Upload
sbsharma
View
241
Download
0
Embed Size (px)
Citation preview
8/10/2019 Audit Methodology ISO 90002000
1/45
1
Aud it Methodo logy as per ISO
9000:2000
8/10/2019 Audit Methodology ISO 90002000
2/45
2
Course Contents
1) Objectives2) What is Quality?
3) Criteria for Selection of the Suppliers
4) Quality audits5) Audit methodology
6) Assessment of audit findings Corrective Action
7) Common findings against ISO Clauses
8/10/2019 Audit Methodology ISO 90002000
3/45
3
Course Objectives
1. To provide participants with an overview of aSupplier Audit.
2. To provide participants with the basic knowledgeand awareness of the tasks required of a
Supplier Audit.3. To provide practical guidance on the proper
conduct of a Supplier Audit.
8/10/2019 Audit Methodology ISO 90002000
4/45
4
What is Quality?
What does quality mean to you?
Conformance to specifications
Fitness for purpose
Meeting needs and expectations
Free from defects Value for money
On-time delivery
Consistency
Safe and reliable Customer satisfaction
Delighting customers
8/10/2019 Audit Methodology ISO 90002000
5/45
5
Selection of Suppliers
Criteria for selection of the Supplier Key Suppliers
Poor Quality Performance
Safety Critical Items
Reliability Critical Items
Special Processes
8/10/2019 Audit Methodology ISO 90002000
6/45
6
Quality Audits (ISO 9000:2000 definition)
1. Audit - systematic, independent and documentedprocess for obtaining audit evidence andevaluating it objectively to determine the extentto which audit criteria are fulfilled.
2. Audit evidence - records, statements of fact orother information which are relevant to the auditcriteria and verifiable.
Note: Audit Recording Sheet
8/10/2019 Audit Methodology ISO 90002000
7/45
7
Quality Audits
Types of audits:
1. First Party audit (Internal Quality Audit)
For organisations to evaluate the conformance ofthe various activities to the quality programme
and effectiveness of the quality system. Internalquality audits are carried out to:
a) maintain or improve the efficiency of theorganisations operations;
b) determine how disciplined and effective theorganisations operations are;
c) conform to ISO 9001 standards requirement(clause 8.2.2).
8/10/2019 Audit Methodology ISO 90002000
8/45
8
Quality Audits
Types of audits:2. Second Party audit (Supplier Audit)
Carried out by an organisations auditors toevaluate the ability of a supplier or potential
supplier to provide a particular product, serviceor process.
Generally, supplier audits are based on nationalor international standards, depending on theorganisations needs or contract requirements.
8/10/2019 Audit Methodology ISO 90002000
9/45
9
Quality Audits
Types of audits:3. Third Party audit (Certification Audit)
Carried out by independent certification bodies(e.g. PSB, DNV, ABS, Lloyds, BVI, SGS .) to
evaluate an organisations quality system withrespect to national or international standards soas to provide registration or certification ofacceptable programme.
8/10/2019 Audit Methodology ISO 90002000
10/45
8/10/2019 Audit Methodology ISO 90002000
11/45
11
Audit Methodology
2. Document review review the relevant quality system
documents and records and determine theiradequacy
3. Preparing for the on-site audit activities
planning the on-site activities
audit team work assignment
preparation of work documents
8/10/2019 Audit Methodology ISO 90002000
12/45
12
Audit Methodology
4. On-site audit activities conduct opening meeting
collecting and verifying information
identifying audit findings
communication during the audit
preparation for the closing meeting
conduct closing meeting
8/10/2019 Audit Methodology ISO 90002000
13/45
13
Audit Methodology
5. Reporting on the audit audit report preparation
report approval and distribution
retention of documents
raise corrective action form
Note: Audit Summary Report
Supplier Corrective Action Request
8/10/2019 Audit Methodology ISO 90002000
14/45
14
Audit Methodology
6. Follow-up activities verify adequacy and effectiveness of
corrective/preventive actions
close CAR if corrective action is satisfactory
8/10/2019 Audit Methodology ISO 90002000
15/45
15
Audit Methodology
Audit Strategies and Techniques
STRATEGIES TECHNIQUES
Trace Forward
Trace Backward
Task-based
ISO 9000 elements
Process flow
Clarifying
Interviewing
Observing
Verifying
Collecting ObjectiveEvidence
8/10/2019 Audit Methodology ISO 90002000
16/45
16
Audit Methodology
1) Horizontal auditHorizontal audit follows a process from startto end. This method requires the auditors toexamine many small samples of activities,
processes, products over a large area.Because of the small samples used, theactivities and articles examined are not ingreat detail, and the audit results will onlygive a general overall condition of the quality
system.
