Criteria of productivity of process

Criteria for measurement of efficiency and productivity of process are given in table 3

Table 3 Criteria of productivity of process "Internal audit"

Process purposes	Criteria of productivity of process
Definition compliance of quality management system to the planned actions, requirements of ST RK ISO 9001:2009, requirements of the Consumer, and also to requirements of the enterprise. Assessment of efficiency of introduction and support of quality management system, identification of possibility of improvement of QMS	1) Number of the booked internal audits 2) Number of the involved procedures and processes of QMS in the checked organization. 2) Amount of the revealed discrepancies 3) Quantity of the carried-out correcting and/or precautionary measures 4) Number of the realized correcting and/or precautionary actions 5) Quantity of the identified areas for improvement of QMS

Methods of monitoring and management of process

1 Planning of internal audit.

2 Distribution of works on auditors taking into account competence, experience, and also ensuring independence of the booked audits.

3 Attraction in necessary cases of technical experts, observers, trainees for training of additional auditors, and also for audit procedure demonstration.

4 Report of the representative of a quality manual to the top management.

5 Operational meeting.

6 Ethics and self-checking of the auditor.

7 Studying of requirements of ST RK ISO 9001:2009.

8 Studying and analysis of documentation of QMS.

9 Preparation for audit.

10 Direct carrying out audit.

11 Interview.

12 Supervision on workplaces.

13 Control from the representative of the management.

14 Verification of the carried-out correcting measures and/or precautionary measures.

15 Consideration and approval of the schedule of carrying out audit by the top management.

16 Internal audit (according to the plan of audit).

17 External audit (according to the plan of audit).

18 Preparation of the report on audit.

19 Increase of competence of auditors by studying of special literature on methods of carrying out audits, continuous professional development and regular participation in audits.

20 Systematic analysis of the booked audits.

21 Certification of auditors according to the plan of certification of the enterprise.

The identified risks and measures for their exception

The main problems in the organization and implementation of process able to arise under certain conditions and offers on their decision depending on their origin are provided in tables 4 and 5

Table 4 "Internal" risks of process

The identified risks of process	Measures for an exception (prevention) of risks
1 Lack of experience of carrying out audit	Carrying out trainings with auditors during preparation for audit
2 Possible conflicts during internal audit	Training of auditors in methods of carrying out audits and explanation of the principles of audit

Table 5 "External" risks of process

The identified risks of process	Measures for an exception (prevention) of risks
1 The claim from the Consumer	Planning of unplanned internal audits
2 Discrepancies found during certified and supervising audits.	Planning of unplanned internal audits

Working procedures

1 The structure and the main stages of process is shown in table 3.

2 The flowchart of process is given in the appendix 1.

3 Realization of process consists in the following.

4 It agrees, to the algorithm given in the table 3, works on internal audits begin with a planning stage.

5 At this stage the schedule of carrying out internal audits the application 2 is developed and approved. The draft of the schedule of carrying out internal audits the forthcoming year is developed by Service of quality till December 20 of the current year, coordinated and transferred to the Representative of the Quality manual in QMS who makes the decision what processes and divisions and in what sequence have to be subjected to internal checks. Development of the schedule of carrying out internal checks is carried out taking into account:

- effective system audit of the processes involved in QMS;

- checks of kinds of activity at least once in two years;

- need of confirmation of performance of the correcting and warning measures developed and realized following the results of the previous checks;

- indications of the top management;

- initiative proposals of heads of divisions and responsible for processes:

6 The schedule of carrying out internal audits (checks) is approved by the director of the enterprise

7 Approved schedule of carrying out internal audits by service of quality is dispatched to all divisions of the organization.

8 The accounting of the trained auditors is carried out by Service of quality of the appendix 3 and 4. The list of the acting internal auditors is revised in process of appearance of new auditors, or dismissal old, but at least once a year.

9 In two weeks before a review period of object of PRK forms group on audit of the available list of auditors, appoints the head of group of auditors and notifies heads of divisions in whom these employees work. Audit can be booked by one auditor.

