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The key to a successful QMS—one that helps us to achieve our quality goals and objectives—is the ability to measure either our progress against those goals and objectives or the lack thereof! Someone has to be responsible for this task. A useful chart for this purpose is shown in Table 13.1.
C/I | Relative Percentage(%) | ||||||||
---|---|---|---|---|---|---|---|---|---|
Elements | |||||||||
Month | Mar. | June | July | Aug. | Sept. | Oct. | Nov. | Dec. | |
Goal | Launch Phase | First Draft Process Documents | First Audit Verification and Validation | Final Draft QM | Management Review | Internal Readiness Assessment | Registrar's Document Review | Registrar's Certification | Activities Where Points Will Come From |
Plan— executive | |||||||||
Management reviews | 30 | 50 | 50 | 60 | 2 Management reviews (15) | ||||
Quality manual | 5 | 70 | 80 | 85 | Readiness audit | ||||
Objectives metrics | 30 | 50 | 60 | 70 | Quantitative analysis | ||||
Demonstration of effectiveness | 5 | 50 | 55 | 60 | Full corrective and preventive action with customer complaints | ||||
Do—operational | |||||||||
Process documents | 5 | 60 | 65 | 75 | Complete marketing and sales, service | ||||
Procedural documents | 30 | 40 | 50 | 55 | Readiness audit | ||||
Format documents | 30 | 50 | 60 | 70 | Production, test | ||||
Implementation | 30 | 40 | 50 | 55 | Engineering, marketing and sales | ||||
Master records lists | 5 | 30 | 50 | 70 | Production, test, service | ||||
Master documents lists | 5 | 30 | 50 | 60 | Production, marketing and sales | ||||
Approved vendor lists | 5 | 30 | 70 | 75 | Purchasing, engineering | ||||
Master calibration lists | 5 | 30 | 50 | 50 | Internal calibrations | ||||
Training program | 30 | 40 | 50 | 55 | Production, marketing and sales | ||||
Check—internal | |||||||||
Customer satisfaction | 30 | 50 | 60 | 65 | Survey analysis | ||||
Quality audits | 5 | 30 | 50 | 60 | 5 points each | ||||
Verification process and product | 30 | 50 | 80 | 85 | Readiness audit | ||||
Act–effectiveness | |||||||||
Data analysis | 5 | 35 | 50 | 70 | Complete intranet | ||||
Corrective actions | 5 | 40 | 50 | 65 | Analyze | ||||
Preventive actions | 5 | 40 | 60 | 60 | Make a list | ||||
Customer complaints | 30 | 50 | 60 | 65 | Analyze | ||||
Continual improvement | 30 | 50 | 60 | 65 | Trending | ||||
Note: 90% implies readiness for the initial assessment. | |||||||||
Guide: startup required = 5%; a clear base exists = 30%; mid-game to ISO readiness = 35–70%; endgame, the last few yards = 75–85%; ready for initial assessment = 90%. |
In Table 13.1, we use the Shewhart cycle of plan-do-check-act to create a quantitative matrix for this measurement purpose. The paradigm has been given a parallel terminology, (i.e., executive-operational-internal effectiveness to emphasize the role that is to be played by management).
In the example, the Excellent Corporation, which started from a fairly weak base, has progressed month by month to the point where the manual is about one more tight-end football pass away from a touchdown and some exceptional work has been done in the verification of product.
A key duty of the steward is to input the scorecard. The scorecard is kept up to date weekly by the ISO 9000 management representative based on inputs from the stewards. Thus, we have defined the first key duty of a steward.
To further determine the duties of stewardship, we note that in Clause 5.1 of the Standard, it is required that top management clearly indicates its commitment to QMS documentation, implementation, and effectiveness. A continually improved QMS effectiveness is to be demonstrated. The Standard then lists a number of directives that can be used to create a matrix that defines stewardship (see Table 13.2).
ISO 9001:2000 Clause | ISO 9001:2000 Requirement | Related Specific Duties of the Stewards with Their Action Teams |
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5.1(b) | Quality policy: establish the quality policy | Formulate the quality policy statement (QPS) Post the signed and controlled QPS Devise methods to propagate the QPS |
5.4.2(a) | QMS planning: ensure that QMS planning meets the requirements of 4.1 | Program manage the quality manual Program manage process documents Program manage procedures and forms Determine effectiveness guidelines Provide resources to complete QMS Determine, monitor, measure metrics Determine continual-improvement metrics |
5.4.2(b) | Revision control: ensure that QMS integrity is maintained when changes are planned and implemented. | Ensure that all documentation is controlled |
5.4.2(a) | Quality objectives: ensure that QMS planning meets the quality objectives | Plan in quality objective metrics into the QMS program management plan |
5.1(c) | Quality objectives: establish the quality objectives | Formulate quality objectives at all levels that support top management goals |
5.5.1 | Responsibility and authority: define responsibilities and authorities and communicate them within the organization | Establish the sections of the Standard that each steward is responsible for and set up teams |
5.1(e) | Resource management: ensure the availability of resources | Include all required resources into the program management plan |
5.5.3 | Communication: ensure that appropriate communication processes are established within the organization | Devise a communication process to inform the steward team members and top management on progress |
5.1(a) | Communication: communicate to the organization the importance of meeting customer, statutory, and regulatory requirements | Include weekly reports that cover all aspects of the QMS creation, including the coverage of customer, statutory, and regulatory requirements |
5.5.3 | Communication: ensure that communication takes place regarding the effectiveness of the QMS | Include weekly steward team reviews in the program management plan |
5.2 | Customer satisfaction: ensure that customer requirements are determined and met with the aim of enhancing customer satisfaction | Include a metric for customer satisfaction in the program management plan |
5.5.2 | Management representative: appoint a management representative | Appoint an ISO 9000 management representative |
5.1(d) | Management reviews: conduct management reviews | Prepare and present steward team status at each top management review |
Thus, the essential role of a steward (process champion) is to ensure that the QMS contains the following:
An effective and visible quality policy statement;
A program management plan to guide the team's activities;
A controlled documentation system;
A set of quality objective metrics and goals at all levels of the organization that includes customer satisfaction metrics;
A clearly defined set of team responsibilities and authority to document, implement, and demonstrate the effectiveness of the QMS via verification and validation analysis;
Clear channels of communication to all groups involved in the creation process;
Documented appointment of an ISO 9000 management representative;
A dynamic presentation role in the top management reviews to clearly define the status of the QMS creation process for the steward's team.
Steward's Information Objectives With regard to communication, each steward ensures the following of their channels of information:
There is a technical correlation from quality policy statement down to the lowest documentation levels (e.g. forms—the channel).
There is an effective link between each quality policy statement and the lower tier documents.
The entire documentation system is complete.
The documented system is completely implemented.
The channel is helping to achieve the quality objectives.
The continual improvement programs are effective.
There is an acceptance at all levels of the QMS directives.
The quality policies are managed at all levels.
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