Maintain quality system and continuous improvement process (kaizen)

Introduction
Kaizen: Kaizen is a concept referring to business activities that continuously improve all functions and
involve all employees from the CEO to the assembly line workers.
Kaizen is the Japanese word for "improvement".
This unit of competence covers the skills and knowledge required to prevent process improvements in
their own work from slipping back to former practices or digressing to less efficient practices. It covers
responsibility for the day- to-day operation of the work/functional area and ensuring that quality system
requirements are met and that continuous improvements are initiated and institutionalized.

LO1 Develop and maintain quality framework within work area

OHS and environmental management requirements:

 All operations must comply with enterprise OHS and environmental management requirements,
which may be imposed through state/territory or federal legislation - these requirements must not
be compromised at any time.
 All operations assume the potentially hazardous nature of samples and require standard
precautions to be applied
 Where relevant, users should access and apply current industry understanding of infection control
issued by the National Health and Medical Research Council (NHMRC) and State and Territory
Departments of Health.

 Information about the enterprise's quality system is distributed and explained to personnel.

Standards, codes, procedures and/or enterprise requirements may include:

 International standards
 General requirements for the competence of testing.
 Quality management systems.
 Requirements for measurement processes and measuring equipment.
 Guidelines for quality management system documentation.
 Quality management systems set
 Association of Analytical Communities International (AOAC International)

 Personnel are encouraged to participate in improvement processes and to assume responsibility

and authority.
 Responsibilities are allocated for quality within work area in accordance with quality system.
All organizations have:
(1) Coordination of effort
(2) Goal or purpose
(3) Division of labor, and Hierarchy of authority
  Coaching and mentoring are provided to ensure that personnel are able to meet their
responsibilities and quality requirements.

What is Mentoring?
Mentoring is essentially about helping people to develop more effectively. It is a
relationship designed to build confidence and support the mentee so they are able
to take control of their own development and work.
Mentoring is not the same as training, teaching or coaching, and a mentor doesn’t
need to be a qualified trainer or an expert in the role the mentee carries out.
They need to be able to listen and ask questions that will challenge the mentee to
identify the course of action they need to take in regards to their own development.
The following definition provides a useful insight.
Coaching
This is a very active role for the mentor where you will be working with the mentee to encourage them in
the development of relevant skills and attitudes for the future. The focus of the coaching role is on the
ability to help the mentee see beyond the current situation and to identify what the future can look like
and what needs to happen to help achieve this.This is helpful in setting goals and identifying what actions
an individual needs to take next.

LO2; Maintain quality documentation

 Required quality documentation, including records of improvement plans and initiatives are
identified.
 Document control system is maintained for work area .
 The development and revision of quality manuals and work instructions are contributed to the
work area.
 Inspection and test plans are developed and implemented for quality controlled products.
Documentation may include:
 sampling plans
 enterprise quality manual
 quality (certification or registration) requirements
 audit documents
 performance plans and reports
 training records and/or plans
 workplace procedures relating to occupational health and safety (OHS), equal opportunity (EO)
and environmental legislative requirements
 industrial awards and enterprise agreements
 Quality documentation is prepared and accurate data records are maintained and kept.
 Best qualities of document may include:-
 Understandable by every one
 Written by clear language
  Precise
 Timely
LO3; Facilitate the application of standardized procedures
Standards, codes,procedures and/or workplace requirements
Standards, codes, procedures and/or workplace requirements include the latest version of one of more
of:
 Australian and international standards, codes and guidelines covering the competence of testing and
calibration laboratories, laboratory design and construction, laboratory safety, quality management
systems, documentation and plans, environmental management, measurement management, accuracy of
measurement methods and results, expression of uncertainty (GUM) and principles of good laboratory
practice (GLP)
 National standards and codes of practice for work health and safety (WHS), and national environment
protection measures.
 National measurement regulations and guidelines
 Registration/licensing and/or National Association of Testing Authorities (NATA) accreditation
requirements.
 industry-specific codes, guidelines, procedures and methods,
workplace documents, such as
 Standard operating procedures (SOPs);
 Quality and equipment manuals;
 Calibration and maintenance schedules;
 Material safety data sheets (MSDS) and safety procedures;
 Material, production and product specifications;
 Production and laboratory schedules; workplace recording and reporting procedures;
 And waste minimization and safe disposal procedures.

