ISO 9001:2008 in Focus Workbook - Nicholas and Smithnicholasandsmith.com/pdfs/PDF SAMPLE ISO 9001...

ISO 9001:2008 in Focus Workbook

Nicholas and Smith Pty Ltd

ISO 9001:2008 in Focus

Workbook

to accompany the video

SAMPLE PAGES Developed and produced by Nicholas and Smith Pty Ltd

Nicholas and Smith Pty Ltd (ABN 19 002 762 307) PO Box 2006, Rose Bay North NSW 2030, Australia

Phone (61 2) 9664 6755 Fax (61 2) 9664 8455 www.nicholasandsmith.com



CONTENTS Generic quality management system standards 3 The ISO 9000 standards 4 Structure and focus 5 A process approach 6 A system approach 9 Supply chain 11 Continual improvement 13 Determine customers 15 Identify customer needs 17 Analyse and evaluate 18 Plan 19 Implement 21 Check and monitor 22 Act and improve 24 Quality principles 25



Generic quality management system standards

• All industries • All organisations • A common goal

• All industries - All industries use the ISO 9000 family of standards

from a manufacturer of chemicals in Malaysia to a transport company in Germany, to a manufacturer of ATMs in Scotland to a repairer of aircraft components located in Sydney. The ISO 9000 family of quality management standards applies equally.

• All organisations - Organisations ranging from large multinationals to

small, one person enterprises. This includes hundreds of thousands of organisations in 150 countries.

• A common goal - It is concerned with managing the things an

organisation does to ensure that customer requirements are being met.



The ISO 9000 standards

• A consistent pair

ISO 9001:2008 ISO 9004:2000

• The standards reflect the need organisations have for their quality

management systems to show evidence of business benefit. That is, improving their organisation’s performance through the achievement of continual improvement in all their key processes.

• ISO 9001 and ISO 9004 are known as a consistent pair of quality

management system standards. They were developed with similar structures so that they can be used together to help organisations achieve improved quality and business performance.

• ISO 9001 contains the requirements for a quality management system

relevant to customer needs, while ISO 9004 gives guidance for performance improvement and a broader view of quality management objectives relevant to satisfying the needs of other interested parties.

Note that ISO 9004 is currently being revised for release in 2009.



Structure and focus

• Process approach • Customer satisfaction • Continual improvement

The focus of ISO 9001 includes: • A process approach - Identifying key processes, those which have an

impact on the customer, and analysing them in terms of inputs, outputs, resources and controls, and their interactions is called the process approach.

• A focus on the customer - Customer satisfaction is a key objective of

ISO 9001:2008. This requires the identification of customer needs, the ability of the organisation to communicate these needs internally, the ability to measure customer satisfaction, the ability to use this information and data to influence and improve processes, and realise products and services which achieve customer satisfaction.

• Continual improvement - Continual improvement of products,

processes and systems should be a permanent objective of an organisation.



A process approach

Understanding and managing the processes which have an impact on the customer and the management of the quality system.

• Process approach - Understanding and managing the processes which

have an impact on the customer. This includes defining the objective and identifying inputs, outputs, resources and controls.

The inputs of pre-kitting are trained manning, material delivery, start signal for the actual pre-kit activity and a delivery signal. The activity itself is the gathering of the parts on a trolley and the output is the delivery of the trolley in the required time. (NCR) The resources are basically a trained workforce as per the user guide that we developed for pre-kitting and that controls the process in conjunction with an access data base. (NCR) The input to the main line assembly is raw material in through the pre-kitting process and (as) we go through the main line process the output to that is a completed customer shippable unit. (NCR)



The key input to the demand planning process is sales opportunities. We need to have visibility to what our sales people are working to out in the field. We also have input on historical trends, market information, competitive information and also our supplier capability. (NCR) Then the key output is the demand plan, and the demand plan gives the factories visibility of what they need to ship up to 6 months in advance to meet customer requirements. (NCR)

Activity Select a process from your organisation. What is the objective of the process? __________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ What is the input(s)? __________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ What is the activity? __________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________



What is the output(s)? __________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ What resources are used? __________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ How is the process controlled? __________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________



A system approach

Identifying, understanding and managing interrelated processes provides opportunity for improved organisational performance.

