Trainer Manual Internal Quality Audit

ASEAN COSMETIC GMP Training Manual Module 9
INTERNAL AUDIT
Project cofinanced by European Union
Prepared by Lam Kok Seng - Singapore EC-ASEAN Economic Cooperation Programme on Standards, Quality and Conformity Assessment Cosmetic Sub-Programme
Project cofinanced by Asean
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1.
TABLE OF CONTENT a. Introduction Objectives Description of Internal Quality Audit Scope of IQA Benefit of IQA The key principle of internal audit The role of internal audit Quality audit documentation b. Managing the internal audit program Process flow for the management of an audit program Authority for internal audit program Establishing the audit program Audit program implementation Monitoring and reviewing the audit program c. Audit activities Overview of audit activities Initiating the audit Conducting document review Preparing for on-site audit activities Conducting on-site audit activities Preparing, approving, and distributing the internal audit report Completing and conducting audit follow-up d. Conclusion e. References
EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency for the Contract No ASIA/2003/069-236 ASEAN SECRETARIAT - Jl. Sisingamangaraja No. 70 A - 12110 Jakarta Selatan Tel: +62.21. 726 2991 Fax: +62.21. 739 8234
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2. 2.1.
INTRODUCTION Objective: to understand the general description and requirement of internal audit to identify the role of self inspection of internal audit in the quality management system to learn how to plan and perform the internal audit and take remedial action based on the result of internal audit Description of Internal Quality Audit Internal Quality Audit" is an independent examination of the arrangements for ensuring quality, e.g. quality assurance structures, mechanisms and procedures, and of the effectiveness of these arrangements. A documented and systematic tool, used by management and done periodically by independent, qualified people to verify and evaluate an organisations commitment to the principles of Good Manufacturing Practice (GMP) as well as compliance to regulatory requirements. An organisation that is highly committed to GMP will not only meet the regulatory requirements but far exceed them. its purpose is to report to the management on the adequacy of the operation of existing quality management system. Principle benefit of audit is that it promotes enhancement through selfreflection Internal audit is used by the organisation to better understand itself or others. The activity and its results must be documented and shared with those who can take action based on the audit findings. The audit must be done is a planned and organised way so that the deficiencies are immediately identified and corrected before they adversely affect the products and the companys reputation. audit" itself is a checking system, it is NOT a quality assessment, because no judgment is made by the auditing group of the actual quality which has been provided by the company. The focus is on continuous improvement through self-evaluation and local control for monitoring and enhancing its own quality.
2.2.
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It also helps the management in communicating their policies and the workers understand and do their jobs well.
2.3.
The scope of internal audit The quality of all systems should meet GMP requirements. This includes: the systems that assure the quality in the design, approval, monitoring and evaluation of products should comply GMP requirements; the systems that assure the quality in GMP implementation and its strategies; the systems that assure quality in appointment, development and performance of staff and key personnel; the systems that assure quality in obtaining and responding the feedback from customers, consumers, employers, employees, government authority, and other relevant institutions.
2.4. Benefit of internal audit Tells you the health of the quality system It serves as a benchmark of current performance against which future improvements are compared. An audit will show the existing system and practices. It enables the organisation to achieve consistent performance throughout the various departments or sites. Identify root of the problem and plan for corrective and preventive actions (CAPA) with timeline Avoiding of potentially big problems. Minimise the chances of if we have known it earlier.. Better allocation of resources Redesignation of job functions and management of resources. Able to avoid potentially big problems (continuous improvement principle) Having a structured internal audit program helps to identify, avoid and/or minimise problems. It also serves as a mean for future improvement. Learn what an auditor looks for Standard or expectations are communicated during the audit. In addition, ideas and solutions to problems can be shared between the
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auditors and aduitees. A qualified auditor should be able to explain the rationale behind the requirements. Each audit is an opportunity to learn about the quality system of a company as well as the various approaches in meeting the GMP expectations. You will finally know whether you comply Compliance brings many benefits in terms of companys reputation, productivity and resources management.
