ISO 9001 Quality Manuals

Archive for June, 2009

The new revision of the ISO 9001 standard has been simplified so that it is equally applicable to small as well as medium and large organizations and that the amount and detail of documentation required to be more relevant to the your  activities. ISO 9001:2008 allows flexibility in the way you document your quality management system. This enables you to develop the minimum amount of documentation needed in order to demonstrate the effective planning, operation and control of your processes and the implementation and continual improvement of the effectiveness of your quality management system.

ISO 9001:2008 requires a “Documented quality management system”, and not a “system of documents”.

The main objectives of your documentation should be:

- Communication of Information – as a tool for information transmission and communication.

- Evidence of conformity – provision of evidence that what was planned, has actually been done.  

- Knowledge sharing – to share and preserve the organization’s experiences. An example would be a technical specification, which can be used as a base for design and development of a new product.

ISO 9001:2008 clause 4.2 Documentation requirements documents may be in any form or type of medium, and the definition of “document” in ISO 9000:2005 clause 3.7.2 gives the following examples:

- paper
- magnetic
- electronic or optical computer disc 
- photograph
- master sample

ISO 9001:2008 clause 4.1 General requirements requires an organization to “establish, document, implement, and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard”

Clause 4.2.1 General explains that the quality management system documentation shall include:

- Quality policy (clause 4.2.1.a)
- Quality objectives (clause 4.2.1.a)
- Quality manual (clause 4.2.1.b)
- documented procedures required by the Standard* See Clause 4.2.2 below
- documents needed by the organization to ensure the effective planning, operation and control of its processes, and records required by the Standard

Clause 4.2 makes it clear that where the standard specifically requires a “documented procedure”, the procedure has to be established, documented, implemented and maintained. It also emphasizes that the extent of the quality management system documentation may differ due to:
- the size of organization and type of activities;
- the complexity of  processes and their interactions, and
- the competence of personnel.

All the documents that form part of the Quality Management System have to be controlled in accordance with clause 4.2.3 of ISO 9001:2008, or, for the particular case of records, according to clause 4.2.4

Clause 4.2.2 of ISO 9001:2008 specifies the minimum content for a quality manual. ISO 9001:2008 specifically requires the organization to have “documented procedures” for the following six activities:

- 4.2.3  Control of documents
- 4.2.4  Control of records
- 8.2.2  Internal audit
- 8.3  Control of nonconforming product
- 8.5.2 Corrective action
- 8.5.3  Preventive action
These documented procedures have to be controlled in accordance with the requirements of clause 4.2.3.
It is sometimes convenient to combine the procedure for several activities into a single documented procedure for example we have combined corrective action and preventive action.

Larger organizations or those with more complex processes will almost certainly require additional documented procedures particularly those relating to product realization processes.

In order to demonstrate compliance with ISO 9001:2008, you need to be able to provide objective evidence, although not necessarily documented, that your quality management system has been effectively implemented.

In order to demonstrate the effective implementation of your quality management system, it may be necessary to develop documents other than documented procedures.

There are several requirements of ISO 9001:2008 where you could add value to your quality management system and demonstrate conformity by the preparation of other documents, even though the standard does not specifically require them. Types of documents that can be useful:

Process maps, process flow charts and/or process descriptions
Organization charts
Specifications
Work and/or test instructions
Documents containing internal communications
Production schedules
Approved supplier lists
Test and inspection plans
Quality plans
Record Requirements

Records specifically required by ISO 9001:2008 are listed below:

Management Review       
- Clause 5.6.1

Education, training, skills and experience  
- Clause 6.2.2 e)

Evidence that the realization processes and resulting product fulfill requirements
- Clause 7.1 d)

Results of the review of customer requirements prior to supply related to the product and actions arising from the review
- Clause 7.2.2

Design and development inputs relating to product requirements
- Clause 7.3.2

Results of design and development reviews and any necessary actions
- Clause 7.3.4

Results of design and development verification and any necessary actions         
- Clause 7.3.5

Results of design and development validation and any necessary actions
- Clause 7.3.6

Results of the review of design and development changes and any necessary actions
- Clause 7.3.7

Results of supplier evaluations and any necessary actions arising from the evaluations
- Clause 7.4.1

As required by the organization to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement
- Clause 7.5.2 d)

The unique identification of the product, where traceability is a requirement
- Clause 7.5.3

Customer property that is lost, damaged or otherwise found to be unsuitable for use
- Clause 7.5.4
Basis used for calibration or verification of measuring equipment where no international or national measurement standards exist
- Clause 7.6 a)

Validity of the previous measuring results when the measuring equipment is found not to conform to requirements
- Clause 7.6

Results of calibration and verification of measuring equipment
- Clause 7.6

Internal audit results and follow-up actions
- Clause 8.2.2

Indication of the person(s) authorizing release of product
- Clause 8.2.4

Nature of the product nonconformities and any subsequent actions taken, including concessions obtained
- Clause 8.3

Results of corrective action
- Clause 8.5.2 e)

Results of preventative action
- Clause 8.5.3 d)

Other records will almost certainly be needed to demonstrate conformity of your processes, products and quality management system. Requirements for the control of records are described in clause 4.2.4 of ISO 9001:2008.

