Operations Management (Prof. Bechis)

ACT PHASE

(pdca)

• PREVENTIVE ACTION: action to eliminate the cause of a potential not

conformity or other undesirable potential situation.

• CORRECTIVE ACTION: action to eliminate the cause of a detected not

conformity or other undesirable situation.

• CORRECTION: action to eliminate a detected not conformity.

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CHECK PHASE (pdca)

AUDIT: are used to determine the extent to which the Quality Management

System requirements are fulfilled.

It is a systematic, independent and documented process to obtain audit

evidence and evaluating it objectively to determine the extent to which audit

criteria are fulfilled.

There are 3 types of audit:

s t

1 P

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t y A

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d

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t : they are conducted by, or on behalf of, the organization itself

an organization’s self

for internal purposes and they can form a basis for

declaration.

n d

2 P

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y A

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d

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t : they are conducted by customers of the organization or by

other people on behalf of the customers.

r d

3 P

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i t

: they are conducted by external independent organizations.

Such organizations, usually accredited, provide certification or registration of

conformity. st nd rd

One audit can be internal (1 party audit) or external (2 and 3 party audit).

The second party audits are generally conducted by parties having an interest

in the organization.

AUDIT FINDINGS: are used to assess the effectiveness of the Quality

Management System and to identify the opportunity for improvement.

AUDIT CONCLUSION: audit outcome provided by the Audit Team (ex.

report).

COMBINED AUDIT: when two or more Management System (Q.M.S.+

E.M.S. for example) are audited together.

JOINT AUDIT: when two or more auditing organizations cooperate to audit a

single auditee.

AUDITEE: is the organization audited.

AUDIT CLIENT: organization or person requesting an audit.

AUDITOR: person with the demonstrated personal attributes and

competence to conduct an audit. 8

AUDIT TEAM: is one or more auditors conducted an audit, supported, if

needed, by technical experts.

One auditor of the audit team is appointed as the auditor Team Leader (or

Lead Auditor). The audit team may includes auditors-in-training.

TECHNICAL EXPERTS: is a person who provides specific knowledge or

experience to the audit team. The technical expert does not act as an auditor

in the audit team.

OBSERVER: is a person who accompanies the audit team but does not

audit. An observer is not part of the audit team and does not influence or

interfere with the conduct of the audit. An observer can be from the auditee, a

regulatory or other stakeholders who witnesses the audit.

GUIDE: is a person appointed by the auditee to assist the audit team (ex.

translator); he is not part of the audit team.

AUDIT PLAN AUDIT PROGRAM

is the description of the Is the arrangement for a

activities and set of one or more audit,

arrangements for an audit. planned for a specific

timeframe and directed to

a specific purpose (many

PRINCIPLES OF AUDITING: audit in a specific time).

1. Integrity (to be honest)

2. Fair presentation (be able to report truthfully and accurately)

3. Due professional care (diligent judgment)

4. Confidentiality (security of information)

5. Independence (impartiality, objectivity)

6. Evidence-based approach (dataaudit evidences)

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AUDIT SCOPE: is the extent and boundaries of an audit. It includes a

description of the physical locations, organizational units, activities and

processes (can be outsource).

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1 P

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t (

I n

t e

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a l A

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:

The organization shall conduct (so is mandatory for certification) an Internal

Audit at planned intervals to provide information about whether the Quality

Management System:

• Conform to:

organization’s own requirement for its Quality Management

o The

System.

o The requirements of the international standard.

• Is effetely implemented and maintained.

The organization shall:

1. Plan, establish, implement and maintain an audit program (including

frequency, methods and responsibilities).

2. Define audit criteria and scope for each audit.

3. Select auditors and conduct audit to ensure objectivity//impartiality of

the audit process.

4. Ensure that the results of the audits are reported to the Top Manager.

5. Take appropriate corrective actions without delay.

6. Retain documented information as evidence of the implementation of

the audit program and the audit results (report).

The PROCEDURE for Internal Auditing should define:

▪ responsibility

▪ requirements for planning audits

▪ requirements for conducting audits

▪ requirements for establishing regards and reporting activities.

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MANAGEMENT REVIEW:

Top management shall review the Quality Management System at planned

intervals to ensure its continuing suitability, adequacy, effectiveness and

alignment with the strategic direction of the organization.

