Professional Documents
Culture Documents
1) This Workbook shall be given to you on the first day and shall be taken back at the end of each day before you depart &
finally compiled on day 5 before the test begins.
2) This workbook dully filled ones shall, be used for your continuous assessment on every day. Please ensure that you submit
this workbook to the tutor(s), for daily continuous assessment at the end of each day.
3) On the last day, please return back the course feedback forms (dully filled in by you – for our reference and
improvements) and the IRCA written answer papers for the course.
4) Tips for SUCCESSFUL COMPLETION OF THE COURSE:
# Exercise # Exercise
Documentation Audit – Performance
1 Introduction to Participants (Interviewing) 11
Evaluation
2 Terms & Definitions pertaining to Quality 12 Documentation Audit - Improvements
3 Mapping Management Principles 13 Facts or Inferences
4 Process Approach 14 Audit Plan Preparation
5 Documentation Audit – Management Issues 15 Audit Checklist Preparation
6 Documentation Audit – Context of Organization 16 Cases – NC Recordings
Role play ( Audit Interview Process &
7 Documentation Audit – Leadership 17
Recording NCs)
8 Documentation Audit – Planning & FMEA 18 Audit Report Preparation
9 Documentation Audit – Support 19 Audit Follow up – NC Closures
10 Documentation Audit – Operation
Working Organization:
Designation:
11 CORRECTIVE ACTION
12 COMPETENCE
MANAGEMENT
13
SYSTEM
14 INNOVATION
15 CONFORMITY
S. Principle
No. (Srl.# -
Feature:
see
above)
1
Every input goes for process giving output
2 Ensuring that the bonded stores dispatch correct material to respective
customers
3
Motivating the factory personnel take care of Quality in production
4 Ensuring that the process interfaces are mapped adequately that the information
is transferred to process owners in effective and safe manner
5 The Quality and Purchase team considers the actual rejections during
inspections in supplier performance evaluations
6 The review of one year customer complaints indicated that % of complaints have
reduced, compared to previous year,
7 Helping the supplier in calibrating his measurement instruments, using master
instruments of the organization
8
Changing bicycles by motorcycles for faster and better service to customers
9 Motivating employees to suggest changes in the processes to reduce cycle time
and set examples
10 People accepting ownership of problems and their responsibility for solving
them.
11 The design manager is present at the commissioning site to make required
changes in the pressure controls based on the actual readings
12 Organization does II party audit on supplier as Customer wants to ensure the
organization supplier’s quality is maintained by performing a system audit
13
Identifying, understanding and managing interrelated processes as a system
14 Defining objectives in a manner by which the gap between objectives and
results reduce
Give the following information in the spaces provided for this bottling line (examples):
1. The inputs
2. Outputs
3. Monitoring & Measuring opportunities
4. Efficiency & Effectiveness
RESOUCES & METHODS
Read the Quality Apex Documented Information of Good Glass company MANAGEMENT ISSUES [including Scope &
Applicability]) and identify those issues which do not comply to the requirements of the standard (up to specific sub-clause) with
reference to chapter & page number of the Apex Documented Information
# Issue
Read the Quality Apex Documented Information of Good Glass Company Leadership and identify those issues which do not
comply with the requirements of the standard (up to specific sub-clause) with reference to chapter & page number of the Apex
Documented Information.
Identify the scope of the FMEA. Is it for concept, system, design, process or service? What are the boundaries? How detailed
should it be?
Review the GGC FMEA procedure (Appendix 1) and audit the same for adequacy.
…………………………………………………………………………………………………………………
…………………………………………………………………………………………………………………
Read the following cases and note the answer the following questions for the incidents:
1) Walker was doing an experiment (in lab) on biological changes in humans, when they tell lies. Walker was surprised to see the results of one test and
wanted to inform the professor of her university..but the telephone lines were dead..no mobile connectivity. Walker thought that since the weather was
very rough when arrived at the lab in the morning….looked out of the window and was surprised to see dark clouds and realized that it might be raining.
Took rain coat & test report and went out of the Laboratory and rushed towards the car, to reach the professor.
2) The swimming pool safe guard was beside the swimming pool and suddenly found that one boy fell into the pool (slipped on the edge). The guard
jumped into the pool to rescue the boy…on approaching the boy he realized that the boy knew swimming and he swim himself to one side and started
smiling..the guard also smiled….but suddenly the boy said “help” and fainted. He was taken out of the pool and given artificial respiration by the guard
and boy came to senses. The guard insisted for medical checkup by duty doctor and taken immediately for checkup.
