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VTU Student's Guide to Auditing

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0% found this document useful (0 votes)
41 views42 pages

VTU Student's Guide to Auditing

Uploaded by

Braham Kumar
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

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MODULE-4
Environmental audit
Environmental auditing is a systematic, documented, periodic and objective process in
assessing an organization's activities and services in relation to: Assessing compliance with
relevant statutory and internal requirements. Facilitating management control of environmental
practices.

Origins of Environmental Auditing

Environmental safety and health auditing developed in the early 1970s, largely among
companies operating in environmentally intensive sectors such as oils and chemicals. Since then
environmental auditing has spread rapidly with a corresponding development of the approaches
and techniques adopted. Several factors have influenced this growth.

 Industrial accidents. Major incidents such as the Bhopal, Chernobyl and Exxon-
Valdez disasters have reminded companies that it is not sufficient to set corporate policies and
standards on environmental health and safety matters without ensuring that they are being
implemented. Audits can help reduce the risk of unpleasant surprises.
 Regulatory developments. Since the early 1970s regulations on environmental topics have
increased substantially. This has made it steadily more difficult for a company to ascertain
whether a specific plant in a particular country is complying with all of the relevant
legislation.
 Public awareness. The public has become increasingly aware of, and vocal about,
environmental and safety issues. Companies have had to demonstrate to the public that they
are managing environmental risks effectively.
 Litigation. The growth of legislation has led to a corresponding explosion of litigation and
liability claims, particularly in the United States. In Europe and elsewhere, there is growing
emphasis on the responsibilities of individual directors and on making information available
to the public.

It is important to draw the distinction between auditing and techniques such as environmental
impact assessment (EIA). The latter assesses the potential environmental effects of a proposed
facility. The essential purpose of an environmental audit is the systematic scrutiny of
environmental performance throughout a company’s existing operations. At best, an audit is a
comprehensive examination of management systems and facilities; at worst, it is a superficial
review.

The term environmental audit means different things to different people. Terms such as
assessment, survey and review are used to describe the same type of activity. Furthermore, some
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organizations consider that an “environmental audit” addresses only environmental matters,


whereas others use the term to mean an audit of health, safety and environmental matters.
Although there is no universal definition, auditing, as practised by many leading companies,
follows the same basic philosophy and approach summarized by the broad definition adopted by
the International Chambers of Commerce (ICC) in its publication Environmental
Auditing (1989). The ICC defines environmental auditing as:

a management tool comprising a systematic, documented periodic and objective evaluation of


how well environmental organization, management and equipment are performing, with the aim
of helping safeguard the environment by:

(i) facilitating management control of environmental practices and

(ii) assessing compliance with company policies which would include meeting regulatory
requirements.

The European Commission in its proposed regulation on environmental auditing also adopts the
ICC definition of environmental audit.

Objectives of Environmental Auditing

The overall objective of environmental auditing is to help safeguard the environment and
minimize risks to human health. Clearly, auditing alone will not achieve this goal (hence the use
of the word help); it is a management tool. The key objectives of an environmental audit
therefore are to:

 Determine how well the environmental management systems and equipment are performing
 Verify compliance with the relevant national, local or other laws and regulations
 Minimize human exposure to risks from environmental, health and safety problems.

Scope of the Audit

As the prime objective of audits is to test the adequacy of existing management systems, they
fulfill a fundamentally different role from the monitoring of environmental performance. Audits
can address one topic, or a whole range of issues. The greater the scope of the audit, the greater
will be the size of the audit team, the time spent onsite and the depth of investigation. Where
international audits need to be carried out by a central team, there can be good reasons for
covering more than one area while onsite to minimize costs.

In addition, the scope of an audit can vary from simple compliance testing to a more rigorous
examination, depending on the perceived needs of the management. The technique is applied not
only to operational environmental, health and safety management, but increasingly also to
product safety and product quality management, and to areas such as loss prevention. If the
intention of auditing is to help ensure that these broad areas are managed properly, then all of
these individual topics must be reviewed. Items which may be addressed in audits, including
environment, health, safety and product safety are shown in table 1.
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Table 1. Scope of environmental audit

Environmental Safety Occupational Product Safety


Health

-Site history -Safety -Employee exposure -Product safety programme


-Process/materials policy/procedures to air contaminants -Product quality control
-Storage -Accident reporting -Exposure to -Product packaging,
of materials -Accident recording physical agents, e.g., storage and shipping
above ground -Accident noise, radiation, heat -Product recall/withdrawal
below ground investigation -Measurements of procedures
-Air emissions -Permit to work employee exposure -Customer information on
-Water discharges systems -Exposure records product handling and
-Liquid/hazardous -Special procedures - quality
wastes for confined space Ventilation/engineeri -Regulatory compliance
-Asbestos entry, work on ng controls -Labelling
-Waste disposal electrical equipment, -Personal protective -Specifications for
onsite breaking into equipment purchased
offsite pipelines, etc. -Information and materials/products/packagi
-Oil/chemical spill -Emergency response training on health ng
prevention -Fire fighting hazards -Materials safety data
-Permits/licenses -Job safety analysis -Medical -Vendor qualification
-Safety training surveillance programme
-Safety programme -QA testing and
communication/prom -Hearing inspections
otion conservation -Record keeping
-Housekeeping -First aid -Product literature
-Regulatory -Regulatory -Process control
compliance requirements

Although some companies have a regular (often annual) audit cycle, audits are primarily
determined by need and priority. Thus not all facilities or aspects of a company will be assessed
at the same frequency or to the same extent.

The Typical Audit Process

An audit is usually conducted by a team of people who will assemble factual information prior to
and during a site visit, analyse the facts and compare them with the criteria for the audit, draw
conclusions and report their findings. These steps are usually conducted within some kind of
formal structure (an audit protocol), such that the process can be repeated reliably at other
facilities and quality can be maintained. To ensure that an audit is effective, a number of key
steps must be included. These are summarized and explained in table 2.
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Table 2. Basic steps in environmental auditing

Basic Steps in Environmental Auditing

Criteria—what do you audit against?

An essential step in establishing an audit programme is to decide the criteria against which the
audit will be conducted and to ensure that management throughout the organization knows what
these criteria are. Typically criteria used for audits are:

 company policies and procedures on environmental matters


 applicable legislation and regulations
 good environmental management practice.

Pre-audit steps

Pre-audit steps include the administrative issues associated with planning the audit, selecting the
personnel for the audit team (often from different parts of the company or from a specialized
unit), preparing the audit protocol used by the organization and obtaining background
information about the facility.

If auditing is new, the need for education of those involved in the audit process (the auditors or
those being audited) should not be underestimated. This also applies to a multinational company
extending an audit programme in its home country to subsidiaries abroad. In these situations, the
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time spent on explanation and education will pay dividends by ensuring that the audits are
approached in a spirit of cooperation and are not seen as a threat by the local management.

When one major US Company proposed extending its auditing programme to its operations in
Europe, it was particularly concerned to ensure that the plants were properly briefed, that audit
protocols were appropriate for European operations and that audit teams understood the relevant
regulations. Pilot audits were conducted at selected plants. In addition, the audit process was
introduced in a way that stressed the benefits of a cooperative rather than a “policing” approach.