2.4.
The key principles of the internal quality audit are:
2.4.1. The principles relate to the audit definition Independence: the basis for the impartiality of the audit and objectivity of the audit conclusions Auditors are independent of the activity being audited and are free from bias and conflict of interest. Auditors maintain an objective state of mind throughout the audit process to ensure that audit finding and conclusions will be based only on the audit evidence. Evidence-based approach: the rational method for reaching reliable and reproducible audit conclusions in a systematic audit process. Audit evidence is verifiable. It is based on samples of the information available, since an audit is conducted during a finite period of time and with finite resources. eThe appropriate use of sampling is closely related to the confidence that can be placed in the audit conclusions. 2.4.2. The principles relate to audit activity: it is reviewed by independent internal or external party the basis of the audit is the critical self-appraisal it tests the system by sampling (i.e. selection of particular issues rather than a comprehensive scrutiny) and the tracking of these issues through the documents provided and during the audit visit. the audit process is designed to be open, constructive and an effective use of staff time. Audit teams should recognize that their primary role is to assist the company to improve its GMP implementation. 2.4.3. The principles relate to audit question
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Audit teams will ask some version of these basic "audit questions" about the quality systems in place: what are you trying to do? why are you trying to do it? how are you doing it? why are you doing it this way? why do you think this is the best way to do it? how do you check its effectiveness? what do you do about the results of the check? 2.4.4. The principles relate to auditors : Ethical conduct: the foundation of professionalism Trust, integrity, confidentiality and discretion are essential to auditing Fair presentation: the obligation to report truthfully and accurately Audit finding, audit conclusions and audit reports reflect truthfully and accurately the audit activities. Significant obstacles encountered during the audit and resolved diverging opinions between the audit team and the auditee are reported Due professionalism care: the application of diligent and judgment in auditing Auditors exercise care in accordance with the importance of the task they perform and the confidence placed in them by auditee. Having the necessary competence is an important factor. 2.4.5. Guidance for auditees
When being audited internally Volunteer information Report deficiencies and difficulties if you know of any - especially those that concern procedures and interfaces with other departments Be honest, open and cooperative Ensure that underlying causes are identified, not just symptoms Ask the auditor if youre not sure When being externally assessed
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Only answer the questions being asked - name, rank and number! Dont draw attention to problems - but dont clumsily try to hide them Dont blame others Be truthful - once credibility is in doubt . . . Prepare in advance - check your documentation, etc. If you dont know, say so - but add that you will find out Report any discrepancies found by the auditor to your manager/supervisor 2.5. The key roles of the internal quality audit are: is a powerful tool for the company to measure the effectiveness of the quality management system. is a good management tool that can be used to review processes and identify any weaknesses, risks and areas of improvement. is used to assess if a process is working, if things are being done the way they are supposed to be done. However at the same time it is an excellent way of measuring the effectiveness of companys procedures. audits are also used to check any previously identified nonconformances or business changes. A good opportunity to assess how effective the changes have been done. Quality Audit Documentation Audit documentation does not need to be complicated, normally there are 3 kind of documents The audit plan, The audit plan is sent to the department being audited a few days prior, it should include the date of the audit, the planned time, duration, auditors names, location (if relevant) and the policies and procedures that will be used during the audit. It should also mention any non-conformances that were found during last audit. The audit notes, The notes are the auditor's questions that will be asked during the audit. It should include references to particular policies and
2.6.
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procedures and what will be asked during the audit. The same document should be used to record the findings and any comments during the audit. The audit report. The audit report is the official document used to report the findings of the audit. This document should include details of the audit, date, auditors names, policies and procedures and findings against them. It should include if it passed audit and any non-conformances or observations found. If non-conformance are found a date should be established for completion of corrective actions. The audit report is normally signed by the auditor and the department manager.
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3. 3.1.
