CONSTRUCTION

GENERAL OF AFENO
MAINTENANCE ROAD 665M
SERVICE X 6M ASPHALT
CONTRACT WORKS
OF NAOC AT IRRI
FACILITIES
COMMUNITY IN DELTA
(BUILDING/ESTATE STATEFOR
SERVICES) - AFENO
LOT 2 ASPHALT ROAD
- LAND AREA - PHASE 1
LOCATION
7200027088
2100002976

26-02-2024
 COMPETENCY MANAGEMENT PROCESS

COMPETENCY MANAGEMENT PROCEDURE

In accordance with International regulations, ISO standards, and OSHA regulations, organizations
must ensure that personnel performing various duties have the appropriate education, training, and
experience to perform those duties. In order to document and demonstrate that the requirements
are being met, those organizations must also keep training records. Appropriate training facilitates
worker productivity, provides assurance to the company that workers are aligned with corporate
practices and procedures, and reduces costly human errors that can result in operational
interruptions or even loss of life. Proactive training plans can also enhance a worker’s perception
about the corporation, helping companies with employee retention.

Ensuring that staff have the proper skills and competencies to consistently perform the tasks
required of them is sometimes a daunting challenge. Managing and tracking individual skill levels in
regulated environments is a continuous process. SHROMB GEOTECHNICAL LTD uses
competencies to articulate and leverage exceptional organizational performance. From a value-
added perspective, competency-based management systems enable the realization of business
strategy and provide a distinctive, enduring advantage for the organization.

Best Practices for Competency Management

1. Integrate competencies into training and development programs.

2. Assess and build team competencies.

3. Reengineer performance management processes with competencies that account for

the highest performance variance.

4. Determine the return-on-investment or economic value of competency initiatives.

5. Implement competency-based organizational transformation and change strategies.

6. Assess and develop leadership competencies.

7. Recruit and select top performers.

8. Implement succession planning and executive development processes.

9. Strengthen functional or technical competencies.

10. Link individual or team-based competencies with core competencies and strategic
intent.
 COMPETENCY MANAGEMENT PROCESS
11. Design and implement a comprehensive competency-based system architecture and
process.

CHANGE CONTROL

The old adage that -- the only thing constant is change -- is true. Within organizations, changes
are always occurring due to market drivers, staff changes, new regulations, resource availability,
and technological changes. These changes can include changes in policies and procedures,
processes, systems, staff, products, services, equipment, materials, emissions, etc. Change
management refers to the ability to request, analyze, and decide on a change in a document,
process, or object, and then to track the status of that change.

Each time a change occurs in the organization, it will impact other areas of the organization and
throughout the value chain. For example, if a new software application is installed within an
organization (an audit system), new SOPs will need to be written for the system, training will need
to be scheduled, and the auditee may need to be notified that their reports will look different. In
order for an organization to minimize the risk that changes can have on the organization, the
organization must identify these potential changes, thoroughly evaluate the impacts of the changes
and the risk of not doing them, obtain the necessary approvals, communicate with the affected
parties, and create action plans to implement the changes.

Change management is not just a matter of best practices; it is the law for most companies. In
accordance with many regulatory standards and guidelines, change control-- or controlling or
managing change within an organization-- must be conducted to ensure that the organization can
maintain and improve quality by identifying changes that could improve the product, ensuring
proper review and analysis of the changes, and documenting and communicating the changes to
the appropriate stakesholders. For example, the ISO regulations, having a continual improvement
and document control tone, infer that change should be managed. In addition, the medical device
regulations of 21 CFR Part 820, specifically regulate change management.

Change Control Challenges

There are many problems associated with documentation and change control. The most frequent
ones are:

 Insufficient documentation
 Need for keeping the documentation up-to-date (including revision history)
 Poor Filing strategy decision framework
 Lack of adequate review by regulatory affairs to develop a filing strategy
 Lack of involvement by regulatory affairs, resulting in variances between the data
developed and the data necessary for submission
 COMPETENCY MANAGEMENT PROCESS
Most problems can be solved by developing procedures and having those procedures embedded
into the change control process. In addition, a key solution is to ensure the more narrow
perspective of change control – the formal process ensuring that any changes to elements within
the organization are performed in accordance with the change specification—is done within the
broader framework of change management. Change management is that broader process which
allows for standardization of procedures and activities for all types of changes, and the monitoring
of those changes within a continual improvement mindset to minimize change-related impacts and
enhance efficiency.

