| What is the Process Approach to Quality?The ISO | | | | are too prescriptive you will end up with |
| 9001 2000 standard is designed to manage and | | | | unmanageable documents which serve no real |
| improve organizations processes. There is a great | | | | purpose. A consultant will be able to minimise your |
| deal of misunderstanding and misinterpretation of the | | | | documentation while ensuring compliance with ISO |
| meaning of the process approach to Quality.If you | | | | 9001 2000.Many organizations already have |
| have at all been involved with quality assurance I am | | | | documented instructions in the form of standard |
| sure that you will at least heard of the "process | | | | operating procedures (SOP's) and work instructions |
| approach" to Quality Assurance even if you are not | | | | (WI's) that define how individual activities are |
| fully aware of its meaning. The process approach to | | | | performed. However, it is often the case that the |
| Quality Assurance is based on the idea that an | | | | interfaces between these instructions are misaligned. |
| organization is a system of interlinked processes.If an | | | | In some cases the interfaces are not even |
| organization does not define how its individual | | | | considered let alone documented. Misaligned process |
| activities work together and the order in which the | | | | interfaces within an organisaton often leads to |
| activities are performed it cannot deliver a quality | | | | process fragmentation and eventually to break down |
| product to its customers.The process approach to | | | | of the organizations processes.The ISO 9001 2000 |
| quality involves analysing and then documenting the | | | | standard has adopted the process approach to |
| actual activities and links between those activities | | | | Quality management systems which is designed to |
| within an organization using simple process flowcharts. | | | | improve an organizations processes.The following |
| This technique is typically used by an auditor when | | | | rules may be used to implement a process approach |
| conducting a gap analysis on a business. If you are | | | | to your Organizations Quality Management |
| unsure about your ability to identify your processes | | | | System.Identify your Organizations key |
| then you can employ a consultant to assist you.Once | | | | processes.Define Quality Assurance levels for those |
| the process and their interactions have been | | | | processes.Decide how process quality will be |
| identified a framework of procedures and work | | | | measured.Document your approach to achieving the |
| instructions can be built around them.It can often be | | | | desired quality.Evaluate your quality level and |
| the case that the output from one process in an | | | | continuously improve it.The following example will help |
| organization is the input for another process within | | | | guide you through the methology of identifying |
| the same organization. As can be seen in the diagram | | | | process inputs, activities and outputs.As an example, |
| below where the output for activity one is the input | | | | let us consider the Purchasing Process:1. The Input to |
| for activity two and similarly the output of activity | | | | the Purchasing process is a requirement to purchase |
| two is the input for activity three.When analysing the | | | | materials, components or services.2. The Purchasing |
| processes within your organization it should be | | | | Activity involves selecting a supplier from our |
| remembered that processes may link to processes | | | | approved supplier list and preparing a purchase order. |
| outside of your organization. A typical example of this | | | | We will interact with - The supplier: to place the |
| might be the product design interface between you | | | | order. - Receiving: to notify them of the material |
| and your customer.Your organization sends a design | | | | ordered. We may interact with - Engineering: if |
| concept to the customer (the Process input).The | | | | Purchasing specifications are needed. - Quality |
| customer approves the design (the Process | | | | Assurance: if Receiving inspection is needed and to |
| activity).You receive back the approved concept | | | | disposition the product if it is non-conforming when |
| design (Process output)In many organizations it may | | | | received.3. The Output of the purchasing process is |
| be possible to break down each process still further | | | | an approved purchase order released to the |
| into their individual sub-process components, (please | | | | supplier.A typical manufacturing company will have the |
| forgive the simplistic example).For example: The | | | | following product realization processes:Customer |
| posting of a letter might be broken down | | | | Enquiry.Review and Quote.Receive OrderPrepare |
| into.Process 1: Selection of the envelope type. E.g. | | | | Process Control DocumentationPurchase |
| Padded, anti static, brown, white, anti-static.Process 2: | | | | MaterialsReceive MaterialsProductionPackLabel and |
| Selection of postal method. E.g. Courier, air-freight, | | | | ShipIn addition, we have the following support |
| secure, insecure.Process 3: Selection of first or | | | | processes:Management ReviewTrainingDocument |
| second class postage, same day, seven day.Each of | | | | ControlInternal AuditingCorrective and Preventive |
| these processes can then be broken down into | | | | ActionSummary: As you develop your quality system, |
| sub-processes. E.g. The closure of the envelope. | | | | you must define the sequence and interaction of |
| Should it be the type you lick, self adhesive, secured | | | | your processes in your quality manual as required in |
| with sticky tape, security fastener or wax seal?One | | | | Section 4.2.2 of the new standard.As you define your |
| always has to look at the common sense approach | | | | processes and prepare the accompanying |
| as to how far you should break each process down | | | | documentation, be sure that the inputs, activities, |
| into sub-processes. | | | | interactions and outputs are fully defined so your |
| For example: If the customer does not specify the | | | | quality system is effective.Driso provide ISO 9001 |
| method of envelope seal to be used then any type | | | | 2000 consultancy, auditing, software, and training |
| of seal may be used as long as it is fit for purpose. | | | | Services. |
| However, if the customer specifies a particular type | | | | They also supply Easy ISO 9001 2000(R) software |
| of seal for certain products the process becomes | | | | for initially setting up an ISO 9001 2000 compliant |
| more important to both you and your customer and | | | | Quality Management System or improving upon an |
| therefore the process is worthy of documentation.If | | | | existing one. |
| you have difficulty documenting your processes, | | | | To contact Driso Consultancy Services visit the web |
| especially regarding the amount of detail required | | | | site below and see what they can do for you and |
| then it may be worth employing a consultant to | | | | your business. |
| guide you through the process. If your procedures | | | | Contact: for more details. |