by N G Nair Manager (Mines) Malanjkhand Copper Project Malanjkhand Copper Project,
Khetri Copper Complex and Malanjkhand Copper Project
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Nair Profile
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A Geologist from Malanjkhand India
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Internal quality audit programme on ISO 9001:2000
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Quality Audit
1. Introduction
One of the requirements of ISO 9000 Standards is to carry out comprehensive system of planned and documented Internal Quality Audits to verify whether Quality activities comply with planned arrangements and to determine effectiveness of Quality System..
There are three important aspects of Quality Audits that emerge from above requirements.
a) Objective of Audit Determine effectiveness
b) Basic audit Planned arrangement such as Quality Manual, Procedures
and work instructions
c) Nature of Audit Comprehensive, Planned and Documented
1.1 Definitions: (ISO 9001:2000)
AUDIT – A Systematic and independent examination to determine whether Quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objective.
AUDIT SCOPE – Extent and boundaries of an audit.
CRITERIA – Set of policies, procedures or requirements determined as a reference.
AUDIT EVIDENCE – Records, statements of fact or other information relevant to the agreed criteria and which can be corsschecked.
AUDIT FINDINGS – Results of an audit.
AUDIT CONCLUSIONS – Out come of an audit provided by the audit team after consideration of all the audit findings.
AUDITEE – Organization being audited.
AUDIT TEAM – Person or group of persons conducting an audit
Note 1 – One or more persons of the audit team generally are qualified auditors and one of them is generally appointed as audit team leader. The audit team can include auditors-in-training and, where required, technical experts.
AUDITOR – A person appointed to conduct an audit.
Note 1 – An auditor generally has the qualifications necessary for the specific audit under consideration.
QUALIFIED AUDITOR – Person who has successfully passed on auditor qualification process.
It may be very clearly brought out that Audit is essentially a sampling exercise. It would be highly uneconomical to carry out Audit on hundred percent bases. The objective does not call for it either. The audit finding are based on objective evidence and not on “tell-tale” sings or surmises. Besides Audit generally brings out the instances of non-compliances or failures. It is not carried out to highlight achievements. Thus two facts must be realized.
(a) No non-compliance or failure defected in Audit does not imply that none exists. Depending on the (Size of the sample) extent of records, persons and activities examined the chance of finding one varies form situation to situation.
(b) However, the Auditee is considred INNOCENT UNTIL PROVEN GUILTY. Audits are not uncommon in other areas such as Finance, Cost, Inventory, Safety and Technical.
1.1.1 OBJECTIVE EVIDENCE
Evidence which exists
Uninfluenced by emotions or prejudice.
Can be documented
Is about Quality System
Can be quantitative (countable)
Can be quantitative (measured by degree)
Can be verified
1.2 Stages of audit
1.2.1 Adequacy Audit – Audit carried out on quality System Documents such as Quality Manual to ascertain that the System outlined in them meets all the requirements of the chosen (one of the ISO:9000 Series of the Standards)
1.2.2 Compliance Audit – Audit carried out of the practice to ascertain that it is according to the documented system.
In case of Adequacy Audit, in addition to the chosen standard, the requirements emanating from policy must also be fulfilled.
In case of Compliance Audit, the practice is compared with requirements stated in all the three levels of Documents i.e. Quality Manual, Procedures and Work Instructions. The practice must satisfy all of them.
1.3 Type of Audit
a) First Party Audit or Internal Audits
b) Second Party Audits, Sub-Contractor or Vendor Audit
c) Third Party Audit
1.3.1 Internal Audit or First Party Audit
Definition
Reasons for Internal Audits
Requirement of Quality System
Control Mechanism by Management
Prior to Second of Third Party Audit
Increase in Customer Complaints or Non-conforming Product
New product Introduction
Cutting Quality Costs
Verify the Corrective Action
1.3.2 Second Party Audit
The audit carried out by the Purchaser or his Representative on the Supplier’s Organization.
The Second party Audit carried out by our organization on our Sub-contractor’s or Vendor’s organization is referred as External Aduit.
The Second Party Audit carried out by our Purchaser or his pepresentative on our organization or on our sub-contractor’s or Vendor’s organization is referred as extrinsic Audit.