MANAGING THE INTERNAL AUDIT PROGRAM Process flow for the management of internal audit program
Authority for the audit programme
Establishing the internal audit program obectives responsibilitties resources procedure and guidance
Plan
Act
Improving the audit programme
Implementing internal audit program scheduling audits evaluating auditors selecting audit team directing audit activiries maintaining records
competence and evaluation of auditors Audit activities
Do
Monitoring & reviewing the internal audit program monitoring & reviewing identifying needs for corrective identifying needs for prevention actions identifying opportunities for improvement
Check
Figure 1. Illustration of the process flow for internal audit
3.2.
Authority for the internal audit program The Good Manufacture Practice require an organization to: have an established internal audit program and conduct regularly document the results of internal audit
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ensure those responsible for the area audited are made aware of the results schedule internal audits on the basis of the status and importance of the activity/area being audited conduct follow-up audit activities to verify and record the implementation and effectiveness of any corrective action taken 3.3. Establishing the internal audit program
3.3.1. Objectives of an internal auditing program Objectives should be established for an internal audit program, to direct the planning and conduct the audits. These objectives can be based on consideration of: to meet requirements for GMP certification or other management system standard to verify conformance with contractual requirements to obtain and maintain confidence in the capability of a supplier to contribute to the improvement of the management system 3.3.2. Responsibility of internal audit program The responsibility for managing an internal audit program should be assigned to one or more individuals with a general understanding of audit principles, of the competence of auditors and the application of audit techniques. They should have management skills as well as technical and business understanding relevant to the activities to be audited. Those assigned the responsibility for managing the internal audit program should: establish the objectives of the audit program establish the responsibilities and procedures, and ensure resources are provided ensure the implementation of the internal audit program ensure that appropriate audit program records are maintained, and monitor, review and improve the internal audit program.
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3.3.3. Audit program resources When identifying resources for the audit program, consideration should be given to the following: Financial resources necessary to develop, implement, manage and improve audit activities Audit techniques Processes to achieve and maintain the competence of auditors, and to imptove auditor performance The availability of auditor and technical expert having competence appropriate to the particular audit program objectives Time availability for auditing activities if done by internal group. 3.3.4. Procedure and guidance of audit program Audit program procedure should address the following: Planning and scheduling audit Assuring the competence of auditors and audit team leader Selecting appropriate audit team and assigning their roles and responsibilities Conducting audit Conducting audit follow-up, if applicable Maintaining audit program records Monitoring the performance and effectiveness of the audit program Reporting to top management on the overall achievements of the internal audit program Audit guidance: auditing should be seen as a positive process not as a fault finding exercise. audits need to be documented, it is important to remember that you are auditing against the Quality Management System and therefore audits should be constructed against policy and procedures, which have been developed by the company. prior to the audit date, auditor reviews the appropriate quality system documentation, records of completed corrective and preventive actions, and past audit findings for the activities to be
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audited, and then develops a checklist covering the quality system elements and activities to be audited. during an audit you need to see evidence that the processes are being done in accordance to the procedures and policies. Evidence should be recorded against each section being audited. Recording of evidence needs to have a description of the documentation sighted, number, date and any other information that will assist in identifying that document. 3.4. Audit program implementation Scheduling audit Audits should be planned on a regular basis so that each activity is audited at least once in the audit cycle. High risk areas should be audited more often to ensure conformance. Special circumstances or unplanned audit can also be carried out as a result of : a particular problem has arisen (such as product recalls, repeated quality rejection), to establish the source of the problem and document any corrective actions. customer complaints following the implementation of actions defined in a corrective action report following the identification of additional or amended procedures for maintain or improve product quality GMP inspections announced by the Regulatory Authority Around 2 4 weeks prior to the audit schedule, the audit team will have a briefing meeting to determine: audit procedures, such as the sampling and tracking methods to be used; the issues to be followed up; preparing the audit plan and visit program additional/follow up documents required; and the individuals/groups to meet during the visit.
3.4.1.
