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Quality only way to survive in ever changing & turbulent Competitive Market
© 2016. Workshop Designed & Conducted by: Gobburu Venkata 1
I M S
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QUICK GUIDE
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Webinar
ISO 9001; 14001; 18001
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www.facebook/generationnext.in 9810052083 @gobburu https://ae.linkedin.com/in/subarao1
Quality only way to survive in ever changing & turbulent Competitive Market
© 2016. Workshop Designed & Conducted by: Gobburu Venkata 2
Gobburu VS Rao comes with 30 years he has worked in automotive, aerospace, food, medical
devices, semiconductor, high technology, and various manufacturing and service industries
implementing management systems, performance-based systems, quality operating systems,
and top management training.
GVS RAO, conducts webinars in ISO 9001, 14001,18001, 22000, 27000 + including Implementing
Integrated Management Systems: QMS, EMS, OHSMS, FSMS –how its done in Aerospace,
Service, Semiconductor/Electronics, Automotive and Food and Workshop s How to Audit ISO
9001:2015, 14001:2015; 18001:2007; 22000:2005; 27001:2013 etc;
GVS Rao also working on a book on Leadership for ISO 9001:2015
This course module HOW TO SUCCEED IN integrated management system using ISO 9001, 14001,
18001.
.
Quality only way to survive in ever changing & turbulent Competitive Market
© 2016. Workshop Designed & Conducted by: Gobburu Venkata 3
Interviewing
It is ironic that probably the most sensitive part of auditing is the most
difficult to teach, and is more an acquired skill. Interviewing is essentially the
technique of gathering information from another individual by asking a series
of questions. This may sound easy, but there are varying styles of questions
that will prompt different types of answers.
For example, closed questions (i.e., yes -no answers) will not yield details or
explanations. It is not feasible to assess how well someone understands a
concept by using closed questions. On the other hand, there is a time for
closed questions, usually when the auditor wishes to verify a point or time is
short. Keep in mind also that the auditor can ask additional clarifying
questions to elaborate on a point. Other types of questions, such as
antagonistic or leading are not recommended. Also, keep in mind that
silence, allowing the interviewee to think, is also a valid technique of
obtaining information. In general, interviews should be characterized by
structured, thoughtful questions, putting the auditee at ease, explaining what
is required, listening to the response, and avoiding personal judgement.
There are a few basic questions that are nearly always asked, at least to
begin discussions. It should be noted that interviews are situation-specific,
and many other clarifying questions may follow those listed below
First Set
Are you familiar with the polic
ies and Integrated
Management System?
What do you do in case of a
procedural non-conformance?
What do you do in case of an
emergency?
What kind of training have
you received?
How do you communicate
concerns or ideas
Second Set
What are the significant
aspects and impacts
associated with your function?
How do you know what to
do? (ask for procedures and
Operating criteria).
What specific training have
you received?
Are there any objectives and
targets associated with your
Function?
Are you responsible for any
monitoring and measurement
Activities?
What records do you keep?
Typical auditees
 Plant management;
Management representatives;
Department managers;
Document control and record
departments;
Research and development;
Engineering;
Operations employees (plant,
administration);
Human resources and training;
Contractor management and
purchasing;
Security
Documentation review during the audit, the auditor will be reviewing a wide
variety of documentation. Documents will vary from high-level management
policies and procedures to specific records. In general, the documentation
Quality only way to survive in ever changing & turbulent Competitive Market
© 2016. Workshop Designed & Conducted by: Gobburu Venkata 4
review is part of the overall evidence, gathering phase. More specifically, the
auditor is looking for the following:
Does your documented system respond to the standard?
Do the procedures describe what's happening?
Is the documentation controlled?
Are all employees informed?
Are the procedures followed by everyone all the time?
Is there objective evidence that the procedures are being followed?
For example, listed below are typical documents reviewed when auditing
against various management standard elements. Obviously, the title and
format will vary from site to site.
The following list includes typical document types in addition to required
Procedures, which will facilitate verifying conformance to the specific
standards:
Sno Item Conformance Partial
Conformance
Non
Conformance
Not
Applicable
Not
Verifiable
Aspects procedure
1 (PROCESSES)
Aspects list - Significant
aspects/impacts list.
Sno Item Conformance Partial
Conformance
Non
Conformance
Not
Applicable
Not
Verifiable
Legal and Other Requirements
1 Applicable legal and other
requirements list;
Appropriate instructions for
compliance;
Permits, manifests, etc.
