Tag Archives: Quality Management system

PURCHASING – ISO 9001 certification

ISO 9001 certification, Quality Management system,

Purchasing is one of the most important processes of the Quality Management System based on ISO 9001 certification standard. The inputs to the Purchasing or the Purchasing Information comes from the Design & Development Process. Design specifies the parts and materials and their grades and qualities that are going to become part of the product. If this step is not correct then the purchased part will not meet the requirement of the Design and hence the Production will not be done correctly.

ISO 9001 certification

The organization shall develop the criteria for the evaluation and selection of External providers (Suppliers). The organization shall monitor the performance of the external providers and periodically re-evaluate them based on their ability to meet requirements for products and processes. The organization shall maintain documented information of these activities and any actions arising from the evaluations. The organization may develop an External Provider Audit Checklist and evaluate External Providers based on that criteria. Calibration is done through measuring a standard .

The main objective of Purchasing is making sure that the purchased product conforms to what you asked for. So the control you place one the Supplier will be based on the effect it will have on the production process and the final product. For example if you bought a nail with a damaged head then you can easily put it aside and replace it with another nail with a good head. There is no need to place a strict control on the supplier.

You have to make sure that the supplier can provide the quantity and quality of products that you require. You also have to look into the financial strength and market reputation of suppliers.

Controls

The organization shall determine the controls to be applied to externally provided processes, products and services when products and services from external provider are intended for incorporation into the organization’s own products and services or products and services are directly provided by the external provider to the customer on behalf of the organization or a process or part of a process is provided by the external provider as a result of a decision by the organization.

Types and extent of control

The organization shall make sure that the externally provided products or services do not negatively affect its ability of providing consistent quality products and services to its customers.

The organization shall make sure that externally provided products and services remain within the control of its Quality Management System.

The organization shall also determine the control’s that it plans to apply to the external provider and to the product.

The organization shall also take into consideration the potential impact of externally provided products and services on its ability to consistently meet customer and applicable legal requirements,

The organization shall also take into consideration whether the controls applied by the external provider are adequate or not.

The organization shall also determine the Verification and other activities required to ensure that the externally provided products and services meet requirements.

Purchasing Information

Information in the Purchase order is the most important information in the purchasing process. You should describe the product being purchased, and if appropriate then add the approval requirements for the product, process, procedure or equipment to be accepted. If you require a specific piece of equipment to be used then this should be included in the Purchase Order. Finally you should check the adequacy of purchasing information before sending the purchase order to the supplier. If the supplier does not have adequate information then it is your fault.

The adequacy of purchasing information shall be ensured prior to its communication to the supplier.

The organization shall communicate to the external providers its requirements for the products, processes or services to be provided. It shall communicate the requirements for approval of products and services, methods, processes and equipment and the methods for release of products and services. It shall communicate the competence requirements of supplier personnel, the requirements for external provider’s interaction with the organization, the control and monitoring of external providers performance to be applied by the organization and the verification or validation that the organization intends to apply at the premises of the external provider.

When the organization receives the products, then it needs to verify that it had got what it ordered. The products are first placed in the Quality Check Area in the store and they are checked for acceptable quality. If they pass the checking then they are placed in the store in designated area. Entry is made in the store register for the product or part. After that they are forwarded to the production area when the requirement arises and the Store Issue Requisition is given to the Store Personnel by the Production Personnel. Any product or part failing the quality check is placed in the Quarantine Area and the Store Manager in consultation with the Production Manager decides what to do. He has the option of using it under concession if the defect is slight. He also has the option of sending it back to the supplier or scrapping it with the supplier’s permission. Calibration is a process through which you confirm that the measurements you have taken are true.

 

Quality management system: The most important points we often neglect

Quality Management system,

Quality management is a management methodology. We often forget the basic management functions and principles, while adopting and implementing quality management system in an organization. Basic functions of management include goal setting, organizing, staffing, planning, coordinating, monitoring and controlling.

Quality Management system

Effective managerial leadership process also involves supervising and directing, motivating, problem solving and communicating with employees for ensuring that the company accomplishes the planned objectives and goals.

