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SMMT AQMS Conference | 20th -21st November 2018 Join the conversation: #AQMS2018
Your Workshop Title Goes Here
Join the conversation: #AQMS2018
SMMT Industry Forum
Process Approach in Auditing
SMMT AQMS Conference | 20th -21st November 2018 Join the conversation: #AQMS2018
The need
Auditors have a significant role to play in ensuring that business management
systems are implemented and maintained in an effective and efficient way.
The competence of the auditors is therefore essential in ensuring that this
objective is achieved.
SMMT AQMS Conference | 20th -21st November 2018 Join the conversation: #AQMS2018
The solution
Our training introduces best practice “process approach” auditing techniques.
Rather than focusing purely on system compliance, the process approach to
auditing focusses on the effectiveness of the processes to achieve the required
output to meet all stakeholders expectations.
We use “Turtle Diagram”
as is a simple tool to plan
and undertake the effective audits.
Process
Support Processes
How?
Input
With What?
Risk? With who?
Output
What Results?
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What is Process Approach?
• Organisations need to determine and
manage many linked activities
• These activities can be considered as
processes
• Outputs from one process generally
become inputs to subsequent processes
The process approach involves the systematic definition and management of processes, and their interactions, so as to achieve the intended
results in accordance with the quality policy and strategic direction of the organisation.
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Process approach - QMS
Input A customer who has a
requirement
Output A customer
whose requirements
are met
Look across organisation
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Single Process
Single Process
Inputs
Outputs
Input Output Step
1 Step
2 Step
3 Step
4 Step
n
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Customer Orientated Processes
COP Process
Input A customer who has a
requirement
Output A customer
whose requirements
are met
Organisation
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Sequence and Interaction
Input Process Output
Input Process Output
Input Process Output
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Benefits of the Process Approach
• Understanding and consistency in meeting requirements
• Consideration of processes in terms of added value
• The achievement of effective process control
• Improvement of processes based on evaluation of data and information
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Process Approach Requirements
determine the processes needed for the quality management
system and their application throughout the organization and shall:
a) determine the inputs required and the outputs expected from
these processes,
b) determine the sequence and interactions of these processes,
c) determine and apply the criteria and methods (including
monitoring, measurement and related performance indicators)
needed to ensure the effective operation and control of these
processes,
d) determine the resources needed for these processes and
ensure their availability
PLAN
PLAN
PLAN
PLAN
Requirements are taken from ISO9001 clause 4.4.1
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Process Approach Requirements
e) assign the responsibilities and authorities for these processes
f) address the risks and opportunities as determined in
accordance with the requirements
g) evaluate these processes and implement any changes needed
to ensure that these processes achieve the intended results
h) improve the processes and the quality management system
DO
CHECK
ACT
DO
Requirements are taken from ISO9001 clause 4.4.1
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Turtle diagram
What
Equipment, tooling, machines
Results
KPIs, effectiveness and efficiency
Who
People, skills, competence, knowledge
How
Procedures, instructions, methods
Process Input Output
Support
Processes
Risk analysis!
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Process Approach in Audit planning
Prepare Audit Findings Reporting N/C
management Programme
Create Turtle Diagram including information on:
Relevant performance indicators/objectives
Management review minutes
Previous audit records
Continuous improvement plans
Procedures, instructions, control plans
IATF 16949, Statutory and regulatory requirements
Customer specific requirements (consider Annex B)
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Process Approach in Audit planning
KPI’s should also be used during the audit
planning stage to understand the
measurable objectives, evaluate progress,
monitor trends, review improvements
actions and support decision making.
Effectiveness:
• Planned results achieved which
result in customer satisfaction
• (i.e. how the customer would
measure a suppliers
performance)
Efficiency:
• Planned results achieved verses
resources used, which results in
organisation satisfaction
• (i.e. how an supplier would measure
it’s own internal performance)
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Example
`
Process Audit Preparation "Turtle Diagram"
Outputs:Audit Programme incl. resource, System Process Audits, Manufacturing Process Audits, Product Audits incl. Audit Plans, Audit Reports and 8D Reports).
Inputs:ISO 4.3; IATF4.3.1; 4.3.2; 7.5.1.1Quailty Management System Scope, System Processes, Maufacturing Processes and Products.