1. Total man days = Calculate audit duration from IAF MD5 Table for 50 employees or take Four (minimum)
[One Man day = 8.30 hrs) or use audit duration as given by tutor.
2. Use all the personnel in your group as auditors (you can use auditor – 1, 2, etc.) as references, rather than actual
names.
3. Avoid if possible two people going for same process area audit.
4. Cover one Installation site also in the audit plan as they do execution as well.
5. The audit plan shall contain basic information as under:
a) The start time of each process area and the auditor allotted for that specific process area.
b) Allot 5 minutes as auditor’s brush up time in middle for effective smooth continuity and effective audit,
for information sharing and judgment on audit proceedings.
c) You can do this in two ways…one plan accommodating all process areas and auditors or separate plan for
each auditor, with distributing the process areas
MAKE THE AUDIT PLAN IN ROUGH ON THE NEXT PAGE & AS A GROUP ON THE FLIP
CHART(S) THE GROUP LEADER TO MAKE A PRESENTATION OF THE EXERCISE FROM
THE FLIP CHART
Objective of Assessment: To assess the conformity of quality management system w.r.t. ISO 9001:2015.
Criteria System(s)
Documented info
ref. (if any):
Team Leader: Audit Start Date Opening
Meeting
Team Audit End Date Closing
Member: Meeting
Audit Schedule
Note: As you are aware, the word shall means “MANDATORY” and all the requirements after shall are action points to be verified in an
audit. Take this as a tip in preparing Audit Checklist
MAKE THE AUDIT CHECKLIST IN ROUGH ON THE NEXT PAGE & AS A GROUP ON THE FLIP
CHART(S) THE GROUP LEADER TO MAKE A PRESENTATION OF THE EXERCISE FROM THE
FLIP CHART
Incident 1
Since our contract is for five years and one year has passed. We need to ensure that for next balance four years you would be providing us the
evidences of compliance of the same, for past three consignments and shall ensure that, you will continue to adhere to the contractual
requirements.
In the eventuality to adhere to requirements of point 1. Above soon, as per the discretion of our management, there may be a possibility that we
may not continue business with you as per the contract terms.
We are taking a stand on this, as need to submit these evidences to all our customers and all of them are concerned on this issue. We cannot afford
to lose our clients, as they are prestigious international airlines. This is very important for our business standard and reputation. Hope you realize
the criticality of the situation and comply to the requirements, ASAP.”
“We have been sending by fax all the evidences to the number as defined in the contract..yes we did not confirm whether you received or not. We
have all the evidences of the faxes sent to you in our files and were shown to your auditors when they were here to perform the II party audits.
Please let us know if the fax machine is working or umber has changed or any other issue. Anyhow now onwards we shall be emailing the same to
your Quality department.
And also we shall be uploading all these evidences in our internal Intranet and giving you the password for access (only to authorized personnel
only - as identified by you), to avoid such issues recurring again.
The NCR – 15 clearly mentions that one report is missing which we agreed and responded back to your closure (after rectifying our recording
system) for closure and requested you to formally close the NCR which is pending from your side for acceptance of the actions and close out.
We assure you the best of services at all time to come. We thank you for this opportunity for improvement which we feel that without you
pointing out this; our communication system would not have been improved.”
Incident 2
While doing the audit of Sheet Metal components for various industry sectors, you found that one of the gauges (GO – NOGO) for final
inspection of circular product, was found to be broken from one of the sides. Upon asking the inspector using the gauge, replied that it was
supplied by the client & would be returned to the client with the last consignment. On verification of the Quality Apex Document, you also
detected that this company where you are presently auditing, had sought exclusion for Customer Property.
Incident 3
A company manufactures compasses for pleasure crafts. During the audit you observed that, to do the inspections of centricity of pin (The arrow
in the compass which points to north), the person lifts a liver to lift the pin up & visually verifies the parallel level of the pin with the surface. You
as an auditor observed that the person doing the job is wearing thick
Incident 4
While review of Management Review Meeting minutes, recorded the issue as - The brand retail business started operations in one country and due
to local laws, they had to recruit local manpower, but their English was not good enough to sell the products to prospective customers, mainly
foreigners. This was identified during interview process also. Human Resources developed competency matrix and detailed job descriptions and
translated to local language. These local personnel had no problems in selling products to local community but failed to sell products to foreign
guests, due to problem in communication. As per the law there is a restriction in law that female employees will not interact with males & vice
versa. HR & Operational Management had this problem but was not able to balance the law and business requirements, for nearly a year due to
which the business targets were not been able to meet business objectives (sales & branding). This aspect was taken up for discussions in
Management Review and it was recorded in the minutes of meeting that local regulatory labor authorities would be contacted for solutions.