Obtaining background information about a site and its processes can help to minimize the time
spent onsite by the audit team and to focus its activities, thus saving resources.

The composition of the audit team will depend on the approach adopted by a particular
organization. Where there is a lack of internal expertise, or where resources cannot be devoted to
the audit activity, companies frequently use independent consultants to conduct the audits for
them. Other companies employ a mix of in-house staff and external consultants on each team to
ensure an “independent” view. Some large companies use only in-house staff for audits, and
have environmental audit groups for this specific function. Many major companies have their
own dedicated audit staff, but also include an independent consultant on many of the audits they
carry out.

Onsite steps

 Understanding the internal controls. As a first step, it is necessary to develop an


understanding of the controls that are in place or are thought to be in place. These will include
assessing formal procedures and practices; record keeping and monitoring; inspection and
maintenance programmes and physical controls for containing spills. The audit team gathers
information on the various controls by observation, interviewing staff and the use of detailed
questionnaires.
 Assessing strengths and weaknesses of internal controls. Evaluating the strengths and
weaknesses of internal controls provides the rationale for conducting subsequent audit steps.
Auditors will look for indicators such as clearly defined responsibilities, competence of
personnel, appropriate documentation and records and systems of authorization. It is more
important to determine whether the system is effective than whether it is sophisticated.
 Gathering audit evidence. The audit team attempts to verify that the steps and controls work
as intended. Evidence may be collected through inquiry (e.g., asking a plant operator what he
or she would do if there were a major chemical spill), observation (e.g., watching specific
activities and operations in progress) and testing (checking records to confirm compliance
with regulations).
 Recording audit findings. All the information obtained is recorded (usually on the audit
protocol document and as working papers), and a comprehensive record of the audit and the
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state of the facility at the time is thus produced. Where a deficiency is found, it is noted as an
audit “finding”.
 Evaluating the audit findings. The audit team integrates and evaluates the findings of the
individual team members. There may also be common findings. For some observations, an
informal discussion with the plant manager may be sufficient; for others, inclusion in the
formal report will be appropriate.

Reporting the audit findings. This usually is done at a meeting with the plant management at the
end of the team’s visit. Each finding and its significance can be discussed with the plant
personnel. Prior to leaving the site, the audit team will often provide a written summary of
findings for the plant management, to ensure that there are no surprises in the final report.

Post-audit steps

Following the onsite work, the next step is to prepare a draft report, which is reviewed by the
plant management to confirm its accuracy. It is then distributed to senior management according
to the requirements of the company.

The other key step is to develop an action plan to address the deficiencies. Some companies ask
for recommendations for corrective action to be included in the formal audit report. The plant
will then base its plan on implementing these recommendations. Other companies require the
audit report to state the facts and the deficiencies, with no reference to how they should be
corrected. It is then the responsibility of the plant management to devise the means of remedying
the failings.

Once an audit programme is in place, future audits will include past reports—and progress in the
implementation of any recommendations made therein—as part of their evidence.

Extending the Audit Process—Other Types of Audit

Although the most widespread use of environmental auditing is to assess the environmental
performance of a company’s operations, there are variations on the theme. Other types of audit
used in particular circumstances include the following:

 Pre-acquisition audits. Concern about potential liabilities has promoted the dramatic increase
in environmental auditing prior to acquisition. Pre-acquisition audits are a means of
identifying actual or potential problems, and taking these into account in the final negotiations
of the deal. Time scales are often very short. However, the information obtained on past
operations (perhaps before the present owner), current activities, past incidents and so on can
be invaluable.
 Pre-sale audits. Less common than pre-acquisition audits, but becoming more popular, are
audits conducted by the owner prior to selling a plant or a subsidiary company. A growing
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number of major organizations, such as the Dutch chemical company DSM and the Finnish
conglomerate Neste, undertake pre-sale audits as part of corporate policy. The rationale is that
the company will then know the status of environmental issues before the plant is sold, and
can take action to remedy any problems if it feels that is appropriate. Equally important, it can
present the results of an independent audit to a potential purchaser as confirmation of the
situation. Should any environmental problems arise after the sale, a baseline has been
established against which issues of liability can be decided.

Issues audits. Some organizations apply the audit technique to a specific issue that may have
implications for the whole company, such as waste. The UK-based oil multinational BP has
carried out audits examining the impact of ozone depletion and the implications of public
concern about tropical deforestation.

Benefits of Environmental Auditing

If environmental auditing is implemented in a constructive way there are many benefits to be


derived from the process. The auditing approach described in this paper will help to:

 safeguard the environment


 verify compliance with local and national laws
 indicate current or potential future problems that need to be addressed
 assess training programmes and provide data to assist in training
 enable companies to build on good environmental performance, give credit where appropriate
and highlight deficiencies
 identify potential cost savings, such as from waste minimization
 assist the exchange and comparison of information between different plants or subsidiary
companies
 demonstrate company commitment to environmental protection to employees, the public and
the authorities.

ISO 19011

ISO 19011 is defined as the standard that sets forth guidelines for auditing management systems.
The standard contains guidance on managing an audit program, the principles of auditing, and
the evaluation of individuals responsible for managing the audit programs. An audit program
consists of the arrangements made to complete all of the individual audits needed to achieve a
specific purpose.

ISO 19011:2018 provides valuable information on how to improve an audit program


systematically, just as other departments in an organization are expected to improve. One aspect
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of such improvement is continuously ensuring the audit program objectives are in line with the
management system policies and objectives. Organizations, in pushing for auditing
improvements, should consider the needs of customers and other interested parties.

An area of increasing importance in auditing management systems and business in general is


the concept of risk. As of the 2011 edition, risk has been integrated throughout the audit program
management section of the ISO 19011:2018 standard.

ISO 19011 offers guidance on every step of auditing a management system or audit program,
including:

 Defining program objectives


o Ensuring you understand the specific objectives you hope to achieve
o Making audit arrangements
o Assigning roles and responsibilities
o Defining number, scope, location, and duration of audits
o Determining criteria and specific checklists
o Establishing review procedures

 Completing the audits needed


o Planning and reviewing internal documents
o Collecting and verifying audit evidence
o Generating findings and preparing reports
o Communicating findings

Reviewing the results and process

o Assessing results and trends


o Conforming with audit program procedures
o Evolving needs and expectations of interested parties
o Analyzing audit program records
o Examining effectiveness of the measures to address risks
o Ensuring confidentiality and information security
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AUDIT

A Systematic and independent examination of trial related activities and documents to determine
whether the evaluated trial related activities were conducted and the data were recorded,
analyzed and accurately reported according to the:

Applicable Regulatory requirement.

 Standard Practice
 Standard operating Procedures
 Protocols

Purpose of Audit:

 Quality System
 Standard Practice
 Standard operating Procedures
 Protocols
 Other applicable Regulatory requirement.
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Qualification of Auditor

The sponsor should specify the qualifications of auditors in auditing procedures and should only
appoint appropriate individual(s) as auditor(s) based on consideration of his/her
education/training, business experience, and ability.

For example:

Knowledge: Necessary laws and regulations,relevant guidelines, the Declaration of knowledge,


SOPs, computerized system validation, etc.