Input :

1. The status of the action from previous Management Review

2. Changes in internal and external issues relevant to Quality

Management System

3. Information on the performance and effectiveness including:

a. Customer satisfaction and feedback

b. The extent to which quality objectives have been meet

c. Process performance/products & services conformity

d. Not conformity/corrective action

e. Results of monitoring/measurements

f. Audit results

g. Performances of external providers

4. The adequacy of resources

5. The effectiveness of the actions taken

6. Opportunities for improvement

Output:

1. Opportunity for improvement (action)

2. Need for changes to Quality Management System

3. Resources need

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t ( C

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:

The initial certification audit of a Management System shall be conducted in

two stages:

• to audit the client’s Management System-

STAGE 1-AUDIT:

documentation. 11

• STAGE 2-AUDIT: to evaluate the implementation, including

of the client’s Management System.

effectiveness It takes place at the

site of the client.

Look at ISO 19011 for guidelines for auditing.

STAGE 1:

Audit the client’s management system documentation.

a. To evaluate the client’s

b. location and site specific conditions to

undertake discussions with the client’s personnel to determine the

preparation for Stage 2-Audit.

c. To review the client understanding regarding requirements of the

standard (in particular with reference to the identification of key

performance aspects, processes, objectives of the Management

System).

d. To collect necessary information regarding the scope of Management

System, processes, location of the client and related statutory and

regulatory aspects and compliance.

e. To agree with the client on the details of the Stage 2-Audit.

f. To provide a focus for planning the Stage 2-Audit.

g. To evaluate if Internal Audit and Management Review are being

planned and performed.

STAGE 2:

a. Information and evidence about conformity to all requirements of the

applicable Management Standard and normative elements.

b. Performance monitoring, measuring, reporting and review against key

performance objective and targets.

The client’s Management System and performance as regard Legal

c. Compliance. of the client’s processes.

d. Operational Control

e. Internal auditing & Management Review.

Management Responsibility for client’s Policies.

f. 12

g. Links between normative requirements and policy, performance

objectives and target, responsibilities, competences of personnel and

procedures.

PERFORMING AN AUDIT:

1) Initiating the audit:

a. Contact the auditee

b. Determine the feasibility if the audit

2) Preparing Audit Activities:

a. Document review in preparation of the audit

b. Preparing the audit plan

c. Assigning work to the audit team

d. Preparing work documents (ex. check list)

3) Conducting the Audit Activities:

Conducting the opening meeting (…) 

a. audit program

b. Performing document review (updated)

c. Communication during the audit

d. Assigning roles and responsibilities of guides and observers

e. Generating audit findings

f. Preparing audit conclusion (report)

g. Conducting the closing meeting.

4) Preparing and distribution of audit reports

5) Conducting audit follow-up: the conclusion of the audit can, depending

on the audit objective, indicate the need for correction/corrective

actions/preventive actions/improvement actions. Such actions are

usually decided and undertaken by auditee within an agreed timeframe.

As appropriate, the auditee should keep the person managing the audit

program and the audit team informed of the status of these actions.

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IF YOU WANT TO BECOME AN AUDITOR? (ISO 19011)

There is a personal behavior made by some characteristics:

• • •

Ethical Versatile Open to

• • improvement

Open minded Tenacious •

• • Collaborative

Diplomatic Decisive •

• • Culturally sensitive

Observant Self-reliant •

• Acting with fortitude

Perceptive 14

WORK ENVIRONEMENT ENVIRONEMENT

Set in conditions under which

work is performed (conditions

can include: physical, social,

psychological, environmental). SA 14001

SA 9001

OHSAS 18001

SA 8000: 2008

ILO: International Labor Organization

It edits ILO Conventions which are all about human rights, divided into three

categories:

• Core conventions

• Other conventions

• Recommendations

Conventions can be ratified by any nation (law) while recommendations are

guidance for the nation who has ratified.

Core Conventions:

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1. N.29 forced labor

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2. N.87 freedom of association

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3. N.98 right to organize and collective bargaining

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4. N.100 equal remuneration

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5. N.105 abolition of forced labor

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6. N.111 discrimination

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7. N.138 minimum age 15

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8. N.182 worst forms of child labor

SA 8000

Is about Human Rights, especially for Labor; inspired to ILO Conventions.

WORKER: all not-management people.

PERSONNEL: includes all individual men and women directly employed or

contracted by a company, including directors, executives, managers,

supervisors and workers.

CHILD: any person less than 15 years of age, unless the minimum age for

work or mandatory schooling is stipu