Best Practices for Good Automated Change Control

A good automated change control system provides these components:

1. Establish consistent enterprise change control procedures. Change control affects the
entire enterprise. It is best practice to establish global internal policies and procedures
from the top down for effective change control management of both documents and
processes.

2. Avoid point solutions. Change control is an essential core component of your quality
management systems infrastructure. Avoid one-off point solutions to address these
requirements. It is recommended best practice to apply consistent change control
procedures across the enterprise and standardize on a systems approach that facilitates
organizational collaboration and process change.

3. Security. Prevents or detects unauthorized or accidental changes. This component of the

change control system will address the internal control requirement that all changes
require authorization prior to implementation.

4. Documented changes. Current best practice is to ensure that the system maintains a
detailed history of all changes and records the time and dates of any changes, who made
them, and their ultimate disposition (successful or deleted). This aspect of an automated
change control system addresses the internal control requirement that stipulates
authorization of changes and requires traceability for actual changes.

5. Quality assurance. The established current best practice for change control is designed
to ensure consistency. Quality assurance procedures for review and approval should be
applied to ensure consistency.

6. Comprehensive document/process lifecycle workflow. Documents and processes

change over the course of business operations. Effective management and change control
of processes and documents is essential to efficient business operations. Current best
practice thinking for mature organizations is to automate compliance processes and
manage their lifecycle while controlling all documents in support of these processes. It is
 COMPETENCY MANAGEMENT PROCESS
recommended best practice to establish an automated change control workflow process to
support both documents and processes.

7. Ensure validation. It is established best practice that all change control systems be
deployed in validated systems environments. Change control is mandated under IKONIBO
predicate rules that require validation for all quality processes. It is important to establish a
set of user requirements for the system so that all validation activities can be performed in
accordance with intended use.

8. Built-in best change control best practices. An effective change control system includes
built-in best practices to support the following regulatory requirements as mandated by the
company predicate rules.

o Ability to define an electronic change request that includes

 Description of change

 Reason for change

 Notes

 Change category

 Electronic signature matrix/electronic signature workflow approval

 Controlled distribution

 Read-and-understood capability

Enterprise content management systems

Content lifecycle management includes check-in/check-out, version control, audit trails and
document-level security for all kinds of document file types, including word processing documents,
Web pages, images, and more.

Compliance Challenges

As part of any compliance initiative, information must be easily accessible so end users can
browse, search, manage tasks and view content as well as electronic documents quickly. These
systems must also manage document content and all associated metadata (properties) that further
describes the document to facilitate content-based searches. Regulated companies often store
information in a structured way, enhance information retrieval by intranet, extranet or Website and
automatically find and index new or modified documents.
 COMPETENCY MANAGEMENT PROCESS
ISO COMPLIANCE
ISO Compliance is no longer a matter of choice for competitive companies. Recent research shows
that ISO accredited companies have a distinct edge while competing for international business and
ensuring customer confidence. ISO compliance is perceived by many as an important value
addition by quality conscious buyers worldwide. In particular, the ISO 9000 Series of Standards is
the most widely accepted quality assurance model in the world. According to The ISO Survey –
2006, ISO 9001 and 14001 certifications increased in 2006 by 16%, ISO 13485 by 60%, and ISO
16949 by 60%. In fact, according to the survey, up to the end of 2006, at least 897 866 ISO
9001:2000 certificates had been issued.

The goal of these standards are to reduce waste and variation in product characteristics and
process parameters, address traceability issues and promote continual improvement of the
effectiveness of quality management systems. Adherence to ISO 9001 standards can be one of the
most effective risk management tools organizations can use to prevent, detect or control
nonconforming products and services, and thus increase sustained compliance.

ISO standards are categorized into several distinct “families” of standards. The quality
management family is defined by ISO 9000. This body of standards addresses all quality
management and continuous improvement standards to ensure compliance with regulatory
standards and guidelines that ultimately help enhance customer satisfaction. Some industries
have specific quality requirements outlined in additional ISO standards.
Environmental management is addressed through the ISO 14000 family. The goal of this body of
standards is to help minimize harmful effects on the environment caused by its activities, and to
achieve continual improvement of its environmental performance.