Incident 5
While auditing the Top Management area (internal audit process), you noticed that one of the internal audit NC reveals the fact of - the internal
audits frequency was annually and three internal audits results revealed that 70% of the Non- conformities were on Product Quality. You also
noted that there were no changes in the quality plan, inspection sampling plan & no trainings imparted in quality inspections.
Incident 6
The results of one of the student (with Srl. #: 098701) of a computer institute has appeared in the Final Evaluation for ORACLE 8 (Five months
diploma course). During the audit you as a member of audit team for ISO 9001:2015, you were to verify the records of the students. Following
were the facts which were revealed from the records (soft & hard copy):
The approved marks allotted on practical exercises test on computer were not traceable (neither in hard copy nor in soft copy form).
The answers for the test revealed that they were correct in the soft copy and the hard copy – the Srl.# is correct but the name was different on the
record.
There was also a letter from the student dated four months back (after the test) mentioning that his marks were not disclosed by the institute and
his new prospective employer wanted to verify the certificate and marks obtained – No corrective action records were evident.
One of the objectives of the institute was “TO BUILD CAREERS OF ATLEAST 75 % OF THE PASSED STUDENTS OF EACH BATCH
THROUGH THEIR PLACEMENT CELL.”
Questions in this section are designed to test student’s ability to analyse audit situations, evaluate audit evidence and apply knowledge of the audit
criteria correctly.
Students are also required to demonstrate their ability to write a well- constructed nonconformity statement that describes clearly the weakness or
failure of the management system, the audit evidence and the requirement(s) of the standard.
Note to marker:
To raise a nonconformity report when there is not sufficient audit evidence should be penalized and markers should normally award
zero mark.
To complete an audit investigation where there is sufficient evidence to report nonconformity can often be supported and be given
marks, normally up to a maximum of 7 marks from a possible 10 marks.
To be awarded marks a student must state clearly their reason for thinking there is not yet sufficient evidence to report the findings as a
nonconformity and describe the investigation they would follow to determine conformity or nonconformity; including audit trails and audit evidence
they would seek and for what purpose, quoting relevant ISO 9001 clause numbers.
Exceptionally, where there was some obvious ambiguity in the description of the audit situation or the student demonstrates logical argument,
knowledge of the subject and the answer shows an ability to make a reasoned judgement leading to a clear determination of conformity or
nonconformity marks up to the maximum available may be given.
Typical solutions for nonconformities follow a standard method of presentation: i.e. failure in the system (3 marks for identifying the failure), audit
evidence (3 marks for identifying the audit evidence) and requirements (1 mark for identifying the ISO 9001 clause and requirement). Alternative
structure or presentation of the nonconformity by a student is acceptable provided these three components of the nonconformity are clearly present
and the distribution of marks adhered to.
Requirement (WHY):
Comments:
Requirement (WHY):
Requirement (WHY):
Requirement (WHY):
Requirement (WHY):
Teams to be made – Each Team will audit for the specific function allotted by tutor.
Tutor will act as Auditee.
Does the role play involving each team so that all get a chance for the LIVE AUDIT?
The group which is not auditing shall observe the other group while auditing and discuss their
observations and findings.
Write NCRs for any Four in the prescribed format on subsequent pages
Questions in this section are designed to test student’s ability to analyse audit situations, evaluate audit evidence and
apply knowledge of the audit criteria correctly.
Students are also required to demonstrate their ability to write a well- constructed nonconformity statement that
describes clearly the weakness or failure of the management system, the audit evidence and the requirement(s) of the
standard.
Note to marker:
To raise a nonconformity report when there is not sufficient audit evidence should be penalized and
markers should normally award zero mark.
To complete an audit investigation where there is sufficient evidence to report nonconformity can often be
supported and be given marks, normally up to a maximum of 7 marks from a possible 10 marks.