Skills: Communication, writing, language, etc.

Nature: Tenacity, power of observation, analytical capability, decision, sense of ethics, maturity,
etc.

Qualified Auditors

 The sponsor should establish an auditing department with qualified auditors so as to


ensure the proper conduct of audits as part of implementing Quality Assurance.
 Each auditor’s qualification should be documented to verify that he/she is a suitable
person to properly conduct audits, e.g., records of education/training and business
experience.
 The sponsor should specify the roles and responsibilities of the auditor before starting to
conduct an audit so as to ensure fair and smooth performance of the audit.
 The auditor is responsible for maintaining the confidentiality of information obtained
during an audit
 Planning (designing and updating) and conducting the audit and reporting the audit
results .

Roles and Responsibilities

1) Planning of audit

2) Conduct of an Audit

3) Report the results of an Audit

4) Corrective and Preventive Actions

5) Completion of an Audit

6) Audit Certificate
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7) Keeping Audit Record

[Link] OF AUDIT

Before conducting an audit, the auditor (including the auditing department manager)should
establish a written audit plan based on the results of the risk assessment according to the written
auditing procedures.

A) Establishing the Goals of Audits

One or more objectives should established for a trial audit based on the importance of the trial
with regard to submissions to regulatory authorities

The most important part of audit planning is to specify the goal(s) of the audit.

By establishing the goal(s) of an audit, the subjects and methods of the audit will be determined
and the consistent conduct of the audit will be ensured

Examples of audit goals

Evaluation of the compliance with regulatory requirements and human subject protection.

Evaluation of the compliance of any organization involved in a clinical trial.

Confirmation of the conduct of monitoring

B) Conduct of an Audit

 Done by Auditor-according to written plan & procedures


 Involves the examination & evaluation of information obtained through investigation of
the Audit trial (SOPs etc) & trial site (facilities & equipment's) as well as interviews with
auditee.
 Auditee should specify reference documents with which they are in comply with.
 Auditor should inform the sponsor about the conduct of audit in advance.

C) Reporting of Audit results

Auditor – reports to Sponsor – to make recognize findings & improve.

To preserve the independence of auditing, the auditor must not be directly involved in the
corrective and preventive action (CAPA) process
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D) Corrective and Preventive Actions (CAPA)

Once audit complete, auditor will should provide CAPA plan to auditee, that will be utilized
to remediate issues of non-compliance.mplementation of CAPA is necessary after audits, to
eliminate errors.

The CAPA plan should, at minimum, require the auditee to identify the root-cause of audit
findings and describe whether corrective and/or preventive actions will be necessary to address
the audit findings.

E) Completion of an Audit

Upon receipt of the preliminary responses to the CAPA from the auditee, the audit is
completed

Follow-up should be performed depending on the significance of the audit findings.

CAPA follow-up and subsequent effectiveness verification should be ensured by continued


interaction between the auditor and auditee until mutual agreement has been met that the CAPA
have been addressed.

F) Audit Certificate

The auditor (including the auditing department manager) should prepare an audit certificate at
the request of the sponsor.

The sponsor should attach the audit certificate to a clinical trial/study report of the targeted trial.

The audit certificate should contain the following information:

 Information that identifies the trial, such as the chemical name or identification code of
the investigational drug, the trial title, and the protocol number.
 The date of issuing the audit certificate.
 The contents of the audit (e.g., subjects and date of the audit, and date of issuing the audit
report).
 The name(s), title and address of the auditor (s) (and the auditing department manager)
 The name and workplace address of the auditee.

G) Keeping Audit Records

Audit records should be kept according to sponsor’s SOPs for record keeping.

The SOPs should specify the procedures for keeping or destroying audit-related records, as
well as the place, subject, and duration of record keeping.
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What are environmental key performance indicators?


Environmental key performance indicators (KPIs) are quantitative measures - actual numbers
- that put values on the environmental performance of your business.

Corporate environmental performance is measured by key performance indicators (KPIs):


Emissions of Greenhouse Gases, Water Consumption, Waste Production and Gross Value
Added. Performance is benchmarked against the production frontier estimated by Data
Envelopment Analysis.

Environmental performance indicators are essential tools for tracking environmental


progress, supporting policy evaluation and informing the public. Since the early 1990s, such
indicators have gained in importance in many countries and in international forum.

Examples of environmental KPIs


You can produce environmental KPIs using facts and figures which your business already
collects, such as:

 energy bills
 water bills
 purchasing records
 vehicle fuel use or vehicle mileage figures
 waste management bills
 travel receipts
An environmental KPI should be accompanied by:

 information on why it was included (its purpose and impact)


 how the information was obtained and calculated
 if any assumptions were made

How to choose your environmental KPIs


You should report on KPIs that you are both directly and indirectly responsible for. For
example, you should report the greenhouse gas emissions resulting from your electricity use, as
well as the amount actually emitted directly from your own premises. You could even report on
your supply chain's KPIs.

The government has produced a list of environmental KPIs that are relevant to businesses.
The four main environmental KPI areas are:

 emissions to air
 emissions to water
 emissions to land
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 resource use
Performance Evaluation What is PE?

Tool which helps companies to measure and evaluate its environmental performance.
Environmental performance: The extent and effectiveness of actions to address its environmental
aspects.

Outline of PE:

1. selecting indicators covering the most important environmental aspects (or problems);

2. collecting and analysing data;

3. assessing the information identify improvement potentials put them into action.

Performance Evaluation Where?

Areas of Application

• To evaluate selected environmental aspects, either - company wide; - for certain


departments/production sites/workshops; - for single machines.

• To support environmental management, e. g. - do we comply with the regulation? - where are


the “low hanging fruits”? during the company’s daily operation

• On a more strategic level, PE - helps to benchmark against competitors; - gives guidance on


investment decisions & strategic decisions .

Performance Evaluation Why?

Benefits

You can only manage what you know, and you can only know what you measure. Why
evaluate the performance?

• to reveal cost-savings and other benefits;

• to identify and prioritise improvement potentials;

• to track and document performance and progress in minimising the environmental impacts;

• to demonstrate and communicate the improved performance to stakeholders (public, financial


sector, insurances, unions etc. );

• to support strategic decision-making with respect to infrastructure investments or the product


portfolio.
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Performance Evaluation How?

How to apply Outline of PE process:

Plan Act Do Check Indicators to assess the Performance are essential.

Two well-known guidelines

• ISO 14031 “Environmental Performance Evaluation – Guidelines”

• WBCSD “Measuring Eco-Efficiency – a guide to reporting company performance ”

Performance Evaluation How?

Step 1 - Plan Act

• Initial scope: - areas under direct management control;

Do Check - aspects caused by activities with high priority by management.

• Determine targets for environmental performance

• Choose or develop appropriate indicators

Performance Evaluation How?

Indicator. . . is something that helps us to understand where we are, which way we are going,
and how far we are from where we want to be.

A good indicator alerts us to a problem before it gets too bad and helps us recognise what needs
to be done to fix the problem (Hart, 1997).

Plan Act Do Check Tool to provide information about environmental performance How to select
indicators:

• prioritise the most significant environmental impacts;

• select impacts where the company is able to make a change;

• select the most characteristic criteria considering the user.


