8/17/2019 Audit (TQM)
1/26
AUDITBy Thers Pacquing
8/17/2019 Audit (TQM)
2/26
Highlights
What is Audit?
Types of Audit
Audit Classication
Purpose of AuditCertication
on!confor"ance
# classication of noncor"ities
8/17/2019 Audit (TQM)
3/26
What is Audit?
• Auditing is the on-site verification activity, such as inspection
or examination, of a process or quality system, to ensure
compliance to requirements. An audit can apply to an entire
organization or might be specific to a function, process, or
production step.
8/17/2019 Audit (TQM)
4/26
• Effective audits are vital to your business as they enable a site
to demonstrate whether control systems are working correctly
and effectively, and help you identify areas for improvement.
8/17/2019 Audit (TQM)
5/26
Types of Audit
• he !roduct
• he !rocess
• he "ystem
8/17/2019 Audit (TQM)
6/26
Audit Classication
Audit can be classified#
INTERNAL AUDIT
EXTERNAL AUDIT
8/17/2019 Audit (TQM)
7/26
• Internal Audit
• $s conducted by the organization itself %or conducted on behalf of the
organization& for internal verification, and review.
• $nternal audit is also known as '(irst !arty Audit) and it is an internal
management tool, by which an organization check the health of its
management system.
8/17/2019 Audit (TQM)
8/26
• he frequency of internal audits may vary, with activities in key
areas such as hygiene, good manufacturing practice, foreign body risks and critical control points %**!s&, +A**!
programme, prerequisite programs and procedures and cover
both the systems in place and work practices.
8/17/2019 Audit (TQM)
9/26
• $%ternal Audit
• his type of audit is conducted by an external, independent audit
organization %generally known as certification body&
• Also known as 'hird !arty Audit)
8/17/2019 Audit (TQM)
10/26
Purpose of Audit
o verify compliance, conformance, or
performance.
"ome audits have special administrative
purposes such as auditing documents, risk,or performance or following up on
completed corrective actions.
*ertification
8/17/2019 Audit (TQM)
11/26
Certication
• Example
• ISO 9001:2008 - QUALITY MANAGEMENT
SYSTEM
8/17/2019 Audit (TQM)
12/26
I&' ())*+,))- ! quality
"anage"ent syste"
Enables continuous improvement of your organization)s
quality management systems %"& and processes. $n turn,
this improves the ability of your operations to meet customer
requirements and expectations.
8/17/2019 Audit (TQM)
13/26
hese standards do not tell processors exactly what they should
do, but instead provide a framework for developing and
implementing systems to meet certain ends, namely quality,
food safety and environmental stewardship.
8/17/2019 Audit (TQM)
14/26
What are the occurrence in Audit?
NON-CONFORMANCE
3 CLASSIFICATION OF NON-CONFORMITIES
MINOR NONCONFORMITY
MAJOR NONCONFORMITY
CRITICAL NONCONFORMITY
8/17/2019 Audit (TQM)
15/26
on!confor"ance
• Nonconformi!
onconformity is the "non-fulfillment of a requirement". $t
is a failure to comply with requirements. A requirement is a need,
expectation, or obligation. $t can be stated or implied by an
organization, its customers, or other interested parties.
8/17/2019 Audit (TQM)
16/26
.inor on!confor"ity
• A minor non-compliance is a non-compliance that is not likely
to compromise food safety or lead to the handling of unsafe or
unsuitable food.
• ote, with minor non-conformities, the auditor should take care
to make sure that the auditee understands that/ a number of minors could demonstrate a system breakdown and perhaps
contribute to a ma0or.
8/17/2019 Audit (TQM)
17/26
.a/or on!confor"ity
• A ma0or non-compliance is a non-compliance that is likely to
compromise food safety or may lead to the handling of unsafe
or unsuitable food if no remedial action is taken.
• ote, with third party audits one ma0or non-conformity
normally results in a "non-c#rific$ion" recommendation.
8/17/2019 Audit (TQM)
18/26
Critical on!confor"ities
• A critical non-compliance is a non-compliance where the
contravention poses an imminent and serious risk to the safety
of food intended for sale.
8/17/2019 Audit (TQM)
19/26
• on-conformances are addressed with corrective
actions.
• Corrective Actions focus on 1existing2 non-
conformances. $s the action being proposed to
addresed the root cause.
8/17/2019 Audit (TQM)
20/26
Insight
8/17/2019 Audit (TQM)
21/26
References• Ph. D. Surak, G. and Stier, R. (2015) “Let’s Get Serius a!ut "nterna# $udits% retrie&ed 'arch
2, 201 fr*
htt+--.fdsafet/*aaine.c*-*aainearchi&e1-ct!ern&e*!er2015-#ete23044sets
eriusa!utinterna#audits-• #tn, $. “6ua#it/ 'anae*ent S/ste*s fr the 7d "ndustr/ $ uide t "S8 4001-2%
retrie&ed 'arch 2, 201 fr* htt+s--!ks.#e.c*.+h-!ks9
id:;$+:P$?>#+:P$?>d@:@ua#it/AassuranceAinterna#AauditAinAfdAind
ustr/>surce:!#>ts:si:7E3d"rR/"tGFcSH1S?*=>h#:en>sa:F>&ed
:0ahC
8/17/2019 Audit (TQM)
22/26
8/17/2019 Audit (TQM)
23/26
8/17/2019 Audit (TQM)
24/26
• "n ther rds, the @ua#it/ s/ste* is !ased n fr*a#it/,
hich itse#f +er*its !Hecti&it/. he audit is seekin t
&erif/ that the c*+an/
“Sa/s hat it des, des hat it sa/s, and has the recrds
t +r&e it.%
8/17/2019 Audit (TQM)
25/26
8/17/2019 Audit (TQM)
26/26
Ho0 to .anage
• $nspection "ystem
• *orrective Action "ystem
• anagement 3eview "ystem
•raining "ystem
• 4ocument *ontrol "ystem