ims-qms & automotive
TRANSCRIPT
-
8/12/2019 IMS-QMS & Automotive
1/46
Integrated Management System (IMS)- ISO
9001:2008 QMS & ISO / TS 16949:2009
Automotive Lead Auditor Course
Akshar Institute of Management Studies (AIMS)
2009-13 copyrights reserved
-
8/12/2019 IMS-QMS & Automotive
2/46
History of Automotive Auditing
The automotive industry has been actively
auditing suppliers for more than 40 years
During World War 2, US skilled workforce wentoff for fight. Loss of skilled work force in
manufacturing component industry occurred.Many techniques were developed for quality
parts, a practice of auditing was developed andwas combined in 1956 in the first Military (Mil)
Specification (Std) 8959
AIMS
2
-
8/12/2019 IMS-QMS & Automotive
3/46
History of Automotive Auditing
The automotive industry came under the mil-Std 8959A
and also wanted to monitor suppliers
Ford and GM started officially auditing suppliers in 1964
with the release of their standards Q-101 and Supplier
Performance and Evaluation Report (SPEAR), respectively
In Europe, British Standard (BS) 5750 became a national
standard for auditing of suppliers. It was this standard the
International Organization for Standardization (ISO) used
as the first draft of ISO 9001:1987
AIMS
3
-
8/12/2019 IMS-QMS & Automotive
4/46
History of Automotive Auditing
Development of AUTOMOTIVE CORE TOOLS:
1. Measurement System Analysis (MSA):1990
2. Statistical Process Control (SPC):1992
3. Production Part Approval Process (PPAP):1993
4. Failure Mode and Effects Analysis (FMEA):1993
5. Advance Product Quality Planning and Control Plans
(APQP):1994
AIMS
4
-
8/12/2019 IMS-QMS & Automotive
5/46
History of Automotive Auditing
Fords Q-101, GMs Targets for Excellence was
combined to form Quality System Requirementsfor internal OEM in 1994
It was renamed as QS-9000 and released in 1994.It used the same auditing scheme as ISO
9001:1994 and registrars began auditing
suppliers to new automotive standard
AIMS
5
-
8/12/2019 IMS-QMS & Automotive
6/46
History of Automotive Auditing
Global automotive industry decided to devise onestandard to replace the variety of nationalstandards
Developing a single global standard under theISO that went beyond requirements of ISO9001:9004 was challenging
US and European automotive manufacturersdeveloped the International Automotive TaskForce (IATF) to have an common standard
AIMS
6
-
8/12/2019 IMS-QMS & Automotive
7/46
-
8/12/2019 IMS-QMS & Automotive
8/46
History of Automotive Auditing
In reference to ISO/TS 16949, the ISO states:The document is a common automotive qualitysystem requirements catalog based on ISO9001:2000, AVSQ (Italian), EAQF (French), QS-9000 (US), and VDA 6.1 (German) automotivecatalogs. This document, coupled with customer-
specific requirements, defines quality systemrequirements for use in the automotive supplychain
AIMS
8
-
8/12/2019 IMS-QMS & Automotive
9/46
ISO 9001 & ISO/TS 16949 Basics
The ISO/TS 16949 specification is an industry-specificversion of ISO 9001
ISO/TS 16949 Standard titles as Quality ManagementSystemsParticular Requirements for the Application ofISO 9001:2008 for AUTOMOTIVE Production andRelevant Service Part Organizations
ISO/TS 16949 specification adds supplemental
requirements unique to the automotive industry
Supplemental requirements are referred as the AutomotiveCore Tools
Both the Standards are well Integrated to conduct IMS
Please note while referring ISO/TS 16949 Standard : The boxed text is the original text ofISO 9001:2008. The sector-specific supplement requirements are outside the boxes.
AIMS 9
-
8/12/2019 IMS-QMS & Automotive
10/46
-
8/12/2019 IMS-QMS & Automotive
11/46
ISO/TS 16949:2009
Automotive Core Tools:
1. Advance Product Quality Planning (APQP)
This methodology provides common guidelines for astructured approach for defining and establishing thesteps needed to ensure a quality product and robust
production processes.
It provides a framework to pull together the otherrequirements and tools in ISO/TS 16949 and associatedreference manuals
Audit questionsnext slide
AIMS
11
-
8/12/2019 IMS-QMS & Automotive
12/46
Advance Product Quality Planning
(APQP)-Audit Questions
Has the organization developed an APQP process specific
to the needs of this plant? If not, how do they know they
have successfully completed the APQP process?
