Consulting business on quality & reliability

I was on a two man team as part of my quality & reliability module with the aim of consulting business students in the United states on implementing a quality management system in their business. This was to become part of their business plan for manufacturing industrial carts.


Every organisation should have a quality management system in place. You need a quality management system because in a manufacturing environment, quality can improve reliability and increase production.

The idea is fewer defects translates to fewer warranty claims and increased customer satisfaction.

If the following can be handled properly, quality can improve:

  • Process can be improved,
  • Wasted eliminated,
  • The workflow and safety enhanced

With Quality being improved some costs can be reduced, customers will be happier and the organisation can gain a more competitive advantage in the market by having a product of a better quality to that of its competitors.


The international standards organisation created the IS09001. The ISO9001 is a quality management system that can be used in an organisation to achieve an international quality standard. This quality standard in turn will allow the organisation to enhance its customer satisfaction by meeting the customer requirements. If your organisation meets the ISO9001 you can be ISO9001 approved.

The design and implementation of an organisation’s quality management system should be influenced by:

  1. The organisations environment, changes in that environment and the risks associated with that environment
  2. The different needs of the organisation
  3. The particular objectives the organisation
  4. The products it provides
  5. The processes it employs
  6. Its size and the organisational structure

Manufacturing the product

The organisation’s product is an industrial cart. This will be manufactured in house. The carts features are it will be:

  • Used on the factory floors,
  • Capable of lifting around 272 Kg (600lbs)
  • Be more manoeuvrability than competitors

The steps involved in manufacturing this product would be:

  1. Customer requirements would be outline at first
  2. A specification document would be created
  3. Material, equipment, people and test equipment would be planned
  4. Raw material would come into the factory
  5. It would be processed into the product
  6. The product would be tested against the specification document
  7. Any further modification needed to meet specifications would be carried out
  8. The product would then be packaged

The product would then be transported to the customers.

Quality Management System

General Requirements (4.1 ISO Standards)

  1. Determine the processes needed for the quality management system and their application throughout the organisation.
  2. Determine the sequence and interaction of these processes.
  3. Determine criteria and methods needed to ensure that both the operation and control of these processes are effective.
  4. Ensure the availability of resources and information necessary to support the operation and monitoring of these processes.
  5. Monitor, measure where applicable and analyse these processes
  6. Implement actions necessary to achieve planned results and continual improvement of these processes.

Quality Documentation

General requirements (4.2.1 ISO Standards)

In order for a company to implement ISO9001 they must determine the minimum number of documented procedures necessary to produce their product or service to the ISO standard. The quality management system must include the following:

  • Documented statements of a quality policy and quality objectives
  • A quality manual
  • Documented procedures and records required by this International Standard
  • Documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes.

Quality Manual

The organisation needs to establish and maintain a quality manual. This should include:

  1. The scope of the quality management system and any details of justification of why some are excluded.
  2. The documented procedure established for the quality management system, or reference to them.
  3. A description of the interaction between the processes of the quality management system.

Control of documents

According to the ISO 9001 section 4.2.3 documents in a quality management system need to be controlled.

A documented procedure should be produced to define the controls needed.

  1. To approve documents for adequacy prior to issue,
  2. Review and update as necessary and re-approve documents,
  3. To ensure that changes and the current revision status of documents are identified,
  4. To ensure that relevant versions of applicable documents are available at points of use,
  5. To ensure that documents remain legible and readily identifiable,
  6. To ensure those documents of external origin determined by the organisation to be necessary for the planning and operation of the quality management system are identified and their distribution controlled.
  7. To prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.

Control of records (special type)

Documents that are of a special type and should be produced in accordance with the ISO 9001 section 4.2.4.

  1. Records created to provide evidence of conformity to requirements and operations of the quality management system controlled.
  2. Establish documented procedures to define the controls needed for the identification, storage, protection, retrieval, retention and disposition of records.
  3. All Records should remain legible, readily identifiable and retrievable.