8/10/2019 Audit Methodology ISO 90002000
17/45
17
Audit Methodology
2) Vertical auditVertical audit look, in depth, at a particularfunction or department. This method requirethe auditors to focus on an activity or a
process and to examine in great detail alldocuments and records pertaining to the areaof focus. The advantage of the vertical auditis that it may uncover discrepancies which arehidden and are unnoticeable in daily activities.
This is very useful, especially if there is aneed to get to the root of a quality problem.
8/10/2019 Audit Methodology ISO 90002000
18/45
18
Audit Methodology
Selection of sample PO
We should select SCI or RCI PO
Condition of the PO (heat treatment, chemicalcoating, material supplied, etc)
Verify the revision of the PO drawings
8/10/2019 Audit Methodology ISO 90002000
19/45
19
Audit Methodology
Quality section
Verify inspection record (sampling size, GD&T,missing dimension, measuring mean, correctspecification, etc)
The inspection records including the following:- In-coming inspection report- First off inspection report
- In-process inspection report- Out-going inspection report
8/10/2019 Audit Methodology ISO 90002000
20/45
20
Audit Methodology
Control of measuring and monitoring devices
Calibration master list
Identify the item and serial number, due date forcalibration
Verify the frequency of the calibration
Verify the evidence of review on the calibrationreport
8/10/2019 Audit Methodology ISO 90002000
21/45
21
Audit Methodology
Production section Verify the process documents (route/travel card,
revision of drawing, etc)
Verify the inspection key point during themanufacturing processes (first off, in-process,etc)
8/10/2019 Audit Methodology ISO 90002000
22/45
22
Audit Methodology
Production section
Verify the parts/material adequatelyidentified/controlled at all time throughout themanufacturing process
Ask the machinist to demonstrate the inspectiontechnique to check their competency
8/10/2019 Audit Methodology ISO 90002000
23/45
23
Audit Methodology
Special process
Verify the training record
Verify WPS, WQP for the welding
Verify the painter qualification
Verify the heat treatment parameter
Verify the analysis of chemical bath
NDT inspector records
8/10/2019 Audit Methodology ISO 90002000
24/45
24
Audit Methodology
Control of non-conformance materials
Who is responsible to review and disposition ofnonconforming material
Nonconforming material segregate at all time
Verify the record of action taken (repair, scrap,concession, etc)
8/10/2019 Audit Methodology ISO 90002000
25/45
25
Audit Methodology
Purchased product
Verify the evidence of reviewing on COC, millcertificate, test report, etc
Verify the chemical composition: yield strengthand hardness
Verify the adequate of identification of the rawmaterial
8/10/2019 Audit Methodology ISO 90002000
26/45
26
Classification of audit findings
1. Non-conformance
The non-fulfilment of specified requirements
In an audit, non-conformance may be due to:
system document did not adequately address
the requirements of the applicable qualitysystem standard or reflect actual systempractices
Practices or implementations did not comply
with established system documents orrequirement(s) of applicable system standard
8/10/2019 Audit Methodology ISO 90002000
27/45
8/10/2019 Audit Methodology ISO 90002000
28/45
28
Classification of audit findings
2. Observation
An observation is not a non-conformance. It isan area where the auditor or audit teamhighlights, so that further investigation can belooked into to improve the overall effectiveness
of the quality system
3. Area of Improvement
The audit evidence is not sufficient for non-conformance report, but it is an area of concernto avoid and for improvement
8/10/2019 Audit Methodology ISO 90002000
29/45
8/10/2019 Audit Methodology ISO 90002000
30/45
30
Corrective Action
2. Process for Corrective Action
The corrective action process usually requiresthe audittee and other responsible persons to:
Investigate and determine the root cause(s)of non-conformance
Analyse the causes (such as man, machine,material, method and environment)
8/10/2019 Audit Methodology ISO 90002000
31/45
31
Corrective Action
2. Process for Corrective Action (continue)
Select and implement appropriate correctiveaction to prevent recurrence of non-conformance
Apply control to ensure effectiveness ofcorrective action taken
Record corrective action taken and updateaffected documents
8/10/2019 Audit Methodology ISO 90002000
32/45
32
Corrective Action
3. Follow-up verification
This is a post audit activity which is part of thecorrective action process. The follow-upverification usually involves the auditor/audit teamverifying the appropriateness and effectiveness of
corrective action(s) taken.
