Quality Management System

Introduction

Management Systems are the basis of how any business operates.

 

Although a few companies never bother to write these down, most have a documented system and the majority will be certified (by a certification body such as BSI, LRQA, SGS, DNV, …). Certification is meant to demonstrate to customers that the company has a system which is consistently followed.

 

All the work done on improvement, such as six-sigma, potentially can be captured in the Quality System, so it will be used, remembered and be available for further improvement in the future.

 

 

Objective of a Quality Management System

Manufacturing processes are typically operating at <100ppm (often 3ppm). Sadly, service/business processes/ systems (all those in the offices), typically have a 50% (500,000 ppm) error rate; this level of quality is so appalling that it is a priority for improvement.
 

The three classic sources of poor quality are variability, complexity and error. In order to improve these in a business process and maintain that improvement, it is necessary to document the system, train those using it to follow the same procedures and audit it to ensure people do adhere to the defined system.

 

 

History

The military were the first to require their suppliers to have a Quality System (AQAP) back in the mid part of the 20th century. They argued that to have confidence that the munitions they bought would work on the battle front, they needed confidence that the supplier had a system that would manufacture product in an effective and consistent method; you can’t check that every bullet will fire, but you can check the system used to make it is capable of doing so.

 

Once industry understood the advantages of a Quality Management System (QMS), the early NATO military standards were superseded by the development of British Standards (BS5750). This in turn led to International Standards (ISO 9000 series) by 1984. ISO 9000 defines how a QMS should be constructed, with the need for policies and procedures for such elements as:

Who is responsible for what? How do we deal with our customers? How do we purchase things? How do we control the design process? How do we control our processes? What do we do with defective product? … and so on.

 

Since then many other topics in a modern business system have been defined by other International Standards.
For example: ISO 14000 (Environment) „ 18000 (H&S) „ 20000 (IT service) „ 22000 (Food Safety) „ 22399 (Business Continuity Management) „ 26000 (Corporate Social Responsibility) „ 27000 (Data security)  „    ??000 carbon footprint, re-engineering.

 

These get built into an Integrated Management System Standard (IMSS). Many customers make it a condition of supply, that their suppliers are certified to one or several of these standards. The theory is that this allows a company to buy from a supplier on the other side of the world and have confidence in the product. The problem is that consistency in the certification in different countries comes into question and you can have a consistent system that makes consistently bad product.

Today there are over 1 million companies in 180 countries who are certified to ISO 9000. It is used as a marketing tool to get business.

 

 

Third Party Certification

Initially, the military sent its own auditors to its suppliers to ensure they were complying with the requirements of the standard. Once industry became more involved, some companies were being audited by many different customers, for the same standard. The concept of one reliable 3rd party audit emerged. Advantages: the customer no longer needed to spend time in checking his customers, the supplier had just one audit to cover the needs of all his customers.

 

 

Structures

A.  To achieve consistency in the certification of companies around the world:

  1. International Standards Organisation (based in Switzerland) … try to ensure consistency between

  2. National Accreditation Bodies (such as BSI in the UK, AFNOR in France, ..)      … who accredit

  3. Certification Bodies (such as LRQA, DNV, SG, ..)      … who certify …

  4. Companies

 

 

B.  Typical levels of a QMS

  1. Mission StatementA brief statement that summarises the important aspects of replies to these questions:

Who are we? Who are our customers? What are we supplying? How do we supply? How do we manufacture? What are our strengths? What are our ambitions? What is our vision for the future?

 

  1. Company’s policies… this provides the values and standards of a company, as defined in its policies, on topics such as customer interface, purchasing, process control, defective products, environment, H&S, … and so on. These policies are established using guidance from the various International standards.

 

  1. Key ProceduresAn effective approach is to decide the top 10 procedures; which procedures really decide whether we succeed or not. These are flowcharted by the people who use them and reference is made to the company polices to ensure the procedure complies with the policy (which in turn complies with the ISO standard).

 

  1. Work InstructionsJust occasionally there will be an important sub-section of a procedure that needs carefully definition in a work instruction, to ensure consistency in operation. For example, purchasing a critical raw material, handling complaints from a key customer who has defined a special protocol, carrying out a critical part of the manufacturing process.

 

 

The world is changing

  1. The concept is good …
    … and indeed most companies now understand the bottom line benefits which a good QMS can provide.This contrasts with perceptions of a QMS at the outset. Many saw them as bureaucratic and just a necessary certificate to put on the wall; they failed and it only added costs. Often employees ignored the documented system, everyone did their own thing, inconsistencies remained and once a year there would be major disruption in the business trying to convince the auditor they complied. The arguments against having a system were misguided and coming from poorly disciplined employees who wanted to do things their way and not the way defined by their colleagues as necessary for the business to survive. Today the concept is understood.

     

  2. Certification is expensive
    To be certified by one of the accreditation bodies is expensive; you are hiring auditors for several days a year to come into your business, collect data and make a report.

     

  3. The death spiral
    As more certification bodies have joined the growing market to certify against Standards, it has become a competitive market, prices have dropped, salaries of auditors have become lower and the perception of many companies being audited is that the competencies of auditors has dropped. This has led to questions about the value of what is known as 3rd party certification. Many companies argue that   industry now understands the benefits of a good QMS, so it is motivated to get the QMSs effective. ‚ companies feel as if they are paying to train up a certification body’s (CB’s) auditor, not improve the system.ƒ it is said that the CB’s auditor can only check the fine detail of forms being correctly filled out, not the higher level effectiveness of an overall Management System; auditor’s are perceived as box-tickers, not value adders.„ the volume of work required to maintain certification reduces the amount of time available for improvement work. Indeed, auditors may demand improvement in a non-priority aspect of the System.… auditors give the perception that it the certificate that is important, rather than the effectiveness of the System.

     

  4. Change is inevitable
    One possible change is the ability for companies to self-certify. This would save money and allow improvement to be more effective.