Planning and coordinating to ensure quality

The planning function creates process, activity and task schedules, along with resource allocation such as manpower as well as equipment, information and knowledge support, enabling the organization to operate successfully, for achieving its goals. What is often forgotten is the need to update and modify plans based on changes in customer requirements, changes in environment, progress in plan implementation and new constraints on resources?

The coordinating function has to interface with planning, organizing, as well as controlling functions, in line with goals of the organization which are driven by customer requirements. Coordinating is usually a weak link in the quality system and higher management must constantly monitor the coordination function.

Organizing and staffing

 Organizing involves allocating responsibilities and tasks to teams and individuals based on specific skill sets needed to complete the tasks. Agile organizations are able to respond fast to changing customer demands. Organizing also involves reporting and line of command. Organizing and staffing together involves complete talent management function involving sourcing and retention of talent and performance management. Non availability of the necessary skills in time can mean risks to the output of the processes and outcome of businesses. This aspect is normally neglected in quality system. Development of skills and monitoring of skill development could be a critical success factor for business organizations.

Motivating teams and involving people in improvement activities are other critical factors related to organizing and staffing.

Strategy for fulfilling quality objectives: role of ISO 9001 consultants

Organization’s strategic plans must take into account resources needed, including expertise, knowledge, updated information and skill requirements, and how to source the critical resources. Sourcing strategy for the critical resources is a major challenge for every organization. But this aspect is usually neglected and companies are often operating in the firefighting mode. ISO 9001 consultants can help you solve such issues and put in place the strategies for sourcing critical resources. 

Evaluating, Controlling and monitoring

The monitoring and controlling function acts as eye and ears of the management. This is to ensure that all the necessary functions of the business organization are operating as planned. Controls are exercised on the basis of process control criteria and other standards of performance and targets set for teams. Any deviations from control criteria must be investigated and risks to final outcome of the company must be evaluated. Measurement of process parameters and product and service characteristics must be utilized for statistical analysis to obtain trends of non-conformity. Impact of non-conformity on other related processes must be analyzed. Necessary corrective actions must be planned across the entire organization, so that learning action from failure can be initiated.

Based on the changes in customer expectations, as well as regulatory changes,   the process acceptance criteria must be changed and process owners trained on the new criteria.

Evaluating and controlling includes monitoring the status and measuring the attributes of a process as well as the output (product or service) and taking appropriate actions based on data and observations. Manager’s wakeup to the need to monitor only when there is a crisis.  If  process evaluation  is done even   when everything appears to be running smoothly, sales are growing along with profits, customers are happy,  then you are going to prevent an impending crisis due to customer complaints, by taking preventive actions.

Voice of the customer

 Top managements of the companies are unable to respond quickly to the changes in customer requirements and latest customer perceptions about company’s products and services. Employees as well as managers across the organization must listen directly to the voice of the customer. Changes in resources and processes required   to meet new expectations of customers and other interested parties, must be analyzed and evaluated. New strategic plans should incorporate necessary changes in processes and process criteria based on changes in customer needs. Risks and opportunities arising out of the voice of the customer must be assessed regularly.  Changes in market place occurring due to competitors coming up with new offerings of products and services need to be assessed.

Thus by following some of the management principles and functions, and listening to the voice of the customer, we can make the quality management system more effective.

How is Systems Thinking as per ISO 9001 connected to Product Management?

Quality Management system,

Product management is a coordinating role that deals with design, planning, production, forecasting, marketing and sales of product during all stages of the product’s life cycle. As people and processes from different departments come together to form a product, so Systems Thinking as per ISO 9001 Quality management system which views the Organization as a combination of interacting processes which affect one another is a great tool to understand this complexity. The barriers across different departments have to be brought down to develop a product. Systems thinking greatly helps in achieving this objective.

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Don Norman says. “No product is an island. A product is more than the product. It is a cohesive, integrated set of experiences. Think through all of the stages of a product or service. Make them all work together seamlessly. That’s systems thinking.”