How? - (Procedures & Methods)Internal Audit Procedure IATF 9.2.2.1 List of qualified auditors IATF 7.2.3 Audit Programme ISO 9.2.1; 9.2.2IATF 9.2.2.1; 9.2.2.2; 9.2.2.3; 6.1.2.1; Audit Plan ISO 9.2.1; IATF16949:2016; ISO9001:2015; CSRs: VDA6.3; VDA6.5Audit Report ISO 9.2.1; 7.5.3.2.1; 8D Report IATF 10.2.1; 10.2.2; 6.1.2.2Control Plans, PFMEAs, IATF 8.5.1.1; 8.5.6.1.1; Drawings & Engineering SpecificationsIATF 7.5.3.2.2;
What Results? - (Performance Indicators)
ISO 9.1; 9.1.3c&g; 9.2.1c, 4&6; 9.3.3; 10.1; 10.3 Effectiveness:
Effectiveness of Audit Programme:Number of Non-conformities raised: Number of opportunities for improvemence:No of overdue Audits:No of overdue Actions:Effectiveness Corrective/Preventive Actions:
Efficiency: Cost/plan:
With Who? - (Competence / Skills / Training)
ISO 7.1.2; 7.2; 9.2.2; IATF 7.2.3; 5.3.1; 5.3.2b; Owner Lead Auditors Internal System Auditors Manufacturing Process Auditors VDA6.3; Product Auditors VDA6.5
With What? - (Materials / Equipment)
Office/Work place,Phone, PC, Email, Word, Excel, Audit Management SoftwarePrinter, Paper, Pen,Measurmement EquipmentISO 7.1.3; 7.1.4; 7.1.5.1;
Process
Internal Audit
(Support Processes)
Problem SolvingHRIT
Calibration
(Risks & Opportunities)IATF 6.1.2.2; 6.1.2.3; 8.5.6.1
Sampling Method; Changes (IATF16949:2016; ISO9001:2015;CSRs,QMS, Products and Processes;
Personnel Changes;Risks of conducting audit.
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Process Approach in Audit execution
Prepare Audit Findings Reporting Programme
Start with questions about performance, what is expected, what are the indicators and objectives, what is the actual performance ?
How is performance being improved ?
How was the process planned, what methods are in place to ensure the process is controlled. Does the process address IATF 16949 and relevant customer requirements ?
Is the process being carried out as planned ? Are the methods understood by all involved in the process ?
PLAN
DO
CHECK
ACT
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Process Approach in Audit execution
Key Performance Indicators (KPI) should be used during the audit, questions
about target setting and performance can help develop audit trials.
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Exercise
Select a processes and create a turtle diagram using the A3
template
Link the items you identify back to the requirements of IATF 16949
Feedback your findings to the group
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Quiz
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Quiz 1/10
Question No 1:
What defines extent and boundaries of an audit?
a) Audit Scope
b) Audit Criteria
c) Audit Findings
d) Audit Conclusions
Hint: only one correct answer
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Quiz 2/10
Question No 2:
Which of the following define Audit Criteria?
a) Set of policies and procedures
b) ISO9001:2015 and IATF16949:2016 requirements
c) Applicable Customer Specific Requirements
d) Applicable Statutory and Regulatory Requirements
Hint: more than one correct answer
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Quiz 3/10
Your
organisation
Your
organisation
Your
organisation
Customer
Certification
body 1st party
or internal audits
2nd party
or external providers or other external
interested parties (customer audits)
3rd party or
certification audits or accreditation,
statutory and regulatory audits.
Question No 3:
Match the correct definition with each type of audit.
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Quiz 4/10
Question No 4:
Which of the following is a type of internal audit?
a) Quality Management System Audit
b) Supplier Audit
c) Manufacturing Process Audit
d) Product Audit
Hint: more than one correct answer
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Quiz 5/10
Question No 5:
Which of the following requires to be audited within three year calendar
period by IATF16949:2016 Standard?
a) all System Processes
b) all Customer Specific Requirements
c) all Manufacturing Processes
d) all Products
Hint: more than one correct answer
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Quiz 6/10
Question No 6:
Who is conducting an audit?
a) Auditee
b) Auditor
c) Technical expert
d) Observer
Hint: only one correct answer
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Quiz 7/10
Question No 7:
Which of the following competencies are required IATF16949:2016 for
quality management system auditors?
a) understanding of the automotive process approach for auditing,
including risk-based thinking;
b) technical understanding of the relevant manufacturing processes;
c) understanding product requirements and use of relevant measuring
and test equipment to verify product requirements;
d) understanding of applicable core tool requirements related to the
scope of the audit;
Hint: more than one correct answer
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Quiz 8/10
Question No 8:
According to IATF16949:2016 Maintenance of internal auditors
competence should be demonstrated through executing a minimum
number of audits per year, as defined by organisation.
a) True
b) False
Hint: only one correct answer
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Quiz 9/10
Question No 9:
Which of the following findings indicates a requirement has been
effectively implemented but, based on auditor experience and
knowledge, additional effectiveness or robustness might be possible with
a modified approach?
a) Major Non-conformity
b) Minor Non-conformity
c) Opportunity for Improvement
Hint: only one correct answer
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Quiz 10/10
Question No 10:
Which of the following is required for problem solving process by
IATF16949:2016 Standard?
a) Define the Team
b) Define interim containment actions
c) Identify root causes
d) Identify systemic corrective actions
Hint: more than one correct answer
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Questions?
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Training
• IATF 16949:2016 Lead Auditor Training
• IATF 16949:2016 Internal Auditor Training
• IATF 16949: 2016 Management Awareness Training
• IATF 16949: 2016 Essential Training
• TPM for IATF 16949:2016
• Standard Work for IATF 16949:2016
• Practical Problem Solving for IATF 16949:2016
• Core Tools Certification (APQP, FMEA, MSA, SPC and PPAP) as a 5 day certified
course or as individual 1 day training courses
For more details please speak to your trainer or look online
at www.industryforum.co.uk/training
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For further information visit us …
@smmtif
company/industry-forum
www.industryforum.co.uk