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Nonconformance management is a set of policies and procedures for identifying,


documenting, evaluating, segregating and disposing of products that do not conform to the
manufacturer's specific requirements.

What is non conformance


Non conformance (NC) is an ISO 9000 audit designation indicating the quality management
system or a portion of it does not meet the requirements established by ISO 9000. Non-
conformance is a sign that something went wrong in a service, process, product or in the system
itself by not meeting a certain set of specifications. The existence of a non conformance implies
that some aspects of a company’s standard operating procedures are not being followed or they
need to be modified or even updated.
These deviations can be identified through internal and external audits, customer complaints,
material inspection or routine testing. A non-conformance report is then prepared. The purpose
of the report is to document the details of a deviation from expectations. The report helps define
the problem in a clear, logical and concise way so that management can take steps to implement
changes. ISO 9001:2015 no longer requires a documented procedure, but one must still keep
records of the nonconformity and what was done to correct it.
Non-conformance could lead to rework, product recall, and decreased productivity. Corrective
actions are reactive – the steps you take once the problem has occurred. Preventive actions are
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not only to prevent a particular instance of non-conformance from re-occurring, but also to
prevent one from ever occurring.

Correction

Correction is the action taken to correct the non-conformance. A correction is not a corrective
action, as the correction simply corrects the non-conformance at hand and does not address the
cause of the problem. Corrections include reworking, recalling, dispositioning non-conforming
materials appropriately (e.g. rejecting), or other actions to address affected product. The term
“field safety corrective action” (FSCA) for recalls and field notifications. While an FSCA
addresses a product problem that may cause an adverse event, a field action is actually a form of
correction with respect to your quality management system, not corrective action While an
FSCA may address the root cause of a potential adverse event caused by a product, it does not
address the root cause of the product problem. That is, you can correct the problem in the field
but you must also implement a corrective action to prevent a recurrence of the non-conformance.
A field safety correction alone is rarely, if ever, adequate to address a nonconformance, as it does
not address the root cause of the nonconformance.

Corrective Action

Corrective action is the action taken to eliminate the cause of nonconformities. To implement
relevant and effective corrective action, the root cause investigation must adequately probe the
sequence and interaction of events that led to the nonconformance. Even when you think you’ve
identified the root cause, consider further evaluation to ensure the totality of root cause is
identified. Your corrective action must remedy the entire root cause(s) of the nonconformance.

Other Requirements

The following actions are required to close out a nonconformance and to ensure compliant
handling of nonconformance information:

 Ensure containment actions, the root cause investigation, corrections, corrective action
and preventive action are all complete and documented. This includes the revisions to all
applicable documents (e.g., procedures, forms, etc.).
 Verify that corrective and preventive actions are effective and document this assessment.
For processes performed infrequently, there will be a significant delay in an opportunity
to assess the effectiveness of any corrective or preventive action. In this case and when
possible, consider a mock activity where you can demonstrate the effectiveness of a new
or revised process in a simulated scenario.
 Notify personnel responsible for the quality of the product or process (or similar products
and processes) and personnel who may prevent the nonconformance or (similar
nonconformances). Consider documenting this notification in the relevant employees
training files. Turn mistakes into training opportunities.
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 Ensure that information related to corrective and preventive actions is provided to


management, at a minimum during management review.
 Ensure the outputs of your CAPA program are evaluated for changes to your technical
documentation.
 Organization requires that corrective and preventive actions are monitored through post-
market surveillance. In turn, your post-market surveillance program must identify the
need for corrective and preventive action. Ensure your procedures enforce these linkages.
 Ensure distributors and importers of your products in the EU are notified of corrective
actions affecting product. Under the EU ,distributors and importers are required to
maintain a quality management system. They are required to maintain procedures
ensuring they are notified by the manufacturer of corrective actions affecting product.
 Corrective and preventive actions are also required inputs for your periodic safety update
report (a new requirement under the EU MDR). Ensure the appropriate procedure exists
and that your processes are adequately linked.
 For each nonconformance affecting product already placed onto the market, ensure you
have a cogent, risk-based evaluation for field safety corrective action (e.g., recall or field
correction) that considers as the highest priority the impact on patient and user safety.

Four ways to prevent or minimize non-conformance:


1. Management Review
Management review is akin to getting your car serviced every year even when there are no overt
signs of problems. Management reviews are generally conducted once a year and present an
opportunity to review the company’s existing quality policy as well as set new objectives for the
rest of the year. New objectives can be invaluable for minimizing non conformance.
Product changes, new requirements, new processes, change management etc. are all reviewed.
The management review process can identify and correct any current or incipient deficiencies
before they might be revealed by an audit or incident. Routinely reviewing the organization’s
process helps spur continuous improvement. A system should be in place for implementing any
resulting plans for improvement or corrective action and verifying their effectiveness.
2. Review
A review is usually a ‘senior management’ exercise. Keeping this in mind, it’s important to
conduct a similar exercise with the actual employees who are involved in the day-to-day process.
These employees have an in-depth understanding of various processes and how they are related.
They have vast knowledge about the product and more importantly about past non-conformance
issues. They very well could have been first to respond to a crisis and would have played a
crucial role in analyzing the situation and solving an issue. On the flip side, this discussion could
reveal a knowledge gap crucial to fixing non- conformance. An end-to-end understanding is
crucial in setting up new objectives to minimize non-conformance. Also, understanding the
process followed by lower-level employees could highlight pain points and provide key insight
into potential areas of non- conformance, those which cannot be identified in a management
review or audit.

3. Internal Audit
An audit is simply another form of testing i.e. comparing things as they are to how they ought to
be. Internal Audits need to be scheduled at regular intervals to check whether the quality system
conforms to requirements and to ensure the system’s efficacy. Unlike an external audit, all the
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processes need not be audited at the same. Internal audits can be conducted as a series of smaller
audits, with different processes audited at different times. The frequency of audit can also be set
depending on the process in question. With changing internal and external dynamics, the criteria
for the audit can be decided prior to the audit rather than the planning stage. Any previous
findings, past audit conclusions, and pre-defined questions all become valuable data.
Observations raised during internal audits could be classed as preventive actions as they can
suggest improvements within the system to prevent non-conformances from occurring in the
future.
4. Feedback
While all customer complaints are recorded and must be actioned, customer feedback also plays
a role in minimizing non-conformance. Feedback from customers helps to understand potential
non-conformance issues and is an opportunity for improvement. Customer suggestions may
prevent any issues from being raised in the future. Negative as well as positive feedback is
valuable data. Spending time to analyze could help spot trends and patterns. Feedbacks help to
dig into the root cause of the issue which may not always be obvious (else it would have been
picked up in audit testing). Understanding the root cause can help differentiate a temporary lapse
from a process flaw.
No system is perfect, therefore problems with the system i.e. non- conformance will occur. The
aim is to resolve the non-conformance as quickly as possible and prevent any recurrence.
Recording non-conformities helps analyze negative trends, examine root cause, and eliminate the
cause of the problems. Corrective actions should also include the longer-term actions to ensure
the problem will not occur again.
While corrective actions are reactive, preventive actions are pro-active. A preventive action can
prevent the occurrence of an issue or stop it from becoming too severe. A preventive mindset
helps to reanalyze the product and process, get a different perspective and help improve the
system as a whole in a timely manner.
Prevention can also be thought of as risks and opportunities. Identifying the potential source of
problems, their effects and the likelihood of occurrence is the first step in risk management. This
is followed by analyzing whether the associated costs with reducing the risk are worth it.
Mitigating risks and avoiding unnecessary costs are some of the biggest and obvious reasons to
minimize non-conformance.
Effectively managing non conformances and preventive actions is an integral part of an
organization’s continuous improvement plan. This should result in fewer defective products and
processes and more satisfied customers.
Quality management systems have compliance, content, and collaboration management
initiatives and strategies at their core. A good nonconformance management software should
assist everyone, from management to the day-to-day employee, in the common goal of better
quality. ComplianceQuest’s salesforce based EQMS system is designed for easy collaboration. It
helps companies across the supply chain with their quality and compliance needs through a
highly scalable, multi-tenant, enterprise cloud system.