To be awarded marks a student must state clearly their reason for thinking there is not yet sufficient evidence to
report the findings as a nonconformity and describe the investigation they would follow to determine conformity or
nonconformity; including audit trails and audit evidence they would seek and for what purpose, quoting relevant ISO
9001 clause numbers.
Exceptionally, where there was some obvious ambiguity in the description of the audit situation or the student
demonstrates logical argument, knowledge of the subject and the answer shows an ability to make a reasoned judgement
leading to a clear determination of conformity or nonconformity marks up to the maximum available may be given.
Typical solutions for nonconformities follow a standard method of presentation: i.e. failure in the system (3 marks for
identifying the failure), audit evidence (3 marks for identifying the audit evidence) and requirements (1 mark for
identifying the ISO 9001 clause and requirement). Alternative structure or presentation of the nonconformity by a
student is acceptable provided these three components of the nonconformity are clearly present and the distribution of
marks adhered to.
Requirement (WHY):
Requirement (WHY):
Requirement (WHY):
Requirement (WHY):
Based on the audit done and findings recorded, plea (A flipchart se prepare Audit Report as below:
ASSESSMENT REPORT
Address:
Mandays : 4
Nonconformities raised during Assessment
NCR Ref. No. NC 01
Minor/Major Minor
Nonconformities raised during last visit
NCR Ref. No. NIL
Closed/Open
Areas Assessed :
The Scope of the Organization is verified and found fulfilling the requirements of
the standard.
**Disclaimer - Auditing & its conclusion is based on a sampling process of the available information**
Leadership
Planning
Support
Operation
Performance Evaluation
Improvement
ASSESSMENT COMMENTARY
Subsequently this Assessment Report Pack along with your satisfactory Corrective Action Plan and objective evidences (if
applicable) shall be reviewed independently with in BSCIC. Once the recommendations are found as sound, BSCIC will be pleased
to issue a Certificate of Registration. This will come along with the BSCIC Logo and Accreditation Mark. The conditions for use of
BSCIC Logo and Accreditation Mark have been stipulated and the same will be provided to you.
BSCIC believes in value added partnership with its clients, and we will be pleased to revisit your company for the Surveillance
Assessments for a visit every Year for 2 Manday per visit.
Activity NA
1.The following have been considered as major concerns during this assessment visit--------NA
2. This assessment is based on random samples therefore nonconformities may exist which have not been identified.
5. Team recommends a Limited Supplementary Assessment for --- Manday(s) or a full Re-assessment for-------Manday(s).
The same could be conducted by ----/----/-------, upon satisfactory corrective action plan submitted by client to BSCIC’s Chief
Executive--------NA
6. Client to inform their readiness to BSCIC’s Chief Executive for the further assessment as in 4 above so that the same could
be satisfactorily planned & conducted.
Man day(s) 2 2 3
MM / YYYY 12/16 12/17 10/18
Functions/ Areas / Site
Leadership
A resource assigned by top
management, the responsibility and
authority for 5.3 (a) to (e)
Planning / Risks and Opportunities
Requirements for products and services
Design & development of products and
services
Control of externally provided
processes, products and services
Production and Service provision
Performance Evaluation / Monitoring
and Measuring resources
HR related processes
Management Review
QMS Documented Information &
Changes
Notice: 1. Fill the areas as per the client activities and processes. Mandatory fields are already mentioned.
2. Assessor to Pl. in boxes indicating a full plan. This is required to be updated upon each Surveillance Assessment.
BSCIC through its Team Leader / Lead Auditor confirms the Confidentiality of the information received, Observed and Reported
by the Team BSCIC.
Team Leader / Lead Auditor by signing this sheet confirm the Non Conflict of Interests with the Organization.
This report and its full contents are completely understood and accepted.
Signed for & on behalf of BSCIC Signed for on behalf of the client
Name: Name:
Date: Date:
Review the closure submitted by auditee and judge weather this closure is acceptable or not, for the below three cases.
NON CONFORMITY NOTE - 1
ACTION TAKEN
Books have been removed from the area in front of the window and librarian has been
trained upon the functioning of photometer to check the amount of light.
ACTION TAKEN
The procedure for evaluating the effectiveness for training has been modified and re-issued and in future these would
be applicable. This procedure is enclosed for reference:
A formal questionnaire consisting of 20 MCQs shall need to be answered post the induction training conducted
irrespective of the knowledge and skills of the people hired. Scoring a minimum of 70 % in the questionnaire will
indicate effective grasping of the induction training.