 All required procedures are ensured to be accessible by relevant personnel.

 Personnel are assisted to access relevant procedures, as required.
 The resolution of conflicts arising from job is facilitated.
 The completion of required work is facilitated in accordance with standard procedures
and practices.
 applying standard precautions relating to the potentially hazardous nature of samples.
 accessing and applying current industry understanding of infection control issued by the
National Health and Medical Research Council (NHMRC) and State and Territory Departments
of Health, where relevant.

LO4; Provide training in quality systems and improvement

Training: it deals with a topic or a skill that is to be passed on to an individual or group that
needs it.
When training is required?
Before starting a new job.
 After making a change on something.
When a staff are newly placed in post.
To update and renew skill through the working life.
 Roles, duties and current competency of relevant personnel are analyzed.
 Training needs are identified in relation to quality system and continuous improvement
processes (kaizen).
Steps for identifying the training needs
1.set clear expectation
2.Monitor performance
3.Ask the audience
4.carry out an organizational work and task analysis.
5.set up personal development plans.
6.Identify a focus group.
7.set up a system of mentoring and coaching
 Opportunities are identified for skills development and/or training programs to meet
needs.
 Training and skills development programs are initiated and monitored.
Accurate training record is maintained.
LO5; Monitor and review performance
Monitoring: is the systematic and ongoing collection, analysis, interpretation and use of data on
key aspects of an intervention and/or its expected results
 It includes group of activities that:
 Follows up priority routine information about a program and its expected
results.
 Follows up the program’s costs and ensure efficient use of resources.
 Compares performance with plan.
 Provides information that can be used for the program’s evaluation.
 Identifies and addresses problems.
Monitoring answer the following questions.

 Which resources do we have for the program?

 What are we doing?
 Where are we now?
 Are we on the right track or not?

 Performance outcomes are reviewed to identify ways in which planning and operations
could be improved.
  The organization’s systems and technology are used to monitor and review progress and
to identify ways in which planning and operations could be improved.
 Customer service is enhanced through the use of quality improvement techniques and
processes.
 Plans are adjusted and communicated to personnel involved in their development and
implementation
LO6 ;Build continuous improvement process
What is process improvement?
A process is a series of actions or operations contributing to an end. In every case,
inputs (patient samples) are turned into outputs (patient examination results) because
some kind of work, activity, or function is carried out.
Process improvement is a systematic and periodic approach to improving quality, and
the inputs and outputs that glue these processes together.
It is a way of solving problems. If there is a problem, however hard to describe, one or
more processes needs to be improved.

1. Create constancy of purpose for improvement: The message here is that there is a need to be
constantly working toward making the process better.
2. Improve constantly and forever: This statement points out that continual improvement will always be
a goal. Perfection is never achieved, but we try to get as close to it as possible.
Process improvement is something that is never finished, but rather continues on “forever”
The plan leads to the goals.
Continuous Improvement is defined as making continuous incremental effective changes to the
products/ process/
organization so that it can meet the customer expectations over time. Customer demands are never
constant. So is the meaning of quality. It means that the definition of quality does not change with time
but the meaning of quality does change with time. What is considered a quality product today might not
be considered a quality product tomorrow. Thus continuous changes to the products/processes are
necessary in accordance with the changing demand. In today’s competitive marketplace it is necessary for
every company to evolve itself and its processes in such a way that they minimize investment and
maximize returns. Wastage cannot be afforded; neither can bad quality be tolerable. Customers are the
most important assets of business. Employee is a fuel without which the company will come to a
standstill. In such a market each and every company needs to improve continuously with time to stay
ahead. This paper attempts to assess the issues involved with implementing and maintaining continuous
improvement in a process based construction organization.

