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Quality Audit and ISO9000 Quality Standard

Kinnison, Chapter 17

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Quality AuditWhy it is needed:Why it is needed:

ISO 9001, “8.2.2 Internal audit”ISO 9001, “8.2.2 Internal audit”Definition:Definition:““A systematic and independent examination to A systematic and independent examination to

determine whether quality activities and related determine whether quality activities and related results comply with planned arrangements and results comply with planned arrangements and whether these arrangements are suitable to achieve whether these arrangements are suitable to achieve objectives”.objectives”.

--- ISO10011(Guideline for Quality System --- ISO10011(Guideline for Quality System Auditing)Auditing)

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ISO 9000 Audit

First Party Auditing Audits carried out by the Organization on its own

systems (e.g. Internal Audit by QA unit) Second Party Auditing

Audits carried out by the Customer on the Organization prior to or after contract placement.(e.g. by Government QA unit)

Third Party Auditing Audits carried out by independent accredited

organizations

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Purpose of quality audit

1st Party audit: To confirm compliance with ‘the rules’. To ensure that the rules are implemented in an effective

manner. To identify ‘the system’ is applicable to the overall objectives

of the organization 2nd Party audit:

To decide whether future contracts can be awarded; or To determine whether existing contractual performance is

satisfactory. 3rd Party audit:

Mainly for the purpose of granting or to confirm continuation of (for ongoing surveillance audit) ISO9001 certification.

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Quality audit exampleISO 9001:2000-c7.5.3ISO 9001:2000-c7.5.3Identification and traceability:Where appropriate, the

organization shall identify the product by suitable means throughout product realization. The organization shall identify the product status with respect to monitoring and measurement requirements. Where traceability is a requirement, the organization shall control and record the unique identification of the product (see 4.2.4).

Four workstations perform a job, and an inspector measures the parts. The measurements are plotted on a single control run chart for SPC.

Does it conform to ISO?

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Sample Audit Checklist

ISO 9001:2000 c6.2 PROVIDE QUALITY PERSONNEL Y N

Q 6.2.1 USE COMPETENT PERSONNEL

1 Does your organization ensure that the people who influence product quality are competent?

…

2 Do you ensure that personnel have the right education?

3 Do you ensure that personnel have the right training?

4 Do you ensure that personnel have the right skills?

5 Do you ensure that personnel have the right experience?

…

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Quality Audit Tool - Check List

Check List is a collection of simple questions. It help to focus the mind on the task in hand and ensure that full coverage is obtain. However, audits based on them can be very shallow, taking little account of the specific circumstance of what is being audit

Check List can be made from: Based on recognized quality standards Developed around departments operating system Based on company standards and procedures Based on product/customer requirements

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Translate IS0 9001 Standard into High Level Requirements

6.2 Human resources6.2.1 GeneralPersonnel performing work affecting product quality shall be competent

on the basis of appropriate education, training, skills and experience.

High Level Requirements: Personnel performing work affecting product quality shall be

competent Personnel performing work affecting product quality shall be

competent on the basis of appropriate education. Personnel performing work affecting product quality shall be

competent on the basis of appropriate training. Personnel performing work affecting product quality shall be

competent on the basis of appropriate skills. Personnel performing work affecting product quality shall be

competent on the basis of appropriate experience.

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Creating check-list (Based on ISO 9001:2000

6.2.1)High Level Organization Requirements: Check List items:

Personnel performing work affecting product quality shall be competent

Does your organization ensure that the people who influence product quality are competent?

Personnel shall be competent on the basis of appropriate education.

Do you ensure that personnel have the right education?

Personnel shall be competent on the basis of appropriate training.

Do you ensure that personnel have the right training?

Personnel shall be competent on the basis of appropriate skills.

Do you ensure that personnel have the right skills?

Personnel shall be competent on the basis of appropriate experience.

Do you ensure that personnel have the right experience?

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ISO 9001 6.2.2 Competence, awareness and training

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Common Training Strategy

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BUSINESS BENEFITS OF ISO 9000 a better spirit amongst employees; a greater degree of internal control; a reduction of scrap, rework and customer returns; a better company image; acceptance of the ISO 9000 quality system by major

customers; easier retention of existing customers; a reduction in the loss of business; a gain in the area of new business a fall in the quality related costs; greater cost effectiveness

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Conducting the Quality Audit

Search for evidence:Audits involve the collection of evidence in order to verify that what should be happening is actually happening. Practice is in line with intent.

Evidence should be collected through interviews, examination of documents and observation of activities and conditions in the area of concern.

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Recording the findings of Quality Audit-Non conformance report:

The following should be recorded- Instance of non-conformance to the

reference Quality System Standard. Instance of non-conformance to

documented working practicesThe instance will be recorded as:

Non-Compliance Report, orNon-Conformance Report, orCorrective Action Request, orDiscrepancies

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Non conformance report - example

ISO9001 Standard & Clause Number :ISO 9001: 2000,C 4.2.3dNon Compliance: Drawing DT132 Issue “E” in use in workshop area,

latest issue according to central register is “F”.

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Non conformance report – bad example

Purchasing policy document :P.18Non Compliance: Supplier review should always be recorded on

form S123

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Non conformance report – bad example

ISO9001 Standard & Clause Number : Non Compliance: Supplier review procedures are not being

followed

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Third-party certification steps

1. Supplier invites bids from several certification bodies.2. Contract with a certification body based on price, reputation, and

competence in the supplier’s business area.3. Certification body makes thorough study (audit) of the supplier’s

rules, practices, organization, documentation, and so on, and raises nonconformance notes on aspects which are not up to ISO 9001.

4. When the supplier has shown that the non conformances are corrected, the certification body issues a certificate saying that the supplier fulfills the requirements of ISO9001.

5. Thereafter, the certification body will regularly (e.g., twice a year) make follow-up audits to check that the certificate is still valid.

6. The certificate expires after three years, when a new certificate must be issued.

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ISO 9000 applies to all types of organizations.

It doesn't matter what size they are or what they do. It can help both product and service oriented organizations achieve standards of quality that are recognized and respected throughout the world.

ISO does it by specify only the ‘Whats’ but not the ‘Hows’

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The ‘What’ and the ‘How’The ‘Whats’ in The ‘Whats’ in ISO9001:2000-cISO9001:2000-c7.5.5

Preservation of product: The organization shall preserve the conformity of product during internal processing and delivery to the intended destination. This preservation shall include identification, handling, packaging, storage and protection. Preservation shall also apply to the constituent parts of a product.

The ‘Hows’ in Organization:

Chickens travel to the market in stacked, tightly packed crates. Dirt and contamination can spread. Temperature fluctuation and delays during transport may cause problems…

How does the shipper avoid the spread of dirt and contamination during shipment?

How does the chicken truck assure that temperature limit do not exceed?