Defining Nonconformance and Noncompliance

Let’s quickly have a look through the basic definitions for Nonconformance and Noncompliance
before diving deep into the details.
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Nonconformance

It generally refers to a product/material that doesn’t conform to the specifications


defined/customer requirements. It could be a deviation in a process, design, documentation,
or procedure that may deteriorate the product quality.

It can be broadly classified as Major and Minor Nonconformance

Major Nonconformance

It refers to the situation where one of the components of QMS or entire QMS breakdowns or the
quality processes fails to address the key requirements specified by a regulatory authority such as
ISO 9001. Auditors consider such nonconformities as a part of a system failure or its inability to
ensure process and product control.

Minor Nonconformance

It refers to the situation that indicates a failure in conforming to the specified requirements,
which may not affect the functionality of the quality management system. It may be a single
incident that may have minimal or no risk for the customers. It could be some abrupt change,
which is not documented or unapproved purchase order, etc.

Noncompliance

It generally refers to the situation wherein a product/material fails to meet the requirements
specified by the regulatory authorities. It could be a deviation in a process, design,
documentation, or procedure that may deteriorate the product quality. For example, setting up the
exceptions for accepting an individual into a program.

Both nonconformance and noncompliance should be managed effectively to ensure minimum


quality issues, regardless of the industry and company-size.

Nonconformance, Noncompliance, and Internal Audits

Internal audits are performed to keep a check on compliance – with ISO, FDA, and other
industry-specific standards as well as the quality management system. Every industry shall
regularly, keeping in consideration the predefined schedules and procedures, perform the internal
audits for their processes and activities to ensure that all their operations are in line with the
requirements of the quality management system and the International standards.
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An internal audit activity shall address all the components of the management system including
the test and improvement activities.

In addition to the internal audits, you can rely on following mentioned sources to get information
regarding a non-conformance record:

 Customer Feedback/Suggestions/Improvements
 Quality Control Data
 Observations/Findings/Self-Reporting
 Proficiency Test Results

Understanding the terms Compliance and Conformance in Details

To have a better understanding of nonconformance and noncompliance, we can have a quick


look through the definitions of compliance and conformance.

Compliance

It is commonly referred to as following the instructions – you need to do only what you are told
to do. This is the most simplistic definition. However, when we talk about the quality industry
and quality management functions, the definition of compliance gets complex. It has some key
traits including legality/standards/requirements specified as the most fundamental one through
which the legal implementations are carried out. The second key trait of compliance also gets
reflected through the first key trait that legalities/standards applied are the requirements that are
specified externally to the person(s) or organization.

The complexity arises with the recognition of the authoritative person who can implement such
legal expectations or external requirements that includes a wide range of entities and
environments.

Conformance

It is referred to as doing something in a recognized way – you need to follow the guidelines for
attaining product quality so that it serves the intended purpose. It has wide implications
throughout the different facets of life; not being limited to work life. The act of going against the
specified guidelines results in a non-conformance. The main objective of keeping the quality
systems and their application conforming is to ensure improved products and processes that a
company may have established to deliver consistent results, products, or services.

The standards of conformance may change for different locations and situations based on the
acceptable things for that particular marketplace. But in any industry, having all the operations in
place and implementing the best practices are required to meet conformity.
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Managing Nonconformance and Noncompliance

Managing nonconformance and noncompliance is important for every organization in terms of


achieving business goals in terms of product quality, which requires different functions in place
including:

 Management Review Process


 Employees and Process Review
 Internal Audits
 Customer Complaints Management

All these activities should be structured in a way that both the non-conformances and non-
compliances can be managed easily. However, these critical activities need proper
documentation, approval, and time-mannered processes that you cannot accomplish manually.

To ensure completion of the review, audit, and complaints management process, you need to
implement a next-generation enterprise quality management software like Qualityze EQMS. It
enables you to establish a closed-loop quality system in your organization to mitigate quality and
operational risks while enabling you to meet the compliance and regulatory standards.

From the management of critical documentation like SOPs, work instructions, etc. to creating
audit checklists using the pre-defined templates, Qualityze is a one-stop-solution for all your
quality management needs. This cloud-driven suite comprises of different products such
as Nonconformance Management Solution, CAPA Management Solution, Document
Management Solution, Audit Management Solution, Supplier Quality Management Solution,
Training Management Solution, and Customer Complaints Management Solution.

You can leverage all the advantages of being on a cloud platform like flexibility, scalability, and
security with Qualityze since it’s built on the world’s most secure and powerful platform. The
features that will help you ensure compliance and conformance are Electronic Signature for
validation and verification process, Outlook Email Approval, Audit Trails, etc.

To Sum Up:

Nonconformance and noncompliance may differ at the fundamental level, but they need to be
managed effectively to ensure the quality of products and services delivered to the customer. The
effective management implies proper documentation for analysis and evidence-based decision
making, planning and scheduling of audits, keeping a regular check on execution of audit
activities, and communicating with the customers to ensure satisfaction. All these activities are
vulnerable to errors, delays, and other risks in manual execution.
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Make sure you have implemented the right quality management system in your organization to
manage all the critical functions with minimal vulnerabilities while creating a culture of
continuous improvements to strive with industry best-practices.

Compliance audit
A compliance audit is a comprehensive review of an organization's adherence to regulatory
guidelines. Audit reports evaluate the strength and thoroughness of compliance preparations,
security policies, user access controls and risk management procedures over the course of a
compliance audit.

Definition:

A compliance audit is the type of audit service that their performance or procedure is mainly
focusing on whether the entity complying with local law, regulation, and related rule.

A compliance audit also reviews whether an entity complying with internal rules, regulations,
policies, decisions, and procedures.

An entity required to comply with the local law and regulations or they will face penalties or
fine. Some fine is only for a certain monetary amount and some fine requires a close operation.

Types of compliance review:

In general, the compliance audit performs its audit against certain requirement as follows:
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1) Local law and regulation:

The entity need to make sure that they are operating in compliance with the law, and related law.
To ensure this business might need to set up proper business procedures and processes. Or
sometime, they might need the legal consultant to have their decision advised.

