Theme: External and internal audit of the quality system: Audit conditions. Plan of audit. Documentation of audit

Lecture plan:

1 Basic concepts about internal audit

2 Main stages of carrying out internal audit

3 Requirements to resources

4 Requirements to auditors - the principles, competence

5 Criteria of productivity of process

6 Working procedures

7 Documentation of internal audit (Appendix)

8 Certification of quality systems

8.1 Purposes and conditions of carrying out certification of quality systems

8.2 Carrying out certification of quality systems

8.3 Final meeting

8.4 Inspection control of the certified quality system

 

1 At introduction and functioning of quality management system at the enterprise (organization) procedure of planning and the organization of carrying out objective and independent internal audits of QMS, assessment of compliance to the carried-out activity to requirements of the RK ISO 9001:2001 ST standard, policy of the enterprise in the field of the quality, the Quality manual and other documents QMS used by the checked organization (division, department, the top management and the director), documentary registration of the conclusion by results of audit, use of these results for maintenance of procedures and processes of QMS in working order and for improvement of procedures, processes of QMS and Quality management system in general is developed.

Procedure serves as the management for auditors (internal), the booking internal audits, to heads of divisions of the enterprise, owners of procedures and processes of QMS. Carrying out internal audits requires knowledge of such concepts as:

Criteria of audit - set of policy, procedures or requirements

Audit area - volume and borders of audit

The plan of audit - the description of activity and actions for audit

The checked organization - the organization subjecting to audit (division of the organization).

"Internal audit" is the process purpose:

- planning of internal audits; carrying out objective and independent internal audits of QMS;

- an assessment of compliance to the carried-out activity to requirements of the RK ISO 9001:2001 ST standard, Policy of the enterprise in the field of quality, Quality manuals, other processes and procedures, and also the standard documentation used by the checked organization (division, department, group, the top management);

- an assessment of compliance to the carried-out activity to requirements of the Consumer;

- documentary registration of the conclusion by results of audit;

- use of results of audit for maintenance of procedures and processes of QMS in working order and for improvement of procedures, processes of QMS and Quality management system in general;

- improvement of methods and procedures of carrying out internal audits;

- continuous increase of competence of internal auditors.

Constantly carried out internal checks and works on identification and elimination of discrepancies provide confidence of the consumer as production of the enterprise.

- internal audits (checks) can be planned and unplanned.

- planned audits are booked according to the schedule of carrying out the internal audits made and approved till December 20 of the current year the next year.

- unplanned audits are booked out of the annual schedule of carrying out internal audits according to the indication of the top management and the representative of the management in the following cases:

a) on request of consumers;

b) changes of organizational structure of the organization;

c) modification of QMS;

d) preparation for certification of QMS;

e) possibility of emergence of problems with quality;

- by inquiries of the organization additional internal audits can be booked.

The representative of a quality manual is responsible for carrying out internal checks. Belongs to its duties:

- definition of the checked organization, areas and the purpose of audit;

- development and the statement at the top management of the annual schedule of carrying out internal audits;

- development and the statement at the top management of the schedule of unplanned internal audits;

- organization of planning and carrying out internal audits;

- operating control and assessment of results of internal audits;

- control of timely registration of reports on audit;

- control of works on development and performance of the correcting and/or precautionary measures for elimination of the discrepancies revealed during audit;

- control of registration and storage of documents on internal audits;

- methodical help to auditors;

- organization of discussions of results of audits;

- permission of the possible conflict situations arising during internal audits;

- preparation of data on results of audits for the analysis from the top management and for process of continuous improvement.

The service of quality of the enterprise annually forms structure of the experts capable to carry out internal quality checks. The structure of these experts is approved by the order on the enterprise and made out in a matrix of distribution of responsibility.