To develop a product, the product managers have to listen to the voice of the customer, the offerings of the competitors, technological change. The design team has its own considerations that take a product from a drawing to a prototype and a launch. Purchases have to be made and storage and production have to be organized and controlled. Selling of the product and market reaction and customer reaction have to be taken into account. How the customer experiences the product through its life cycle has to be observed. A television is more than a product, it is an experience and a family get together social phenomenon.

The product managers have to understand the eco-system in which a product exists, the peoples who shall interact with it and its life cycle. Product management is about working with and understanding, explaining and interpreting and fine tuning different sub-systems. Product management is about managing systems that become more complex and dynamic with evolution.

Systems thinking brings together all these discordant elements together in a whole and makes the different parts understandable to those dealing with product management. Product managers have to understand the whole of the product as well as its parts. Frequently, the design will change a component such as a processor of a Lap top or a hard drive or put in a screen with a new technology. Product management has to understand how the change in the part affects the whole and also the effect on the market response to the innovations and changes.

Systems thinking is important for Product Managers to fully understand the different stakeholders and other variables that affect the business of the product. How is the product discovered by the buyer, how is it purchased, first use, continued usage, returns and upgrades are functions handled by different parts of a company. But the product management is tasked with overseeing all these activities, and Systems thinking provides them with the tools to achieve them.

The Systems thinking is a great model for enabling Product management through product design, development, prototyping, development and launch. It is also used to understand competition or market reaction. ISO 9001 Consultants play an important role in creating awareness about Systems Thinking to their clients for its use in Product Development.

 

Core Principles of Systems Thinking as per ISO9001

ISO 9001,

Systems Thinking is at the base of the ISO 9001 Quality Management System. A system has been defined as “A collection of interrelated, interdependent components or processes that act in concert to turn inputs into some kind of output in pursuit of some goals. Systems influence and are influenced by their external environment”

A single process is defined as actions on inputs in a controlled manner which are transformed into outputs. The organization is a collection or system of interrelating processes which are glued by many input –output relationships.

ISO 9001

ISO 9001 states that “Identifying, understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its objectives.”

System thinking is opposite to the normal form of analysis. Analyze comes from the root “to break into constituent parts” Instead of isolating smaller and smaller parts of the system being studied, in systems thinking the view is expanded to look at larger and larger interactions. It focuses on how the thing being studied interacts with other constituents of the system. A system is a set of elements that interact to produce behavior, of which it is a part. The systems thinking results in sometimes different conclusions from the traditional form of analysis.

Examples of situations in which systems thinking has proved its use are

  • Complex problems that require helping many actors see the big picture and not their part in it.
  • Recurring problems or those problems that have been made worse by past attempts.
  • Where the action influences the environment surrounding the issue.
  • Problems in which the solution is not obvious.

Systems have been organized into four categories:

  • The whole
  • The goals
  • The internal workings
  • The long term results

Once we observe and understand the relationship between the system and behavior, we can understand how the system works. What makes it deliver poor results and how to shift it into better behavior patterns? Processes that cover the organization are managed and results are the outputs or outcomes of the organization which must satisfy all stakeholders and should lead to sustained success.

Feedback is an important element of the systems thinking. In the case of a quality management system, feedback is received from interested parties like vendors, customers, regulators, employees.

External boundary of the system may be set and the interaction with outside parties noted and how it effects the organization also understood.

A quality management system is made up of three sub systems, a social, a technical and a management sub-system.

  • Social Subsystem

Requires a change in organizational culture (values, attitudes, norms and role expectations, communications (level of relationship between individual s and groups, symbols of power and reward structure) and behavioral attributes. It encapsulates customer satisfaction, respect for people, continuous improvement and management based on facts.

  • Technical Subsystem

Includes a transformation process as an interaction among inputs, resources and outputs and all the tools, techniques, machinery and quantitative aspects of quality.

  • Managerial Subsystem

Includes the framework for policies, practices, procedures and leadership in the organization. Includes the organizational structure, mission, vision, and goals of the organization as well as administrative activities like planning, directing, organizing, coordinating and controlling activities

The System approach enables the organization to meet customer requirements and achieve continual improvement by finding a cause and effect relationship in its processes and their interrelationship.