Changing The Way We Audit - Continuous Improvement Online

Changing the way we audit.

Internal AuditsInternal auditing is an independent,objective assurance, and consulting activitydesigned to add value and improve anorganization's processes. It helps anorganization accomplish its objectives bybringing systematic and a disciplinedapproach to evaluate and improve theeffectiveness of the quality managementprocesses.

Internal Audits When and Why?Minimum once a year but may be performedmore frequently or on a staggered basis.However, if during an internal audit of adepartment, deficiencies are discovered, it isadvisable to increase the audit frequency ofthat department until the auditor is assuredthat the deficiencies will not repeat themselves.

Internal Audits When and Why?Internal audits are another source ofvaluable information on the effectiveness ofthe management system, the effectivenessof training and to ensure that the personnelare following the procedure.

Becoming an Internal AuditorThis responsibility must be accepted and itwill require training, discipline, commitmentand attention to details. The internal audit isthe greatest defense against external auditsby a customer or an auditing registrar and isa preventive program to ensure continuouscompliance to the organization’s qualitypolicy, objectives and system requirements.

DefinitionsQuality AuditA systematic, independent examination of aquality system. Quality audits are typicallyperformed at defined intervals and ensuresthat the organization has clearly-definedinternal quality monitoring procedureslinked to effective corrective action.

DefinitionsQuality AuditsThe auditing determines if the qualitysystem complies with applicable regulationsor standards. The process involvesassessing the standard quality systemprocedures for compliance to theregulations, and also verifying the actualprocesses against what is stated in theapplicable procedures.

DefinitionsAuditor : A person who has the training andqualification to perform the audits.Auditee: An organization or part of theorganization to be auditedClient: A person or organization requestingthe audit

DefinitionsObjective EvidenceQualitative or quantitative information orrecords pertaining to the quality of an item orservice or to the existence andimplementation of a quality system element,which is based on observation, measurementor test that can be verified

DefinitionsObservationA statement of fact made during an auditand substantiated by objective evidence.Observations are made in an effort torecommend improvement.

DefinitionsLead Internal AuditorA lead internal auditor shall be placed inoverall charge of internal auditing at theorganization, whether the audit is carriedout by a team or an individualInternal Audit TeamThe internal audit team may include expertswith specialized background, auditortrainees or observers.

DefinitionsAuditor IndependenceInternal Auditors must be independent ofthe processes that they audit. Internalauditors cannot have any direct responsibilityto perform the processes or have any interrelations with the auditees that may have anaffect on their judgment during the audit.

Clarification of IndependentIndependent does not mean that an internalauditor can not audit their own department.Independent is different for an ISO auditorand includes many different conflict ofinterest clauses. Internal Auditors may auditmost areas in the organization with theexception of their own work. For example;an auditor can not audit document control ifthey actually do that job themselves.

Audit objectives To determine conformity or non-conformityof the quality system elements withspecified requirements; To determine the effectiveness of thequality system; To provide the opportunity to improve thequality system; To initially evaluate a supplier (externalaudits);

Audit objectives To verify that the facility’s quality systemmeets specified requirements; To ensure compliance with quality policies; To optimize relationship quality/cost; Identify weakness in the quality system; To provide the opportunity to improve theprocesses; To provide the opportunity to improveoverall product quality.

Creating the TeamThe internal audit team shall consist of agroup of auditors that are trained andcompetent in auditing. The internal auditteam must have an understanding of theprocesses that they are auditing. When theinternal auditors do not have experience in aspecific process, they may invite anindependent expert to assist in theevaluation of the processes and auditing.

Creating the TeamIn CIS, it is recommended that amanagement meeting be created to establishthe internal audit team. The agenda shouldinclude the internal auditor’s names, theirtraining, experience, and the processes thatthey can audit with no conflict of interest.

Creating the TeamThis will serve as a record of the InternalAudit Team and the meeting should berevised if new experts or auditors arecreated. This record will help when aregistrar for ISO 9001:2000 certificationaudits your organization. Also, to close theloop, each auditor’s training should berecorded in the HR database of CIS as arecord to show that all the Internal Auditorsare trained and competent.

Creating the Internal Audit Team

Planning An internal audit must be planned inadvance and a schedule created for eachinternal audit process. The ManagementMeetings can be used to plan the auditand to record the results of each internalaudit process. When planning the internalaudit, consideration to following criteriashall be included when planning aninternal audit:

Planning Each process and procedure must beaudited; The audit frequency shall be determinedby the importance of the process and frompast auditing experience. The schedulemust include a date and time and anestimate of how long the audit of theprocess will be.

Planning Determine which internal auditor will auditthe process based on experience andtraining. During each audit, the auditor should alsoreview the documented quality system andcompare it to the ISO 9001:2000standard, statutes, regulations andcustomer specifications to ensure that thedocumented system meets theserequirements.