Product procedure – calibration procedure for Vernier callipers


According to ISO 9001:2008- section 7.6 “Control and monitoring of measuring equipment the organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements”. To ensure the accuracy requirements of a Vernier Callipers and other measuring equipment they must be calibrated on a regular basis. It is vital that this equipment is calibrated so that it can be used to test the finished product, or parts of the finished product, to ensure it conforms to the design specification document.

Equipment and documentation required

  • Different size gauge blocks of known dimensions certified by NIST (National Institute of Standards and Technology)
  • Cleaning Solvent
  • Lint free towels
  • Calibration record data sheet


  1. Clean all surfaces of the callipers and gauge block using the cleaning solvent and lint free towels
  2. Write down the know dimension of the gauge block on the calibration record data sheet
  3. Using the callipers measure the dimension of the block at three random locations and record each number on the data sheet.
  4. Repeat step 3 for various size gauge blocks.
  5. Depending on the accuracy required for the process set the acceptance criteria. For example ±0.002cm
  6. Give each piece of equipment a pass or fail symbol for example a tick for pass and cross for fail.
  7. Any product that passes can be handed back to production for use, any produce that fails must be repaired before it can be uses again.

Additional ISO standards to be considered

Before setting up a company to produce an industrial cart there are a number of other ISO standards that should be adhered to. If the cart is to be used on a factory floor, the product needs to be risk assessed. A risk assessment should be written up to consider if this idea is viable. The procedure for risk assessment is detailed in the ISO31000- Risk Management.

When setting up a production line to make these carts the employee’s health and safety is paramount. If anything happens to an employee while working in the factory it is the employer’s responsibility. They must ensure that it is virtually impossible for workers to get injured.

The ISO18001- Occupational Health & Safety Management document defines the procedures that an employer must enforce to help keep his/her employees safe.

For the product to be capable of lifting around 272 Kg (600lbs) there are ISO standards that the material must adhere to. For example Aluminium or steel must be tested and approved to meet certain tensile stresses and Elastic Modulus.

Finally for the product to be more manoeuvrability than competitors a ‘quality function deployment’ must be put in place (ISO standards 5.4.1).

To do this the organisation should appoint someone to do the following (ISO standards 5.5.2):

List the what’s:

  1. What are your customer requirements?
  2. How do you know?
  3. Do you have a complete list of requirements?
  4. What might you be missing?

Classify and rank the what’s

List the how’s:

  1. How are you going to satisfy your customer requirements?
  2. What are your design requirements?
  3. Are they complete?
  4. In which direction do you want to drive those requirements?

Determine the relationship between the what’s and how’s

Analyse the correlation within the how’s

  1. What is the trade-off among design requirements?
  2. Which requirements are in conflict?
  3. Which requirements are complementary?

Calculate the scores for each how

  1. What is the most important design requirements based on your analysis?
  2. How might we quantify scores for each requirement?

Define the targets and limits on the how’s

  1. What are your objective measures?
  2. What are the units, targets, upper limits and lower limits?

Perform technology, measurement and competitive gap analysis

  1. What are your gaps?
  2. Are there any others?
  3. If you do these steps for your competitors, what are your competitor’s products like compared to yours?

With this information you can create the ‘house of quality’ and determine if your product’s features such as it being manoeuvrable is better than your competitors.


Quality Assurance

Given their key processes, what specific measures you would propose operate in their company in terms of Product/Process, Customer Satisfaction?

For specific measures that need to be in place in terms of product/process and customer satisfaction (ISO standards 7.1) must be put in place.


ISO states that the product requirements be determined in the planning stage, establish processes and documents to provide resource specific to the product.


The diagram below is the processes required to build this product. Verification, validation, monitoring, measurement, inspection and test activities specific to the product would be set up. The criteria for product acceptance needs to be clearly laid out with these processes and documentation created to reflect evidence of these.

Check materials when it enters the factory from suppliers. Material would then go into first processes. After worked has been done in the first processes, samples will need to be tested to see if it meets both customer requirements and overall design requirements. This is repeated in the next set of processes. If any batch of samples failed the process will need to be examined and corrected. Finally after the product is transported to the customer their feedback needs to be monitored and corrections in processes need to be changed or improved to meet their satisfaction (ISO Standards 7.2.3).

