Inspection Principles and Methodology

By ketema D.
MAY, 2022
 Out line
• Introduction
• Types of Inspection
• Inspection Procedures
• Good Practices for Regulatory Inspections
• Attributes ( Personal Qualities ) of Inspector
• Code of Ethics and Conduct for Inspectors
• General Obligations
• Physical Resistance/Threats/Assaults
• Personal safety plan
• Conclusion
 Introduction
Inspectors should be embodied in an organization
usually called an Inspectorate.
The Inspectorate represents the Enforcement arm of
national and regional regulatory Authorities.
An inspection can be seen as a process that starts
once a government regulation has been adopted,
focuses on reducing non-compliance, and ends
with the resolution of any compliance problems.
An inspection system is only one piece of a larger
and complex legal system.
 What is Inspection?
• To “inspect” is “to look closely at
something, especially to check that
everything is in good order.”
• Inspection is, the act of looking
closely at something to ensure that it
meets certain prescribed or known
standards and specifications.
• Inspection is vital element of
healthcare regulation.
 What is purpose of inspection?
To inspect is to carefully examine. The main
objective of inspection is to meet customer
requirements, wants, and needs. The objective is
to prevent defective product flowing down the
successive operations and prevent loss to the
company. Many characteristics cannot be inspected
at the final stage of production
 Why inspect? What are the benefits?

Verifies that product specifications are being met
and avoids unnecessary reengineering work later.

Confirms important quantity verification.

Checks packaging integrity to avoid costly damage
during transit.

Reduces overall quality risks and cost.
 Types of inspection
There are four types of inspection
Inspection can be classified based on the purpose of
inspection
Pre-approval inspection
Concise
Follow-up
Investigative inspection
 Types of inspection cont.
Pre-approval Inspection
This is an inspection generally intended for a new
establishment which has applied for permit to
operate a new practice or has changed premises or
wants to extend scope of operation. The inspection
should be announced.
 Types of inspection cont.
Concise Inspection
Concise inspections are generally for establishments
that have previously been inspected. These
inspections are done with a view to assessing
standards of good practice, and the outcome helps in
the proper assessment of the establishment. Concise
inspections can be announced or unannounced .
 Types of inspection cont.
Follow-Up Inspection
Follow-up inspections are normally carried out to
ensure that corrective measures have been
undertaken following advice and notice given
during a previous inspection. If a time limit was
given for applying the corrective measures, the
inspection should be unannounced.
 Types of inspection cont.
• Investigative / Special Inspection
This type of inspection is undertaken to deal with
specific complaints received about lapses or non
compliance with standards of professional practice
or performance of new establishment whose scope
of operation was previously unknown. Such
inspection may be focused on one product, a group
of related products or specific operations such as
mixing or labeling etc.
- The inspection should be unannounced.
 Inspection procedure
1) Pre inspectional Activities
The purpose of planning inspection visits is to
ensure that:
• Resources to visit the firm as frequently as needed
are allocated.
• Inspectors receive appropriate training on processes
and sampling to perform the auditing and inspection
activities, or any other quantitative field method
chosen to support the inspection.
 Inspection procedure cont.
Plan, budget and schedule
 year, Inspectorate should plan the required number of
visitsBased on the total number of entities that should be
visited and experiences from previous
 Estimate the financial resources that will be needed
considering:
• Personnel
• Transportation and fuel
• Approximate number of samples to be analyzed and cost
• Other issues such as approximate number of extra-visits
 Report to the head of your institution the plan, the schedule
and estimated budget to carry out the plan.
Inspection procedure cont.
The Inspectors should review necessary documents
like
◦ Previous Inspection reports,
◦ Manuals,
◦ Standard Operating Procedures,
◦ Checklist and Aid-Memoire
The Inspectors should develop a Program as per the
plan of the Inspectorate
 Inspection procedure cont.
2 ) Conducting Inspection
Inspector/s should
• Contact the person in charge of the establishment by
approaching him or her in a dignified, authoritative,
and cordial manner. Avoid being arrogant.
• Present credentials (e.g., your identity card) and
explain the purpose of your visit.
• Use diplomacy, tact, and persuasiveness to acquire the
necessary information and all necessary inspection
details. To achieve this, use the appropriate standard
operating procedures (SOPs) for the particular type of
inspection and fill in the respective inspection form.