8/10/2019 Audit Methodology ISO 90002000
33/45
8/10/2019 Audit Methodology ISO 90002000
34/45
34
Quality requirements of ISO 9001:2000 standard
4.2.3 Control of Documents
Documented Procedure shall be established todefine the controls needed:
To approve for adequacy prior to use
To review, Update and Re-Approve To identify Current and Current Revision
Status
To ensure availability at Point of Use
8/10/2019 Audit Methodology ISO 90002000
35/45
35
Quality requirements of ISO 9001:2000 standard
4.2.3 Control of Documents (Continue)
To ensure documents are Legible and ReadilyIdentifiable
To ensure documents of external origin (e.g.
customer) are identified and controlledTo ensure obsolete documents are
Prevented from unintended use
Identified if retained
8/10/2019 Audit Methodology ISO 90002000
36/45
8/10/2019 Audit Methodology ISO 90002000
37/45
37
Quality requirements of ISO 9001:2000 standard
7.5.1 Control of Production and Service Provision
Control conditions include:
Product Characteristics
Work InstructionsEquipment
Monitoring & Measuring Devices
Monitoring & Measurement
Product Release, Delivery and PostDelivery
8/10/2019 Audit Methodology ISO 90002000
38/45
38
Common findings against ISO Clauses
Production and service provision (7.5.1)
Wrong specifications stated in the processdocuments
Use of non-approved process documents
8/10/2019 Audit Methodology ISO 90002000
39/45
39
Quality requirements of ISO 9001:2000 standard
8.3 Control of Non-conforming productRecord the nature of non-conformities
Record the subsequent actions taken
Re-evaluate the corrected non-conformingproduct
Non-conforming product detected afterdelivery
8/10/2019 Audit Methodology ISO 90002000
40/45
40
Common findings against ISO Clauses
Control of non-conforming product (8.3)
Rejected parts are not properly identified and notsegregated from the acceptable parts
8/10/2019 Audit Methodology ISO 90002000
41/45
8/10/2019 Audit Methodology ISO 90002000
42/45
42
Quality requirements of ISO 9001:2000 standard
7.6 Control of Monitoring and Measuring Devices
(continue)
Ensuring device give valid results:
Calibrated or Verified at specific intervals
Adjusted or re-adjusted as necessary
Identified to enable the calibration status
Safeguard from adjustments
Protected from damage and deteriorationduring handling, maintenance and storage
8/10/2019 Audit Methodology ISO 90002000
43/45
43
Common findings against ISO Clauses
Control of monitoring and measuring devices (7.6)
Use of un-calibrated or expired gauges andmeasuring instruments
Use of inappropriate measuring instruments orgauges
Use of non-approved work instructions for in-house calibration
Measuring instruments are not calibrated to theirfull range
8/10/2019 Audit Methodology ISO 90002000
44/45
44
Quality requirements of ISO 9001:2000 standard
8.2.4 Monitoring and Measurement of Product
Monitor the product characteristics
Record the evidence of conformity &authority for product (4.2.4)
Release product and deliver service onlywhen the monitoring requirements aresatisfactory completed
Waiver with relevant authority approval (and/ or customer approval where applicable)
8/10/2019 Audit Methodology ISO 90002000
45/45
45
Common findings against ISO Clauses
Monitoring and measurement of product (8.2.4)
Inspection samples are not taken according to thesampling plans
Measuring instruments used are not reflected inthe inspection record
The GD&T dimensions are not reflected in theinspection report
The tolerances are not reflected in the inspectionreport