Quality management system: why are there so many systems and ISO 9001 certifications and so few quality products and services?

You could recall your bitter experience, when you were made accountable for some challenging project, without authority to use the critical resources, available within the organization. There are situations when top management thinks that this project is a regulatory requirement, a necessary evil, which can in no way contribute to the bottom line. Sometimes top management as well as the senior staff members feel that Quality management system is forced on them by outsiders, and its outcome (success or failure) wont impact the organization. Some such issues may result in partial or complete failure of the QMS, resulting in poor quality of products and services.

Often a Government agency or a major client of yours insists on your implementing QMS, and getting it certified to ISO 9001 certification requirements. Third party audit as per ISO 9001 is able to reduce second party auditing costs.  Many of the certified vendors however, forget about QMS, once the certification is successful. They revisit it, only when the surveillance audit becomes due. QMS fails to make an impact on the business processes, as it is not used in planning the business operations of the company.

There are no doubt so many standards for the QMS, and there are regulatory requirements which add to burden of documentation and record keeping. International Standards Organization (ISO) is trying to adopt common structure for all of its standards, to reduce the duplication of documentation.

Quality management system partly successful

In some sectors of the economy however, QMS appears to be marginally successful in driving the realization of   better quality of products and services. Automobile part manufacturers, for example, who got their QMS certified, have been able to fulfil the requirements of some global customers. Second party audits by clients too have played a significant role, in maintaining product conformity.

Common causes of failure

There are some common reasons for the failure of Quality management systems. These are as follows:

1. Attitude of helplessness and indifference:

Lack of involvement of people results in an enforced system. People feel helpless and indifferent about new procedures and methods to be adopted for the success of the QMS processes. If people are involved in writing procedures, they are more likely to be enthusiastic about implementing the same.

2. Alignment of strategy and planning

Lack of alignment of business strategy, strategic plans and critical processes (process criteria) can result in a system that may not be successful in achieving results. Sustained efforts are needed in aligning and integrating the processes and their criteria, to drive improvement of quality for products and services. Planning must take into account the risks involved, due to unplanned changes in resources as well as the customer requirements.

3. Visibility of improvements

While improvement may be just trickling in, communication and visibility may be lacking in most cases. Excessive expectation can also harm the chances of success. We must show patience in looking for improvements. 

4. Visible leadership and support

Owners and top managers must be optimistic and willing to spare their time and energy to demonstrate visible commitment and support for ensuring success of the quality management system. They must motivate the process owners and employees to succeed in improving quality of products and services. Recognition of improvement effort too is important for driving the successful implementation of the system.

5 constraints of skills and other resources

Skill gap is an important bottleneck in many organizations that aspire to deliver world class products and services. Right HR policies and conducive working environment can ensure that right talent can be acquired. Performance management systems and people development plans must ensure that people keep upgrading critical skills and work in teams to ensure success for the organization through quality product and service offerings.

Management must invest in appropriate technology to be able to meet the changing   expectations of customers. Funds needed for QMS development and people development need to be made available.

Expertise in development of appropriate QMS is sometimes a constraint.  Selecting a competent ISO 9001 Consultant can help you overcome this bottleneck.

6. Clarity of Relationships and communication

Lack of clarity of area of responsibilities and overlaps sometimes cause nonconformities resulting in poor output quality. Effective communication by the top management must ensure that roles and responsibilities and interrelation ships are clearly understood and process interfaces don’t become ‘no man’s land’. Customer requirements and regulators expectations must be very clearly understood by each of the employees, as well as the vendor’s process owners. Interdependence and interaction of different processes and criteria of the processes must be clearly communicated.

7. Not being driven by customer

When the quality improvement is not driven by customer, the probability of success appears to be low. Customer involvement in quality improvement through QMS is a crucial requirement for visible quality improvement. When the voice of the customer is captured and used for improvement in product and service features, then the improvement efforts get aligned to customer requirements.

8. Audit which doesn’t look at the big picture

Auditors are trained to look at individual clauses of ISO 9001, but they fail to look at the big picture of quality of goods and services delivered by the company. Issues related to integration of network of processes and optimum balancing between customer expectations and needs of other interested parties such as shareholders and vendors can’t be easily audited. Auditor’s expertise in the business process and technology adopted by the company can sometimes add value to auditing process.

Safety Management System (SMS): The Safety Policy and Commitment Element

A safety management system is designed with the intent to serve as a framework for an organization, as a minimum, to meet its legal occupational safety and health obligations. A safety management system is only as good as its implementation and sustainable efforts.  A world class safety management system involves every level of the organization, instilling “the value of safety” within the workforce that reduces incidents and improves a reduction of risk. Furthermore, a world class safety management system provides evidence of continuous improvement. A business that embraces a safety management system, will have a story to tell and capturing continuous improvement within the elements of safety management system is a key factor of validating the safety management system.

As you know, within a safety management system, all parts are interrelated and affect each other. All elements within the safety management system are related to all other elements of the system. A flaw in one element will most likely impact all the other elements, and therefore the quality of the system as a whole.

