CREATE YOUR OWN SYSTEM - 1

Getting Started

The Chief Executive may pound on his desk, demanding that his managers and executives increase the company's profits by improving the quality of the company's products, or by reducing wasted time & materials, or by reducing Customer complaints etc, but all the pounding in the world will have no real effect unless there is some sort of plan and a suitable organisation to carry it out.

The organization must have clear policies, defined objectives and an effective system to get it where it wants to go.

The first step in this process is to decide what your policy is. Will you produce the "best in the world" and sell it for high prices, or will you produce "exactly what the customer expects, at that price"? You need to make that statement.

Based on your quality policy, what do you need to measure to see how well you achieve the aim of the policy? Will you need to measure how many defects occur during the manufacturing process, or levels of warranty returns? What is your target? State it/them in measurable terms.

The policy and objectives need to be documented and made known to all staff.

The next step is to define how all relevant tasks are performed, and make sure that everyone knows about the sections that affect them. 

This means that the organisation must create a documented system, describing the organisation's quality system, policies and its operating instructions where needed, plus the procedures required by ISO 9000. This will :

• define the structure of the organisation, and the responsibilities, lines of communication, etc
• define what the tasks are, and how they interact
• define who is responsible for each task
• ensure continuity as new employees join the team and others depart
• clarify exactly what actions are to be conducted
• define what information is to be recorded and who should do it

The Management Representative

But, before you get started, someone must be made responsible for getting the system implemented. This person must also have the authority and resources which they will need for this task. 

The organisation must appoint a senior member of its management to head the project, and this person must have sufficient authority and freedom to take whatever action is required to make the system work. The person selected may be known as the "Quality Champion", or "Quality Manager" or some other title, but is referred to by the standard as the "Management Representative".

Defining the system

From this point, the needs of the customers, and indeed, who the customers really are, must be defined. In the case of an administration department, for example, its customers will be the recipients of its services, e.g. internal customers - other departments within the organisation - & external customers)

Next, the activities of each area must be documented in sufficient detail. Where there are various ways of performing the same task, it is generally best for the relevant head to decide which is the best way to conduct the activities and to standardise on that, or else to clearly define the conditions under which method is used (i.e. if condition X, do action A; if condition Y, do action B otherwise do do action C)

Once the activities have been documented, they must be reviewed so as to ensure that sufficient data is collected at key points to enable problems to be discovered and to measure the effectiveness of any resulting changes. In addition, the requirements of the standard must be reviewed to ensure that they have all been addressed. Where problems are discovered, the activities must be altered to meet the requirements, or else the documented procedures amended to reflect best practice.

Some of the key points are briefly explained below:

Here are some procedures that you will require. (See "ISO9000 clause-by-clause" for more details)

Document & Record Control

You will need to ensure that all of your staff are using the correct pieces of paper. This includes drawings which they use for manufacturing purposes, instruction sheets (or Work instructions / procedures / etc) forms which are used to record information (sales order forms, purchase orders, delivery notes, etc) and so on.

You will need to set up a system which makes sure that old versions of documents are removed from use and new versions are distributed to all those people who will need them. You will also need to keep records of the changes made to documents, and to have some method of identifying which version is which!

In addition, you must identify and control the records which you need to keep (i.e. those which ISO 9001:2000 requires, and also those which your organisation requires in order to run the business).

You must have procedures for both of these types of control.

Nonconforming Product, Corrective & Preventive Actions

Here, the term "product" means any goods or services that you supply to your customer. 

Contrary to the belief of many people (including many Assessors), this does not include goods or services your organisation receives from its suppliers, unless these are to be supplied to your Customers. (the note in section 1.1 of ISO 9001:2000 says "the term 'product' applies only to the product intended for, or required by, a customer."

When things go wrong, you must make sure that there is a defined process for 

• fixing the problem (control of nonconforming product), 
• identifying any changes required to your processes, to stop it happening again (corrective action)

You should also have a process which identifies potential problems and prevents them (or minimises their effect) - (preventive actions).

You must have procedures to describe these controls. Also, you must keep records of the actions that you take, etc.

You could have a single procedure which covers all of these requirements or several procedures. It's up to you!

Training

You must make sure that your staff are suitably trained and/or experienced, so that they are capable of carrying out their allotted tasks. you must keep records of their previous experience and education, and also of the training that you provide (whether this is on-the-job, show-and-tell or external training, etc)

You should already be aware of the previous experience and/or training of your staff. You should be aware of the required abilities needed to accomplish the various tasks within your organisation. You should also be aware of the abilities of your staff. Also, you should be aware of any future changes to your operations which may involve a requirement for new skills (new equipment, new products, etc)

By combining these facets of your knowledge, you will arrive at a set of requirements for further training, (on-the-job, external, etc) which will ensure that your staff are able to conduct the required tasks.

You don't have to use a procedure for this, but you may find it useful.

Internal Quality Auditing

After sufficient time has elapsed, the activities must be checked by an independent person, working on behalf on the organisation. This is known as Internal Quality Auditing. The auditor will to ensure that the activities are being conducted as described in the documented system, and are sufficient to meet the requirements of ISO 9000. Where problems are found, the documented system or the activity itself must be altered.

From this point onwards, the cycle of audits, review, determination of changes and then re-audits followed by review, etc is a never-ending cycle, which should lead to continual incremental improvements.

You must have a procedure to describe how audits are planned, conducted and recorded.