Are true cross-functional teams used (versus one person
doing all the work)?
Is the process functional with data being updated
regularly?
Does the top management include data from APQP as an
input to the management review process?
AIMS
12
-
8/12/2019 IMS-QMS & Automotive
13/46
ISO/TS 16949:2009
Automotive Core Tools:
2. Production Part Approval Process (PPAP)
This methodology defines generic requirements for
production part approval.
It is used to determine if all customer engineering design
record and specification requirements are properly
understood and the process has the potential to produceproduct consistently meeting these requirements during an
actual production run at the quoted production rate
Audit questionsnext slide
AIMS
13
-
8/12/2019 IMS-QMS & Automotive
14/46
Production Part Approval Process
(PPAP)-Audit questions
Are data available for all parts that havenot received formal tool scrap
authorization from the customer?
Are data in a retrievable format? Are sample/master parts available and in a
state as to prevent possible damage?
AIMS
14
-
8/12/2019 IMS-QMS & Automotive
15/46
ISO/TS 16949:2009
Automotive Core Tools:
3. Failure Mode and Effects Analysis (FMEA)
This provides general guidelines for preparing a FMEA
of products and processes, including the application
techniques used to conduct the analysis.
It provides guidance on how to use the FMEA toimprove current and future product and process designs
Audit questionsnext slide
AIMS
15
-
8/12/2019 IMS-QMS & Automotive
16/46
Failure Mode and Effects Analysis
(FMEA)-Audit questions
Are true cross-functional teams used (versus one person doingall the work)?
Have plant-specific occurrence and detection tables beendeveloped? If not, then the process will not work the way it isintended to!
Are design FMEAs available?
Have all process FMEAs been completed and are they current?
Have data from the FMEA been filtered down to control plansand work instructions?
Have there been past problems that the FMEA should havecaught? What is management doing to correct it?
How is the FMEA being used as a preventive tool?
AIMS
16
-
8/12/2019 IMS-QMS & Automotive
17/46
ISO/TS 16949:2009
Automotive Core Tools:
4. Measurement System Analysis (MSA)
This methodology provides an introduction to MSA,
along with guidance on how to conduct measurement
system studies to ensure the quality of data used for
product and product evaluationAudit questionsnext slide
AIMS
17
-
8/12/2019 IMS-QMS & Automotive
18/46
Measurement System Analysis (MSA)-Audit
questions
Have families of gages been identified?
Are master parts available for each part for the gauging
requirements? Is at least one stability study being done for each family? What
about bias and linearity study?
Does the GR&R include a full graphical analysis as outlined in
the manual? What is being done to study the measurement error in your
plant?
Are any data available to demonstrate continual improvement of
the gauging system?
AIMS
18
-
8/12/2019 IMS-QMS & Automotive
19/46
ISO/TS 16949:2009
Automotive Core Tools:
5. Statistical Process Control (SPC)
This methodology provides an introduction to SPC and
presents general guidelines for the selection and application
of statistical techniques to monitor, analyze, and improve
production and supporting processes
AIMS
19
-
8/12/2019 IMS-QMS & Automotive
20/46
Statistical Process Control (SPC)
Audit questions
Do all the key processes have statistical process charts to
monitor how the processes are doing? Are statistical toolsappropriately used?
Are the charts updated in real time and do the operators havethe tools and authority to make appropriate changes as indicated
by charts?
Are trends, runs, patterns responded to in a timely andappropriate manner?
Is everyone in the organization trained to understand and usestatistical information?
AIMS
20
-
8/12/2019 IMS-QMS & Automotive
21/46
Auditing Statistical Data Analysis
(Automotive Core Tools)
Audit questions:
Are the data being collected in this area important? Is there toomuch data collection?
Have the measurements for the processes been identified and is thedata correlated to the process?
Have linkages between the processes and the measurements beenidentified and correlated?
Automotive core tools (FMEA, SPC, MSA) manuals is thefoundation for collecting and analyzing data.