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Result of the above briefing will be informed to the relevant auditees, Quality Control Manager, and Production Manager, so they can prepare before the audit schedule will be carried out. The length of the internal audit will depend on the issues identified by the Audit Team and should be approved by management.
3.4.2. Audit program implementation The implementation of an internal audit program should address the following : communicating of an internal audit program to relevant party coordinating and scheduling audit and other activities relevant to audit program establishing and maintaining a process for the evaluation of the auditors and their continual professional development ensuring the selection of audit team providing necessary resources to the audit team ensuring the conduct of audit according to the audit program ensuring the control of records of the audit activities ensuring review and approval of audit report, and ensuring their distribution to the auditees ensuring audit follow-up, if applicable. 3.4.3. Internal audit programs record Records of internal audit should be maintained to demonstrate the implementation of the internal audit program, and should included the following : records related to individual audits, such as audit plan audit report nonconformity report corrective and preventive action report, and audit follow-up, if applicable. results of audit program review records related to audit personal covering subjects such as auditor competence and performance evaluation
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audit team selection, and maintenance and improvement of competence records should be retained and suitably safeguarded 3.5. Monitoring and reviewing the audit program The implementation of the audit program should be monitored and, at appropriate intervals, reviewed to assess whether its objectives have been met and to identify opportunities for improvement. The results should be reported to top management.
3.5.1. Monitoring the audit program Performance indicators should be used to minitor characteristics such as : The ability of the audit teams to implement the audit plan Conformity with audit program and schedules, and Feedback from auditees and auditors 3.5.2. Reviewing the audit program The audit program review should consider, for examples: Result and trends from monitoring Conformity with procedures Evolving needs and expectation of interest parties Audit program records Alternative or new auditing practices, and Consistency in performance between audit teams in similar situations Results of audit program reviews can lead to corrective and preventive actions and the improvement of the audit program
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4.
AUDITING ACTIVITIES
Initiating the internal audit
appointing the audit team leader defining audit objective, scope and creteria determining the feasibility of the audit selecting the auditthe audit team establishing intial contact with auditee
Conducting document review

- reviewing relevant documents, including records. - determining their adequacy with respect to audit
Preparing for the on-the audit activities

- preparing the audit plant - assigning work to the audit team - preparing work document
Conducting on-site audit activities

conducting opening meeting communication during the audit roles and responsibilities of guides and observers collecting and verifying information generating audit findings preparing audit conclusion conducting closing meeting
Preparing audit report

- collecting all audit finding - preparing the audit report - approving and distributing the audit report
Conducting audit follow-up
Figure 2 Overview of audit activities
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4.1.
Initiating the audit
4.1.1. Appointing the internal audit team: The management of cosmetic company should appoint the audit team leader for the specific audit. When the internal audit has been declared feasible, an audit team should be selected, taking into account the competence needed to achieve the objective of the audit. The company do not need to employ specific auditors, it is always best to choose a team of auditors from within the company. The audit team should comprise people from all areas and levels of the company. By choosing a broad spectrum of auditors from all levels of the organisation, it will ensure that everyone has commitment to the Quality System and gain a better understanding of the overall management process of the company. It is a good way for people from various areas to gain an understanding on how their department fits into the organization. Auditor training is always recommended, and a formal auditing method will assist in keeping the audits uniform. It is a pre-requisite that an auditor cannot audit a department or process that they are involved in, for obvious reasons. It is also best not to use top management as auditors, this way an audit will not be perceived as a personal evaluation or appraisal. Those assigned the responsibility for conducting the internal audit program should appoint the audit team leader for specific audit. When the company can not do by themselves, internal audit can be performed by external party. 4.1.2. Defining audit objectives, scope and criteria Preparing for an internal audit involves developing of audit plan, identifying what to be examined and communicating with the auditee. The preparation phase is time consuming but the time spent on auditing later will be more productive. In ensures auditing is carried out in a planned and structured way. Within then overall objectives of an audit program, an individual audit should be based on documented objectives, scope and criteria
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The audit objectives define what is to be accomplished by the audit and may include the following : Determination of the extent of conformity of the implementation of Good Manufacturing Practices, or part of it Evaluation of the capability of the management system to ensure compliance with GMP requirements Evaluation of the effectiveness of the management system in meeting its specific objectives Identification of areas for potential improvement. The audit scope describes the extent and boundaries of the audit, such as physical locations, organization units, activities and processes to be audited, as well as the time period covered by the audit The audit criteria are used as a reference against which conformity is determined and may include applicable policies, procedures, laws and regulations, management system requirement, or contractual agreement with suppliers.
