Safety Management and Audit: Analysis of Audit Programs and Checklists

This report provides a comprehensive analysis of safety management and audit practices, focusing on internal and external audits. It begins by defining and differentiating between internal and external audits, outlining their objectives, responsible parties, and users. The report then details the process of forming an audit team, considering the necessary expertise for a company like Cromwell Pte Ltd, which manufactures military equipment. Furthermore, the report outlines a step-wise audit program planning process, including the development of an audit schedule and the importance of timely completion. An audit checklist for Cromwell's safety management system is provided, covering general controls, organizational responsibilities, employee training, plant security, and quality assurance. Additionally, the report includes a checklist for internal audit physical inspections, addressing areas like general safety, storage, and equipment maintenance. Overall, the report offers a practical guide to establishing and executing effective safety management and audit procedures.

Running head: SAFETY MANAGEMENT AND AUDIT
SAFETY MANAGEMENT AND AUDIT
Name of the Student:
Name of the University:
Author Note:

1Safety management and audit
Table of Contents
Answer to question 1:......................................................................................................................2
Answer to question 2:......................................................................................................................5
Answer to question 3:......................................................................................................................8
Answer to question 4:....................................................................................................................12
Answer to question 5:....................................................................................................................16

2Safety management and audit
Answer to question 1:
1. Basic difference between the internal audit and external audit are following:
 Basic definition: internal audit can be considered as a set to calculate and analyze firm’s
control that includes the corporate governance and accounting process. The auditors
ensures that they are following all the guidelines, laws and regulations so that they can
post the financial statements on-time. Whereas, the external audit is done for the purpose
of recognizing that the company is provided complete, real and true representation of
their financial position maintaining their bank balance, bookkeeping records and financial
transactions or not (Inspired Pharma Training., 2020).
 Objectives: the objectives of internal auditors is to routine review the process and
activities in the company which provides a scope of improvement and maintain the
financial statements as well (Auditnet.org., 2020). Whereas, the main objective of the
external audit is to analyze prepared financial statements of company and verify whether
it shows true figure or not.
 Who conducts the audit program: internal audit is conducted by selected internal
employees of the organization known as internal audit department and the external audit
is conducted by any third party for that company.
 Reporting responsibilities: the reporting responsibility of internal audit can be directly to
the company’s board of directors of that company because they are independent and they
are not answerable for it to the management. Whereas, the external audit has to inform
the shareholders in the Private sector companies and in Public sector companies they
have to inform the legislative body like Parliament. However, they are also not
answerable to the management (Pcaobus.org., 2020).

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 Users: management of the company is the user of internal audit and the users of external
audit are mainly the members, shareholders, the public at large and etc.
2. While preparing the list for audit team, the audit leader have to keep in mind about
the knowledge each team member possess.
 There has to be one director of that team and that person can be the audit team
leader (RCV Academy., 2020).
 Three auditors has to be chosen form the company who are seniors in that team.
However, they have to be from different fields. So one member each from
Chemical manufacturing department, research department and quality assurance
department. It is important that every member must have some knowledge
regarding the audit or auditing process.
 One of those members must be capable of understanding the language of that
country so one of the member must be selected who is the native resident of that
country (Aabri.com., 2020).
 Two experienced auditors should also be present into the team and hence both the
members will be selected form the finance and accounting team who have great
knowledge of how to prepare the financial statements on-time and they will help
the other members as well to understand the auditing process.
 It is also important to include at least one scientist and one engineer into the audit
team of Cromwell Pte Ltd because the firm is manufacturing equipment for
military department which has to be perfect. These members will help the other

4Safety management and audit
members to take decision on the basis of exact requirement regarding the military
needs and prospects.
 Apart from them, one OECI A&D Coordinator is also supposed to be present
during the review visit so that they can coordinate the peer review activities.
So, the audit team will consist one senior from each department who will have minimum
knowledge of auditing process and the team leader of the internal audit would be the coordinator
of Health, Safety and Environment because he was told to conduct an audit and form an audit
team. Without the presence of the audit leader the audit will not be conducted timely and the
financial statement may consist of some fraud figures (Mihret, 2014).