This article will briefly focus on the Safety Policy and Commitment element. This particular element set the foundation of all the other elements for the one and only reason.  That reason is that the other elements must circle back to the safety policy and commitment. Remember, all activities within the safety management system are to reflect the safety policy and commitment set forth by the organization. 

SAFETY POLICY AND COMMITMENT

The organization must prepare an effective occupational safety policy that provides a clear direction for the organization tofollow in order to improve and continuously improve worker safety.  Once written, the policy and commitment will contribute to all other aspects of conducting day to day business within the organization.  The policy should provide a commitment to continuous improvement along with compliance to occupational safety law.  Defining expectations of customers’, stakeholders, employees and contractors should also be documented within the policy.

An example of a Safety Policy is:

• Safety and health in our company shall be a part of every operation.
• Safety is every employee's responsibility at all levels.
• We shall comply with local safety and health jurisdictional regulations.
• We shall maintain a safety and health management system conforming to the best practices within our specific industry.

An example of a Safety Commitment is:

The safety and health of every employee is a high priority. Management accepts responsibility for providing a safe and healthy working environment and employees, at all levels, shall take responsibility for performing work in accordance with established safety and health standards and practices. Safety and health will only be achieved through teamwork.  Everyone must join together in promoting safety and health and taking every reasonable measure to assure safe working conditions within our place of work.

In conclusion, operating on the principle of PLAN – DO – CHECK – ACT, a safety management system enables an organization to carefully examine what they do, define and implement safety improvements and continuously review and manage safety systems and processes.

PLAN - Plan the safety management system.

DO – Implement the safety management system.

CHECK - Evaluate the safety management system.

ACT - Improve the safety management system.

The PDCA activities should always, lead a path back to what is stated in the safety policy and commitment.   It will be a waste of time and energy to engage in activities that do not mirror the policy and commitment since those activities will not be based upon reducing hazards to an acceptable level of risk.

ISO 9001 Consultants And Auditors: How To Select Them

In many organizations ISO 9001 consultants play a significant role in the implementation of ISO 9001 and the subsequent certification audit. Their role is crucial because they can do the hand holding during your journey towards attaining business excellence through successful Implementation of the ISO 9001 quality management system. They enable faster learning and help you establish and implement a system that suits you very well. They help you choose the auditing firm(certification body), which is best suited to your business processes.

In order to attain successful ISO 9001 certification, it is essential to have a certification audit conducted in your premises. An independent auditing firm (registrar or the certification body) chosen by you will send qualified ISO 9001 auditors to visit your establishments for performing the external audit.  The firm will register your company for the audit and issue the certificate as soon as the audit process is completed successfully.

Sometimes there is confusion about the role of the external auditors and consultants. The consultants can’t audit and certify you, because they are meant to assist and coach you, whereas auditors must act as independent examiners. Consultants assist in planning and creating documentation so that a formal system is in place. If a QMS already exists; they will do the gap analysis to enable you to know what is missing, so that new procedures and other information can be added to ensure conformity. They train the internal auditors needed to conduct internal audit and provide awareness training to employees. They advise you on weaknesses in the system and preventive actions required. After the audit, they help you to resolve the NCs and other audit observations.

Selection of the ISO 9001 consultant

Consultant is selected on the basis of his or her past performance as well as the background. Trade bodies such as chambers of commerce, as well as professional bodies sometimes keep a list of approved   QMS consultants. Minimum requirement is that the consultant or his staff must have attended lead assessor training courses and transition courses and qualified themselves as lead assessors for the latest revision of the QMS standard. Websites of the consultants may give some idea about the industries they are able to guide and advice. Prior experience and knowledge of the applicable business processes could be a plus point.

 References from previous clients, as well as the results of previous projects in terms of time and cost incurred are considered. Often a small part of the project such as gap analysis is awarded initially. Milestone based fee is also one of the options. Consultants often provide a written proposal for a fee based on the size of the clients operation.

Selection of  the ISO 9001 Auditors (Registrars or Certification body)

 The ISO 9001 Registrar (certification body) is the independent entity that sends the auditors to conduct your certification audit. One must look for officially accredited registrars. The reputation of registrars should also be ascertained with the help of trade bodies or the professional bodies. The criteria for the selection of registrar can be finalized with help of your consultant.

Critical factors to be considered in the selection process include:

• accreditation and other credentials of certifying body or registrars (Every country has an accreditation body: ANSI-ASQ National accreditation Board in USA)
• scope of the accreditation: determine if the scope of accreditation certificate applies to  your business processes,
• references and global reputation/recognition
• fee for certification audit as well as subsequent surveillance audits
• their terms and conditions
• comfort level, flexibility to suit your time frame
• confidentiality and ethical issues
• how to tackle issues of interpretation of clauses of the applicable standard
• credentials and competence of  the auditors, who will be assigned to audit you.

Thus the selection of  a  competent consultant and  a reputed  certification body at a later stage, paves the way for successful certification of your company for ISO 90001.