10 The group on audit studies results of the previous audits and makes the plan of audit the appendix 5 which has to include:

- audit purposes;

- audit area;

- criteria of audit;

- date of audit;

- the checked organization (the top management, departments and groups);

- distribution of responsibility and powers between members of group of check (in respect of audit in column 4, appendices L it is specified by the first First name, middle initial, last name the head on audit);

- the list of the documents which are subject to obligatory check;

- method and procedure of carrying out audit:

11 The head of group on audit notifies the checked organization in five days prior to the planned date of audit.

12 The group on audit carries out preparation for carrying out audit for what develops the List of control questions on the basis of the Auditor questionnaire the appendix 6.

13 The representative of a quality manual checks readiness of group on audit for carrying out audit.

14 V the head on audit start the planned day carrying out audit. The head of the checked organization represents auditors, appoints attendants, allocates employees for work with auditors.

15 The head of group on audit holds introduction meeting at which explains the purposes, criteria, audit areas, acquaints with methods and procedures of carrying out audit, to an order of classification of discrepancies.

16 During internal audit the auditor studies documentation of the organization, carries out collecting and verification of information, conducts interview to employees, watches performance of work by employees on workplaces, compliance of the performed works to requirements of criteria of audit makes sure, reveals and classifies discrepancies.

17 At detection of essential discrepancies the appendix 7 makes out a leaf of the revealed discrepancies.

18 Each auditor carries out preparation of the conclusion by results of audit as a part of the report on audit the appendix 8.

19 If necessary auditors hold meeting and make decisions on a being of audit.

20 Upon termination of audit the final meeting at which the head of group on audit orally informs the head of the organization about result of audit is held and together with the head of the organization solves need of carrying out the correcting and/or precautionary measures.

21 If necessary the head of the checked organization develops the correcting and/or precautionary measures about which realization reports to service of quality.

22 Auditors in addition check extent of realization of the taken correcting and/or precautionary measures; in case of controversial issues the final decision on them is made the representative of the management.

23 Result of check are made out within two working days in the form of the report on audit the appendix 9. In the report need of carrying out and preliminary date of unscheduled inspection can be established. The report is formed the head of group of auditors, or the auditor authorized by it, on the basis of written reports of each auditor participating in check and is signed by all members of group of auditors.

24 Written reports are formed auditors in day of carrying out audit according to the appendix 10.

25 The head of group on audit acquaints the head of the checked organization with the report on audit, under a list in the report, with the right of expression of a dissenting opinion in writing.

26 The report on audit is approved by the representative of a quality manual. In case of need carrying out unscheduled inspection the Representative of a quality manual in QMS prepares request addressed to the president for modification of the schedule of carrying out internal audits.

27 The report is registered the head of group of auditors of the appendix 11 and together with reports of members of group of auditors is stored within 5 years in SK. For transfer of the report to the head of the checked organization by the head of group of auditors the copy is made it and in the free column on each of sheets writes: "True copy", specifies date, subscribes and puts the position, a surname and initials. For example:

"True copy 22.05.04 (signature) engineer of SK First name, middle initial, last name"

Mailing of the report on audit is carried out according to the list mailing (appendix 10)

28 On the discrepancies specified in the report the head of group of auditors, within two working days, "Sheets of the revealed discrepancies" according to PR QMS prepare and registered. The correcting measures.

Note - If discrepancies were eliminated during check, "Sheets of the revealed discrepancies" are not filled in, in the report the mark "Becomes is eliminated during check". On the discrepancies revealed repeatedly the mark "Becomes is revealed repeatedly".

29 Development and implementation of the correcting actions is carried out according to PR QMS. The correcting measures.

30 The assessment of efficiency of the correcting actions is given by group of auditors at the subsequent checks. If it is established that the discrepancies revealed before are eliminated, in "a leaf of registration of discrepancies" the mark becomes, it is considered "closed".