Reason for Second Party Audit
Requirement of Quality System
Improve Supplier’s quality system
Selection of New Supplier
Improve mutual understanding on Quality requirement (Supply chain turning)
1.3.3 Third Party Audit
Audit carried out by a Registering organization under a National or International scheme for certifying the Quality System or an Organization.
The Third Party Audit is also referred as assessment.
Reasons for Third Party Audit
Improve the Quality System
National / International Recognition
Recognition as achieving a bench-mark
Elimination or reduction of Second party Audit
1.4 Duties, Responsibilities and Role of Auditor
1.4.1 Duties
Remain with in the Audit Scope
Exercise Objectivity
Collect and Analyze relevant evidence sufficient to draw conclusions
Remain alert to any indications that may require deeper investigation
Find out if personnel have access to and are aware of documents, understand and
use them.
Find out if the System is adequate to achieve objective
1.4.2 Responsibilities
Comply with audit requirements
Communicate and clarify requirements.
Planning and executing assigned tasks in allotted time
Documenting observations
Reporting results
Verify collection actions, if required
Ensure confidentiality of documents and privileged information
1.4.3 Role of an Auditor
Find facts leading to improvement
Catalyst for change and improvement
Management instrument to find facts and changes required in the system.
Interface with Suppliers and Colleagues.
Avoid giving suggestions for corrective action.
1.5 Auditors Qualifications
Education and experience
Professional Competence
Communication Skills
Training and Qualification as Auditor
Record of Certification
Maintenance of Proficiency
Technical expertise in Area audited not essential but helpful. However, familiarity wit h major activities management system and working environment is desirable.
Qualification of Good Auditor
1. Objective
2. Preserving
3. Polite
4. Professional
5. Progressive
6. Industrious
7. Precise but Practical
8. Punctual
9. Principled
10. Positive
11. Pragmatic
12. Prepared
2. PREPARING FOR AUDIT:
2.1 Audit Plan
In case of Internal Audit, the plan and schedule of Audit is the responsibility of the Management Representative. He selects the team of Auditors, allocates department and sections to each Auditor or team of Auditors, defines the scope of audit and issues the schedule of them and the Auditee Department / Section.
2.2 Audit Objective
The objective of the audit is generally to find out suitability and effectiveness of Quality System. The extent or degree of compliance to the documented system is a part of the above objective. However, sometimes the objective may be as limited as the ability to produce a particular product and deliver it on time to the customer or to locate a problem area in fulfilling the planned targets.
2.3 Audit Scope
The Audit scope defines the extent of coverage of the audit. Generally, the following may form the scope:
a) Any particular (s) from among the many produced by the company.
b) Any particular department (s) Section (s)
c) Ascertaining implementation of corrective action to clear Non conforming reports.
d) Assessing status of changes made in the system.
2.4 Other information
The Auditor (s) must be provided the following information on the subject to plan for the execution of the Audit:
a) Quality policy objective
b) Functions and Activities
c) Quality system documents
d) Non-Conformity reports and progress on follow-up actions on previous Audits.
e) Number of Personnel and their levels
f) Any part of activity which is of ‘Strict Confidential’ nature and not accessible.
2.5 Strategy for Audit
The Strategy for Audit is generally decided by the Audit Planner.
a) Up-Stream Audit – In this, the Auditor begins with an identified product and traces all its record right from the beginning, e.g. product dispatched during last week, product on which a Customer Complaint is received or has been identified as non-conforming.
b) Down-Stream Audit – Here the Audit begins b selection of action at initial stage and traces all records down the line, e.g. beginning with an enquiry from a customer to the product supplied to him, beginning with a lot of raw material through all stages upto supply to a customer.
c) Across – Here a sample selected by one Auditor is referred to other Auditor to get related information from that department.
d) Random – Here each Auditor selects his own sample in the area allotted to him. No reference is made to other Auditor to get related information elsewhere.
Each strategy has its plus and minus points in terms of benefits from findings, possible uses of findings, complexity of actual audit and coordination required among different Auditors.
2.6 Preparation of Checklist
2.6.1 This is found to most useful technique to make the exercise of Audit more meaningful, objective and effective in terms of getting findings from the allotted time available. Every department or section has one or a few major, some minor and many supporting functions / activities. This is essential that a representative sample is drawn by the Auditor. Thus the numbers selected or time spent for Audit in major activities is comparatively much more than for other activities. Check sheet provides an action plan for Audit. In the absence of this Action Plan even an experienced Auditor is likely to lose track on many locations.
