ISO 9001 Quality Manuals

Posts Tagged ‘Quality Assurance’

The first step in the process of implementing a quality management system is to communicate with customers and potential customers and determine their expectations and requirements. Once this is completed confirm with the customers to ensure your understanding of their requirements is correct.

Senior management should decide which markets the company quality management system should address and develop relevant policies.

Based on these policies, management should then establish objectives for the company products, environmental performance, occupational health and safety performance

Example Quality Policy

The company’s quality policy is to provide competitive products and services of the highest standards of performance and reliability, satisfy the needs and expectations of its customers and achieve business success.This level of quality is achieved through adoption of a quality management system that reflects the competence of the Company to existing customers, potential customers, and independent authorities.

The next step is to determine the quality management system processes needed for achieving the policies and objectives. The Senior Management Team determines all the quality management system processes needed including Management Team Resources, Training & Competence Product Realization Design and Development Sales, Planning, Measurement, Analysis, Improvement, Suppliers, 
Audits, Management System and Customer Service

The Senior Management Team should use flowcharts to support the development of the quality management system process sequences and their interactions.

Senior Management should define individual roles and responsibilities for ensuring the implementation, maintenance and improvement of each quality management system process and its interactions. Establish a Process Management team that has an overview across all the quality management system processes, and which includes representatives (Process Owners) from each of the interacting processes.  

Determine the activities needed to achieve the objectives of the quality management system process. For example Product Realisation may require the following activities:
Planning, Processing, Production, Packing, Final Inspection and Storage

Assess each quality management system process and determine and the most appropriate way of managing them and if they are to be documented. Documentation is to enable the consistent and stable operation of the quality management system processes. Determine which quality management system processes are to be documented, on the basis of the: 

- size of your company and your activities
- complexity of the processes and their interactions
- criticality of the process
- availability of competent personnel

Different methods of documentation can be used. Decide which is best to represent and comprehend the quality management system process. Suitable documents include graphical representations, written instructions, checklists, flow charts, visual media and electronic methods

Determine the resources including Human resources, Infrastructure, Work environment, Information, Natural resources, Materials and Financial resources that are needed for the effective operation of each quality management system process.

For example for product realization resources required may be:
Human resources – Production Staff, Training & Competence
Infrastructure – buildings, workspace layout, process equipment, tools, supporting services and information systems
Work environment – layout of facilities, plant equipment, pest control, waste control, work wear, noise, temperature, humidity, lighting and weather.

Determine where and how monitoring and measuring should be applied both for control and improvement of the quality management system processes.
Develop a project for implementation that includes Communication, Awareness, Training, Change management, Management involvement, Review activities

Implement the quality management system processes and their activities as planned.

Measure or monitor to determine the effectiveness and efficiency of the quality management system process, taking into account such factors as Conformity with requirements, Customer satisfaction, Supplier performance, On time delivery, Waste, Process costs, Incident frequency, determine the need to record results

For example measurement criteria for measurement of customer satisfaction could be Complaint levels, % on time Deliveries, % Order Completion

Regularly analyze and evaluate quality management system information obtained from monitoring and measuring data in order to check your performance. Management Review is an ideal tool for this. 

Key Areas for Business and quality management system improvement should be identified during Management Review and could include: Complaint Levels, Production Efficiency, Process Simplification, Waste Reduction, Delivery Performance and Order Lead Time

Our Small Business ISO 9001 Manual contains the basic requirements of a quality management system and comes with implementation guides and implementation checklists.

Some organisations use up huge resources setting up rigorous final product testing regimes to ensure that products meet the specification and customer requirements. The problem is that whilst this stops poor quality product from reaching the customer it actually is of little benefit to a business.

The real secret to a successful quality management system is to control the process. Some people call this quality assurance, in essence as a business you should concentrate your resource at stages where you can still take corrective action to produce a satisfactory product. Yes you need to confirm the final product meets specification but if you have control of the process then less resource is required at the final stage to confirm this.

The problem lies with figuring out what you should do to control the process. The easiest way to do this is to carry out a Quality HACCP analysis. This will indicate to you the key points in the process where you can apply controls. You may already have a HACCP which you can use as a template.

Principle 1 If you don’t already have one, prepare a flow diagram of the steps in the process. Conduct an analysis by identifying potential quality hazards.  Assess likelihood of occurrence of these defects and identify control  options.
Principle 2 Identify the Quality Control Points in the process using the same principles as the decision tree.
Principle 3 Establish quality limits, which must be met to ensure each Quality Control Point is under control.
Principle 4 Establish a monitoring system to ensure control of the Quality Control Point by scheduled testing or observations. Principle 5 Establish the corrective action to be taken when monitoring indicates that a particular Quality Control Point is moving out of control.
Principle 6 Establish procedures and records appropriate to the Quality Control Points and their application.
Principle 7 Verify that your Quality Control Point system is working effectively. This can be done in the normal way but also you should measure the difference in conforming final product.

I don’t really like to use the phrase Quality Control point as I much prefer to use the term quality assurance but what you should be generating in effect is Process Quality Control points which is different. Your system should increase the effectiveness of your process and also identify weaknesses and areas for improvement. For instance we went through this analysis and decided that one of the key quality control points in the filling process was capping and sealing. It wasn’t really a food safety hazard but it was really annoying if you were a customer and the stuff leaked all over your car. So to improve our performance we didn’t carry out more extensive tests to make sure less defective product got to the customer, what we did was put controls and checks in place to ensure a better capping and sealing performance. We put in place procedures to check capping torque settings prior to start up and checks on sealing head temperatures. There were many other things we implemented as well but the long and the short of it was that we reduced customer complaints and product wastage with the same resource.