1 Apr 2020 Oleh Dr Edly Ramly

Rata-rata syarikat tidak bersedia untuk menghadapi perintah kawalan pergerakan (PKP) akibat dari pandemik Covid-19 dengan tidak menyediakan pelan kelangsungan perniagaan (business continuity plan-BCP), mengikut pemerhatian yang dijalankan melalui audit sistem pengurusan kualiti yang dijalankan pada 2019 kepada lebih 70 syarikat.

Hampir semua syarikat SME tidak mewujudkan BCP secara formal. Walaubagaimanapun, ada beberapa syarikat multinasional mempunyai pelan kelangsungan perniagaan (BCP), tetapi pelan tersebut tidak mengenalpasti ganguan dari pandemik yang menyebabkan PKP dikeluarkan kepada hampir semua syarikat dalam rantaian bekalan kecuali kepada perkhidmatan perlu (essential services).

Kesan paling besar yang dihadapi oleh syarikat pada masa ini ialah kehilangan punca pendapatan dan berkemungkinan besar menghadapi pengurangan permintaan pada fasa pasca pandemik Covid-19 pada masa hadapan. Walaubagaimanapun, tinjauan terkini kepada beberapa buah syarikat, BCP sedang dirangka untuk memulihkan dan meneruskan perniagaan, apabila PKP ditamatkan untuk menempuh fasa seterusnya. Malah syarikat masih tidak terlewat untuk menyediakan BCP untuk ganguan kawalan dan sekatan pergerakan yang sedang berlangsung sekarang.

Untuk syarikat telah membangunkan BCP sebelum ini mengikut standard ISO22301, tugasan penyediaan dan menambahbaik BCP berkaitan pandemic Covid-19 ini akan menjadi lebih mudah dan bersistematik.

Menurut standard sistem pengurusan kelangsungan perniagaan (business continuity management system – BCMS) ISO22301 versi 2019, BCP adalah dokumen yang akan membimbing organisasi untuk bertindak apabila berlaku ganguan termasuk tindakan menyambung semula, memulihkan dan mengembalikan penyampaian produk atau perkhidmatan selaras dengan matlamat kelangsungan perniagaan. Di dalam standard tersebut, BCP dibangunkan melalui rangka kerja sistem pengurusan kelangsungan perniagaan termasuk mengenalpasti aktiviti utama (prioritised activity – PA), mengenalpasti jenis-jenis ganguan (disruption), dan juga strategi-strategi untuk bertindak balas.

Pada masa hadapan, syarikat digalakkan untuk menambahbaik BCP sediaada, dengan menjalan pengujian terhadap BCP tersebut, serta menjalankan pelbagai persediaan awal untuk mengurangkan risiko dan kesan terhadap apa-apa ganguan kepada kelangsungan penyampaian syarikat. Syarikat juga digalakkan untuk mendapatkan persijilan ISO22301 untuk memastikan sistem pengurusan kelangsungan perniagaan tersebut dibangunkan dengan berkesan.

Determine product and scope for certification

Why “Determine product”?

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 PRODUCT

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.

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.

Understanding Context of Organization

Why “Context of Organization”?

The newly revised standard of ISO9001 and ISO14001 version 2015 have the common requirements named as “Context of organization” on the first clause of requirements which is clause 4. 

Purpose of this requirements

The main purpose of this clause is to determine:

1. Organization profile (Adopted term from Baldrige Business Excellence 2016/2017: See below for detail)
2. Issue or Threat face by organization
3. The interested party of organization
4. Scope and boundary of management system

Definition and Description

ISO9000:2015 defined:

Context of the Organization is “business environment“, “combination of internal and external factors and conditions that can have an effect on an organization’s approach to its products, services and investments and interested Parties“

ISO14001:2015 (Annex A4.1) further decribed:

The intent of 4.1 is to provide a high-level, conceptual understanding of the important issues that can affect, either positively or negatively, the way the organization manages its environmental responsibilities. Issues are important topics for the organization, problems for debate and discussion or changing circumstances that affect the organization’s ability to achieve the intended outcomes it sets for its environmental management system.

