Process Approaches

Why “Process Approaches”?

Extract from ISO9001:2015

Clause 0.1

This International Standard employs the process approach, which incorporates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking.

The process approach enables an organization to plan its processes and their interactions.

The PDCA cycle enables an organization to ensure that its processes are adequately resourced and managed, and that opportunities for improvement are determined and acted on.

Clause 0.3

  • Process approach
  • General

This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements. Specific requirements considered essential to the adoption of a process approach are included in 4.4.

Understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its intended results. This approach enables the organization to control the interrelationships and interdependencies among the processes of the system, so that the overall performance of the organization can be enhanced.

The process approach involves the systematic definition and management of processes, and their interactions, so as to achieve the intended results in accordance with the quality policy and strategic direction of the organization. Management of the processes and the system as a whole can be achieved using the PDCA cycle (see 0.3.2) with an overall focus on risk-based thinking (see 0.3.3) aimed at taking advantage of opportunities and preventing undesirable results.

The application of the process approach in a quality management system enables:

a) understanding and consistency in meeting requirements;

b) the consideration of processes in terms of added value;

c) the achievement of effective process performance;

 d) improvement of processes based on evaluation of data and information.

Figure 1 gives a schematic representation of any process and shows the interaction of its elements. The monitoring and measuring check points, which are necessary for control, are specific to each process and will vary depending on the related risks.

Clause 5.1

Top management shall demonstrate leadership and commitment with respect to the quality management system by:

d) promoting the use of the process approach and risk-based thinking;

Determine type and family product is one of important criteria for “Operation process” clause 8, support process clause 7, planning process clause 6 and performance evaluation clause 9 of ISO9001:2015. After the product have been determine as process output, the product criteria, risk and their performance measure need to be determine and measure. In addition, the process sequence, interaction need to determine and resources provided.

In ISO14001:2015, the product need to be determine in order to study the life cycle of product.

Determine product effectively is also one of Baldrige business excellence criteria in Category 3.2a as followed:

(1) Product Offerings HOW do you determine product offerings? HOW do you

• determine CUSTOMER and market needs and requirements for product offerings and services;

• identify and adapt product offerings to meet the requirements and exceed the expectations of your CUSTOMER groups and market SEGMENTS; and

• identify and adapt product offerings to enter new markets, to attract new CUSTOMERS, and to create opportunities to expand relationships with current CUSTOMERS, as appropriate.

Issues

In some organization, they produce hundreds of products. Hence, the organization should profile their product to segment, family or category in order to manage the product realization process effectively.

Purpose of this criteria

The idea to determine the type and family of product is to:

  1. Define the scope of quality/ environmental management system;
  2. Effectively plan, monitor and measure the product performance;
  3. consistently provide products and services conforming to their requirements;
  4. Effectively improve the product

Definition and Description

ISO9000:2015 defined:

Clause 3.7.6 Product

Output of an organization  that can be produced without any transaction taking place between the organization and the customer

Note 1 to entry: Production of a product is achieved without any transaction necessarily taking place between provider  and customer, but can often involve this service  element upon its delivery to the customer.

Note 2 to entry: The dominant element of a product is that it is generally tangible.

Note 3 to entry: Hardware is tangible and its amount is a countable characteristic (e.g. tyres). Processed materials are tangible and their amount is a continuous characteristic (e.g. fuel and soft drinks). Hardware and processed materials are often referred to as goods. Software consists of information regardless of delivery medium (e.g. computer programme, mobile phone app, instruction manual, dictionary content, musical composition copyright, driver’s license).

3.7.7 Service

Output of an organization with at least one activity necessarily performed between the organization and the customer.

Note 1 to entry: The dominant elements of a service are generally intangible.

Note 2 to entry: Service often involves activities at the interface with the customer to establish customer requirements as well as upon delivery of the service and can involve a continuing relationship such as banks, accountancies or public organizations, e.g. schools or hospital

CATEGORIZING PROCESS BY PRODUCT FAMILY

Commonly product is categorized by:

  • Customer
  • Profile i.e. commodity
  • Process Family

The benefit to categorise the product by customer is performance evaluation and analysis of the sales .  However, one customer may purchase different product commodity and process family. Hence to determine the improvement opportunities of products, the recommended tools and techniques is product-process matrix to determine the product family.

Product family is product that passing through similar processing steps and common equipment just prior to shipment to the customer. The significance of product families for lean thinkers is that they are the unit of analysis for value-stream maps, which are defined from the most downstream step just before the customer.

Note that product families can be defined from the standpoint of any customer along an extended value stream, ranging from the ultimate customer (the end consumer) to intermediate customers within the production process.

PRODUCT FAMILY MATRIX

A chart above constructed by lean thinkers to identify appropriate product families.

In the illustration below, a firm with seven product lines, as perceived by its customers, arrayed its assembly steps and equipment across the top of a product family matrix and quickly found a common path for Products A, B, and C, which it then value stream mapped as a product family.

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