31 The service of quality by results of the carried-out inspections carries out every quarter preparation of data in the form of the report for the analysis from the management in which the following information is reflected:

- the volume of the carried-out inspections;

- the typical revealed discrepancies;

- efficiency of the actions which are carried out correcting and warning;

- conclusions and suggestions for improvement of QMS;

- the list of the persons guilty of the discrepancies revealed repeatedly.

The report is transferred to the representative of the management in QMS for the further analysis of a state and efficiency of QMS the appendix 11.

32 Responsibility for reliability of results of checks, completeness and accuracy of reflection of results of checks in reporting documentation are born by the auditors who are carrying out checks.

33 The representative of a quality manual operates inappropriate production according to PR QMS.

34 The representative of a quality manual carries out the correcting measures according to PR QMS.

35 The representative of a quality manual carries out the warning measures according to PR QMS.

36 Records on audit are stored in service of quality and after a period of storage are destroyed under the act the appendix 12, PR QMS.

Records on quality

- The list of records on quality is provided in table 3.

- The description of entrance documents is given in the appendix 2.

- The description of output documents is given in the appendix 3.

7 Appendices

Appendix 1

Appendix 2

Entrance documents (the documents arriving from other processes of Quality management system)

No. of a payment order

No. within the flowchart

Name of the document (message)

Purpose of the document (message)

supplier of the document (message)

Document identifier

Representation form

Note

Division

Process (subpro-tsess)

1-1

Indication of the top management

1-2

Instructions of the representative of the management

Notes - 1 are specified identifying designations of documents according to their designation in P where the form of documents is regulated in column 10;

2 purpose of the document Is specified in columns 4-7: "At" - for management; "П" - for confirmation; "And" - for the analysis; "Ud" - for use by other subsystems of management;

3 the form of documents is specified in columns 11-13: B - paper, E - electronic, At - the oral message.

Appendix B

Output documents (the documents and messages which appeared as a result of actions within process)

No. of a payment order

No. within the flowchart

Name of the document (message)

Purpose of the document (message)

consumer of the document (message)

Document identifier

Representation form

Note

Division

Process (subprocess)

1-1

Schedule of carrying out internal audits appendix E

2-1

List of internal auditors of the ave.

2-2

Personal leaf of the accounting of the auditor of the ave. And

3-1

Plan of audit of the ave. L

4-1

Auditor questionnaire of the ave. To

4-2

Tasks to internal auditors of the ave. of N

9-1

Leaf of the revealed discrepancies of the ave. M

11-1

Report on audit appendix P

Appendix 3

Output documents (the documents and messages which appeared as a result of actions within process)

No. of a payment order

No. within the flowchart

Name of the document (message)

Purpose of the document (message)

consumer of the document (message)

Document identifier

Representation form

Note

Division

Process (subprocess)

1-1

Schedule of carrying out internal audits appendix 6

2-1

List of internal auditors of the ave. 7

2-2

Personal leaf of the accounting of the auditor of the ave. 8

3-1

Plan of audit of the ave. 9

4-1

Auditor questionnaire of the ave. 10

4-2

Tasks to internal auditors of the ave. 11

9-1

Leaf of the revealed discrepancies of the ave. 12

11-1

Report on audit appendix 13

14-1

Protocol of meeting

17-1

Oral message

21-1

List of mailing appendix 14, PR QMS

22-1

Condition of carrying out internal audit of QMS of the enterprise appendix 15

23-1

Leaf of registration of reports on internal audits appendix 16

24-1

Act of destruction of records appendix 17, PR QMS

Notes

1 identifying designations of documents according to their designation in P where the form of documents is regulated are specified In column 10.

2 purpose of the document Is specified In columns with 4 on 7: "At" - for management; "П" - for confirmation; "And" - for the analysis; "Ud" - for use by other subsystems of management. 3 the form of documents is specified In columns with 11 on 13: B - paper, E - electronic, At - the oral message.
Appendix G