ISO9001/14001:2015 Requirements

Both ISO9001 and ISO14001 have four requirements (sub-clause) which are:

4.1         Understanding the organization and its context 

4.2         Understanding the needs and expectations of interested parties

4.3         Determining the scope of the quality management system          

4.4         Quality management system and its processes  

BEF organization profile

The Organizational Profile is a snapshot of your organization, the KEY influences on HOW it operates, and your competitive environment.

P.1 Organizational Description: What are your key organizational characteristics?

a. Organizational Environment

(1) Product Offerings What are your main product offerings (see the note on the next page)? What is the relative importance of each to your success? What mechanisms do you use to deliver your products?

(2) MISSION, VISION, and VALUES What are your stated MISSION, VISION, and VALUES? What are your organization’s CORE COMPETENCIES, and what is their relationship to your MISSION?

(3) WORKFORCE

What is your WORKFORCE profile? What recent changes have you experienced in WORKFORCE

composition or your WORKFORCE needs? What are your WORKFORCE or employee groups and SEGMENTS,

• the educational requirements for different employee groups and SEGMENTS, and

• the KEY drivers that engage them in achieving your MISSION and VISION?

What are your organized bargaining units (union representation)? What are your organization’s special health and

safety requirements?

(4) Assets What are your major facilities, technologies, and equipment?

(5) Regulatory Requirements What is the regulatory environment under which you operate? What are the KEY applicable occupational health and safety regulations; accreditation, certification, or registration requirements; industry standards; and environmental, financial, and product regulations?

b. Organizational Relationships

(1) Organizational Structure What are your organizational structure and GOVERNANCE system? What are the reporting relationships among your GOVERNANCE board, SENIOR LEADERS, and parent organization, as appropriate?

(2) CUSTOMERS and STAKEHOLDERS What are your KEY market SEGMENTS, CUSTOMER groups, and STAKEHOLDER groups, as appropriate? What are their KEY requirements and expectations for your products, CUSTOMER support

services, and operations? What are the differences in these requirements and expectations among market SEGMENTS,

CUSTOMER groups, and STAKEHOLDER groups?

Recommended Best Practice

How to conform to the ISO9001/14001 requirements for clause 4.1-4.3

4.1       Understanding the organization and its context

The organization shall determine external and internal issues that are relevant to its purpose and that affect its ability to achieve the intended outcomes of its environmental/ quality management system. Such issues shall include environmental conditions being affected by or capable of affecting the organization.

Even there are many approach to address this requirement, one of the most common tools and technique is 4P (sometime 5P) matrix with PESTLE and/or SWOT

What is 4 P?

P – PRODUCT

P – PROCESS

P – PEOPLE

P – PLACE

In marketing some organization add P – PROMOTION and PRICE

What is PESTLE?

P – Political

E – Economy

S – Social

T – Technology

L – Legislation

E – Environment

What is SWOT?

S – Strength

W – Weaknessess

O – Opportunities

T – Threat

EXAMPLE 1

The organization can determine the internal and external issues by developing the matrix

4P	Internal Issues	External Issues
Strength	Weakness	Opportunities	Treat
Product/ Service
Process
People
Place
People
Promotion

EXAMPLE 2

The Internal Issues may relate to 5P while the external issues may relate to PESTLE

EXTERNAL (PESTLE)	ISSUE	R -Risk (Environmental/ Quality Concerned )	O – Opportunities	Action to address R & O
POLITICAL
ECONOMY
SOCIAL (Neigbourhood)
TECHNOLOGICAL
LEGAL
ENVIRONMENT (Surrounding)

INTERNAL (P-P-P-P)	ISSUE	R -Risk (Environmental Concerned )	O – Opportunities	Action to address R & O
PRODUCT & SERVICES
PROCESS
PEOPLE
PLACE
PROMOTION

What is the minimum requirement accepted by EFR Certification?

The documented information shall be retained at minimum in management review minutes (Clause 9.3). At least 2 external and 1 internal issues shall be identified.

The external issues shall cover:

• Customer of the organization product or services i.e. customer complaints
• Legal Authority such as legal non compliance to business licencing authority

Internal issues shall cover internal complaints or rejections