 Inspection procedure cont.
• In case of refusal to undergo inspection, explain that
refusing is a criminal offence and courteously discuss the
matter with the owner or responsible person on the
premises.
• Make suggestions for minor corrections to be made as
you perform the inspection. Upon completion of
inspection, discuss the findings with the owner or person
in charge. Adopt a courteous attitude in calling attention
to the practices or conditions observed at the time of
inspection.
• If any samples have been taken for testing, furnish a
receipt for these samples to the person from whom
samples are taken.
 Inspection procedure cont.
• Inspection techniques
Observation
The inspector must observe the processes and
procedures carried out at the facility, paying
particular attention to those that may adversely
affect product safety, to ensure that they are done
correctly.
Inspection
Inspection may require actual handling of
product(s) to determine such sensory
characteristics of the products as odor (e.g.
fresh fish) , Checking Expiry dates etc……
 Inspection procedure cont.
Measuring
Measuring goes a step further than simple inspection in
that the inspector uses an instrument to determine such
parameters as temperature (e.g. of cold rooms or the
product), pH, weight
Sampling and testing
The inspector may take samples for testing on site or
later testing at a laboratory. Sampling must be done
using adequate sampling plans. Samples must be
handled in ways that ensure that the product is not
adversely affected by time, temperature and the
mode of transportation to the laboratory and testing
must be performed using standard methods.
 Inspection procedure cont.
Questioning
The inspector should feel free to talk to facility operators during
the inspection and question them about the procedures they follow
when performing their tasks. The inspector should have advised
the management during the opening meeting about his/her
intention to talk to operators and emphasized that this would be
done in the least disruptive manner.
Record review
Reviewing the facility’s records is a very important
part of the overall inspection process. It begins
ahead of the actual inspection with the review of
previous inspection reports, and continues during
the inspection. A checklist may be used to facilitate
the recording process
Inspection procedure cont.
3) Post inspectional Activities
An inspection has not been properly completed
until four post-inspection activities have been
finished.
1 The inspection team, under direction of the Team
Leader, meets, critiques, discusses, reviews, and
consults with others, including non-team members
and Management as appropriate, concerned in the
inspection findings.
2 Each team member prepares her/his part of the
report in final format. The Team Leader assembles
the draft report, edits it and issues the summary
report of the inspection.
 Inspection procedure cont.
3 The Team Leader sends the inspection report to the
firm listing exceptions found, arrangements for any
corrections agreed upon, and confirms dates for
achieving compliance, when appropriate.
4 The inspectors arrange follow-up inspections in
consultation with their supervisor and the Inspection
Section Leader to determine compliance.
 Inspection procedure cont.
Writing the Report
The inspection report is a critical document
providing a record of activities of the inspectors
and documenting the suitability of a firm to be
licensed under FMHACA. Information
documented in the report has profound and long
lasting impact on the manufacturer, importer,
exporter or distributor. The Team Leader has
the responsibility to plan appropriately to assure
the report is out on time.
Inspection procedure cont.
 Good Practices for Regulatory Inspection
• Good Practices in Inspection can help Regulatory
Authorities to achieve their objectives and
contribute tremendously to
a) increase compliance
b) reduces the cost of Enforcement
c) minimize regulatory burdens
d) minimize risks for business
• There are 10 Good practices which can help
regulators to use in systematically improving their
inspection function
Good Practices for Regulatory Inspection
cont.

1) Setting the Mandates of the Inspectorate Clearly

Inspectorates should carry out responsibilities within a legal sphere
that is well defined and transparent. Inspectors should enforce only
those regulations specifically under their authority. The mandate
and goals of the inspectorate should be communicated to all
stakeholders. Setting the Mandates clearly reduce vague and
confusing regulations that permit excessive discretion from
inspectors and setting more precise standards that help firms
comply. It also helps to avoid pirate inspectors from preying on
business. A lack of clear mandates can also encourage discrepancies
and differences of type and procedures of inspections across
products and regions, increasing regulatory risks.
Good Practices for Regulatory Inspection
cont.
2) Proper Human Resource Management of the
Inspectorate
Recruiting and retaining a professional, skilled
staff of inspectors can be difficult in countries where
civil servants are not paid living wages. But Putting
into place a system of bonuses and performance
incentives to attract and reward good inspectors.