5Safety management and audit
Answer to question 2:
a) Step wise audit program planning
Step 1: identifying the need of audit the auditor need to identify the departments and the areas
where auditing needs to be done. Here the auditor will investigate all the department and look
out for any loophole or fraud in the figure of financial statement of that department
(Ehs.missouri.edu., 2020)
Step 2: preparing an audit calendar for how often the audit must be prepared. This will be
prepared as per the need of auditing. If the auditor fees that there is a huge difference between
the actual figure and recorded figure then frequent auditing or quarterly auditing will be
suggested otherwise it can be annually or half yearly.
Step 3: according to the audit calendar prepared by the auditor, the departments will be informed
to maintain their figures (Zhang, Yang & Appelbaum, 2015). The auditor will develop a calendar
identify the need
calender
inform
departments
proposal for audit
form a team
start auditing
submit report

6Safety management and audit
which will include the dates on which auditing will be done and the departments will be
informed accordingly so that they can rectify their mistakes before the audit team catches and
penalizes them.
Step 4: propose for audit conduction proposal has to be given to the board of directors of that
company. The auditor will propose for conduction of audit because after investigating the
departments he realized that it is necessary to conduct an audit so that the irregularities can be
minimized (Oyedepo & Oladele, 2013).
Step 5: Form an audit team according to the requirement which will consist of the internal
employees explained above. He will develop an audit team which will consist the members from
the internal company employees who have a simple knowledge regarding the auditing process.
Step 6: auditing process will start and all the financial figures will be analyzed accordingly.
Then the main investigation and analysis part will start where the auditors will extract the
financial figures and match with the actual figures.
Step 7: when the analysis is done then the audit report should be submitted to board of directors.
After the conduction of the audit program the report should be submitted to board of directors.
b) Audit schedule: Conducting an audit program within two days will be quite hectic for the
auditor. However, if every work is done with equal speed then it is possible (Powell et al., 2013).
Following are the steps that the auditor can follow to schedule the audit plan and they are:
1. This step will start after the investigating process. On the 1st day he will plan for the
internal audit by selecting two members of accounting team whom he have selected for

7Safety management and audit
the audit team. He will investigate regarding the organization risk and their goals in
market.
2. Then he will select the department heads of three departments stated above to understand
and estimate the risk and process of each department. The department can only specify
the external as well as internal risks of the department.
3. The auditor must have knowledge regarding the integrated framework. However, he
should revise and convey the whole framework to the whole auditing team he have
selected for the audit program.
4. On the same day the initial documents will be collected at emergency basis on the same
day so that work can be completed on the next day (Al-Khaddash, Al Nawas & Ramadan,
2013).
5. On the next day the work should be completed and each member should meet the
deadline. Along with this a meeting should be conducted with the stakeholders of the
business.
6. In the meeting the program and the plan will be reviewed by the stakeholders and the
actual result will be revealed. Accordingly future plans will be suggested by the audit
leaders and stakeholders for betterment of the firm (Costelloe et al., 2015).

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Answer to question 3:
AUDIT CHECKLIST FOR CROMWELL’S SAFETY MANAGEMENT SYSTEM
QUESTION
NO.
INSTRUCTION/QUSETIONS Yes/No/NA
1. General controls
Does every department and facility in the organizational unit
operate in the stage of controls?
2. Organizational & management responsibilities
Do the facility and business unit operates under facility or
corporate quality policy?
Sec 211.22(a) Do the quality assurance of unit is separate from
organizational entity?
Sec 211.22 Do QA department engage themselves in routinely
review of their production records for being sure of the
procedures which is being followed with proper document?
Sec 211.22(c) Are all quality assurance procedures written or
recorded properly?
3. Employee Orientation, their job training and quality awareness
Sec 211.25(a) Does each and every employee of the
organization receive considerable retaining on SOP if there is
any critic change in procedure?
Does on-going or periodic training in the organization is

