Tuesday, 3 July 2012

What is a Quality Management System (QMS)?


What  is a Quality Management System (QMS)?



A Quality Management System can be seen as a complex system consisting of all the parts and components of an organisation dealing with the quality of processes and products. A QMS can be defined as the managing structure, responsibilities, procedures, processes, and management resources to implement the principles and action lines needed to achieve the quality objectives of an organisation.

There are many definitions of a QMS (ISO 8402, 1994), but most definitions don’t provide any more information than the words ‘quality management system’. The definition of a QMS isevolving into a definition of good management. It is not an addition to an organisation. It is an integral part of its management and production.

A good QMS does not in itself make an organisation more profitable, efficient or customer focussed, but it will give to an organisation the ability to do anything better, from production to sales.

The history of QMS systems and the associated standards has meant that until recently there was considerable emphasis on documentation. Although successful in many production and assembly line environments, many other organisations found the emphasis on documentation detracted from what the QMS was trying to achieve. It is very easy to simply concentrate on the detail of the documentation process. However, a modern QMS is much more than this. It is a major contributor to helping an organisation focus on its goals – better service to users and customers, reduction of waste and rework, helping staff in all areas to ‘do it better’. This has been recognised by the ISO standards body, and the objectives are reflected in the new edition of the ISO 9000 standard, due to be published at the end of year 2000.
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The benefits of a QMS


In "Good reasons for implementing a QMS" (CERCO SWGA, 1999), a number of direct benefits of a QMS are stated:
·          improved customer satisfaction;
·          improved quality of products and services;
·          workers’ satisfaction and more commitment to the organisation;
·          better management and a more effective organisation;
·          improve relations with suppliers;
·          improved promotion of corporate image.
Besides these direct benefits, there are also several indirect benefits to identify, which give opportunities to:
·          review business goals, and assess how well the organisation is meeting those goals;
·         identify processes that are unnecessary or inefficient, and then remove or improve them;
·         review the organisational structure, clarifying managerial responsibilities;
·         improve internal communication, and business and process interfaces;
·          improve staff morale by identifying the importance of their output to the business, and by involving them in the review and improvement of their work.
These benefits and opportunities apply to any business. The specific benefits to NMAs can include:
·          removal of non-conformance from topographic data;
·          a faster registration of cadastral records; more efficient map production;
·          complete and consistent land (tenure, use, cover) records;
·          improved data and equipment supply management.


QMS and ISO9000


The ISO 9000 standard (ISO 9001,1994) provides comprehensive guidance on the principles, scope and implementation of a QMS. Each NMA must decide for itself to what extent it wishes to comply with the standard. The options are:
·          implement a QMS without reference to the standard;
·          use the principles and concepts within the standard;
·          adopt the standard and seek an ISO 9000 certificate.
Many organisations successfully adopt a QMS without an ISO 9000 certification, relying on their internal review procedures to keep the whole process on track. IS0 9000 certification leads to formal review and approval of the QMS by an outside body and, more importantly, the certification body will review the QMS every six months. Accreditation bodies are being established in a growing number of countries, sometimes with a government mandate. Certification bodies that fulfill the criteria of the accreditation system are duly accredited; relevant criteria are for instance the EN 45000 series). This independent review is very useful for identifying potential problems early, and provides an incentive to keep the QMS current and relevant.

Saturday, 23 June 2012

ESTABLISH CORRECTIVE ACTION PROCEDURES FOR EACH CCP


ESTABLISH CORRECTIVE ACTION PROCEDURES FOR EACH CCP (HACCP PRINCIPLE 5)

During the development of the HACCP plan, the HACCP team must establish procedures to be followed if and when the monitoring of a CCP reveals that the critical limits are not respected (i.e., a deviation occurs), and therefore there is a loss of control of the hazard at the CCP. A product that is obtained at a process step where the CCPs are not respected is a nonconforming product and is likely to be unsafe if consumed. The procedures that are established to prevent unsafe product from reaching the consumer are the corrective action procedures or deviation procedures. This HACCP principle recognizes that in spite of the fact that a CCP is operating in a process, it is possible that there could be loss of control at the CCP and this loss of control will be detected during the monitoring procedure.
The following points must be addressed in the corrective action procedures:
• The specific, immediate action to be taken when it is discovered that the critical limits at a CCP are not respected, and therefore there is a deviation from the critical limits
• Identification of the cause of the deviation from the critical limits at the CCP
• The actions to be taken to correct the cause of the deviation so that the deviation does not recur
• Determination of the period of time for which the deviation occurred and the quantity of nonconforming product that was prepared during this time
• The actions to be taken with respect to the nonconforming product to ensure that it does not reach the consumer
• The importance of keeping records of all the actions taken to address the deviation and the nonconforming product
For all of the points listed here, the corrective action procedure must identify the personnel who are responsible for the actions to be taken when there is a deviation from the critical limits at a CCP.
In the event that a deviation from the critical limits at a CCP is discovered only after the non-conforming product has been shipped from the establishment to the customer, then the HACCP prerequisite program Traceability and Recall (Chapter 4) must be used to address this situation.