Please refer the SUPPLEMENT for Auditing the AutomotiveCore Tools
AIMS
21
-
8/12/2019 IMS-QMS & Automotive
22/46
-
8/12/2019 IMS-QMS & Automotive
23/46
INTEGRATING ISO 9001 QMS
TO ISO/TS 16949 AUTOMOTIVE
AIMS
23
-
8/12/2019 IMS-QMS & Automotive
24/46
Conducting IMS
Common components of the ISO 9001 and ISO/TS
16949 provides an opportunity to conduct IMS
Common components include:
A planning component An operational component
A moni toring and corrective action component
An improvement process
AIMS
24
-
8/12/2019 IMS-QMS & Automotive
25/46
Benefits of IntegratedAudits
Reinforces the concept of an IMS
It also reinforces the transition from managing functional
elements to managing processes and systems of processes
Auditors can evaluate a holistic process of product and
process planning rather than auditing quality planning,
environment planning, or health and safety system
planning
It provides more efficient audits; auditors can evaluate the
process once, which includes all controls (QMS &
Automotive) relating to that process instead of analyzing
all separately
AIMS
25
-
8/12/2019 IMS-QMS & Automotive
26/46
Benefits of IntegratedAudits
QMS, Automotive controls for a process are often
interdependent; evaluating one form of control provides
important information on other controlsFor example:
Quality system controls designed to minimize scrap and rework may
directly impact on the organizations ability to reduces its volume of
oily scrap steel and the conserve natural resources.
Evaluating quality and environmental controls at the same time allows
evaluation of these interdependencies & provides for a more effective
audit.
(Refer Figure A. IMS Structure on next slide)
AIMS
26
-
8/12/2019 IMS-QMS & Automotive
27/46
Figure A. ISO 9001 & ISO/TS 16949 IMS Structure
Customer Customer
Quality Management System Resource Management
General
Requirements
DocumentationProvision of
resource
Human
resourcesInfrastructure
Work
environment
Management Responsibility
Management
Commitment
Customer
focus
Quality
policyPlanning
Responsibility,
authority, and
communication
Management
review
Product and/or Service Realization
Planning for
product
realization
Customer-
related
processes
Design and
developmentPurchasing
Product and
service
provision
Control of
measurement
devices
Primary Customer Value chain
Measurement, analysis and Improvement
GeneralMonitoring
and
measurement
Control of
nonconforming
product
Analysis
of dataImprovement
Resource and Support Processes
-
8/12/2019 IMS-QMS & Automotive
28/46
AIMS
28
Resource and Support Processes
Monitoring, Measurement, and Improvement
Document
control
Record
controlPurchasing Training
Order Generation and Quality Planning
Process design
and development
Product design
and development
Order
generation
Production
Production
Planning
Production Packaging
and
Storage and
Distribution
Product
verification
Control of
NCP
Customer
Production Support
Maintenance Tooling
management
Calibration
and testingCorrective and
preventive action
Internal
audits
Analysis
of data
Customer
satisfaction
monitoring
Continual
improvement
Management Responsibility
Management review
QMS
planning
Quality
objectives
Customer
pp
Figure B QMS/Auto Audit Grouping
-
8/12/2019 IMS-QMS & Automotive
29/46
Areas of Commonality
Various standards have significant areas of commonality,
these can be leveraged by conducting integrated audits ofthese processes as following:
Planning
Process and Operational Controls Measurement, Analysis and Improvement
Management Responsibility
Resource and Common Support Processes
AIMS
29
-
8/12/2019 IMS-QMS & Automotive
30/46
Areas of Difference
Despite the many commonalities between the three
management system standards, some areas requires focused
reviews, the most notable are as follows:
Product design skills
Design and Development Validation-supplement
Prototype program
Product approval process Regulatory conformity
Supplier quality management system development
Customer-approved sources
Laboratory requirements etc
AIMS
30
-
8/12/2019 IMS-QMS & Automotive
31/46
IMS Audits
Tips for I ntegrated QMS/Auto Audits steps:
1. It is recommended that the organization should first
combine its QMS & Automotive commonsystem audits
2. Then, integrate the Automobile core tools audits into to
its Quality Management System (QMS) audits
Such an audit program will be focused on auditing
processes versus programs or elements and will result in
the most efficient, effective audits
AIMS
31
-
8/12/2019 IMS-QMS & Automotive
32/46
AIMS
Auditor Responsibility for IMS Audits
Auditor should be aware of the current status of the
standards
Auditor should be aware of the top management using the
Policies to manage the organization effectively
ISO certificates that are issued by registrars are site
specific
Process identification
Customer identification
32
-
8/12/2019 IMS-QMS & Automotive
33/46
AIMS
Integrating QMS with support services
Activities in service organization can be visualized byreplacing the termproductwithservice.
