So, as you make the decision to implement your Quality Management system you must first understand the requirements of the standard(s). Whether you are focused upon ISO-9001:2008, ISO/TS-16949:2009, or AS-9100 you will need to be able to understand and answer the following:
- What clauses in the standard apply to the process?
- What are the specific requirements identified in the clauses?
- How do the clause requirements relate to your current process?
- How can you make the requirements fit your current process?
- What are the requirements that need to be modified in order to not only meet the requirements, but also make good business sense to your operations?
Let's first identify the specific clauses in the standard that apply to the Business Planning and Management Review process. For our purposes in this blog, we will use the ISO-9001:2008 technical specification). The specific clauses are:
- 4.1 General requirements (process map, goals/objectives, management reviews)
- 4.2 Documentation requirements (quality policy, quality objectives, procedures, work instructions, necessary records)
- 4.2.2 Quality manual (scope, details of exclusions, procedures, process map)
- 5.1 Management commitment (policy, objectives, management reviews, resource planning)
- 5.3 Quality policy (quality manual, policy statement)
- 5.4.1 Quality objectives (objectives, measurable, actions)
- 5.4.2 Quality management system planning (management reviews)
- 5.5.1 Responsibility and authority (organizational chart, job descriptions)
- 5.5.2 Management representative (organizational chart, job descriptions)
- 5.5.3 Internal communication (posted performance reports)
- 5.6.1 Management review - general (meeting matrix, agenda, review minutes)
- 5.6.2 Review input (agenda, review minutes)
- 5.6.3 Review output (agenda, review minutes)
- 6.1 Provision of resources (business plan, management reviews, quality planning)
- 6.2.1 Human resources - general (job descriptions, reviews, records)
- 6.2.2 Competence, awareness and training (job descriptions, employee reviews, training records, quality planning)
- 6.3 Infrastructure (business plan, quality planning, management review)
- 6.4 Work environment (quality planning, management reviews)
- 8.1 Measurement, analysis and improvement - general (internal audits, management reviews)
- 8.2.1 Customer satisfaction (customer perception,performance to requirements, management reviews)
- 8.2.2 Internal audit (scope, schedule, records, management reviews)
- 8.2.3 Monitoring and measurement of processes (goals and objectives, performance reports, internal audits, Management reviews)
- 8.2.4 Monitoring and measurement of product (customer reports, management reviews)
- 8.4 Analysis of data (internal reports, external reports, management reviews)
- 8.5.1 Continual improvement (quality policy, goals and objectives, internal audits, corrective/preventive actions, management reviews)
So, where do you start? First of all, management must first define the business processes and develop the process map. ( There are many excellent reference books available that will help you complete this task. One of our favorites is "Process Mapping, Process Improvement and Process Management", written by Dan Madison and published by Patton Press, LLC).
A business process is made up from many sub-processes. Each of these processes will have "inputs" that the process needs to be able to start; the actual process that converts those inputs; and the outputs of the process. The outputs from one process become the inputs to the next process. Pay close attention to the identification of the process inputs and outputs.
There are four types of processes, they are:
- Customer Oriented Processes (COP) - these are processes with inputs coming from the customer and outputs going back to the customer (design, manufacturing process)
- Management Oriented Processes (MOP) - these are processes exercised by management to manage the business (business planning, management review)
- Support Oriented Processes (SOP) - these are processes not directly adding value, but providing support to other processes (purchasing, maintenance, calibration)
- ISO-9001:2008 Processes - these processes are required by the standard (document control, control of records, internal audit, control of non-conforming product, corrective actions, and preventive actions)
- Business Planning - Management Review
- Sales, Quote and Contract Review
- Quality Planning
- Provision, or Manufacturing
- Measurement and Analysis
The Business Planning - Management Review process has at its core they Quality Manual . The quality manual sets the philosophy and vision for the company and the management team and serves as the engine that drives the successful implementation and management of the QMS. You can read a thorough explanation of the development of the Quality Manual in our previous blog.
The Business Process Map describes the linkage of the business processes for the company. The map shows how the processes work together in unison in order to meet the requirements of the customers and other interested parties. The management team uses this definition of the flow of the individual processes to define the goals/targets and measure's processes needed to monitor the effectiveness and efficiency of each of the processes that make up the business and lead to success.
Although the standards don't specifically require a documented Management Review processes, we, at Foster and Associates, believe a formal Management Review procedure is necessary to reinforce the business processes and to document managements' commitment and role in the management and continuous improvement of the QMS.
The Management Review procedure defines the process for:
- the identification of the goals and objectives for the company.
- the monitoring and analysis of the QMS effectiveness.
- the monitoring and analysis of the performance data for effectiveness and efficiency of the business processes.
- the monitoring and analysis of product conformance to requirements.
- the identification of plans for corrective actions, preventive actions and continuous improvement of the Quality Management System, the processes and the products / services of the company.
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