Managing quality - You can do it! - Part 4
In Part 3 we started to look at the detailed procedures, in this section we continue with some of the important control procedures for ISO 9002.
The documentation requirements given in Part 2 of this series largely cover the requirements of this clause. The system must be fully documented and controlled by internal audits and management reviews to meet the requirements. For certificated systems there will also be external audits by third party assessors.
The Quality System consists of:
- The Quality Manual - which relates to the requirements of BS EN ISO 9002 and the company objectives.
- The Quality System Procedures - which give full details of the Quality Management System and the records kept.
- The Works Instructions - which give details of methods and processes to be carried out.
The Quality Management Representative (QMR) is responsible for compiling and maintaining the Quality System Manual and the related Procedures.
Quality planning is carried out to check that the quality requirements are met. The plan should cover all aspects of quality management that can affect the product or service. Quality planning allows you to have an overview of the current and proposed procedures and to make sure that you give the customer the product that they ordered. It is recommended that this is one of the first documents created in the quality system development.
The plan is a summary document which shows the checks carried out by the fabricator at various stages and is designed as an overview document to see where the checks are being made and how the system fits together as a whole. The Quality Plan forms a basis for the generation and linking of all the other procedures.
A format of both flow charts, a simplified example is shown in Figure 4.1 (below), and tables is useful for clarity and ease of use.
The Quality Plan should be relatively stable unless procedures change significantly or new products requiring different testing and manufacturing procedures are introduced. The Quality Plan may also change as a result of a Management Review, if it is decided that extra checks are needed for particular processes or stages.
In the initial stages the Quality Plan provides the road map for the system development and may only be approximately correct. The plan needs to be checked when all the other procedures are complete so that it accurately represents what happens in the company.
This clause effectively covers the basics of processing and checking an order. Contract review is carried out on every customer quotation and order at the order placement and order processing stages to ensure that:
- The quotation or contract is complete.
- The product can be made as requested by the customer.
- The quotation has been accurately translated into an order.
- Communications with the customer are accurately recorded to give clear instructions for manufacture and supply
This is often the most difficult procedure to document due to the number of weird and wonderful ways that fabricators have thought up to process orders. It is not unusual to find information being recorded several times by different people and other significant duplication of effort. The process of documenting the procedure often leads to simplification and work reduction. Simple process improvements such as 'default' window specifications can reduce paperwork considerably and improve customer service at the same time. The creation of a flow chart for information and paperwork at this stage is strongly recommended before any documentation is attempted.
ISO 9002 also requires a method for controlling amendments to orders (and how you tell the other people in the organisation) and that you record your contract review by some means.
ISO 9002 does not include design control in the scope of the standard.
Document and data control is essential to ensure that:
- Documents and data are reviewed and approved before being issued and after being amended.
- Up-to-date documents and data are available.
- Obsolete documents are removed.
Document and data control ensures that your customers get the products that they want, that the products conform to the latest standards and specifications and that your internal records are complete and accurate. This requirement covers all documents and data that relate to the Quality Management System.
The types of documents and data you will need to control are shown in Figure 4.2 (below).
Figure 4.2: Typical Document and Data Registers
This is a master copy of all of the Master Documents and Data for the quality system. The documents here will be the signed copies of all the procedures, the Quality Plan and other reference documents. The Master Document and Data file can also be used for previous issues of any document (clearly marked OBSELETE) for reference purposes. A working copy of each document and data is provided to the QMR as part of the standard pack but the signed and approved masters will always be kept in the register in good condition. The Master Document and Data Register will need an index specifying the issue date and who is responsible for the document, in most cases this will be the QMR but this may vary with the document.
The control of the forms used in a company is essential for consistent working practices. This register is used to keep master copies of all the forms used and they are controlled as with other Master Documents. Again an index is needed and the QMR is responsible for the maintenance of most of the forms.
These are the standards that the company works to and will be the relevant British Standards (originals only please!), the supplier manuals and any customer specific specifications that will be used repeatedly instead of simply for one order. Control is as per the other registers.
"Managing quality" is designed to give you direct and clear information on the requirements of ISO 9002. The series has been written specifically for window fabricators but most of the information is equally relevant to plastics processing of a general nature. The series is:
Part 1: Introduction
Part 2 - The requirements of ISO 9002
Part 3 - The procedures (Section 1)
Part 4 - The procedures (Section 2) (This section)
Part 5 - The procedures (Section 3)
Part 6 - The procedures (Section 4)
Part 7 - The procedures (Section 5)
Last edited: 11/03/10
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