The organisation should collect all relevant data with a view to continuously improving their product and demonstrate the effectiveness of the quality management system in place.  With regard to this specific product the types of data that should be recorded are

  • Customer satisfaction- If there are any complaints from customers about the product these should be recorded and taken into consideration for future products produced. Similarly any positive feedback should be noted also for example feature they might  like in particular or would like
  • Conformity to product requirements- The cart should be tested at various stages throughout its manufacture. If there are any differences in conformance to the products requirements these issues should be addressed immediately.
  • Characteristics and trends of processes and products, including opportunities for preventive action- If there are any unusual trends noticed in the production process these should be rectified before they become an issue which may cause the final product to fail the final inspection. For example if the colour of the cart is noted to be getting fainter as the day or weeks goes on there may be a problem with how it is applied .
  • Suppliers- When material enters your factory from an outside supplier or vendor it should be tested to ensure it is of high enough quality for what you require. For example the wheels for your cart, which will be bought in from an outside vendor, could have a number of faulty in each batch. If your factory was to accept these and use them then when you sell on your final product it could have faulty wheels which would make your customer unsatisfied. There are a number of different methods of which can be used to sample incoming batches from suppliers depending on the accuracy required.

To gain the opportunity to identify good or bad quality, the organisation must monitor and measure the characteristics of the product to verify that product requirements have been met. Records should be set up to indicate the person or persons authorising release of the industrial cart for delivery to the customer (ISO Standards 8.2.4).


Unless specified by authorised personal or where applicable by the customer no release of product or service to the customer shall proceed until planned arrangements are met. Records of this should be created and maintained. If a product does not meet customer requirements it should be identified and controlled to prevent it from being delivered (ISO standards 8.3).


The organisation will need to determine, collect and analyse appropriate data to demonstrate the suitability and effectiveness of the quality management system.

Evaluate where continual improvement of the effectiveness of the quality management system can be made.


Include data generated as a result of monitoring and measurement and from other relevant sources.


This data should relate to

  1. customer satisfaction
  2. conformity to product requirements
  3. characteristics and trends of processes and products, including opportunities for preventive action
  4. suppliers




Managing Corrective and preventative action

Corrective action

Corrective action is the action taken to eliminate the causes of nonconformities encountered to prevent the recurrence of the problem. A documented procedure should be written up to define the requirements. The document should include all nonconformities including customer complaints. The causes of these should be researched and define to one single cause (Root Cause). The need for action should be evaluated and the steps for implementation defined. The results of the action taken should also be written down and recorded.  The process should be then monitored to ensure the issue has been resolved and doesn’t occur again.


Preventative Action

Preventative action is the action taken to prevent the likelihood of nonconformities happening. Preventive actions shall be appropriate to the effects of the potential problems. A documented procedure should be established to define the requirements.

The potential nonconformities should be listed down and defined along with their potential causes and effects.  The need for action should be evaluated and the steps involved in implementing the procedures involved.  The results of the action should then be recorded to ensure they work.

Management review – inputs and outputs

The organisation’s management will need to review quality management system, at planned intervals, to ensure it’s the following


  1. Continuing
  2. Suitability
  3. Adequacy
  4. Effectiveness.


The review will need to include assessing opportunities for improvement and the need for changes to the quality management system,

Include the following

  1. Quality policy
  2. Quality objectives.


All records from management reviews will then need to be maintained

For review input include the following information

  1. Results of audits,
  2. Customer feedback,
  3. Process performance and product conformity,
  4. Status of preventive and corrective actions,
  5. Follow-up actions from previous management reviews,
  6. Changes that could affect the quality management system, and
  7. Recommendations for improvement.


For review output include the following information

  1. Improvement of the effectiveness of the quality management system and its processes,
  2. Improvement of product related to customer requirements, and
  3. Resource needs.


By following this document and conforming to the international standards organisation the company can set the quality standard or quality design required by the customer, plan to achieve the required quality, be able to manufacture it right first time, make use of quality data collected and finally provide for long-term quality control and planning.

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