Following steps can be followed to implement the continuous improvement system,

1. Organize a steering committee
2. Identify areas of improvement
3. Think of potential solutions
4. Develop a detailed solutions
5. Implement your plan
6. Evaluate your solution
7. Repeat with increasing frequency
The continual improvement process cycle.
Plan

Do
Act

Check

 Plan—Identify the problems, the potential sources of system weakness or error. Decide on the
steps to be used to gather information. Ask the question, “how can you best assess the current
situation and analyze root causes of problem areas?” Using the information that is gathered
through these techniques, develop a plan for improvement.
 Do—Implement whatever plans have been developed–put the plan into action.
 Check—This refers to the monitoring process. It will be important to assess the effectiveness of
the action taken, using focused review and audit processes. If the system weakness is complex, a
pilot study may be needed in order to understand all the complexities. After “checking”, revise
the plan as required to achieve the improvements needed.
 Act—Take any corrective action that is required, and then re-check to be sure that the solution
has worked. This cycle is a continuous process, so the laboratory will begin again with a
planning process to continue the improvement

 Improvement team is organized and facilitated.

 Work group members are encouraged to routinely monitor key process indicators.
 Capacity in the work group is built to critically review the relevant parts of the value
chain.
 Work group members are assisted to formalize improvement suggestions.
 Relevant resources are facilitated and work group members are assisted to develop
implementation plans.
 Implementation of improvement plans taking appropriate actions is monitored to assist
implementation where required.

ISO 15189 [4.12] describes a very similar set of activities for achieving continual
improvement in work area.
These are outlined as follows:
• Identify potential sources of any system weakness or error;
• Develop plans to implement improvement;
• Implement the plan;
• Review the effectiveness of the action through the process of focused review;
• Adjust the action plan and modify the system in accordance with the review results;
 Following are some of the problems that organizations face in implementing and
maintaining Continuous Improvement. How these problems can be tackled is also
specified along with each problem.
A) Lack of clear organizational goal;
 The first step to tackle this problem should be to have a clear organizational goal.
The organization must have thorough understanding of its goals and limitations.
It must also set realistic targets and must allot practical duration to achieve those
targets.
B) Continuous improvement also needs a change in organizational culture;
 When Continuous improvement is deployed in an organization it should be
confirmed that everybody is ready and trained for it. Change in work culture is
critical for the success of the process.
C)Involvement of everyone in the organization.
D)Failure to enable real time visibility and transparency;

 For applying Continuous improvement process one needs to have clear picture
of the organization and its processes. However what one gets is the data and logs
of various processes and outputs. But what the managers really need is the real
time visibility and transparency of the system to determine the root causes of the
problems. In fact one of the biggest problem of organizations is they cannot
clearly see into their own business.
FACTORS FOUND IN ACTIVITIES WHERE CONTINUOUS IMPROVEMENT WAS
ACHIEVED AND MAINTAINED
• Top management leadership and support
• The role of Quality Assurance Department
• Training and Recognition
• Measurement and Analysis
• Employee Empowerment and Teamwork
• Strategic Quality Planning
• Quality and Productivity Improvement Results

LO7; Facilitate the identification of improvement opportunities

To facilitate the identification of improvement opportunities the following points are important.
• Top management support is a must.
• Plan that integrates the factors necessary for continuous improvement into a workable initiative
• Everyone in the organization must be involved
• Leadership and Motivation
• Training
• Quality Culture implementation
• Employee Empowerment
• Teamwork
• Rewards and recognition
• Quantify achievements
• Measurement

 The job completion process is analyzed.

 A relevant question of job incumbent is asked.
 Job incumbents are encouraged to conceive and suggest improvements.
 The trying out of improvements is facilitated, as appropriate.

LO8 Evaluate relevant components of quality system

 Regular audits of components of the quality system that relate to the work area are
undertaken.
 Continuous improvements tools are implemented in the quality system in accordance
with own level of responsibility and workplace procedures.
 The updating of standard procedures and practices is facilitated.
The capability of the work team aligns with the requirements of the procedure is ensured.