Some organisations use up huge resources setting up rigorous final product testing regimes to ensure that products meet the specification and customer requirements. The problem is that whilst this stops poor quality product from reaching the customer it actually is of little benefit to a business.

The real secret to a successful quality management system is to control the process. Some people call this quality assurance, in essence as a business you should concentrate your resource at stages where you can still take corrective action to produce a satisfactory product. Yes you need to confirm the final product meets specification but if you have control of the process then less resource is required at the final stage to confirm this.

The problem lies with figuring out what you should do to control the process. The easiest way to do this is to carry out a Quality HACCP analysis. This will indicate to you the key points in the process where you can apply controls. You may already have a HACCP which you can use as a template.

Principle 1 If you don’t already have one, prepare a flow diagram of the steps in the process. Conduct an analysis by identifying potential quality hazards.  Assess likelihood of occurrence of these defects and identify control  options.
Principle 2 Identify the Quality Control Points in the process using the same principles as the decision tree.
Principle 3 Establish quality limits, which must be met to ensure each Quality Control Point is under control.
Principle 4 Establish a monitoring system to ensure control of the Quality Control Point by scheduled testing or observations. Principle 5 Establish the corrective action to be taken when monitoring indicates that a particular Quality Control Point is moving out of control.
Principle 6 Establish procedures and records appropriate to the Quality Control Points and their application.
Principle 7 Verify that your Quality Control Point system is working effectively. This can be done in the normal way but also you should measure the difference in conforming final product.

I don’t really like to use the phrase Quality Control point as I much prefer to use the term quality assurance but what you should be generating in effect is Process Quality Control points which is different. Your system should increase the effectiveness of your process and also identify weaknesses and areas for improvement. For instance we went through this analysis and decided that one of the key quality control points in the filling process was capping and sealing. It wasn’t really a food safety hazard but it was really annoying if you were a customer and the stuff leaked all over your car. So to improve our performance we didn’t carry out more extensive tests to make sure less defective product got to the customer, what we did was put controls and checks in place to ensure a better capping and sealing performance. We put in place procedures to check capping torque settings prior to start up and checks on sealing head temperatures. There were many other things we implemented as well but the long and the short of it was that we reduced customer complaints and product wastage with the same resource.

I have been involved in many projects to improve product quality and reduce food complaint levels. One of the best tools for indicating where action for improvement needs to be applied is by analysing your complaint data appropriately.
Whilst you can identify faults in your factory your customers are your 100% inspection service so respect their feedback. Whilst all of your customers will not complain when they find a problem so you will not capture all of your product faults you will however identify trends.
The first step is to collate all of your complaint data. Your data should then be categorised by product type, complaint type and size. Analysing complaints by numbers alone will not give you a real picture of your performance. What you need to know is the proportion of complaints you are getting for each product. By far the most practical way of doing this is by using the sales volumes to calculate the proportion of complaints you get for each product. Some people use weight or volume such as complaints per tonne or 1000 Litres. My preference is to use complaints per million units.
So you analyse your complaint data product type, complaint type and size per million units. From this data you can easily spot the worst performing product lines.
You should then analyse the results for the worst performing products:
Are they all the same size?
Are they produced on the same filling machine/production line?
Is it the same type of complaint?
The answers to these questions will generate your corrective action plans. If products with the highest complaint levels are all the same size it could be a particular problem with that size of packaging. If it is all the same type of complaint then why are some product lines worse than others? If product from one particular production line is generating the highest number of complaints per million units then there must be a reason for this, it needs investigating. You should compare product performance and if there are significant differences you should ask the question why? At this point complaint trends are useful. For example when I worked with fresh pasteurised milk sour complaints were higher in larger sized containers. The reason for this was not related to the quality of the product but the fact they took longer to consume and spent more time in and out of the fridge. Such products would be targeted for improvement projects as opposed to corrective action to remedy a problem area.
A few words of caution though, your analysis needs to take into consideration the comparative value of the products and the market. People are more likely to complain about higher value products. Also some retail customers are much better at reporting complaints from customers to the extent that I used to get 10 times the complaint levels from one particular retailer compared to another for exactly the same product.
My last tip the more data you analyse the better. In the past I have analysed 3 years worth of data. Why? It gives a year on year performance so you can see if things have been improving or deteriorating and also it shows any effects of seasonality. For example it is not reasonable to compare summer levels of “off” complaints on a fresh product with winter levels. This is why in the UK I would compare August complaint performance with the complaint levels for August in the previous year.
Try out a sample annual analyser for free by clicking on the link below:
http://iso9001manual.com/analyser.php