2.6.2 The check sheet list is somewhat different from the conventional checklist used in industrial practices where a direct yes / No response is intended. The auditor Checklist is used as aid-memoir. Corresponding to a question on the Checklist, there may be many supplementary is selected from the answer to the main question. The general two questions to keep in mind while preparing a Checklist are ‘what to look for’ and ‘what to look at.’
2.6.3 Where do we begin to prepare a checklist, of course, the quality system requirements? We find them stated in the Clauses of relevant ISO 9000 Stands, the approx. Quality Manual and the procedures. Keeping the objective and scope of the Audit in mind, select the ISO: 9000 requirement from the relevant clauses of the standard or the selection of the Manual or the Procedures. Note that the ISO:9000 clauses have two types of statements, or ‘the supplier shall’. The Auditor begins with these statements for the area of Audit defined by this scope. He raises a question to ascertain if such a requirement is satisfied or not. The answer to the question will lead to a number activities that the organization under takes which are generally given in the procedures and Documents / Records to establish that these activities are actually performed. These Documents / Records provide facts as verifiable evidence or objective evidence known as finding of the audit. The conclusions or objective evidence known as findings of facts as verifiable evidence or objective evidence known as finding of the audit. The conclusions or results of the Audits are based on these Documents / Records that an Auditor is going to look into. It also must indicate the approximate time the auditor is going to devote in scrutiny of the sample selected. It is worth while to use the enclosed profroma for preparing the checklists.
2.6.4 It is necessary for the Auditor to cover all requirements in his Audit, i.e. should audit the exhaustive in relation to the requirements? Generally, in the time available for audit, this may not be feasible. Even when the time is large enough, it may be worthwhile to concentrate on some of the requirements and see Documents / Records i.e. take a large sample. If he non-compliance / non-conformities. Again, while selecting the audit questions, it is important to include more questions related to major functions and activities and also select larger sample for scrutiny. Thus, the Auditor need not cover an exhaustive Checklist. Again the supplementary questions may or may not be included in the checklist. But for a new Auditor, it is a good practice to write them as well. Over a period of time, the compilation of checklists prepared by different Auditors would automatically given an exhaustive checklists for each area to the organization. an Auditor, it is important to include more questions for security. Thus, the Auditor, it is a good practice to write them as well. Over a period of time, the compilation of checklists prepared by different Auditors would automatically given an exhaustive Checklists for each area to the organization.
2.6.5 Benefit of Checklists
(a) Keeps audit objective and scope clear
(b) Evidence of planning of the audit
(c) Maintains audit pace and continuity
(d) Reduces Auditor’s bias (objectiveness improvement)
(e) Records of audit sample get generated
(f) Reduces workload
3 Execution of Audit
3.1 The internal audit execution formalities are much simpler. The Auditor(s) go to the Department / Section to be audited and talk to the Head. The audit plan is explained to him. This includes personnel to be interviewed. Documents and Records to be scrutinized and actual activities instruments and / or processes to be observed. In case there are questions on Checklists that the Head of Department / Section needs to answer, he can be interviewed at the beginning of audit or end of the examination of audit as mutually agreed. The Departmental / Sectional Head may himself or nominate some one else to accompany the auditor if considered necessary.
3.2 Since the Internal Auditor has a good understanding and grasp of management system, he needs little time to question people to understand the same. However, he may question them to assess their understanding and / or any differences that may be present among different personnel. He then proceeds with his checklist, examines the samples, asks supplementary questions, records the funding and proceeds with next question on the checklists. In case a potential trail the investigation depending on time available. However, in Internal Audit the time constraint is not as severe as in second / third party audits. If no problems are noticed, the Auditor should move on and not continue audit till a non-conformity is found out. Remember that audit is a sampling exercise and deviation from selected sample should be done only under special circumstances.