 ESTABLISH VERIFICATION PROCEDURES FOR EACH CCP AND FOR THE ENTIRE HACCP PLAN (HACCP PRINCIPLE 6)

 

This HACCP principle requires that the HACCP team develop measures that will evaluate (a) the effectiveness of the HACCP plan that has been developed and (b) the effectiveness of the HACCP system on an ongoing basis after its implementation.
• Verification of initial HACCP plan: The verification of the initial HACCP plan involves validation to ensure that the critical limits, the monitoring procedures and the corrective action procedures (HACCP
Principles 3–5, Steps 8–10) established at each CCP are indeed capable of controlling the hazard that is required to be controlled. This validation must be conducted during the development of the HACCP plan; it is therefore an essential part of the HACCP plan development.
The verification activity must also demonstrate that every aspect of the HACCP plan that has been developed must be fully and correctly implemented.
• Verification of the HACCP plan on a continuous basis: The HACCP plan that has been developed must include activities that will demonstrate the following:
The measures (monitoring procedures, corrective action procedures, record-keeping procedures) which have been implemented at each CCP, must continue to be effective and must operate as required by the HACCP plan. The most common form of verification is ongoing review of the required records of monitoring and corrective actions by personnel other than those who were responsible for the monitoring activity or the corrective action.
Supervisory personnel should carry out this type of verification.
Verification activities could also include periodic sampling and analysis to verify the effectiveness of the CCP to control a hazard.
Table 5.5 gives examples of verification activities for some CCPs.
Every aspect of the entire HACCP plan that has been implemented must continue to function as  originally intended; this type of verification is typical of a system audit, and includes an independent review of the entire HACCP plan at a predetermined frequency. In the event this verification activity discovers that there are deficiencies in the HACCP plan, these deficiencies must be corrected immediately.

Contact me for HACCP support at reet.gmp@gmail.com

ESTABLISH MONITORING PROCEDURES FOR EACH CCP


ESTABLISH MONITORING PROCEDURES FOR EACH CCP (HACCP PRINCIPLE 4)
 

For each of the CCPs that have been determined, the HACCP team must establish the monitoring procedures which will be used to monitor or measure the parameters at the CCP to determine whether the critical limits are being respected. Monitoring can also reveal whether a trend toward loss of control at the CCP is developing so that appropriate action can be taken to prevent loss of control before it actually occurs.
It is essential that the monitoring procedures be reliable; if the monitoring procedure involves a measurement, the reliability of the method used should be known. Visual inspection and physical and chemical measurements are frequently used as monitoring procedures. In some situations microbiological analysis may be required; however, this should only be the case if no other appropriate monitoring procedure is available.
The monitoring procedures must address the following points:
• The reliability of the method; in some situations Official Methods or Reference Methods may be required (e.g.; when some chemical or microbiological methods are used)
• The sampling and sample handling techniques, if applicable
• Whether the method is appropriate for monitoring, in some situations continuous monitoring may be required
• The frequency at which the monitoring is done, if the monitoring is not continuous
• The skill and training of personnel responsible for the monitoring activities
• The equipment used in the monitoring procedure; any equipment used for monitoring must be maintained and calibrated, if required (this is also covered in the HACCP prerequisite programs)
The monitoring procedures should be adequately documented to ensure that these points are addressed. In addition, a record must be generated whenever a monitoring procedure is performed; this record shows that the monitoring was done as required, the person who performed the monitoring,and the actual results of the monitoring. The monitoring record is an essential part of an operating HACCP plan for a product since it is the evidence for whether or not the critical limits were respected.

NACMCF Critical Control Point Decision Tree


Question 1: Does this step involve a hazard of sufficient likelihood of occurrence and severity to warrant its control?
(a) If the answer is Yes, go to Question 2
(b) If the answer is No, this step is not a CCP; proceed to the next step of the process.
Question 2: Does a control measure for the hazard exist at this step?
(a) If the answer is Yes, go to Question 3
(b) If the answer is No, is control at this step necessary for the safety  of the product?
(i) If the answer is Yes, modify the step, the process or product, and return to start of Question 2
(ii) If the answer is No, this step is not a CCP; proceed to the next step of the process.
Question 3: Is control at this step necessary to prevent, eliminate or reduce the risk of the hazard to consumers?
(a) If the answer is Yes, this step is a CCP; proceed to the next step  in the process.
(b) If the answer is No, this step is not a CCP; proceed to the next  step in the process.

Contact me for HACCP support at reet.gmp@gmail.com

ESTABLISH CRITICAL LIMITS FOR EACH CCP


ESTABLISH CRITICAL LIMITS FOR EACH CCP (HACCP PRINCIPLE 3)

For each of the CCPs that have been determined, the HACCP team must establish critical limits which will serve as the criteria for accepting or rejecting a raw material or ingredient that is a CCP, or a semi-finished or finished product that is obtained at a process step that is a CCP. A critical limit is commonly a maximum value of a parameter that must not be exceeded or a minimum value of a parameter that must be reached at a CCP. At a CCP, the critical limits must be respected for the hazard to be prevented, eliminated or reduced to an acceptable level, and therefore for the product obtained at the CCP to be acceptable. If the critical limits at a CCP are not respected, the product obtained at the CCP will not be acceptable.

Codex Alimentarius Critical Control Point Decision Tree


Question 1: Do preventive control measures exist?
(a) If the answer is Yes, go to Question 2.
(b) If the answer is No, is control at this step necessary for the safety of the  product?
(i) if the answer is No, this step is not a CCP; proceed to the next identified hazard in the process
(ii) If the answer is Yes, modify the steps in the process or the product, and return to start of Question 1.

Question 2: Is this step specifically designed to eliminate or reduce the likely  occurrence of the hazard to an acceptable level?
(a) If the answer is Yes, this step is a CCP
(b) If the answer is No, go to Question 3.

Question 3: Could contamination with the identified hazard(s) at this step,  occur in excess of acceptable level(s) or could these hazards increase to  unacceptable level(s)?
(a) If the answer is Yes, go to Question 4
(b) If the answer is No, this step is not a CCP; proceed to the next identified  hazard in the process.
Question 4: Will a subsequent step eliminate the identified hazard(s) or reduce the likely occurrence to acceptable level(s)?
(a) If the answer is Yes, this step is not a CCP; proceed to the next identified  hazard in the process
(b) If the answer is No, this step is a CCP

Contact me for HACCP support at reet.gmp@gmail.com