Good Practices for Regulatory Inspection
cont.
3) Training of Inspectorate Staff
The quality of the inspectorate staff is a key determinant of its
performance. In general, it appears that higher quality inspectorates
uniformly train their inspectors more. In other words, the extent of
staff training may be a reliable proxy for inspection quality.
A lack of capacities and expertise among inspectors means that
enforcement is unpredictable and ineffective, and increases
regulatory risks among businesses. For example, poorly trained
inspectors may contribute to inadequate inspection reports that are
illegible, incomplete, and lack follow-up. Extensive training must
be done throughout the official inspection system to ensure
uniform, accurate results at all locations. The modes of training
seem to vary considerably. Some countries use in-house training
programs; others contract out training services.
 Good Practices for Regulatory Inspection
cont.
4 ) Accountability for performance of Inspectorate
In many developing countries, administrative accountability of
inspectorates is nonexistent or weak, except in cases of calamity.
There are strong public accountability and efficiency reasons for
better oversight of the performance of regulatory inspectorates. This
can be fostered by
a ) Develop annual targets and goals for the inspectorate, based on
performance indicators of number of inspections to actual results in
reducing events/risks.
b) Develop information system for monitoring against performance
targets.
c) Consult regularly with regulated community on the performance
of the inspectorate.
d) Encourage third-party monitoring of performance.
Good Practices for Regulatory Inspection
cont.
5) Targeting Inspection Visits
There is a strong international trend toward risk-based
targeting of inspections. The targeting and frequency of
inspections constitute one of the main decisions to be
made by an inspectorate. Risk assessment is an essential
means of directing regulatory resources where they can
have the maximum impact on outcomes. On the basis of
this information, regulators can reduce unnecessary
inspections and data requirements for less risky
businesses. Risk-based inspections also reward businesses
that comply voluntarily, and penalize the minority of
businesses that do not comply, and hence reduce unfair
market competition.
Inspectorates can Target inspection visits where they can
have maximum impact on the outcome by
Good Practices for Regulatory Inspection
cont.
• Set up information system that identifies high-risk
sectors and the businesses in those sectors.
• Set up historical data bases to detect trends and
patterns of compliance and non-compliance by
sectors, regions, etc.
• Track repeat offenders in high-risk sectors and
potential “usual suspects” based on trends and
sector wide patterns.
• Shift inspection resources toward the highest risk
sectors and businesses.
Good Practices for Regulatory Inspection
cont.
6) Inspectorate Information System
A high-quality inspectorate should have up-to-date data
collection and database systems to ensure that it knows
which firms are operating in fields under its jurisdiction,
where they are, and their compliance history for risk
targeting. It should also know about who performed the
inspection and its results. Such a management
information system is vital for risk targeting .
The information system can help the inspectorate to target
inspections, manage performance of inspectors and
units, and shift inspectors among inspected firms to
avoid the risk of capture. For instance, the system can
avoid the situation in which the same inspector visits the
same site regularly, increasing the risk of collusion.
Good Practices for Regulatory Inspection
cont.
The system can be developed by
• Develop an inventory of data needs in the inspectorate.
• Assess data availability in the inspectorate and in the
business sector.
• Develop data collection mechanisms to respond to the
most urgent data needs.
• Solicit public-private cooperation in collecting
information.
• Cooperate with other public agencies to gain access to
their data.
• Develop an integrated database that is usable in making
daily management decisions and tracking key variables.
Good Practices for Regulatory Inspection
cont.
7) Set Standard procedures for all inspection process
High-quality inspectorates have developed
extremely detailed procedures covering every
aspect of the inspection from beginning to end.
These procedures or field manuals regulate the
inspectors themselves. They are usually published,
and are used by businesses to protect their rights
during the inspection. Such consistent and public
procedures protect both the integrity of the
inspector and the rights of the businesses, and
improve the efficiency of inspections.
 Good Practices for Regulatory
Inspection cont.
This can be done by
• Draft a procedures manual that is mandatory for
inspectors.
• Consult with the business community on the manual.
• Discuss with due process and judicial authorities how
procedures can be organized to best support appeals
and due process.
• Train inspectors in basic elements of the process,
including an opening conference, the rights of
employers and employees, and a closing conference.