4.1.3. Selecting the audit team The audit team comprises of a lead auditor with a few members. The lead auditor draft up the audit plan and schedule. On the other hand, the team members assist in the preparation of audit documents (eg. checklists) and conduct the audits. Auditor competency : Confidence and reliance in the audit process depends on the competence of those conducting the audit. This competence is based on the demonstration of the personal attributes and the ability to apply the knowledge and skill during the auditing process. Personal attributes Auditor should possess personal attributes to enable them to act in accordance with the principles of auditing. An auditor should be : ethical, i.e. fair, truthful, sincere, honest and discreet; open minded, i.e. willing to consider alternative ideas or points of view; diplomatic, i.e. tactful in dealing with people;
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observant, i.e. actively aware of physical surrounding and activities perceptive, i.e. instinctively aware of and able to understand situation versatile, i.e. adjusts readily to different situation tenacious, i.e. persistent, focused on achieving objectives decisive, i.e. reaches timely conclusions based on logical reasoning and analysis; and self-reliant, i.e. acts and funchtions independently whi;e interacting effectively with others. Has knowledge and skills of GMP and QMS Has generic knowledge and skills of Good Manufacturing Practices and quality management system Audit principles, procedures and techniques to enable the auditor to apply those appropriate to different audits and ensure that audits are conducted in a consistent and systematic manner. Management system and reference documents to enable the auditor to comprehend the scope of audit and apply audit criteris. Organizational situations to enable the auditor to comprehend the organizations operational context. Auditor will : record, in the Audit Report, the people, program/course/area and documents they interviewed or examined. note, in the Audit Report, any people, program/course/area or documents they were unable to interview or examine. always review the previous audit report prior to conducting an audit to help in determining the strategy for the coming audit.
4.2.
Conducting document review Prior to the on-site activities, the auditees documentation should be reviewed to determine the conformity of the system. The documentation may include relevant management system documents and records, and previous audit reports.
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Review documents (SOPs, audit findings, corrective action/preventive action, etc.), check the integrity of the quality system and various controls are effective. If the documentation is found to be inadequate, the audit team leader should inform the auditee, those assigned responsibility for managing the audit program, and the auditee. A decision should be made as to whether the audit should be continued or suspended until documentation concerns are resolved.
4.3.
Preparing for the on-site audit activities
4.3.1. Preparing the audit plan The audit team leader should prepare an audit plan to provide the basis for the agreement among the auditees and audit team regarding the conduct of the audit. The plan should facilitate scheduling and coordinating of the internal audit activities. The amount of detail provided in the audit plan should reflect the scope and complexity of the audit and should be sufficiently flexible to permit changes, such as changes in the audit scope, which can become necessary as the on-site audit activities progress. The audit plan may cover the following: the audit objectives, criteria and any reference documents the audit scope, including identification of the organizational and functional unit and processes to be audit the dates and places where the on-site audit activities are to be conducted the expected time and duration of on-site audit activities the role and responsibilities of the audit team members and accompanying persons the allocation of appropriate resources to critical areas of the audit any audit follow-up actions 4.3.2. Assigning work to the audit team The audit team leader, with the agreement and consultation the audit team, should assign to each team member responsibility for
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auditing specific procedures, processes, functions, sites, areas or activities. Such assignment should take into account the need for independence and competence of auditors and the effective use of resources, as wwll as different roles and responsibilities of auditors, and if needed the technical experts. Changes to the work assignments may be made as the audit progresses to ensure the achievement of the audit objectives
4.3.3. Preparing work documents The audit team members should review the information relevant to their audit assignments and prepare work documents as necessary for reference and for recording audit proceedings. Such work documents may include : audit checklists and audit sampling plans, and forms for recording information, such as supporting evidence, audit finding and records of meetings. The use of checklists and forms should not restrict the extent of audit activities,which can change as a result of information collected during the audit Work documents, including records resulting from their use, should be retained at least until audit completion. Document which is confidential or proprietary information should be suitably safeguarded at all times by the audit team members. 4.3.4. Detail of an audit checklist It identifies what is to be examined during an audit and define desired level of performance (Refer to Figure 3).