Example:
For a hospital, order generationand quality planningmight become initialpatient assessmentand treatment
planning
Production can be replaced by delivery of patient care
Production supportactivities can be replaced by treatmentsupportlike pharmacy operations, facilities and equipment
maintenance, and nutrition planning
33
-
8/12/2019 IMS-QMS & Automotive
34/46
AIMS
Referring Five Primary Clauses of ISO
9001:2008
1. Clause 4: Quality Management System
2. Clause 5: Management Responsibility3. Clause 6: Resource Management
4. Clause 7: Product and/or Service realization
5. Clause 8: Measurement, analysis andimprovement
Refer Figure 1 QMS/TS 16949 Model
34
-
8/12/2019 IMS-QMS & Automotive
35/46
AIMS
Five Clauses Grouped into Six AuditGroupings / Operational components of
QMS-Auto
1. Order generation and quality planning
2. Product and / or Service realization
3. Production / Service support
4. Resource and support processes5. Monitoring, Measurement and Improvement
6. Management Responsibility
Refer Figure 1: ISO 9001 & ISO/TS 16949 QMS ModelRefer Figure 2: QMS-Automotive Audit Groupings
Refer QMS, Automotive Audit Check lists
Refer QMS Process Matrix
Refer Supplement for Auditing Core Automotive Tools
35
-
8/12/2019 IMS-QMS & Automotive
36/46
AIMS
Audit Issues
Top six witness audit issues:
Readiness review incomplete by topmanagement
Not auditing to the process approach
Lack of auditing either the customerspecific requirements or core tool
Failure to audit all shifts in operation
Failure to write clear, complete findings
36
-
8/12/2019 IMS-QMS & Automotive
37/46
AIMS
Roles of Auditor
As a powerful tool to measure the effectiveness ofQMS, EMS, OHSAS and other management
system standards Evaluates manufacturers compliance with Good
Manufacturing Practice (GMP) in all aspectsrelated production and quality control
Detects any shortcomings in the implementationof GMP
Recommend the necessary corrective andpreventive actions
37
-
8/12/2019 IMS-QMS & Automotive
38/46
AIMS
Scope of Auditor
Ensures quality in design, approval,
monitoring and evaluation of products shouldcomply ISO requirements
Ensures quality in ISO implementation and
its strategies Ensures quality in appointment, development
and performance of staff and key personnel
38
-
8/12/2019 IMS-QMS & Automotive
39/46
AIMS
Scope of Auditor ...contd
Ensures quality in obtaining and responding tothe feedbacks from customers, consumers,
employers, employees, government authority andother relevant institutions
Includes all written quality documents,instructions and records
Covering all elements of GMP including resultsof previous internal quality audit and anycorrective and preventive actions (CAPA) taken
39
-
8/12/2019 IMS-QMS & Automotive
40/46
AIMS
Audit Guidance
Auditing should be seen as a positive process not afault finding
Audits need to be documented Prior to the audit date, an auditor needs to review
the quality system documentation, corrective andpreventive actions, and past audit findings and
develop a checklist
During an audit, an auditor need to see evidencesthat the processes are being done in accordance to
procedures and policies
40
-
8/12/2019 IMS-QMS & Automotive
41/46
AIMS
Audit Documentation
Audit plan
- should be sent to auditee prior to audit activity- findings from the last audit should be also mentioned
Audit note should include
- an audit questionnaire
- all records and comments during the audit
Audit report is an
- official document to report the audit findings
41
-
8/12/2019 IMS-QMS & Automotive
42/46
AIMS
Audit Report
Objectives
Audit scope
Identification of audit team leader andmembers
Date and place where the on-site auditactivities were conducted
Audit criteria and findings
Conclusions
42
-
8/12/2019 IMS-QMS & Automotive
43/46
AIMS
Audit Closure
Follow-up and closing of loop:
Receive a satisfactory response from auditee and
their commitment to correct for any deficiency Ensure Corrective actions / Preventive actions
(CAPA) identify the root cause and they are
satisfactory, accomplished and documented
Timeframe for CAPA is being followed
Verify and track CAPA by scheduling a follow-up
audit
43
-
8/12/2019 IMS-QMS & Automotive
44/46
-
8/12/2019 IMS-QMS & Automotive
45/46
-
8/12/2019 IMS-QMS & Automotive
46/46
AIMS
46