Sno Item Conformance Partial
Conformance
Non
Conformance
Not
Applicable
Not
Verifiable
Objectives and Targets
1 Minutes of objectives and
target development-Plan
List of objectives and targets;
Related action plans
Quality only way to survive in ever changing & turbulent Competitive Market
© 2016. Workshop Designed & Conducted by: Gobburu Venkata 5
Sno Item Conformance Partial
Conformance
Non
Conformance
Not
Applicable
Not
Verifiable
Structure and Responsibility
1 Job descriptions
Organizational charts
Sno Item Conformance Partial
Conformance
Non
Conformance
Not
Applicable
Not
Verifiable
Training Awareness and Competence
1 Training needs listings/matrix
Manuals, course materials;
Sign-in sheets;
Test records, certificate copies,
etc
Sno Item Conformance Partial
Conformance
Non
Conformance
Not
Applicable
Not
Verifiable
Communication
1 Specific work instructions;
Records of communication and
correspondence
Sno Item Conformance Partial
Conformance
Non
Conformance
Not
Applicable
Not
Verifiable
Document Control
1 Documents, procedures, and
manuals
Sno Item Conformance Partial
Conformance
Non
Conformance
Not
Applicable
Not
Verifiable
Operational Control
1 Critical operations/aspects
listing/matrix;
Specific work instructions;
Environmental issues and
instructions within other work
instructions;
Contractor policies, work
orders, etc.
Supplier requirements
Quality only way to survive in ever changing & turbulent Competitive Market
© 2016. Workshop Designed & Conducted by: Gobburu Venkata 6
Sno Item Conformance Partial
Conformance
Non
Conformance
Not
Applicable
Not
Verifiable
Emergency Preparedness and Response
1 Emergency plans and
protocols;
Practice and drill results
Sno Item Conformance Partial
Conformance
Non
Conformance
Not
Applicable
Not
Verifiable
Monitoring and Measurement
1 Function-specific procedures
and work instructions;
Objectives and target action
plans;
Records of monitoring and
measurement data collected,
including calibration records
Sno Item Conformance Partial
Conformance
Non
Conformance
Not
Applicable
Not
Verifiable
Non-conformance, Corrective and Preventive Action
1 Corrective action reports;
Evidence of discussion and
follow-up
Sno Item Conformance Partial
Conformance
Non
Conformance
Not
Applicable
Not
Verifiable
Records
1 Records;
Specific audit procedures,
checklists, forms, schedule;
Audit notes and working
documents;
Audit reports
Sno Item Conformance Partial
Conformance
Non
Conformance
Not
Applicable
Not
Verifiable
Management Review
1 Meeting agendas and
attendance;
Meeting minutes and action
items;
Evidence of follow-up actions,
reports, etc.

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Integrated Management System: 3 Party AUDIT -GUIDE

  • 1. Quality only way to survive in ever changing & turbulent Competitive Market © 2016. Workshop Designed & Conducted by: Gobburu Venkata 1 I M S ------------------------------------------------------------------------------------------------ QUICK GUIDE ----------------------------------------------------------------------------------------------- Webinar ISO 9001; 14001; 18001 ----------------------------------------------------------------------------------------------- www.facebook/generationnext.in 9810052083 @gobburu https://ae.linkedin.com/in/subarao1
  • 2. Quality only way to survive in ever changing & turbulent Competitive Market © 2016. Workshop Designed & Conducted by: Gobburu Venkata 2 Gobburu VS Rao comes with 30 years he has worked in automotive, aerospace, food, medical devices, semiconductor, high technology, and various manufacturing and service industries implementing management systems, performance-based systems, quality operating systems, and top management training. GVS RAO, conducts webinars in ISO 9001, 14001,18001, 22000, 27000 + including Implementing Integrated Management Systems: QMS, EMS, OHSMS, FSMS –how its done in Aerospace, Service, Semiconductor/Electronics, Automotive and Food and Workshop s How to Audit ISO 9001:2015, 14001:2015; 18001:2007; 22000:2005; 27001:2013 etc; GVS Rao also working on a book on Leadership for ISO 9001:2015 This course module HOW TO SUCCEED IN integrated management system using ISO 9001, 14001, 18001. .