3.3 Taking Notes – Since the audit results are based on findings supported by ‘Objective Evidence’ it is necessary to take notes records the following:
a) Admissible statement made by a responsible personnel (designated)
b) Documents – indicate number and issue status.
c) Identifier – indicate item, batch, job
The information used as ‘Objective Evidence’ must be retrievable. The notes may be useful for present investigation or subsequent one, for further investigation in other departments or at the time of subsequent audit and hence must be legible and retrievable.
3.4 Audit Interviews – Since audit involves talking to people, the Auditor must be tactful in asking questions or soliciting information. He should talk as less as possible and make others talk more but relevant. He must be a good listener, respond mono syllabically to indicate his interest in what he is listening, not lose eye-to-eye contact and be polite and patient. Even when he realizes that the Auditee has misunderstood his question, he should not less his patience and avoid sudden interruption or contradict the Auditee. Without losing time, he must tactfully reframe his question. Auditors are generally seen as fault finders hence it is necessary for them to present themselves in such a way that people do not become defensive and non-communicative.
3.5 Questioning Technique – Make use of S W S and one H i.e. ask question b using words what, why, when, how where and who in that order. Since the auditor is involved with Quality System. It is better to avoid ‘who’ except when the authority or responsibility needs to be questioned. Ask ‘right’ questions – open, investigative, themed, expensive or opinioned questions. Some times it is useful to ask non-verbal and repetitive / dump questions. But their use should be limited. Avoid leading, hypothetical, assumptive or rhetorical questions.
3.6 Non-conformity Report / Discrepancy Report. The Audit result is finally comes out in the form of non-conformity / discrepancy report. It is necessary to indicate the following preparing this report:
a) Where was it found
b) What was exactly found
c) Why it is a non-conformity / discrepancy
d) Who was there – particularly when (b) includes an admissible statement
e) Use local terminology
f) Make it helpful to take corrective action
The auditor must be clear in his mind that he is focusing attention on the deficiency in the Quality System – the problems, which are related to the System. His report is not indicating a person or find him guilty.
3.7 Classification on Non-conformity – Generally they are categorized into the classes:
(a) Major and (b) Minor
Major Non-conformity
A significant non-compliance of a quality System Standard Requirement.
or
A failure of a complete system or the lack of Quality System requirement
or
A significant number or minor non-conformities together and leading to system failure.
Minor Non-conformity
An isolated witnessed incident of failure to comply with a procedure or Quality Management System Requirement.
During the initial stage of implementation of Quality System, it is better not to categorize the non-conformities and treat each on equal footing.
4. Follow-up Action on Audit
4.1 In case the exercise of the Audit is considered closed on receipt of NCR’s and Audit Report, it will not be beneficial to the organization at all. It must be understood that ‘improvement’ is the basis for Quality and Quality Management System. Hence follow-up action on Audit must be considered as integral part of system.
4.2 It must also be understood that Audit is a sampling exercise and hence correcting deficiencies pointed out in the Audit is an incomplete follow-up. The NCR found out are symptoms. He must understand the root cause and the corrective action must take this root cause. That can only result into a effective dynamic system.
4.3 Corrective action
4.3.1 The auditor is not responsible for suggesting the corrective action. It is the responsibility of the Auditee to find take remedial measures to ensure that the deficiencies reported do not recur in the system.
4.3.2 Certain deficiencies which relates to provision of some facilities, creating awareness, training people to follow procedures and making some minor modifications to Work Instructions or procedures can be easily identified. The remedial actions are known and need management perseverance to take them. However, in many situations simple solutions are not readily perceived. In such cases a structured approach based on ‘PDCA’ is necessary. The steps will include the following:
a) Identification of extent of discrepancy
b) Establishing the responsibility for controlling the Process (es)
c) Establish the receiver of the output
d) Establish the provider of inputs
e) From a Team to study the problem
f) Suggest Causes – all possible
g) Collect data and establish true causes
h) Suggest remedies
i) Suggest data to prove remedies
j) Test – out remedies by implementation
k) Determine the extent of success
l) Monitor – to make foolproof
m) Audit to conform results
4.3.3 The Auditee may be tempted to suggest and adopt quick – fix solutions to deficiencies reported. But unless a Holistic view is taken, some problem may arise in some other area. It is worthwhile to note that the objective of the entire exercise is to provide Quality Product to our customers which satisfies his needs.
A Mining Engineer from Copper Mines in India
NARAYANAN NAIR