Good Practices for Regulatory Inspection
cont.
8) Proportionality and variety of sanctions
Measures such as shutting down a business are
seen as the natural result of inspections, but in
reality the goal should be compliance, not
punishment. Penalties make sense only as part of a
larger effort to induce compliance. Good practice
recommends that inspectorates develop a large and
flexible toolbox of actions to encourage
compliance. Authorities should be able to wield a
variety of enforcement actions . It is important to
define as precisely as possible these actions and
when they are to be used.
Good Practices for Regulatory Inspection
cont.
A better approach is to develop a “pyramid” of
enforcement options with a wide range of possible
actions that an inspectorate can take to improve
compliance . Encouraging voluntary compliance
should always be the first step. But voluntary
compliance depends on ensuring that non compliers
do not profit from their non-compliance.
Cooperative compliance is contingent upon
persuading those of goodwill that their compliance
will not be exploited by free riders who will get
away with the benefits of noncompliance without
being held to account. Deterrent and punitive
sanctions must be available in the background for
the minority.
An Enforcement option pyramid
Good Practices for Regulatory Inspection
cont.
9 ) Complaint Mechanisms
Set up a system take complaints from citizens or
businesses.
Designate a senior official to assess complaints
and make recommendations to the head of the
agency.
Good Practices for Regulatory Inspection
cont.
10) Inspectorate mechanisms and procedures to
combat corruption
There is no single answer to the corruption problem. Assess extent of
problem using international benchmarks and business consultation.
The following strategies can be used to fight corruption
1) set up inspection brigades of more than two persons who rotate
regularly.
2) rotate inspection staff frequently enough to discourage corrupt
relationships.
Good Practices for Regulatory Inspection
cont.
3)The creation of firewalls - between the inspector
coordinator preparing the inspection order (i.e., selecting
the firms to be visited) and the inspectors. This division has
reduced the typical problem of collusion and capture
between an inspected firm and its inspector.
4) National Strategic Plan for Combating Corrupt. For
example, inspectors as public officials submit income
declarations each year aimed at controlling incomes of
public servants and avoiding illegal income.
 Attributes(Personal Qualities )of an
inspector
• An inspector should possess the following attributes:
-Good knowledge of Health, laws and regulations to be
enforced.
-Good command of technical terms and excellent
communication skills.
-Awareness of the probable methods of using forged or
false documents for transactions in pharmaceutical and
food preparations and skills in determining the
genuineness of documents presented for examination.
-Maturity, honesty and integrity.
-Responsible conduct which commands respect.
-Willingness to accept challenges.
Attributes of an inspector cont…
Ability to organize their own work with
minimum supervision.
 Ability to assess facts quickly and take
rational and sound decisions without delay.
 Ability to assess character and honesty of
persons being interviewed.
Ability to hold discussion with company
management at the completion of inspection.
Ability to motivate other inspectors.
Code of ethics and conduct of
Inspectors
1. Inspector should strive to achieve the highest ethical
standards for conduct that he/she is capable of.
2. Inspector should uphold the honor and dignity of
his/her profession and avoid association with any
enterprise of questionable character or apparent
conflict of interest.
3. Inspector should protect and promote the interests of
the client to the best of his/her ability and knowledge,
recognizing that the client has placed its trust and
confidence in the institution where.
4. Inspector should always Endeavour to maintain and
increase his/her level of knowledge regarding new
developments in the field.
 Code of ethics and conduct of
Inspectors cont…
5.Inspector should conduct his/her business in a
manner that will ensure that he/she is
independent from outside influence and interest,
which would compromise his/her ability to
render a fair and impartial opinion regarding any
activity conducted.
6. Inspector should promptly disclose to the client
any interest in any other business that may affect
the client or the quality or result of his/her work
or remediation.
Code of ethics and conduct of
Inspectors cont…
7. The inspector shall not knowingly use
his/her position or the remediation process
to obtain work in another field.
8. The inspector shall make every effort to
uphold, maintain, and improve the
professional practice, integrity, and
reputation of the institution where he/she
works as technical experts and the
institution as a whole.
 General obligation
1.The Inspector shall put forth an honest effort to follow
established procedures in discharging his/her duties
and in making decisions.