Entity sometime setting the legal department to review on the certain significant process. It
wants to make sure that the penalty is minimized and the right procedure that complies with the
law is in place.

Along with this, the entity might need its internal audit department to have its review on the
compliance section with local law requirements.

The internal auditor might need to assess the significant procedures and process, as well as
certain official documentation.

2) Business-related regulation and framework:

Besides reviewing against local law and regulation, compliance auditors might need also to
review compliance with related regulations and frameworks.

For example, if the corporation is listed on the stock exchange outside the country that they are
operating. Then they need to make sure that the entity complies with the requirement of that
stock exchange requirement.

The compliance auditor also needs to review these areas by checking whether the related entity’s
current practices follow the requirement.

If not complying with, the compliance auditor needs to discuss with related departments as well
as chief executive that the findings found, as well as the recommendation that makes by the
auditor.

All the finding need to report to the audit committee and the board of directors for their action.

3) Entity’s policy, procedure, and processes:

The compliance auditor also performs its audit again entity’s internal policy, procedure, and
processes. Those internal policies and procedures are very important to the entity for sustainable
growth.

Fail to comply with the internal policy and procedure might lead to a waste of time and
resources. Serious in-compliance could lead to serious fraud.
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Compliance audits sometimes performed by the compliance officer and sometime performed by
internal auditors.

The big company has compliance departments work separately from internal audit departments.

Who is normally perform a compliance audit?

A compliance audit is normally conducted by the internal auditor and sometime services could
be offered by external auditors.

Sometime internal audit department leaks of resources or leak of competency to provide the
services. In such a case, the entity might need to seek services from an external firm to provide
the services.

Internal audit is the independence department and works under the direct supervision of the audit
committee.

The compliance audit report is communicated to the related department or division, CEO, and
CFO. The reporting result is direct to the board of directors and the audit committee.

For the big corporations, compliance officers are the one that enforces each unit, department, or
division to compliance with the required procedures, policy, regulations, and laws.

The compliance officer is also the one who performed a compliance audit sometime.

For example, a compliance audit could be issued to determine a textile mill is following the
EPA (or Environmental Protection Act) guidelines for disposing waste. The EPA could send
someone from their business, or they could hire a third party to assess the mill and send in the
results.

How to Conduct a Compliance audit


1. Select who will be performing the audit. ...
2. Initial planning. ...
3. Meeting with key stakeholders. ...
4. Evaluating controls. ...
5. Evaluating risks. ...
6. Analysing operations & confirming information. ...
7. Working with other assurance providers.
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What is the purpose of a compliance audit?


A compliance audit is an independent evaluation to ensure that an organization is following
external laws, rules, and regulations or internal guidelines, such as corporate bylaws,
controls, and policies and procedures.

Waste audit
A waste audit is a physical analysis of waste composition to provide a detailed understanding
of problems, identify potential opportunities, and give you a detailed analysis of your waste
composition. A waste audit will help you clearly identify your waste generation to: ...
Characterise and quantify waste streams.

the purpose of a waste audit?


A waste audit is a method for analyzing an organization's waste stream. The goal is to
discover what types and quantities of waste (paper, plastic, food etc.) you produce within a given
timeframe—usually a week. Auditing also measures how much waste is recycled

How to Conduct a Waste Audit

Step 1. Assemble a Team & Set a Date

Find a volunteer from each department to form your waste auditing team. Aim for at least five
people. Deirdre Fitzgerald of Badger Balm, a certified B Corp that holds audits every quarter,
recommends making this group an ongoing “Sustainability Committee” who can oversee any
changes you want to make as a result of your audit.

Next, pick a week for the audit. You want a clear picture of your normal trash output, so choose
a week without any special events and when most of your staff will be in the office. If you have
outside custodial staff, make sure they know to hold off on emptying the trash that week.

Why Badger Balm Does Waste Audits

"We wanted to codify and measure our commitment to positive environmental and social
practices in a transparent way. Quarterly waste audits are one of the ways that Badger tracks its
progress of reducing and diverting waste to landfills through composting and recycling best
practices."

Deirdre Fitzgerald | Badger Balm

2. Determine Your Waste Categories

Before “Waste Audit Week” rolls around, make a list of the most common trash types your
business produces. This list can be general for now—if the audit reveals different categories, you
can always add them to the list as you go.

Common Waste Audit Categories:


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 Paper
 Cardboard
 Plastic bottles
 Other plastic
 Aluminum cans
 Glass
 Food waste
 Materials packaging
 Signage
 Display materials

3. Gather Your Tools

Before the main event, you’ll need to stock up on a few supplies to make sure your team can
work safely.

Tools Needed for a Waste Audit:

 An open area for sorting the trash.


 Rubber gloves for each volunteer.
 Face masks for each volunteer.
 Tongs for each volunteer (optional).
 Labelled boxes for sorting each waste category.
 A bathroom scale for weighing each category.
 Clipboards for recording your findings.
 Trash bags for re-bagging your waste after the audit.

4. Sort Your Trash

It’s time for the real work to begin. Here’s how to do a waste audit.

1. At the end of the week, round up all the trash and recycling from your building.
2. If you’d like to gather department-specific data, label each trash bag with the department
it came from.
3. Weigh all the trash to get a baseline for how much you throw out each week.
4. Weigh all the recyclables to establish how much you recycle each week.
5. Wearing gloves, sort all materials into the boxes for their categories. If you labelled your
trash by department, make sure each has separate boxes.
6. As you work, note any recyclables mixed in with trash.
7. Once everything has been sorted, weigh each category.
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5. Analyze Your Results

Now that you’ve recorded all weights, you can use this data for a waste stream analysis.

1. Calculate and record your waste diversion rate using this process:

 Divide the weight of your recyclables by the combined weight of all your waste (trash +
recyclables).
 Multiply the result by 100.
 This gives you the percentage of waste you divert from the landfill each week.

2. Look at the weights you recorded for individual waste categories.

 Which categories are highest?


 Did the highest categories differ between departments?
 Did you find any recyclables mixed in with the trash?
 Were there categories you didn’t realize you had?

Don’t lose track of this waste audit report. As you take steps to reduce waste, these numbers will
become a powerful marketing tool you can use to show customers how hard you’re working at
greening your operation.

Next Steps After Waste Auditing


1. Determine whether your dumpster size and pickup frequency still matches your
needs. If your trash output changed, a different size or number of pickups may be more
cost-effective.
2. Hire a recycling service if you don’t already have one. If you’re only recycling a few
items, consider recycling more—either through your current service or one that
specializes in waste from your industry.
3. Set a goal for increasing your recycling rate.
4. Create recycling guidelines for meeting that goal and share them with your staff.
5. Set a goal for reducing the amount of waste in your largest categories.
6. Determine the steps to meet that goal and let your staff know. For example, you might
switch to online bill pay to reduce paper. Or buy a different coffee maker to avoid
wasteful coffee pods.
7. Identify any items you can reuse. For example, can you repair or recycle your
electronics instead of purchasing new ones? Can you repurpose any of your packaging
materials?
8. Decide on a timeline for meeting your recycling and reduction goals. One or two
years usually makes sense. Plan to conduct another waste audit at that time to see if you
met your goals.