To achieve compliance with ISO guidelines, organizations must establish an effective system to
facilitate the management of its core processes. Processes such as customer satisfaction, product
quality, compliance, or environmental all require effective controls to meet ISO standards. Most
forward-thinking companies have automated critical procedures to help increase operational
efficiency and reduce error, using the latest technology solutions available on the market.

ISO Best Practices

To achieve compliance with ISO guidelines, the following best practices should form the basis of all
ISO programs:

1. Establish clearly defined business processes. The first step in ISO compliance is
to clearly define business processes that are essential to quality control. Once these
processes are identified and documented, steps can be taken to optimize processes
for maximum efficiency.

2. Conduct detailed internal audits and identify gaps. An internal audit of all quality
and business processes is a good first step towards ISO compliance. The audit will
reveal quality gaps and identify process inefficiencies. Once this proactive step is
 COMPETENCY MANAGEMENT PROCESS
taken, it is important to take corrective action to ensure that all audit issues are
addressed in a timely manner.

3. Conduct quality audits. Internal audits are a mandatory aspect of ISO

compliance. However, organizations interested in becoming a best-in-class company
should consider additional external audits to serve as an independent validation and
verification of your processes and look for improvement opportunities.

4. Establish effective closed-loop corrective and preventive action processes.

Once processes are established, an effective closed-loop corrective and preventive
action process should be implemented for optimal results. The closed-loop nature of
the process ensures that all issues will be addressed and closed as is appropriate.

5. Define and publish quality control procedures. Quality standards mandate written
quality control procedures. These procedures should be written, approved, and
distributed throughout the organization to ensure compliance.

6. Define quality monitoring processes. No ISO process is complete without an

effective way of monitoring processes. Monitoring is an essential requirement for ISO
because it ensures that guidelines are consistently being followed.

7. Establish continuous improvement guidelines and procedures. The monitoring

process will reveal the need for continuous improvement of the product or process
governed. Continuous improvement guidelines should be established to ensure that
these issues are addressed in the most appropriate manner. These guidelines should
be published and distributed to ensure consistency and completeness.

8. Establish and maintain an effective training program. ISO compliance also

mandates that all affected persons within an organization receive proper training. This
is essential to quality assurance and risk mitigation. It is current best practice to
automate the training and tracking process to ensure compliance with stated training
requirements. Most organizations use training tracking technology to address these
requirements.

9. Implement quality process automation. As organizations mature in their approach

towards ISO compliance, they are seeking to automate ISO-related processes. More
importantly, they seek to do this without expensive software customization and
professional services, which are the bane of the industry. Amadeus solutions empower
organizations to achieve ISO compliance by delivering solutions that address these
requirements in the most comprehensive manner. The Amadeus solution represents a
“best practice” in and of itself as the best way to achieve sustained compliance and
establish a consistent approach across the organization.

10. Drive quality from the top down. Quality impacts every aspect of business and
ultimately affects the client or end user. Thus, it is current best practice to drive ISO
 COMPETENCY MANAGEMENT PROCESS
initiatives from the very top of the organization to ensure adequate resource allocation
where appropriate and enforcement of ISO policies.

Risk Assessment

It is impossible to construct an effective compliance plan to control risk without conducting an initial
risk assessment. A risk assessment is a high-level, mandatory compliance exercise that varies in
complexity based on the size and business profile of an organization.
As an example of one type of risk assessment, a compliance risk assessment includes an
assessment of people, processes, and technology required to effectively manage the business in a
compliant manner.

A comprehensive compliance risk assessment includes several key steps. These steps are:

 Identify all key compliance requirements;

 Identify those that apply to your staff, processes and systems;
 For each area of potential compliance risk, identify the nature of that risk of non-
compliance as it applies to the firm;
 Use a risk rating scale, score the risk and record it;
 For each identified risk, prescribe a mitigating, controlling or corrective action and
timescale for completion (including assigning it to a person or function).

Risk Management

Risk management is achieving continuous control over the incidence and impact of risk. It requires:

 Comprehensive understanding of the business and operations environment;

 Detailed risk assessment process founded on quality principles;
 Experienced resources to identify risks and assess their importance and implications;
 Creative minds to develop cost-effective risk mitigation strategies that control and
neutralize unacceptable risks;
 Top-down management commitment to implement protective strategies and monitor
progress;
 Continuous management vigilance to control new risks.