Presentation topic- Audit and Inspection of the dairy/food industry. From DSFT, IAS - BHU

1. DEPARTMENT OF DAIRY SCIENCE AND
FOOD TECHNOLOGY
INSTITUTE OF AGRICULTURAL SCIENCES
(IAS)
BHU, VARANASI
Topic- Audit and Inspection.
PRESENTED BY:-
Upendra Singh
M.Tech Dairy Technology
22412MDT017

2.  Introduction.
 Why do we need quality assurance ?
 Who should be involved in the QA process ?
 Audit and inspection.
 How to prepare for an audit ?
 Major Mistakes & Problems Mistakes.
 Alternative System of Inspection and Audit ?
 Local Audit and Accountability Act 2014.
 Role of Audits in Food Safety.
 Limitations of Audits.
 Improving Audits & Inspections.

3.  It is important there are appropriate audit and inspection
arrangements in place.
 For the purpose of this report public audit refers to
financial audit providing an opinion on financial accounts
and whether Value for Money (VfM) arrangements are in
place.
 Audit and inspection are often seen as inter-related with
inspection an extension of audit into performance.
 District Audit Service was set up in 1844, originally as
part of the Treasury, to ensure probity and proper
stewardship of public money.

4.  The sponsor is responsible for implementing and
maintaining quality assurance & quality control systems
with written SOPs.
 To insure that trials are conducted & data are generated,
documented (recorded) in compliance with protocol, GCP
& applicable regulatory requirements.
 The sponsor is responsible for securing agreement from
all involved parties to ensure direct access.
 All trial related sites, source data/documents & reports
for the purpose of monitoring and auditing by the
sponsor & inspection by domestic & foreign regulatory
authorities. ICH GCP 1997

6.  Audit
 The independent, systematic action to ensure the quality
of study data generated, is accurate reliability, and right is
protected and followed GCP, SOPs & applications in the
country.
 Inspection act by a regularities of conducting an official
review of documents, records and any other resources
that are deemed by the authority.
 Support regulatory authority decision
 Safety, Validity of data, regulatory compliance etc.
 When the data from the trial will be used for authority
approval.

7.  Should start from the beginning of the study.
 Ensure that we have the documents to prove that study
has been conducted properly.
(According to ICH-GCP, Local regulation, Institution SOP)
 All Party understand the protocol procedure.
 Any concern raised by any party should be documented.
 Third-party audits are relied upon within a single
company or supply chain for a number of reasons. For
some, it is a genuine desire to improve food safety, quality
and sanitation.

8.  Misconduct of the study-
- Study not being approved.
- Major protocol violation.
- Fraud data.
 Cause loss of reputation of investigator/ institute.
 Loss of reputation of sponsor.
 Withdrawal, termination of product license.
 Auditor’s job is to find mistake !
 Don’t arrange or make up, he/she will find anyway.
 Too good to be true when everything is perfect.
 As long as the mistake is minor & acceptable.

9.  It is possible, I believe, to devise a method of audit and
inspection that is committed to the achievement of
common agreed standards.
 It would be possible, however, to achieve a consensus
about what basic standards should be - even about
desirable improvements in these over time - that would
not divide the inspected from inspectors.
 The government has to some degree moved towards such
an acknowledgement in its advocacy of specialist schools
and even foundation hospitals, though it is clear that
other purposes, favouring not only difference but also
enhanced stratification and ranking.

10.  One of the purposes of inspectors would be, in
consultancy or facilitation mode, to assist and catalyse
this process, from their own knowledge and experience.
 Audits would be required first to report on how far
institutions met basic objectives.
 A process of inspection and audit which encourages
innovation and discovery might, one would hope, have
some effects all the way down on the habits of
managements, staff, and pupils and clients themselves.
 Much stress is now laid by government on
responsiveness to customers and customer-satisfaction
as criteria of good practice and good governance.

11.  Section 1 - Main Finding.
 Section 2 - Evaluation of the new audit regime and Audit Commission
abolition.
 Section 3 - Fragmentation of public sector audit regulatory space and
accountability under the new audit regime.
 Section 4 - Auditor independence.
 Section 5 - Audit scope.
 Section 6 - Inspection and improving services.
 Section 7 - Competition in the audit market and audit fees.
 Section 8 - Implications for accountability and democracy, and
 Section 9 - Conclusions.

12. Section 1 - Main Finding-
 The main finding of this report is that public audit should,
and should be seen to, serve the public interest.
 Public audit is not just another professional service.
 The audit and inspection system is not broken in terms of
what it does, but the question is whether it does the right
thing.
 Currently, for local government, it is known what local
authorities.

13. Section 2 - Evaluation of the new audit regime
and Audit Commission abolition-
 It is important that there is post-legislative scrutiny of the
Local Audit and Accountability Act 2014 to ensure the
new audit and inspection regime is fit for purpose,
together with an evaluation of the business case for Audit
Commission abolition.
 Outside of post-legislative scrutiny, a broader review of
the financial sustainability of local government (and
other local public bodies in general) should consider the
impact and implications arising from the new regime for
audit and accountability arrangements.

