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Auditing Management systems based on ISO19011 By Eng. Karam Malkawi - Jordan

Date post:13-Jan-2015
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A material summarize the ISO 19011 standard
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  • 1. A systematic and functionally independent examination to determine whether activities and related results comply with a conforming standard, whereby all the elements MUST BE covered.

2. Is done According to ISO19011:2002 and this Standard describes in details: The Audit Standards. Managing the Audit. Audit Activities. Auditors Competency. 3. The Internal audits are conducted by the organization itself, or on its behalf, for management review and other internal purposes (e.g. to confirm the effectiveness of the management system or to obtain information for the improvement of the management system. 4. Internal audits can form the basis for an organizations self declaration of conformity. In many cases, particularly in small organizations, independence can be demonstrated by the freedom from responsibility for the activity being audited or freedom from bias and conflict of interest. 5. Audit Criteria Set of policies, procedures or requirements used as a reference against which audit evidence is compared. Examples; HACCP, ISO22000, Statuary Regulations, etc. 6. Audit Evidence; Records, statements of fact orotherinformation which are relevant to the audit criteria and verifiable. Audit evidence can be: Qualitative. Quantitative. 7. Audit findings Results of the evaluation of the collected audit evidence against audit criteria.; Audit Findings: Indicate conformity or nonconformity. Can lead to the identification of opportunities for improvement or recording good practices. If the audit crite ria are se le cte d fro m le g al o r o the r re q uire m e nts, the audit finding is te rm e d co m pliance o r no n-co m pliance . 8. Audit conclusion Outcome of an audit afterconsideration of the audit objectives and all audit findings. 9. Auditee, Organization being Audited. Auditor, Person who conduct the Audit. Audit team one or more auditors conducting an audit , supported if needed by technical experts . One auditor of the audit team is appointed as the audit team leader. The audit team may include auditors-in-training. 10. Technical expert, person who provides specific knowledge or expertise to the audit team. Specific knowledge or expertise is that which relates to the organization, the process or activity to be audited, or language or culture. 11. Observer, Person who accompanies the audit team(3.9) but does not audit. An observer is not a part of the audit teamand does not influence or interfere with the conduct of the audit . An observer can be from the auditee , a regulator or other interested party who witnesses the audit. Guide, Person appointed by the auditee to assist the audit team. 12. Audit Programme, arrangements for a set of one or more audits (3.1) planned for a specific time frame and directed towards a specific purpose. Audit Scope, Extent and boundaries of an audit. The audit scope generally includes a description of the physical locations, organizational units, activities and processes, as well as the time period covered. 13. Audit Plan, description of the activities and arrangements for an audit. Risk, effect of uncertainty on objectives. Competence, Ability to apply knowledge and skills to achieve intended results Ability implies the appropriate application of personal behavior during the audit process. 14. Conformity, fulfillment of a requirement. Nonconformity, Non-fulfillment of a requirement. 15. Integrity, the foundation of professionalism Auditors and the person managing an audit programme should: Perform their work with honesty, diligence, and responsibility; Observe and comply with any applicable legal requirements; Demonstrate their competence while performing their work; Perform their work in an impartial manner, i.e. remain 16. Fairpresentation; The obligation to report truthfully and accurately Audit findings, audit conclusions and audit reports should reflect truthfully and accurately the audit activities. Significant obstacles encountered during the audit and unresolved diverging opinions between the audit team and the auditee should be reported. The communication should be truthful, accurate, objective, timely, clear and complete. 17. Due professional care; The application of diligence and judgment in auditing. Auditors should exercise due care in accordance with the importance of the task they perform and the confidence placed in them by the audit client and other interested parties. An important factor in carrying out their work with due professional care is having the ability to make reasoned judgments in all audit situations. 