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8 Quality  Degree to which a set of inherent characteristics fulfils a need or expectation that is stated, generally implied or obligatory.  ISO 9000:2000  Definition

9 Quality audit  Systematic, independent and documented process for obtaining evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.  ISO 9000:2000  Definition 2.9.1

10 Audit criteria – –Set of policies, procedures or requirements against which collected audit evidence is compared. –Ex:Customer requirements, Documented quality system, Company standards, ISO 9001:2000 –ISO 9000:2000 –Definition 2.9.4

11 ISO 19011:2001 m Scope  It is applicable to all organizations implementing, maintaining or auditing a quality and/or environmental management system and thus having a need to conduct and manage internal and/or external management system audits.

12 Quality system audit types  1st Party - WE auditing our own system (Internal)  2nd Party - WE auditing our supplier (External)  3rd Party - WE being audited by a registration body, (TUV) (External)

13 Audit objectives  Objectives for an audit might be any of the following:  a)determining the extent of conformity of the auditee's management system to specified requirements.  b)evaluating the capability of the management system to ensure compliance with legislative requirements  c)evaluating the effectiveness of the implemented management system in meeting specified objectives  d)identifying areas of potential improvement of the management system

14 Auditing benefits * Verifying compliance  *Providing information for management  review  * Increasing quality awareness  *Reducing risk of product/service failures  Identifying improvement opportunities

15 Auditors responsibilities *Complying with company requirements *Assist with preparing audit schedule *Carrying out the audit *Record and report the findings *Carry out follow-up audit *Maintain independence and confidentiality *Maintain audit records

16 Auditor attributes  Open mindedness  Tenacity  Diplomacy  Decisiveness  Observant  Self-reliance  Perceptiveness  Integrity

17 Auditing Process  Six phases of a structured audit:  - audit scheduling  - Preparation  - conducting the audit  - reporting the results  recording proposed corrective action and timescales  -following up actions

18 Audit planning *The organization shall plan the audit programme taking into account the status and importance of the activities and areas to be audited as well as the results of previous audits (ISO 9001:2000 Clause 8.2.2)

19 Audit planning  Departments Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec  Principals offi p p A p A  Agricultural Coll. P  City college p A A  Eastlands college p A  Technical college A p A  Purchasing A pA p  Kitchen A A p  Chem. Laboratory A p  Documents/records AA p  Auditing AA p  Food storeA p  Key:P = Audits scheduled on the basis of IMPORTANCE only  A = Additional audits taking into account the STATUS and  IMPORTANCE. 

20 Planning decisions  frequency  timing  scope  objectives  auditors

21 Preparing for the audit  An audit plan needs to be prepared which  includes as appropriate:  a)audit objectives and scope  b)audit criteria and reference documents  c)areas and /or activities to be audited and the agreed dates of the audit(s)  d)identification of any processes to be audited  e)audit duration  f) the need for guides and their responsibilities  g) audit method

22 Audit documents *audit procedures *nonconformity report forms *audit summary report forms *corrective action schedule *checklists

23 Checklist benefits  Maintains clear audit objectives  Evidence of planning  Maintains audit pace and continuity  Reduces risk of auditor bias  Manages auditor workload  Records sample of activities in the audit

24 Audit method Vertical (Upstream/ downstream) *Horizontal

25 Conducting the audit  Opening meeting  Collecting and verifying information  Record audit findings  Keep auditee informed  Prepare reports  Report audit findings

26 Questions  The six "friends" of an auditor: The auditors seventh "friend"  What?  Show me (please)  Why?  Where?  When?  How.?  Who?

27 Classifying  Major nonconformity might be defined as:  A nonconformity of such severity that its existence would indicate that a nonconforming product or service could be released to the customer or, where the requirements of an appropriate clause of ISO 9001:2000 has not been adequately addressed.

28 Classifying  Minor nonconformity might be defined as:  A situation where there is a likelihood that nonconforming product or service will occur, or where the benefits of ISO are not being realised, because of the absence of, or lack of adherence to a procedure.

29 Report meeting  Summarise findings  Review nonconformities  Agree commitment for corrective actions  Agree timescales

30 Follow-up options  Verification at location of audit findings  Review of documentation  Verification at next audit