Quality Audit and ISO 9000 Quality Standard Kinnison

Quality Audit and ISO 9000 Quality Standard Kinnison, Chapter 17 March 18 393 SYS 1

Quality Audit Why it is needed: ISO 9001, “ 8. 2. 2 Internal audit” Definition: “A systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are suitable to achieve objectives”. --- ISO 10011(Guideline for Quality System Auditing) March 18 393 SYS 2

ISO 9000 Audit n First Party Auditing n n Second Party Auditing n n Audits carried out by the Organization on its own systems (e. g. Internal Audit by QA unit) Audits carried out by the Customer on the Organization prior to or after contract placement. (e. g. by Government QA unit) Third Party Auditing n Audits carried out by independent accredited organizations March 18 393 SYS 3

Purpose of quality audit n 1 st Party audit: n n 2 nd Party audit: n n n 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 To decide whether future contracts can be awarded; or To determine whether existing contractual performance is satisfactory. 3 rd Party audit: n Mainly for the purpose of granting or to confirm continuation of (for ongoing surveillance audit) ISO 9001 certification. March 18 393 SYS 4

Quality audit example ISO 9001: 2000 -c 7. 5. 3 Identification 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). March 18 393 SYS 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? 5

Sample Audit Checklist ISO 9001: 2000 c 6. 2 PROVIDE QUALITY PERSONNEL Q N 6. 2. 1 USE COMPETENT PERSONNEL 1 Y 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? … March 18 393 SYS 6

Quality Audit Tool - Check List is a collection of simple questions. It help to focus the mind on the task in hand 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: n Based on recognized quality standards n Developed around departments operating system n Based on company standards and procedures n Based on product/customer requirements March 18 393 SYS 7

Translate IS 0 9001 Standard into High Level Requirements 6. 2 Human resources 6. 2. 1 General Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience. High Level Requirements: n Personnel performing work affecting the basis of appropriate education. n Personnel performing work affecting the basis of appropriate training. n Personnel performing work affecting the basis of appropriate skills. n Personnel performing work affecting the basis of appropriate experience. March 18 product quality shall be competent on product quality shall be competent on 393 SYS 8

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? March 18 393 SYS 9

ISO 9001 March 18 6. 2. 2 Competence, awareness and training 393 SYS 10

Common Training Strategy March 18 393 SYS 11

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 March 18 393 SYS 12

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. March 18 393 SYS 13

Recording the findings of Quality Audit -Non conformance report: The following should be recordedn n Instance of non-conformance to the reference Quality System Standard. Instance of non-conformance to documented working practices The instance will be recorded as: Non-Compliance Report, or Non-Conformance Report, or Corrective Action Request, or Discrepancies March 18 393 SYS 14

Non conformance report - example ISO 9001 Standard & Clause Number : ISO 9001: 2000, C 4. 2. 3 d Non Compliance: Drawing DT 132 Issue “E” in use in workshop area, latest issue according to central register is “F”. March 18 393 SYS 15

Non conformance report – bad example Purchasing policy document : P. 18 Non Compliance: Supplier review should always be recorded on form S 123 March 18 393 SYS 16

Non conformance report – bad example ISO 9001 Standard & Clause Number : Non Compliance: Supplier review procedures are not being followed March 18 393 SYS 17

Third-party certification steps 1. 2. 3. 4. 5. 6. Supplier invites bids from several certification bodies. Contract with a certification body based on price, reputation, and competence in the supplier’s business area. 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. 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 ISO 9001. Thereafter, the certification body will regularly (e. g. , twice a year) make follow-up audits to check that the certificate is still valid. The certificate expires after three years, when a new certificate must be issued. March 18 393 SYS 18

ISO 9000 applies to all types of organizations. n n 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’ March 18 393 SYS 19

The ‘What’ and the ‘How’ The ‘Whats’ in The ‘Hows’ in Organization: ISO 9001: 2000 -c 7. 5. 5 Preservation ISO 9001: 2000 -c of product: The organization shall Chickens travel to the market in stacked, tightly packed crates. Dirt and contamination can spread. Temperature fluctuation and delays during transport may cause problems… 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. March 18 n n 393 SYS 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? 20