SOP for Quality Management System

Purpose

The purpose of this procedure is to highlight the processes needed for the quality management system for continual improvement.

Scope

This International Standard specifies requirements for a quality management system where an organization 

1. Needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and
2. Aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

References

U.B.C. & ASTM

Abbreviations & Definition of Terms

Top Management – Managing Director, Operation Director

Product – The end item result of meeting all contract terms and conditions.

Responsibilities

Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by

1. Communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements,
2. Establishing the quality policy,
3. Ensuring that quality objectives are established,
4. Conducting management reviews, and
5. Ensuring the availability of resources.

Management Representative

Top management shall appoint a member of the organization's management who, irrespective of other responsibilities, shall have responsibility and authority that includes

1. Ensuring that processes needed for the quality management system are established, implemented and maintained,
2. Reporting to top management on the performance of the quality management system and any need for improvement, and
3. Ensuring the promotion of awareness of customer requirements throughout the organization.

Procedure

The benefits of a QMS

A fully documented QMS will ensure that two important requirements are met:

• The customers’ requirements – confidence in the ability of the organization to deliver the desired product and service consistently meeting their needs and expectations.
• The organization’s requirements – both internally and externally, and at an optimum cost with efficient use of the available resources – materials, humans, technology and information. These requirements can only be truly met if objective evidence is provided, in the form of information and data, to support the system activities, from the ultimate supplier to the ultimate customer.

ALSO READ: Quality Assurance Vs Quality Control

A QMS enables an organization to achieve the goals and objectives set out in its policy and strategy. It provides consistency and satisfaction in terms of methods, materials, equipment, etc., and interacts with all activities of the organization, beginning with the identification of customer requirements and ending with their satisfaction, at every transaction interface.

Management systems are needed in all areas of activity, whether large or small businesses, manufacturing, service or the public sector. A good QMS will:

1. Set direction and meet UBC & ASTM
2. Improve process control
3. Reduce wastage
4. Lower costs
5. Increase market share
6. Facilitate training
7. Involve staff
8. Raise morale

The major clauses and sub-clauses are:

• Scope
• Normative reference
• Terms and definitions
• Quality management system

1. General requirements
2. Documentation requirements

• Management responsibility

1. Management commitment
2. Customer focus
3. Quality policy
4. Planning
5. Responsibility, authority and communication
6. Management review

• Resource management

1. Provision of resources
2. Human resources
3. Infrastructure
4. Work environment
5. Product realization
6. Planning of product realization
7. Customer‐related processes
8. Design and/or development
9. Purchasing
10. Production and service operations
11. Control of measuring and monitoring devices

• Measurement, analysis and improvement

1. General
2. Planning
3. Monitoring and measurement
4. Control of non‐conforming product
5. Analysis of data
6. Improvement

Setting up a QMS

As illustrated in the Process section, for organizations to function effectively, they have to identify and manage numerous interlinked, cross‐functional processes; always ensuring customer satisfaction is the target that is achieved. The schematic illustrates this concept:

The adoption of a QMS needs to be a strategic decision of an organization and is influenced by varying needs, objectives, the products/services provided, the processes employed and the size and structure of the organization. A QMS must ensure that the products/services conform to customer needs and expectations, and the objectives of the organization. Issues to be considered when setting up a QMS include its:

• Design
• Build
• Control
• Deployment
• Measurement
• Review
• Improvement

Taking each of these in turn:

Inhouse Design and build includes the structure of the quality management system, the process, and its implementation. Its design must be led by senior managers to suit the needs of the organization, and this is ideally done using a framework to lead the thinking. Design of the QMS should come from determining the organization’s core processes and well‐defined goals and strategies, and be linked to the needs of one or more stakeholders.

The process for designing and building the QMS must also be clear, with the quality function playing a key role, but involvement and buy‐in to the system must also come from all other functions.

Deployment and implementation is best achieved using process packages, where each core process is broken down into sub‐processes, and described by a combination of documentation, education, training, tools, systems and metrics. Electronic deployment via Intranets is increasingly being used.

ALSO READ: Interview Questions and Answers for Quality Assurance

Control of the QMS will depend on the size and complexity of the organization. ISO is a site-based system, and local audits and reviews are essential, even if these are supplemented by central reviews.

Local control, where possible, is effective, and good practice is found where key stakeholders are documented within the process and where the process owner is allowed to control all the process.

Ideally, process owners/operators are involved in writing procedures.

Measurement is carried out to determine the effectiveness and efficiency of each process towards attaining its objectives. It should include the contribution of the QMS to the organization’s goals; this could be achieved by measuring the following:

• Policy definition completeness
• Coverage of business
• Reflection of policies
• Deployment
• Usage
• Whether staff find the QMS helpful in their work
• Speed of change of the QMS
• Relevance of QMS architecture to the job in hand

A form of scorecard deployed through the organization down to individual objective level can be employed, and the setting of targets at all levels is vital.

A review of the effectiveness, efficiency, and capability of a QMS is vital, and the outcome of these reviews should be communicated to all employees. Reviewing and monitoring should be conducted whether improvement activities have achieved their expected outcomes.

Improvement should follow as a result of the review process, with the aim of seeking internal best practices. It is part of the overall improvement activities and an integral part of managing change within the organization.

• Customer focus
• Leadership
• Involving people
• Process approach
• Systems approach
• Continual improvement
• Factual decision-making
• Mutually beneficial supplier relationships

Taking each one in turn, they are explained more fully as:

• An effective QMS must ensure that the organization has a strong Customer Focus. Customer needs and expectations must be determined and converted into product requirements.
• Top management has to demonstrate Leadership. Providing unity of purpose through an appropriate quality policy, ensuring that measurable objectives are established, and demonstrating that they are fully committed to developing, sustaining, and improving the QMS.
• Managers must ensure that there is Involvement of People at all levels in the organization. This includes ensuring that there is an awareness of the importance of meeting customer requirements and responsibilities in doing this, and people are competent, on the basis of appropriate training and experience.
• An effective QMS must be a strategic tool designed to deliver business objectives and must have, at its core, a Process Approach, with each process transforming one or more inputs to create an output of value to the customer. 
• The key business processes may be supported by procedures and work instructions in those cases where it is judged necessary to rigidly define what rules are to be followed when undertaking a task. Most organizations will have core business processes that define those activities that directly add value to the product or service for the external customer, and supporting processes that are required to maintain the effectiveness of the core processes.
• The understanding of the many interrelationships between these processes demands that a Systems Approach to management is adopted. The processes must be thoroughly understood and managed so that the most efficient use is made of available resources, to ensure that the needs of all the stakeholders –customers, employees, shareholders, and the community ‐ are met.

Reviews and Assessments

• A good QMS will not function or improve without adequate review and assessment.
• Review and Assessment are carried out to ensure that actual methods are adhering to the documented procedures, whilst system reviews should be carried out systematically, to ensure the system achieves the required effect.
• There should be a schedule for carrying out reviews, with different activities possibly requiring different frequencies.

Flow Chart

Abbreviations

QMS: Quality Management System

Annexure

Nil

Revision History

Nil

ALSO READ: Checklist for OOS Investigations in Pharmaceutical Industry