- •"Quality management system" for students of specialty
- •5В073200- «Standardization, certification and metrology»
- •Content
- •1. The main objective of studying of discipline of "Quality management system" and a task solved in the course of studying
- •2 Essence of quality as object of management
- •2.1 Concept of quality
- •4 Qualimetry
- •Table 1
- •Table 2 - Classification of indicators of quality
- •1 Main stages of development of control systems of quality
- •1.1 Formation and development of quality management. The factors influencing quality of production
- •1.2 The international standards on control systems of quality of production
- •2 General quality management is based on the following basic provisions:
- •3 Principles of tqm
- •5 Iso 9000 and tqm Standards
- •Iso 9000 and tqm standards
- •2 Standard algorithm of introduction of qms includes the following stages:
- •I claim:
- •Representative of the management
- •Interests of employees:
- •Interests of the enterprise:
- •Interests of suppliers:
- •Examples of the purposes in area of quality and Plans of quality
- •The purposes in area of quality of jsc Kaztsink on 200_ g.
- •Chief of of of f.I.O.
- •Director of az f.I.O
- •I claim:
- •Plan of quality of jsc Kaztsink
- •4 Responsibility and powers and exchange of information
- •Appendix a The terms and definitions relating to documents
- •Appendix b
- •1 Concept about processor approach to a control system at the enterprise (organization)
- •4 Cals Standards
- •3.3 Advantages of cals technology
- •4 Cals Standards
- •Elements of systems of management which benefit from integration
- •Ims is effective?
- •Process
- •Purpose
- •4 Methodology of statistical quality control
- •4.1 Mechanism of statistical product quality control
- •4.3 A role of statistical methods in management of productions
- •4.3.1 Control leaves
- •4.3.2 Pareto's analysis
- •4.3.3 Chart of the reasons and results
- •Control cards
- •3 Requirements to resources
- •5 Criteria of productivity of process
- •Methods of monitoring and management of process
- •The identified risks and measures for their exception
- •6 Working procedures
- •Appendix b Output documents (the documents and messages which appeared as a result of actions within process)
- •Appendix 3 Output documents (the documents and messages which appeared as a result of actions within process)
- •Matrix of distribution of responsibility of participants of process
- •Appendix d The requirements of st rk iso 9001:2009 and the requirement of the organization considered in process
- •Appendix e
- •Appendix Zh
- •List of internal auditors of qms of the enterprise
- •Appendix I
- •Personal leaf of the accounting of the auditor No. ____
- •(Signature, Surname)
- •Auditor questionnaire
- •Appendix l
- •Iso 9001 code: 4.2.4, 7.1, 7.2.3, 8.2.2, 8.3 Plan of audit
- •Appendix l
- •Iso 9001 code: 4.2.4, 7.1, 7.2.3, 8.2.2, 8.3 Plan of audit
- •Appendix m
- •Leaf of the revealed discrepancies No. ____
- •Analysis of discrepancy
- •Appendix n
- •Report on audit
- •Iso 9001 code:
- •The note - by italics the example of filling of this form is shown. Appendix p
- •Iso 9001 code:
- •8 Certification of quality systems
- •9 Tell about the identified risks and measures for their exception when carrying out internal audit
6 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 |
|||||||||||
|
|
|
|
|
|
|
|
|
B |
E |
At |
|
||||||
|
|
|
|
|
|
|
Division |
Process (subpro-tsess) |
|
|
|
|
|
|||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|||||
1 |
1-1 |
Indication of the top management |
|
|
|
|
|
|
|
|
|
|
|
|||||
2 |
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.