• System approach - Identifying, understanding and managing

interrelated processes provides the opportunity for improved organisational performance.

Cycle time is very important to our customers; a need to deliver on time to their requirements is very much a competitive requirement in the market place. We’ve found that demand planning, supply line management and manufacturing are the key interacting processes to enable us to reduce cycle time. (NCR)

Activity Continuing with the previous example of a process from your organisation, is the input an output of another organisation process? If so, describe that process. ________________________________________________________________________________________________________________________________________________________________________________________________________________________________________



Does the output of the selected process become an input to another process? __________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________



Supply chain

Extending the process chain out from the organisation to include suppliers and customers creates a supply chain.

• Extending the process chain out from the organisation to include

suppliers and customers creates a supply chain. • The quality of a supplier’s products or services have an impact on

your organisation’s performance. • The output of your organisation has an impact on the performance of

your customers.

Our supply chain begins with the customer, identifying his requirements, taking his order, bringing materials together from our suppliers to build that order, converting those materials into a finished product and delivering that finished product to the customer. We have found that due to the wide range of material in our ATM products that it’s essential that we have the correct material here to build the orders for our customers on time. And therefore we’ve developed very strong relationships with our key suppliers. (NCR)



Activity How are your organisation’s processes effected by your suppliers’ processes? __________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ How do your organisation’s processes impact on your customers’ processes? __________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________



Continual improvement

Continual improvement must be a permanent objective of the organisation.

• Understanding the process approach and system approach to quality

management provides an appreciation of how even small improvements in a number of processes, together work to achieve significant improvements for an organisation. How these improvements then contribute to the improved performance of the customer also becomes clear.

The plant cycle time is the time taken from receipt of the customer order to plant to the time when that order is dispatched from the plant. We have been able to achieve an improvement of about 50% and we are now at a cycle time of 28 days. (NCR) The pre-kitting is the established process we have for the gathering of the piece parts and the module parts for the building of an ATM. We have been able to improve the complete trolley yield from 59% to better than 95% while at the same time improving delivery time from what could take 5 hours down to 15 minutes at the moment. (NCR)



We have two measures that we work from ….. process yield quality and out of box quality. The out of box quality is the quality level as received by the customer at installation. We have improved that measure by 0.8% through our process improvement activity. (NCR) We’ve changed this work environment, and by changing this work environment we’ve been able to halve our reaction time by 50% to typically one and a half days of an item landing on the work in progress bench. (TRW) Well a few of the changes we have made have been the shadow boards, they make the tools a lot more visible, they are easy to find and complete the job a lot quicker. (TRW) Our three major organisational goals are product quality, turnaround time of our components and cost reduction exercises that we undertake. All our continual improvement activities are focused on these three major issues. (TRW)

Activity Identify a process for improvement within your area including the process owner and its objectives? Describe this process. __________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________



Determine customers

• Who are the customers of the process? • Who are the other interested parties?

Our customers are all the production teams within this facility. (TRW) Our customers are the operations teams and the customer service department who are in turn suppliers to our general aviation customers, the airlines themselves. (TRW) The customers of pre-kitting are the assembly operators and the supervisors of main line assembly itself. (NCR) The customers of main line assembly are our actual customers who are buying the ATMs. We ship to a high number of customers within 128 countries world wide. (NCR) The key things that the customers are looking for are a good product from the installation, no defects at installation, and also high reliability of the product throughout its lifetime. (NCR)



Our customers are looking for a fast turnaround time from TRW. They may have an aircraft sitting in Changi Airport Singapore waiting for screwjacks from us and they are looking to get their aircraft back in the sky as soon as they can as it’s costing them money while it’s sitting on the ground. (TRW) In addition to our external customers we have air worthiness authorities in each country and many countries around the world that we need to ensure and demonstrate to them that our processes, our systems and the final inspection of our product … that it complies fully with the requirements of the regulations for each one of those countries. (TRW)

Activity Who are the customers of the process selected? __________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________



Identify customer needs

• What are the needs and expectations of the customer? • How are the needs identified?

