October SYS 1 Quality Audit and ISO9000 Quality Standard Kinnison, Chapter 17

October 15393SYS2 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”. --- ISO10011(Guideline for Quality System Auditing)

October 15393SYS3 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

October 15393SYS4 Purpose of quality audit 1 st 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 2 nd Party audit: To decide whether future contracts can be awarded; or To determine whether existing contractual performance is satisfactory. 3 rd Party audit: Mainly for the purpose of granting or to confirm continuation of (for ongoing surveillance audit) ISO9001 certification.

October 15393SYS5 Quality audit example ISO 9001:2000-c7.5.3 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). 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?

October 15393SYS6 Sample Audit Checklist ISO 9001:2000 c6.2 PROVIDE QUALITY PERSONNELYN Q6.2.1 USE COMPETENT PERSONNEL 1Does your organization ensure that the people who influence product quality are competent? … 2Do you ensure that personnel have the right education? 3Do you ensure that personnel have the right training? 4Do you ensure that personnel have the right skills? 5Do you ensure that personnel have the right experience? …

October 15393SYS7 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

October 15393SYS8 Translate IS Standard into High Level Requirements 6.2 Human resources General Personnel 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.

October 15393SYS9 Creating check-list (Based on ISO 9001: ) 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?

October 15393SYS10 ISO Competence, awareness and training

October 15393SYS11 Common Training Strategy

October 15393SYS12 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

October 15393SYS13 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.

October 15393SYS14 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 practices The instance will be recorded as: Non-Compliance Report, or Non-Conformance Report, or Corrective Action Request, or Discrepancies

October 15393SYS15 Non conformance report - example ISO9001 Standard & Clause Number : ISO 9001: 2000,C 4.2.3d Non Compliance: Drawing DT132 Issue “E” in use in workshop area, latest issue according to central register is “F”.

October 15393SYS16 Non conformance report – bad example Purchasing policy document : P.18 Non Compliance: Supplier review should always be recorded on form S123

October 15393SYS17 Non conformance report – bad example ISO9001 Standard & Clause Number : Non Compliance: Supplier review procedures are not being followed

October 15393SYS18 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 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 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.

October 15393SYS19 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’

October 15393SYS20 The ‘What’ and the ‘How’ The ‘Whats’ in ISO9001:2000-c ISO9001:2000-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?