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