 

3 of a stage of carrying out internal audits treat the main:

Name of stages of process The responsible Records (output)
1 Planning of internal audit Representative of a quality manual The schedule of carrying out internal audits (the approved form)
2 Choice of group on audit Representative of a quality manual The list of internal auditors the appendix Zh, the Personal leaf of the accounting of the auditor (the approved form)
3 Scheduling of audit and the notification of the checked division Head of group on audit Plan of audit appendix L
4 Preparation for carrying out audit Auditors The auditor questionnaire the appendix K of the Task to internal auditors (the approved form)
5 Representation of auditors and appointment of attendants Unit manager  
6 Carrying out introduction meeting and an explanation is more whole than audit Head of group on audit  
7 Direct carrying out audit Auditors  
8 discrepancy Is revealed? If yes, that transition to a stage 9, differently to a stage 10 Auditors  
9 Registration of a leaf of the revealed discrepancies Auditors Leaf of the revealed discrepancies (the approved form)
10 The volume of check is finished? If yes, that transition to a stage 11, differently to a stage 7 Auditors  
11 Meeting of auditors and decision-making Auditors The report on audit (the approved form)
12 Final meeting Auditors  
13 Preparation of the report Auditors  
14 Elimination of discrepancies Unit manager Protocol of meeting
15 the Correcting measures are necessary? If yes, that transition to a stage 16, differently transition to a stage 20 Auditors  
16 Development of the correcting measures Division Leaf of the revealed discrepancies (the approved form)
17 Realization of the correcting measures Division Oral message
18 Check (verification) of realization of the correcting measures    
19 Objectives are achieved? If yes, that transition to a stage 20, differently to a stage 16 Auditors Mark in Liszt of the revealed discrepancies (the approved form)
20 Preparation of the report on audit Auditors The report on audit (the approved form)
21 Mailing of the report on audit   List of mailing appendix P, PR-02
22 Preparation of data for the analysis from the management and for process of continuous improvement Representative of a quality manual Condition of carrying out internal audit of QMS of the enterprise (the approved form)
23 Storage of records on internal audit Service of quality  
Destruction of records on internal audit after a period of storage Service of quality The act of destruction of records (the approved form), PR-03

 

Requirements to resources

The resources demanded for successful performance of stages of works, process of the project in general are given in the table

Table 1 - The demanded resources for process realization "Internal audit"

 

Types of resources Quantity Note
Human resources: - internal auditors In process of development of system, expansion of amount of works the number of internal auditors is specified
Infrastructure: - buildings, rooms; - computer personal; - printer; - copier; - fax; - e-mail; - internet - Requirements to buildings and rooms it is described for century of PK-01
Conditions of the production environment - it is described in PK-01
Information, all documents (entrance and output) - it is described for century of the appendix B, B
Method of performance of work, normative documents - ST RK ISO 9001:2009, documents on QMS

 

 

4 Auditors have to be guided by the following principles:

a) ethic behavior professionalism basis The trust, honesty, confidentiality and politeness are a condition of carrying out audit;
b) impartiality The obligation to report truthfully and precisely supervision of audit, the conclusion by results of audit and record reflect truthfully and precisely activities for audit. The essential hindrances revealed during audit and also unresolved problems or disagreements between group of auditors and the checked organization are reflected in Reports;
c) professional diligence Manifestation of accuracy and common sense when carrying out audit auditors show professional diligence according to importance of the carried-out task and trust on them the customer of audit and other interested parties. Existence of necessary competence is an important factor;
e) independence Basis of impartiality and objectivity by results of audit auditors are independent of the checked activity and are free from prejudices and the conflict of interests. Auditors rely on objective judgments during all process of audit for the purpose of providing that at the heart of supervision and the conclusions by results of audit there is only evidence of audit;
e) approach on the basis of the facts Rational method for achievement of the reliable and reproduced conclusions of audit at systematic process of audit the evidence of audit is checked. It is based on selections of available information as audit is carried out during the limited period of time and limited resources. Use of the corresponding selections is closely connected with reliability which has to be present at the conclusions by results of audit.

 

Ensuring competence of internal auditors:

- internal auditors take courses according to the program of internal auditors;

- internal auditors participate during the developing, approbation and introduction of the procedures and processes issued in the form of firm standards;

- the representative of a quality manual provide training with internal auditors;

- internal auditors have to study and know requirements of ST RK ISO 9001:2009;

- internal auditors owe the nobility Politika and the purposes in area of quality of the organization;

- internal auditors have to study and know requirements of processes of Quality management system;

Requirements to internal auditors:

a) should not be the staff of the checked division and should not participate in the checked process of QMS;

b) should not bear responsibility for the checked sphere of activity;

c) to have idea of specifics of the checked processes;

d) to know fundamental normative documents of QMS of the enterprise, methods of the organization of carrying out internal audits;

e) to be able to work with documents, to analyze results of check.