14. Section 3 - Fragmentation of public sector audit
regulatory space and accountability under the new
audit regime-
 The new audit regime is more fragmented compared to
the Audit Commission.
 However, in passing the Local Audit and Accountability
Act 2014, Parliament deliberately wanted to separate
functions.
 If a separate body was established should it cover all
public bodies, only local public bodies.
 This would cut across central government departments
and so need wide support.

15. Section 4 - Auditor independence-
 As a principle to uphold auditor independence, local
authorities should not be able to appoint their own
auditors.
 The public interest is for the auditors to represent the
public and not the officers and councillors of a local
authority.
 The principle of independent appointment of auditors
for all local bodies was breached under the new local
audit regime.
 In practice, however, most local authorities adopted the
central procurement arrangements of the PSAA.

16. Section 5 - Audit scope-
 The Audit Commission had both audit and inspection
elements to their regime.
 The additional responsibilities around inspection
extended the auditors work to give a qualitative
assessment that led to rankings and league tables.
 This led to the perception of the Audit Commission
being a regulator and not merely an auditor.
 This led to the perception of the Audit Commission
being a regulator and not merely an auditor.

17. Section 6 - Inspection and improving services-
 However, contrary to popular belief, the inspection and
intervention were never part of the audit, but a separate
function that has ceased.
 The sector-led approach of the LGA is there as a
voluntary means of the sector improving itself and is not
designed to be a substitute for the Audit Commission
inspection process.
 The MHCLG should not therefore attach too much weight
on that in the accountability system.

18. Section 7 - Competition in the audit market and
audit fees-
 The new audit regime has failed to increase audit market
competition for local government.
 The cost of the new audit regime and audit fees are lower
reflecting reduction in audit.
 scope, changes in activity and procurement efficiencies,
but benefits have also been lost.
 The quality component of the procurement bid process
should be higher.
 Staff training and technology.

19. Section 8 - Implications for accountability and
democracy-
 Arrangements for local people to be informed about VfM
and fairness are not in place.
 The new audit regime provides an opinion on financial
audit and conclusion on whether VfM arrangements were
in place.
 However, it does not say if there was delivery of VfM or if
fairness has been achieved.
 This is something that is lost from an accountability and
democracy perspective under the new local audit regime.

20.  The popularity of third-party audits has increased
corresponding to a shift in food safety governance away from
government regulation and inspection toward the
development of private food safety standards.
(Busch, 2011).
 There are many different food safety standards available
to food producers and manufacturers even within a single
industry segment.
 Third-party audits are relied upon within a single
company or supply chain for a number of reasons.
 It has been determined that creating a food safety culture
is imperative to an effective food safety risk management
system (Powell, Jacob, & Chapman, 2011; Yiannas, 2008).

21.  Audit systems, in their current form, have limitations in
improving food safety.
 There are no current empirical evaluations that look at
the correlation between audit scores and foodborne
illness.
 Third-party audits are analogous in many ways to
regulatory municipal inspections of foodservice
operations: the effectiveness of both audits and
inspections.
 Foodservice inspection is a cornerstone of local public
health, yet inspection scores can be poor predictors of
foodborne illness. (Powell et al., 2012)

22.  Food safety auditors and inspectors are an integral part
of the food safety system, and their use will expand in the
future, for both domestic and imported foodstuffs.
 Auditing can be helpful, in theory.
 Audit reports, are only useful if the purchaser who
requires them reviews the results.
 Audits and inspections can assist in the development of a
food safety culture by dictating criteria for the sale of
goods. (Acheson, 2010).

23.  On the contrary, I am in favour of a lively system of audit
and inspection, but one which has as one of its principal
goals to stimulate, facilitate, and support on going
improvements in practice.
 This goal is consistent with that of improving common
standards.
 Systems of inspection and accountability could become a
form of democratic empowerment, encouraging collective
identification with the public sphere.
 The micro-regime of regulation developed in recent years
has been in part the instrument of this conception.

24.  Laurence Ferry (2019). Parliamentary Academic Fellowship report by
Professor Laurence Ferry to Housing, Communities and Local
Government Select Committee, Audit and Inspection of Local Authorities
in England: Five years after the Local Audit and Accountability Act 2014.
 https://www.parliament.uk/business/committees/committees-a-
z/commons-select/housing-communities-and-local-government-
committee/audit-inspection-local-authorities-england/
 Rustin, Michael. (2004). Rethinking Audit and Inspection pp 86-107.
 http://www.ingentaconnect.com/content/lwish/sou/2004/00000026/0
0000001/art00007
 http://www.lwbooks.co.uk/permissions.html
 D.A. Powell a,*, S. Erdozain b,1, C. Dodd f, R. Costa c,2, K. Morley d,3,
B.J. Chapman e. (2012). Audits and inspections are never enough: A
critique to enhance food safety, Food Control 30 (2013) 686e691.
 http://dx.doi.org/10.1016/j.foodcont.2012.07.044