functions required for each key activity is also listed in Figure 13.1.

Figure 13.1: Corrective and preventive action with customer complaints and interface to 8.3— Control of Nonconforming Product.

We have found that this area requires the most intensive training and takes the longest to optimize. When one looks in detail at the requirements of Elements 8.3, 8.5.2, and 8.5.3, the difficulty in interpretation is not such a surprise.

We offer some suggestions in this regard:

• Use SCARs to manage the interface with subsuppliers (subcontractors) as defined at receiving/receiving inspection. Nonconforming material reports (NCMRs) are also often used for this purpose and limited to incoming material issues.

• Limit 8.3: Control of Nonconforming Product to nonconformance reports (NCRs) that occur after incoming (receiving) and prior to shipment.

• Limit corrective action reports (CARs) to the internal quality audit findings and for big-time nonconformances that require a team. By their nature, CARs are expensive and time consuming. Allow local area managers and supervisors to correct small-time issues with on-the-spot corrective actions. Keep a log of such actions for trend analysis.

• Assign one person to decide on the level of CAR responses (e.g., manager of QA). Filter out those that can be handled quickly without a lot of paper work and those that really need some time and effort and are worthy of documentation and trend analysis.

• Run the preventive action program via memos and reports. Stay away from a specific format—preventive actions by their nature are broad in scope and need a lot of creativity to carry them through to completion. Preventive actions should include significant improvements in organizational, material, facility, root-cause analysis, instrumentation, and MIS changes.

• Manage customer complaints via the returned material authorization, returned goods authorization, or returned authorization transactions, on logs kept by sales and marketing and maintained by customer service or an equivalent organization.

• Assign one person to filter the customer complaints for the required response (e.g., manager of sales and marketing). For regulatory organizations, the same person can make the decision to proceed if, for example, a medical device report is necessary. The complaint would then be immediately forwarded to the manager of regulatory affairs for investigation and action.

• Assign one person to take primary responsibility for the overall review and trend analysis of the databases (e.g., manager of quality assurance, manager of business development, manager of business operations). That person manages the preparation and reporting functions of the quality improvement team with regard to trend data and analysis.

• This function directly supports the requirement 8.4: Analysis of Data and 8.5.1: Continual Improvement.

13.3.4 Typical Real-Time Action Team Plan

Figure 13.2 illustrates a typical real-time action team plan that has been used successfully to achieve impressive action team performance. In this scenario, a facilitator is assigned by top management, and a team leader, scribe, and scorekeeper are also chosen. The scribe keeps the minutes and the scorekeeper calculates potential and real-time cost savings as the program proceeds. If possible, the scorekeeper should be a member of the finance department to ensure that bottom-line considerations are prominent in the calculations ^[3].

Figure 13.2: The continuous improvement cycle based on the Deming PDSA cycle (Deming 1986).

All of these positions require extensive training to ensure a meaningful and productive team exercise. Top management oversight is required periodically to make sure that the team is coupled to the organization's objectives both technically and financially ^[4]. A team plan should use the following:

• The stewardship concept to effectively control QMS design;

• Cross-functional teams to ensure the accuracy and usefulness of documentation;

• Top management oversight periodically to ensure compliance with the enterprise's objectives when cross-functional teams are used.

^[2]See, for example: Defeo, Joseph A., "The Tip of the Iceberg," Quality Progress, ASQ, May 2001, p. 29.

^[3]See, for example, Neuscheler-Fritsch, Debbie, and Robert Norris, "Capturing Financial Benefits from Six Sigma," Quality Progress, ASQ, May 2001, p. 39.

^[4]Based on the work of Dr. Anthony F. Costonis, president and founder of Corporate Development Services, Inc., of Lynnfield, MA, at http://www.corpdevelopment.com.