  • 3. Quality only way to survive in ever changing & turbulent Competitive Market © 2016. Workshop Designed & Conducted by: Gobburu Venkata 3 Interviewing It is ironic that probably the most sensitive part of auditing is the most difficult to teach, and is more an acquired skill. Interviewing is essentially the technique of gathering information from another individual by asking a series of questions. This may sound easy, but there are varying styles of questions that will prompt different types of answers. For example, closed questions (i.e., yes -no answers) will not yield details or explanations. It is not feasible to assess how well someone understands a concept by using closed questions. On the other hand, there is a time for closed questions, usually when the auditor wishes to verify a point or time is short. Keep in mind also that the auditor can ask additional clarifying questions to elaborate on a point. Other types of questions, such as antagonistic or leading are not recommended. Also, keep in mind that silence, allowing the interviewee to think, is also a valid technique of obtaining information. In general, interviews should be characterized by structured, thoughtful questions, putting the auditee at ease, explaining what is required, listening to the response, and avoiding personal judgement. There are a few basic questions that are nearly always asked, at least to begin discussions. It should be noted that interviews are situation-specific, and many other clarifying questions may follow those listed below First Set Are you familiar with the polic ies and Integrated Management System? What do you do in case of a procedural non-conformance? What do you do in case of an emergency? What kind of training have you received? How do you communicate concerns or ideas Second Set What are the significant aspects and impacts associated with your function? How do you know what to do? (ask for procedures and Operating criteria). What specific training have you received? Are there any objectives and targets associated with your Function? Are you responsible for any monitoring and measurement Activities? What records do you keep? Typical auditees  Plant management; Management representatives; Department managers; Document control and record departments; Research and development; Engineering; Operations employees (plant, administration); Human resources and training; Contractor management and purchasing; Security Documentation review during the audit, the auditor will be reviewing a wide variety of documentation. Documents will vary from high-level management policies and procedures to specific records. In general, the documentation
  • 4. Quality only way to survive in ever changing & turbulent Competitive Market © 2016. Workshop Designed & Conducted by: Gobburu Venkata 4 review is part of the overall evidence, gathering phase. More specifically, the auditor is looking for the following: Does your documented system respond to the standard? Do the procedures describe what's happening? Is the documentation controlled? Are all employees informed? Are the procedures followed by everyone all the time? Is there objective evidence that the procedures are being followed? For example, listed below are typical documents reviewed when auditing against various management standard elements. Obviously, the title and format will vary from site to site. The following list includes typical document types in addition to required Procedures, which will facilitate verifying conformance to the specific standards: Sno Item Conformance Partial Conformance Non Conformance Not Applicable Not Verifiable Aspects procedure 1 (PROCESSES) Aspects list - Significant aspects/impacts list. Sno Item Conformance Partial Conformance Non Conformance Not Applicable Not Verifiable Legal and Other Requirements 1 Applicable legal and other requirements list; Appropriate instructions for compliance; Permits, manifests, etc. Sno Item Conformance Partial Conformance Non Conformance Not Applicable Not Verifiable Objectives and Targets 1 Minutes of objectives and target development-Plan List of objectives and targets; Related action plans
  • 5. Quality only way to survive in ever changing & turbulent Competitive Market © 2016. Workshop Designed & Conducted by: Gobburu Venkata 5 Sno Item Conformance Partial Conformance Non Conformance Not Applicable Not Verifiable Structure and Responsibility 1 Job descriptions Organizational charts Sno Item Conformance Partial Conformance Non Conformance Not Applicable Not Verifiable Training Awareness and Competence 1 Training needs listings/matrix Manuals, course materials; Sign-in sheets; Test records, certificate copies, etc Sno Item Conformance Partial Conformance Non Conformance Not Applicable Not Verifiable Communication 1 Specific work instructions; Records of communication and correspondence Sno Item Conformance Partial Conformance Non Conformance Not Applicable Not Verifiable Document Control 1 Documents, procedures, and manuals Sno Item Conformance Partial Conformance Non Conformance Not Applicable Not Verifiable Operational Control 1 Critical operations/aspects listing/matrix; Specific work instructions; Environmental issues and instructions within other work instructions; Contractor policies, work orders, etc. Supplier requirements
  • 6. Quality only way to survive in ever changing & turbulent Competitive Market © 2016. Workshop Designed & Conducted by: Gobburu Venkata 6 Sno Item Conformance Partial Conformance Non Conformance Not Applicable Not Verifiable Emergency Preparedness and Response 1 Emergency plans and protocols; Practice and drill results Sno Item Conformance Partial Conformance Non Conformance Not Applicable Not Verifiable Monitoring and Measurement 1 Function-specific procedures and work instructions; Objectives and target action plans; Records of monitoring and measurement data collected, including calibration records Sno Item Conformance Partial Conformance Non Conformance Not Applicable Not Verifiable Non-conformance, Corrective and Preventive Action 1 Corrective action reports; Evidence of discussion and follow-up Sno Item Conformance Partial Conformance Non Conformance Not Applicable Not Verifiable Records 1 Records; Specific audit procedures, checklists, forms, schedule; Audit notes and working documents; Audit reports Sno Item Conformance Partial Conformance Non Conformance Not Applicable Not Verifiable Management Review 1 Meeting agendas and attendance; Meeting minutes and action items; Evidence of follow-up actions, reports, etc.