9Safety management and audit
indicated properly?
Sec 211.25 (a) Are all temporary employees provided with
similar orientation and training like the permanent employees?
Sec 211.34 Are all consultants hired for the purpose of advising
the employees on manufacturing process, packaging or holding
and approval of releasing the drugs is asked to show verification
of their training, experience and educational degree?
4. Plant security and safety
Does the safety training procedure involves the details of the
employees like their name, the type of training they will be
provided, their date of providing training along with their
assigned trainer and also the participants.
Does all this facility involve corporate safety and security
program in it?
Does the security person of the organization available in the
place on a 24 hours basis?
Does the facility involve a written formal security policy?
Describe how all the entry is being restricted and monitored?
5. Internal quality/Cromwell’s Audit program
Does all the business facility and unit has written policy
regarding the quality of the accounting?
Does the copy of all the facility documents provided to the
employees?

10Safety management and audit
If “yes” to the above questions then when is it provided?
_________________________________
Does a formal written SOP include the details of who will
conduct the audits along with their qualifications like their
education degree, experience and training to provide to the
officials who conducts the audit program?
Do the officially written SOP describe the frequency and the
scope of audits and how it shall be written in a document?
6. Program for quality cost
Does the facility has a formal and periodic review for the
quality cost?
Does the facility has the through personnel, accounting records,
software, ability, capture quality and identifying cost?
Does the specified facility is capable of making a conscious
effort for reducing the cost of the quality in the organization
production?
7. Design control
Is this not related directly to 21 CFR Parts 210 and 211?
8. Facility control
Sec 211.42 (a) Do all parts of facility is prepared in such a way
that the product becomes perfect for manufacturing, holding and
testing of the drug products?
Sec 211.42 (b) is there enough space in the facility for typical

11Safety management and audit
volume of production and type of work?
Do the organization and layout of the facility prevent the drugs
from any contamination?
The facility NOT situated in the location which perfectly
reflects workers or the product that particulate infestation and
matter of the drug?

12Safety management and audit
Answer to question 4:
Checklist items for internal audit physical inspection Yes No NA
A. General – All areas
1. Are all of the ceiling tiles in proper place and in better
condition?
2. Are the machine and belt guards in proper place and in better
condition?
3. Are all the equipment properly adjusted and maintained to
prevent equipment damage and personal injury?
4. Do all the areas which requires use of protective equipment are
adequately displayed with warning signs and enforced?
5. Is damaged/malfunctioning equipment tagged “OUT OF
SERVICE”?
6. Does the consumption of beverages, food and etc., prohibited
where required?
B. Storage
1. Are all chemicals stored in air-tight containers?
2. Are all dangerous chemicals properly leveled?
3. Are protective valve caps in proper area when chemical is not
used?
4. Does the company uses correct regulator for their chemical
service?
5. Is empty and full chemical containers stored separately?

13Safety management and audit
C. Equipment for Personal protection
1. Are the equipment for personal protection enforced?
2. Do all personal protective equipment are free from any damage
and deterioration?
3. Do all employees uses the respiratory protection properly as
trained and authorized?
4. Do self-contained breathing equipment properly being
maintained/ inspected?
When a physical inspection took place in the last month by an auditor then the following points
were noted and revealed the situation of the firm (Ngoepe & Ngulube, 2016).
Checklist items for internal audit physical inspection Yes No NA
A. General – All areas
1. Do all the ceiling tiles in proper place and in better
condition?

2. Are the machine and the belt guards in place and in better
condition?

3. Does the equipment properly adjusted and maintained to
prevent equipment damage and personal injury?

4. Are all the areas which requires usage of protective equipment
adequately displayed with warning signs and enforced?

5. Does damaged and malfunctioned equipment tagged “OUT OF
SERVICE”?


14Safety management and audit
6. Is consumption of food, beverage, etc., prohibited where
required?

B. Storage
1. Are all chemicals stored in air-tight containers? 
2. Are all dangerous chemicals properly leveled? 
C. Equipment for Personal protection
1. Are the equipment for personal protection enforced? 
2. Do all the personal protective equipment free from any damage
and deterioration?