CHECKING LIST FOR GMP ASSESSMENT
Date Auditor
DESCRIPTIO N Personnel
: :
GMP.RE F. 1.2.1 5.1.2 2.1.5
Location Auditee
PARAMETER - Organization structure - Personnel hygiene - Training record
: Warehouse :
AUDIT FINDING
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10.1.1 3.1 3.6 3.9 & 3.10 3.12.2 3.1 5.3 - Design and layout of defined area - Flow of personnel and goods - Structure of the storage area, based on GMP - HVAC system - Record of monitoring parameter - Pest record program - The map of bait - The cleanliness of weighing apparatus - Record of maintenance and calibration of weighing apparatus - The effectiveness of label system - Inventory stock control
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Storage area
Sanitation
Documentatio n
4.3 10.2.2.3 10.2.2.1
Figure 3 General format of an audit checklist
Standardise audits and ensure consistent data collected over time. It is designed based on: GMP regulations or guide Company policy and management expectations SOPs Audit findings Warning letters from the authority (FDA 483) of other inspections Best of industry practices It can be in the form of questionnaires with open-ended questions and no built-in requirements (Refer to Figure 4). GMP Cosmetic Audit Questionnaire
Area audited : Date:
Question (QSR-GMP Reference)

1. Does the company have a quality policy ? 2. How is the quality policy communicated? 3. To whom is the quality policy communicated? 4. Is there a current organization chart
Response
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available? 5. How does the quality unit related organizationally and functionally to other parts of the company? Figure 4 An example of a questionnaire with open ended questions
4.4.
Conducting on-site audit activities auditees management for the functions or
4.4.1. Conducting the opening meeting An opening meeting should be held with the or, where appropriate, those responsible processes to be audited. The purpose of an opening meeting is : to confirm the audit plan to provide a short summary of how the undertaken to confirm communication channels, and to provide an opportunity for the auditee to
audit activities will be
ask questions.
4.4.2. Communication during the audit Depending upon the scope and complexity of the audit, it can be necessary to make formal arrangements for communication within the audit team and with the auditee during the audit. The audit team should confer periodically to exchange information, assess audit progress, and reassign work between the audit team members as needed. Evidence collected during audit that suggests an immediate and significant risk (e.g. safety or product quality) should be reported without delay to the auditee, and as appropriate to the respective Manager. 4.4.3. Roles and responsibilities of guides and observers
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Guides and observers may accompany the audit team but are not a part of it. They should not influence or interfere with the conduct of the audit When guides are appointed by the auditee, they should assist the audit team and act on the request of the audit team. 4.4.4. Steps in conducting on site audit The auditor will contact the personnel in the area being audited at the time indicated on the audit program, and briefly review the audit criteria, scope, methods and objectives with them. The checklists only serve as a guide to the auditors, and other areas may be investigated as deemed necessary by the auditors or as requested by the auditee. Carry out both horizontal and vertical audits, and focus on the aspects related to safety, identity, strength, purity and quality of the product. Check with the different personnel-in-charge. Use Trace-back method: Identify a lot number from the product previously made and request for batch record. Determine the raw materials and components (eg. facilities, equipment) use; testing or acceptance records, any deviations recorded. Find out the personnel involved on the producing, testing and approving the product; examine their training records and qualifications Find out whether there is any product complaint or returned product or out-of-specification (OOS) Examine how investigation was conducted; how deviation was resolved before release of product Some tips in making an inspection If the surface is dusty, make a mark in the dust with your finger and return later to see whether it has been cleaned. Look for things in the wastepaper baskets or things lying on the floor. Examine how the records are continuously being monitored.