Main aim is to achieve zero waste, so set annual goals based on the progress
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Waste minimisation is a set of processes and practices intended to reduce the amount of
waste produced. By reducing or eliminating the generation of harmful and persistent wastes,
waste minimisation supports efforts to promote a more sustainable society.

Why Is Proper Waste Management Planning Important for Industries?


Knowing how to dispose of waste properly is essential for many reasons. Here are some of the
benefits of crafting a useful waste management plan for your business:

 Reducing environmental impact: Effective waste management enables you to minimize


your company’s adverse effects on the environment. A proper waste disposal plan
ensures safe, sustainable waste disposal practices to prevent waste from contaminating
nearby soil and groundwater.
 Staying compliant with regulations: A robust waste management program keeps your
company in compliance with local and federal laws. When business is busy, your
organization may not always have time to stay apprised of regulatory changes and
nuances. If you work with a professional waste management company, though, the
professionals there can also keep you updated about any applicable changes in the law
and ensure your facility’s compliance.
 Lowering disposal costs: Many businesses wonder whether professional waste
management will be too expensive. Proper waste management services, though, can often
reduce your disposal costs. Disposing of industrial waste is usually more costly than
disposing of standard municipal waste, so finding ways to reuse and recycle your waste
instead can curb your expenses significantly.
 Reducing your logistical burden: Proper waste management services reduce the
logistical strain on your organization and its resources. When you work with a
dependable waste disposal company, its professionals strategize about and handle your
waste so you can focus more energy on your core business processes.
 Ensuring worker health and safety: You want your company to maintain a safe,
comfortable working environment for employees. A good waste management plan helps
you do that by educating your workers about safe waste handling practices and reducing
the likelihood of disposal-related injuries.

Effective Waste Management Planning

1. Identify the Waste Your Facility Creates

When you’re thinking about how to manage waste most effectively, the first step is to identify
your waste. Run a waste audit to figure out what waste your facility generates, what volumes of
those wastes it produces and what departments produce the most waste.
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Identifying waste with the help of a waste audit is essential because it allows your organization
to manage its waste more strategically. If you know much of your waste is regulated medical
waste, you can contract with professionals who can dispose of it responsibly. If you know the
bulk of your waste is wastewater that requires treatment before disposal, you can seek out a
disposal company that treats wastewater at a dedicated facility.

An audit like this is also beneficial for determining where excessive waste occurs in your
business. If you know most of your waste disposal practices are relatively sustainable but one
department produces disproportionate amounts, you can tailor your strategies toward helping that
department reduce and recycle more.

2. Identify Waste Streams

Identifying waste streams at your facility is an essential component of your waste management
plan. You’ll want to know how much hazardous waste and non-hazardous waste you’re
producing, as well as how much liquid and solid waste. You’ll need this information to develop
targeted disposal practices for each type of waste and ensure regulatory compliance. Or you may
break your waste streams down into more specific categories like biologically contaminated
waste, electronic waste and vegetative debris.

To dispose of certain waste streams, you may need specialized professional services. They can
mitigate the risks associated with these wastes and ensure safe, responsible practices around
them.

As you identify various waste streams at your facility, be sure to gather data like this:

 What potential waste streams your facility can produce


 What local and federal laws apply to these waste streams
 How much waste each stream is likely to generate
 What risks, if any, the waste streams present
 What source reduction and hazard mitigation practices, if applicable, you can implement
for each waste stream
 What criteria you will use to select storage sites and disposal methods for various waste
streams
 Which waste streams your waste management facility can accept
 How much of each waste stream your waste management facility can accept
 Which waste streams are suitable for recycling or waste-to-energy programs rather than
traditional disposal
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3. Establish a Waste Management Team

The next step of your planning should be assembling a capable waste management team. Select
responsible employees, perhaps from your existing management team, to take charge of your
waste management program. If your team responsibilities will be particularly complex, consider
appointing one person as the waste management coordinator. You might also consider choosing
several team members to provide dedicated oversight for one waste stream apiece.

One of the main benefits of creating a waste management team is the accountability it generates.
If no one is explicitly responsible for dealing with waste, this essential process may fall through
the cracks. A dedicated team will put strict deadlines and protocols in place to ensure
comprehensive, dependable management.

4. Assess Current Waste Disposal Methods

The next step is to evaluate your existing waste disposal methods. Take a tour of your facility
and observe your performance in areas like these:

 Placement of refuse and recycling bins


 Labeling of refuse and recycling bins
 Reliability of the services that pick up your facility’s waste

Determine where your organization is strongest and where it could improve. For instance, you
might notice that your recycling bins are poorly labeled, so recyclable waste goes into the trash
instead. You might see that your waste bins are too far from where your processes generate
waste, so the waste tends to pile up where it shouldn’t. Or you might discover that although your
facility handles its waste appropriately, your disposal services fail to remove the waste on time,
leaving your facility with accumulated waste that may violate regulations.

In any case, you can use the knowledge you gain from this appraisal to inform and enhance your
waste management practices.

5. Consider Your Waste Hierarchy

As you plan your waste management practices, consider implementing a hierarchy that
prioritizes sustainable processes like reusing and recycling over landfill disposal:
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1. Reduce: Start by examining where your facility can reduce its waste generation. You
might discover that more material is coming into your facility than is necessary.
Brainstorm ways to scale the sourcing back and minimize the amount of waste you
produce.
2. Reuse: Consider what types of waste your facility can repurpose. For instance, if you
have a construction business, find ways to reuse leftover materials from a construction
site or repurpose salvaged materials from a demolition.
3. Recycle: Consider what waste you can divert from your disposal stream and break down
for recycling. For instance, if you’re throwing away old electronics, look into sending
them to a specialized facility that can recycle their metals. If you have waste paper, glass,
metal or plastic products, check to see if you can recycle those in your area.
4. Recover: Waste products you can recover for resale often include scraps of metal and
leftover construction materials. With a waste-to-energy program, you may also recover
energy from combusting waste.
5. Dispose: Generally, everything that remains after you’ve exhausted the options above
must go to a landfill. With effective waste management practices, you can often minimize
the amount of waste that falls into this category and develop strategies for responsible
disposal.

6. Select Waste Management Partners

One of the most critical points of your waste management plan involves choosing the right waste
management partners for your business. You need a company that has experience handling the
types of waste your facility produces and can help you work toward your sustainability goals.