Planning and CIS Using the management meeting in CIS willsimplify the auditing process. Themanagement meeting module has manyuseful features and will serve as a recordof the internal audit plan and results. Thefollowing are a list of the useful features ofthe CIS Management Meeting:

Planning and CIS The plan may be cloned for future auditsto avoid re-entering the data; Allows to specify the audit processes andcriteria to be audited in the agendasection; Allows to plan a date and assignresponsibility for the audit;

Planning and CIS Allows for supporting documents to beuploaded in each meeting (audit); Multiple audits may be created andplanned at the same time; CIS will send out the agenda for the auditto all parties concerned for planningpurposes;

Planning and CIS The agenda allows the auditor to enterresults and assign actions; Any observations or nonconformities maybe instantly entered into the action sectionof the meeting and assigned to a managerto be resolved; All audits planned and action itemsresulting from an audit will appear on themaster calendar and the participant’spersonal web page when signing into CIS;

Planning and CIS The completed management meeting of aninternal audit will serve as an audit recordthat the internal audit was performed andmay be used by management forestablishing quality objectives forimprovement.

Planning and CIS Create a management meeting for eacharea to be audited. For example, you maywant to divide the audit into processessuch as receiving, shipping, re-work etc

Planning and CIS When completing the internal auditmanagement meeting select the internalauditors and the auditees since both willbe advised of the planned audit when CISsends out the Agenda E-mail. Rememberthat you may create multiple meetings orinternal audit plans or you may clone thismeeting for future internal audits.

Planning an Audit using CISReceiving Process Example

Specific Details for Each Audit Create the agenda items. The agendaitems will include the activities to beverified during the audit. To establish theactivities to be audited, the internal auditteam must take the time to review all theapplicable procedures and establish inputand outputs that can be verified during theinternal audit that will determine if theprocesses are performed correctly andeffectively.

Specific Details for Each Audit The agenda items (audit specifics) shouldalso include: Introduction and closing meeting; Procedure review and applicable ISOelements.

Creating the Audit Agenda Plan

Completing the Plan and CIS Once the Internal Audit meeting isestablished with the agenda items, themanagement meeting may then be sentout to all internal auditors and auditees sothat they may plan for the audit. The management meeting of the internalaudit will now appear on the mastercalendar.

Completing the Plan and CIS

Sharing the plan

Auditing Tips Make sure the authority of the auditteam is established. This will increase thecooperation from auditees;Determine the scope of the audit - is itan overview of the area being audited oris it to concentrate on a specific systemwithin the area?

Auditing Tips Determine the purpose of the audit - is itto comply with government regulations,quality standards, internal proceduresand system?Hold a meeting with the auditors todiscuss the plan, purpose, and scope ofthe audit;

Auditing Tips Read the documents you will be auditing.Know what they say. Develop questions toask the auditees; A PDA is extremely handy. You can haveall the required procedures and check listsat your finger tips. A PDA connects withCIS and you can download the procedureseach time you audit. A PDA also can recordresults and findings and take pictures.Pictures and result files can be uploadedinto CIS.

Auditing Tips Conduct an opening and closing meetingwith the auditees; Be professional at all times. Avoid beingjudgmental; Follow safety procedures, clean roomprocedures, and all other requiredprocedures;

Auditing Tips Explain the purpose of the audit to theauditees;Answer questions or discuss complianceproblems brought to your attention byauditees;Be flexible - if you find a potentialproblem not within the scope of theaudit, evaluate the potential risks of theproblem if left unaddressed;

Auditing Tips Encourage honesty with the auditees;Remain within the audit scope;Exercise objectivity;Collect and analyze evidence that isrelevant and sufficient in order to drawthe conclusions;Act in an ethical manner!

Performing the Audit First print the agenda topics or in thiscase, the auditing criteria. The print outwill act as a checklist during the audit anda place to record notes and findings to beentered later into the CIS records. You can use the traditional check list,however, remember that the problem witha check list is that it tends to narrow ourvision during an audit;

Printing the Agenda Topics

Understanding the processes Review the audit agenda topics and print-out all the procedures that are applicablefor the processes to be audited. Reviewthe procedures and highlight or makenotes of important inputs and outputs tobe verified and reviewed during the audit. Understand the intent of each procedureso that during the audit, effectiveness canbe evaluated.

Understanding the processes The printed procedures that have notesand highlights may be filed andmaintained since they are one of manyobjective evidence of the internal auditprocess. However, do not use them again foranother audit since the procedures maybe revised between the two audits. Alwaysprint out the procedures during theplanning stage.

Performing the Audit The audit team should always be on time forthe internal audit and start the audit with anopening meeting with the auditees. The opening meeting should: introduce the members of the auditteam; review the scope and the objectives ofthe audit; provide a summary of the auditingmethods to be used;