2. Inspector should not solicit or accept gifts or any
other item of monetary value from any
individual/organization/company/entity doing
business with or carrying out activities regulated by
the Authority he works for or whose interest may be
substantially affected by the performance or
nonperformance of the inspector’s duties.
 General obligation cont.
3.The Inspector should not participate in any
matter with an outside
individual/organization/company/entity that
will substantially affect his/her financial
interest, performance, or efficiency.
4.The inspector should not use the non public
information gained in the course of
discharging their duties or from their day-to-
day duties for their personal gain, nor allow
the improper use of such information to
further their private interests.
 General obligation cont.
5.The inspector sh0uold not, without prior approval by his/her
institution, engage in outside employment or activities and
shall not seek or negotiate for employment that will directly
conflict with the duties/interests of the institution he/she
works.
6.The inspector should act impartially and not give preferential
treatment to any individual/organization/company/entity.
7. The inspector should conserve his/her institution property
and shall not use it for private gain or any activity that is not
authorized.
8. The inspector shall disclose fraud, abuse of power, or
corruption, including the appearance of such, to the
Institution he/she works.
 General obligation cont.
9. The inspector shall endeavor to avoid any actions
that create the appearance that they are violating the
law or ethical standards or not acting impartially, as
determined by the perspective of a reasonable person
with knowledge of the relevant facts.
10. The inspector shall be required to adhere to the
established rules, regulations, and standard operating
procedures in executing his/her functions.
11. It should be noted that failure to comply with the
established rules, regulations, and standard operating
procedures is an offence that shall warrant
disciplinary action.
 Physical
Resistance/Threats/Assaults
• The work of inspectors as law enforcers is certainly
associated with risks to their safety. This risk is
understandable because in the process of discharging
their duties, inspectors frequently interfere with
illegal commercial interests. In many instances, the
inspection activities cause financial losses to
proprietors. In some cases, the inspector may
encounter illegal individuals whose business may
have thrived in the unregulated environment and who
may resort to any means to maintain their illegal
business dealings.
Physical
Resistance/Threats/Assaults
Some of the risks faced by inspectors in
the course of executing their duties
include but are not limited to physical
assault leading to bodily injuries,
permanent disability, or death; restrictions
in their freedom to perform their duties;
and threats
 Personal safety plan
Problems of security for inspectors cannot be entirely
eliminated, but the risks to the inspector can be reduced if
inspectors adhere to the following guidelines:
1. Up on a new appointment or transfer to a new station, make
sure that you are introduced and that you have an
introductory letter from FMHACA . Introduce yourself and
present your credentials and letter. Explain to them what your
duties and responsibilities as an inspector are. By doing so,
you create a politically and technically conducive work
environment for executing your duties with support from
other state entities and stakeholders.
2. Whenever you have inspection work to do, it is good practice
and safer not to do it alone. (It is easier to threaten an
individual than a group of officials.) To meet this
requirement, involve the relevant militia or police officers),
whenever necessary.
 Personal safety plan cont.
3.Always perform inspections in a courteous but firm
manner. Follow the SOPs. Inform the other members of the
inspection team and the owner of what is expected and of
any deficiencies identified during the inspection.
4. Whenever there is a threat to your life (communicated
verbally, in writing, or through a third person), inform the
police. The Chief Inspector should be appraised of this
situation by telephone and in writing immediately.
5. If a threat has been issued, be careful with whatever you
do, especially after office hours. Avoid situations that
would put your life in jeopardy. Don’t let people know
about your travel plans. If possible, do not drive your car
alone and be careful where you take your meals. The risk of
intentional food or drink poisoning cannot be over looked
when threats have been made against you.
 Conclusion
What are quality inspections?
Defining “quality” for an inspection system is not easy,
because an inspection system is only one piece of a larger
and complex legal system. At bottom, inspections are meant
to improve compliance with clear rules in order to achieve
desired policy results. But compliance alone is not a
sufficient standard of quality. Many case studies and
research proposes four quality criteria:
1.maximizes compliance with clear government regulations
by detecting and deterring noncompliance consistently and
fairly ;
2 .minimizes uncertainty and regulatory risks for businesses
by operating transparently and under the rule of law;
3. fights corruption;
4. minimizes costs to regulated entities and optimizes costs to
governments using resources efficiently to target the
highest risks.
THANK YOU