Here are a few of the services you’ll want to look for from a potential waste management
partner:

 Chemical waste management: If your facility produces chemical waste, you’ll need
specialized services to handle and dispose of it. Look for trustworthy chemical waste
management services that can prevent toxins from leaking into the surrounding
ecosystem.
 Environmental waste and recycling services: If your facility engages in
environmentally invasive processes, you may need a dependable waste management
company to help you clean up your sites. Look for environmental services like lab pack
services, tank cleaning, site remediation, pit and trench cleaning, industrial cleaning, air
and hydro-excavation, and underground storage tank (UST) removal.
 Industrial wastewater treatment: Your facility’s wastewater may require treatment
before it can undergo disposal. Look for a waste management partner that can provide
ethical wastewater treatment to prevent soil and groundwater contamination.
 Liquid waste solidification: Sometimes, the best treatment for waste involves
solidifying its liquid components to prevent them from leaching into the
environment. Liquid waste solidification services make many types of waste, including
even some medical and radioactive waste, much safer for disposal.
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 Sludge and solvent management: If your facility generates silt, solvents or sludge
during its operations, you may require sludge and solvent removal and recycling services.
These services clean the accumulated grime from your equipment, process it and dispose
of it safely while meeting applicable government regulations.
 Waste-to-energy services: Waste-to-energy programs enable you to capture energy from
incinerating your waste. Your facility can either use the energy, making its consumption
practices more sustainable, or send it along for homes and businesses to use.
 Waste transportation: To dispose of your facility’s waste, your waste management
company will first have to transport it, potentially over substantial distances. You’ll want
to choose a company with sustainable waste transportation services that can move your
waste safely and reduce the risk of spills and pollution along the way.

7. Set Targets for Waste Reduction

As part of your waste management strategy, you should also set facility goals to work toward.
Before implementing your new waste management plans, measure and quantify your existing
waste management practices so you’ll have a baseline to work from.

Then set targets you’d like your facility to reach. For instance, you might want to reduce your
waste disposal volumes by 20% or see no compliance violations during six months. When you
meet your target, celebrate with your team, and then set new goals so your facility’s operations
consistently become more sustainable.

8. Create a Waste Management Action Plan

Along similar lines, your facility may wish to develop a waste management action plan. For best
results, consider formalizing the plan in writing and displaying it where employees can read it
frequently.

Your action plan should contain specific, detailed procedures for separating your facility’s
various types of waste, getting waste to its proper containers and arranging disposal pickups. It
should also include the protocols you will follow to ensure compliance and address the
procurement of adequate personal protective equipment (PPE) to protect your employees from
contaminated waste.

9. Train Employees on New Procedures


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Even the best-crafted waste management action plan won’t provide results if your employees
don’t understand or feel engaged with the new procedures. You’ll likely want to make a
company-wide announcement of the new policies and then set up training sessions for your
workers to increase their familiarity, confidence and investment.

You should also educate your staff about the company’s sustainability targets. Doing so will give
employees context for the new processes and provide goals to strive for.

10. Track Your Progress and Monitor for Adjustments

Over time, track your organization’s progress toward its goals, and alter your processes as
necessary to enable consistent achievements. For instance, you should record the new costs of
your waste management program, compare them to your goal costs and tweak your strategies if
you’re coming in over budget.

If your progress doesn’t measure up to your expectations at first, there’s still plenty of reason for
optimism. You can always adjust your waste management goals and try again. Over time, this
process will lead your facility toward substantial gains in environmental responsibility and
sustainability.

Environmental Statement Form V


It is the information gathered from every industry.

In the Environmental Statement every industry should to provide Information on Production,


Consumption of raw, Water, Pollutants discharged in environment, Solid and Hazardous
waste with their Treatment Processes.

Environmental Statement Submission Date

Notification for Environmental Statement form v Published on 28 Apr 1992 by Ministry of


Environment and Forest. As per act (Water, Air and Hazardous waste) Every Industry should
submit environmental Statement for financial year ending (i.e. 31st Mar) to concerned state
Pollution Control Board.
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Information Collected through Environmental Statement Form V

In the Environmental Statement every industry should to provide Information on Production,


Consumption of raw, Water, Pollutants discharged in environment, Solid and Hazardous waste
with their Treatment Processes.
Important things to be reported to Pollution control board are:

• If that company is reusing its by-products or waste material which results in Reduction in
consumption of Air, Water or energy.
• Production cost
• Additional Investment proposals for environmental Protection i.e. up-gradation, Improvement
in Process or New Equipments to reduce Environmental Pollution.

Environmental Statement Form V Filling Process

There are total Nine Section in Environmental Statement Form V. it Can be Downloaded
from here
Part A
Basic Information About Company Like Name, Address, Industry Category, Production
Capacity and Date of Last Environmental Audit Submitted.

Part B
This Part is for Comparison of Water and Raw Material consumption for this financial year to
previous year.

Part C
This Part is to measure Pollutants Discharged to Environment through medium Air and Water.
How much in excess, an industry is releasing the pollutants into the environment.

Part D
This part to Measure Hazardous Waste from processes and from Pollution control Facilities

Part E
This Part is to measure Solid waste generated by industry. Also details like Quantity recycled,
Sold and Disposed

Part F
Any new practices adopted to reduce Hazardous waste.

Part G
Impacts of pollution control measures on natural resources and with Cost of Production.

Part H
Additional Investment / Process / measures to minimization or prevention of pollution.
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Part I
In this part other information / initiatives to improve quality of Environment needs to be given.

Whenever Part C, indicates high Variation then Part H (i.e. Additional Investment Proposals for
environmental protection including abatement of pollution) should be taken more seriously

Perfect Pollucon Services offers Services in Environmental Statement, Environmental Impact


Assessment and Cess Returns. Also it has Experts to carry out Form V Filling, Submission to
Pollution Control Board. For more information Fill up contact us form on this page.

Types Of Due Diligence


Legal
This form of due diligence ensures that there is no involvement of legal issues in business
investment or procurement.

Tax
This due diligence focuses on making sure that seller’s firm does not hold any past tax liability
that may be passed on to the acquiring firm.
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Operational
This form of due diligence assists the prospective purchaser to get an analysis of the operational
aspects of the target company.

Intellectual Property
This form studies the various intellectual properties that the company may own.

Commercial
This form aims at gaining an understanding of the market which the target company operates in.

Information Technology
This form assists in identifying if there are any information technology concerns in the target
entity.

Human resources
The human resources due diligence understands the impact of human capital on the planned deal.

On gaining insight on types, let’s understand the steps involved in the preparation of the same.

Process of Due Diligence


The following is the step by step process:

Understand Compliance Concerns


In the ever-growing corporate world, the number of regulations imposed on the entity keeps
increasing. The firm must gain an understanding of the compliance they need to match.

Define Corporate Objectives


The due diligence process needs to align with the regulatory, strategic, reputational and financial
risks which the entity may face.

Gather Key Information


Information of the entity needs to be gathered on a number of bases such as political
connections, board members, incorporation documents, key shareholders, etc.
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Screen Prospective Third Parties against Watchlists


Watchlist screenings can determine if the particular party poses any form of significant risks.
The entity should be checked against points of law enforcement lists, global sanctions list,
published lists of debarred companies, etc.

Conduct a Risk Assessment


There has to be the preparation of the risk assessment. The assessment must consider points such
as high level of government involvement, country risk and financial risks arising due to
deficiencies in internal factors.

Validate the Information Collected


After completing the risk assessment step, the next step in the due diligence process is to verify
and validate all the information that has been procured.

Record the Process


One should maintain a record through the due diligence process. The record should include all
relevant assessments and documents. This record will later enable an entity to calculate the
return on investments.

Establish an On-Going Monitoring Plan


There has to be proper scrutiny throughout the to avoid any form of unanticipated problems.

Review Your Process Regularly


A business should keep adapting to changes. Periodic reviews should be conducted and required
amendments should be incorporated in the process.
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