We sat down as a group, the eight operators, we looked at what we had, we looked at what our customers required, and then we tried to work out what we had to have to give the customers their one and a half day turnaround time. (TRW)

Activity What are the needs or expectations of the customers of your process? __________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ How could these needs be measured? __________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________



Analyse and evaluate

• How are needs analysed? • How is the performance of a

process evaluated?

Activity

How well is the process currently performing? __________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ What problems have been identified and what are their root causes? __________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ What are the potential solutions? __________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________



Plan

Does the plan take into account the means: • procedures/instructions • resources • personnel • equipment • work environment

When we are implementing any changes in processes we make sure the planning is done properly. The planning includes making sure that the required people are available at the required time, making sure that the test equipment is available if required, and making sure that all the resources to support that are available. We always pilot any implementation, any change to implementation we are doing, understand the results that we are getting back, that they do actually meet our expectations. And then we will do a staged approach to implementing across the whole of the line. (NCR) As a result of the planning process that we went through, we were able to come to the realisation that we needed more room. The room that we ended up with had to be divided to house two different work areas. So then by doing that we could have two operators working together on different jobs or the same job. We needed a brand new magnetic particle test machine which we now have. (TRW)



When we were deploying the demand planning process it became apparent quite quickly that in order the key improvements in the area we really needed to resource the area and we decided that the best way to do that was to deploy field based demand planners out in the regions where the sales people are based. (NCR)

Activity How does your plan take into account procedures/instructions (process descriptions), and the availability of resources including equipment, trained personnel, and work environment? __________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________



Implement

Implement the means.

We’ve customised our label, it’s now system generated whereas before it was hand written, so the information is down loaded directly from our system. It’s more visible and the process is streamlined which ultimately has an impact on our turnaround times. (TRW) The labeling process has been documented. It has its own unique procedure which is incorporated within our quality procedures. (TRW) The implementation plan required no additional equipment; mostly we needed to focus on management controls such as the need to split the module assembly and main line assembly supervisory functions. Previously we had supervisors as a customer and as a supplier to pre-kitting. (NCR) We produced a document which is given to each individual operator, a small half sized A5 booklet which has pictorial representation of quality standards. Which are also very difficult to put into words. We’ve given a good picture and a bad picture and they can reference this document any time they like throughout the process. (NCR)



Check and monitor

Is the process monitored and data collected for analysis of performance effectiveness and improvement?

Each individual machine that is shipped out of here has a customer installation report return form with the machine. It has the serial number of the unit and all the information regarding that unit on the form. The customer then fills out the form. We then feed that information back into the manufacturing process making any process changes if required indeed any design changes if required. (NCR) We get feedback from the production teams after they have their weekly meetings. And anything that they then bring us as requirements we try to utilise in any further improvements that we can make to this workstation. (TRW) A data base was developed for the pre-kitting project and every kit picked is recorded into this data base. This gives us a live position at any time of the day. From this we have historical data for any improvement plans or future development plans that we may have. In addition to this the finance department recorded the freight budget and over the period of the improvement project we made a 300 thousand pound saving on freight budget for the time of the project. (NCR)



The main way we monitor work performance is through run hours which are direct labour hours. They show how many hours a person puts on the job, so if the run hours are reducing we know we are going the right way which they are at the moment. Another thing we do is we have morning meetings where management or support departments go to the shop floor and address areas of concern for the team to make sure that all the jobs go out on time. Customer service gives us priorities, we have logistics to tell us the status on spares, engineering with respect to any engineering issues. (TRW)

Activity How will the process be monitored to determine whether the planned objective and target have been achieved? __________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________



Act and improve

How is corrective action used to further improve performance?

Activity How will you use corrective action for eliminating problems which were identified and measured during the operation of the revised process? __________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________



Quality principles

• Continual improvement • Customer focus • Process approach • System approach • Factual approach • Supplier relationships • Involvement of people • Leadership

There are 8 agreed, quality management principles.

Activity For each of the principles, discuss examples from the video which illustrate their meaning. Continual improvement __________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ Customer focus __________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________



Process approach __________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ System approach to management __________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ Factual approach to decision making __________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ Mutually beneficial supplier relationships __________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ Involvement of people __________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ Leadership __________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

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