Comments over the above inspection table:
 When the auditor physically inspected and marked the checklist it was noted that the
checklist reflects true and similar condition of the firm in last month also. The current
auditor need to keep all the above points in mind and highlight the situation in the board
meeting while he will present the audit report in front of the board of directors and the
stakeholders (Lachwani, Srinivasan & Patnaik, 2015). All the points shows the actual
reason as why the production is lacking quality and quantity and these points need to be
considered in the audit program.
 All the points reveal that the workers are ignoring a lot of duties and responsibilities like
using the machine properly and shutting them down at the lunch time. They use to store
some food and beverages in the rest room which is prohibited. The lighting condition is
also poor in the staircase area where the workers use to smoke and waste their working

15Safety management and audit
time. They are also not using their ear-guards properly instead they are using them to
clean their dresses form any dust (The Thriving Small Business., 2020).
 The harmful chemicals are also not properly stored in the storage room. The lids are not
closed and the ceiling of that area is also ripping off due to the heavy chemical reaction.
Proper maintenance is done for the storage room and the employees are also not properly
supervised. Due to lack of supervision they have started to use the manufacturing area
and the machines as per their convenience. This has also affected the production of that
company (ISPE | International Society for Pharmaceutical Engineering., 2020).

16Safety management and audit
Answer to question 5:
After the completion of the audit report, the auditor will conduct one closing meeting to
Cromwell’s management to submit the report and prepare policies and agendas accordingly. The
minutes of closing meeting would involve the following points:
 Thank the auditees for their time.
Here all the audit members who were involved into the audit program will be given a thank you
note so that their work is recognized in front of the management.
 Thank them for allowing the audit leader to audit them.
The auditor will thank the organization who have appointed and allowed them to audit them by
providing the accurate figures and true picture of the manufacturing process (Knechel & Salterio,
2016).
 Remind the auditees of the reason for the audit.
The exact reason for the auditing program shall be accurately described like the difference that
was shown in the accounts of Cromwell and their manufacturing department’s condition.
 Remind the auditees of the standard that was audited against.
The auditees must be clarified regarding the accounts which were audited along with the reason
for auditing.
 Remind everyone that the audit is confidential.
The members who will be present in the meeting, they should be clearly informed that the
auditing process and result should be confidential (Martikainen, 2016).

17Safety management and audit
 Stating that the auditor have only looked at the sample of system.
It should be also clarified that the auditor have maintained the general guidelines and rules of the
auditing process (Ngoepe & Ngulube, 2014).
 Stating if the audit is invalid.
It is also important for the auditor to clarify that if the auditor has ignored or forgot to see some
specific activities then the audit must be invalid.
 Explaining how to present the findings.
The auditor have to present or declare how they have extracted, analyzed and put all the
information in a systematic way.
 Confirming any non-conformities and observations raised.
All the observation related to the condition of the manufacturing department has to be specified
in the meeting so that the audit report will be justified (Allford, 2016).
 Providing a closing summary on how the audit has gone.
As the auditor was provided with only 2 days for auditing, it is necessary to clearly state the
experience and the process which was implemented to complete the audit program
(Cleanenergyregulator.gov.au., 2020).
 Stating the final conclusion of the audit regarding satisfactory or unsatisfactory and
etc.
After the audit report is displayed, the auditor must provide a comment regarding how
satisfactory was the process. Here the auditor can state that the manufacturing department was

18Safety management and audit
under the level of satisfaction and the workers are also not paying attention to the condition of
the machines (Oeci.eu., 2020).
 Telling the auditees when they will receive the audit report.
The auditees must be informed regarding when they can access the original audit report in detail.
 Telling the auditees what is expected form them that they will do once they receive
the report.
The audit leader will state that the agendas and the policies which should be implemented when
the original audit report will get submitted to them for betterment of their organization
(Wallstreet Mojo., 2020).
 Allowing questions from other side.
The meeting should allow questions and solutions from both the sides and hence the managers
and other members in the meeting shall be allowed to ask any questions regarding the process of
the audit program and the conclusion part. Any suggestions can also be taken from the auditor
for the purpose of making policies and agendas regarding the betterment of the organization. The
auditor should also ensure that the organization agrees to the suggestion and implements it
afterwards. There should not be any clash between the managers and the audit leader
(PandaDoc., 2020).

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