18. Independence; The basis for the impartiality of the audit and objectivity of the audit conclusions. Auditors should be independent of the activity being audited wherever practicable, and should in all cases act in a manner that is free from bias and conflict of interest. Auditors should be independent from the operating managers of the function being audited. Auditors should maintain objectivity throughout the audit process to ensure that the audit findings and conclusions are based only on the audit evidence. 19. Evidence-based approach; The rational method for reaching reliable and reproducible audit conclusions in a systematic audit process. Audit evidence should be verifiable 20. Internal audits play a critical role in : Basically Maintaining and Improving a Management System. Determine if the system is meeting requirements. Identify non-conformances. Drive continuous improvement. Measure compliance with the documented system. 21. AUDITORCOMPTENCY: Auditorneeds to understand the principles of HACCP Auditorneeds to understand the process and the product which is produced. Internal auditors must complete an internal auditortraining course. 22. Internal auditors are responsible for verifying the effective implementation of the food safety management system. Auditors have to: Find objective evidence that the system is implemented and effective. Identify non-conformances. Where the system is not implemented or operating as planned. Where the system does not meet requirements of the standard. 23. There are three main types of audit: a) First Party b) Second Party c) Third Party 24. Also known as internal audit is being conducted systematically and periodically to evaluate the organizations own process, procedures, and products. Parties Involved = 1 (the Organization OnlyParties Involved = 1 (the Organization Only) ) The organization gets the reportThe organization gets the report 25. Also known as external audits, customer audits or supplier audits which is a very Flexible and commonly based on customer requirements or what he wants. Parties Involved = 2 (the Organization and the customerParties Involved = 2 (the Organization and the customer Supplier) Supplier) The reports goes to the customerThe reports goes to the customer 26. Also known as registration audit and is Carried out by an independent organization which characterized by flexibility it must follow the audit process completely. Parties Involved = 3 (Parties Involved = 3 (Organization, customer and the certification body) ) Report goes to the organization and the certification Body 27. Focus on compliance to the organization as documented food safety system. Auditors will compare what is being done to the documented policies, procedures and other FSS documentation. Is the process done according to the plan? Are employees aware of, trained on and following ? the FSMS documentation and requirements? 28. Many companies have GMP inspections or regularly scheduled inspections of Prerequisite Programs but this completely differ from audits because inspection is typically based on a standard checklist that designed to look at each point individually and determine if a requirement is being followed, BUT Internal audits look at the system at all of its sides and include the interaction of processes. 29. Firstly an audit program must be planned and implemented. And the program is designate responsibility for an audit coordinator that will: Maintain the audit schedule Assign auditors Initiate audits 30. The audit programme should include information and resources necessary to organize and conduct its audits. objectives for the audit programme and individual audits; extent/number/types/duration/locations/schedule of the audits; audit programme procedures; audit criteria; audit methods; selection of audit teams; necessary resources, including travel and accommodation; 31. When Preparing an audit schedule; Each area must be audited at least one a year, but for an effective program plan on auditing each area at least twice. 32. Organization Name FST-L: Date: .. Approved By: .. Date: . Dept. / Audit # 1 2 3 4 5 6 Management 15.01 21.06 Sales & Marketing 10.02 Quality Assurance 31.03 Production 10.04 Stores and Purchasing 20.01 15.03 09.05 HR and Training 01.02 20.04 20.06 . . 33. Identify what processes or procedures must be audited in each area or Department. And These will be included in the audit plan for the area. Example,Procedure Code /No. Management & Administratio n Q.A Sales Production Purchasin g HR Document Control DC-01 X X X X X X Q.C Records QC-02 X X X X X X Mngt. Responsibilities MR-03 X Training & HR HR-04 X X X X X X Corrective Actions CA-05 X X X X X . . 34. When an internal audit is coming up on the schedule, the audit coordinator will determine how much time and how many auditors are required Based on the status and importance, as well as the number of procedures that apply to the area and must be included in the audit. The amount of time allotted has a direct effect on the scope and depth of the audit. The auditor/s assigned must be independent of the area being audited. 35. Once the schedule is complete; after, it is time to get ready for your first audit ; Prepare your audit plan based on the proce

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