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Observe how the personnel clean their hands. Look for any traces of pests (even ants!). When a nonconformance is identified, the auditor presents the nature of the nonconformity and the evidence to the personnel involved for verification, clarification, and addresses any questions or concerns that the personnel may have, as well as to give advice, when requested, regarding any problems which are uncovered. After the facts of the nonconformity are verified (or modified), the auditor either drafts nonconformance statement or documents the necessary information. The nonconformance statement includes : the nature of the nonconformity the factual evidence obtained, and the nature of the requirement that is not being complied with (i.e., the appropriate GMP clause, the appropriate quality system document section/ page/paragraph, what the personnel says is the normal practice, contract requirements, statutory regulations, current standards, and any other relevant requirements). If the possible nonconformance requires further clarification the auditor will discuss the situation with the responsible person in charge.
4.4.5. Collecting and verifying audit information During the audit, information relevant to the audit objectives, scope and criteria, including information relating to interfaces between functions, activities and processes, should be collected by appropriate sampling and should be verified. Only information that is verifiable may be audit evidence. Audit evidence should be recorded. The audit evidence is based on samples of the available information. Therefore there is an element of uncertainty in auditing, and those acting upon the audit conclusions should be aware of this uncertainty.
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Sources of information
Collecting by appropriate sampling and verifying Audit evidence
Evaluating against audit creteria Audit findings Reviewing
Audit conclusions
Figure 5. Overview of the process from collecting information to reaching audit conclusion
Methods to collect information include : interview, observation of activities, and review documents 4.4.6. Generating audit finding Audit evidences should be evaluated against the audit criteria to generate the audit findings. Audit findings can indicate either conformity or nonconformity with audit criteria. When specified by
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the audit objectives, audit findings can identify an opportunity for improvement. The audit team should meet as needed to review the audit findings at appropriate stages during the audit. Conformity with audit criteria should be summarized to indicate locations, functions or processes that were audited. If included in the audit plan, individual audit findings of conformity and their supporting evidence should also be recorded. Nonconformities and their supporting audit evidence should be recorded. Nonconformities may be graded. They should be reviewed with the auditee to obtain acknowledgement that the audit evidence is accurate, and that the nonconformities are understood. Every attempt should be made to resolve any diverging opinions concerning the audit evidence and/or finding, and unresolved points should be recorded. Sort out isolated and systemic deficiencies (See Figure 6). Isolated deficiency Tends to happen randomly; no meaningful pattern; or rarely happens. Systemic deficiency Could be connected to a particular process, product, material, person or organisation; shows pattern; happens more than once NON CONFORMITY EVIDENCE ISOLATED SYSTEMIC
Latex gloves rip Wrong expiration date written on a reagent bottle Operator or lab technician spills a sample Pressing machine of eye shadow burns out SOP contains an error Batch record is poorly written so instruction can be confusing Area management does not reinforce requirement to continually record information properly Preventive maintenance program does not include liquid filling machine motor
Figure 6. Isolated versus systemic deficiencies
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Determine the impact of the deficiency affecting the quality, safety, strength, identity and purity of the product and whether the consumer is at risk. Need to make recommendations for improvement. Before an observation is made, it is necessary to verify against the documents or people. Always share your findings with the auditee so that it builds trust and give them opportunity to respond as well as correct the problem. If an issue is corrected during the audit, the auditors have to ensure that it is done correctly and appropriate preventive measures are taken to avoid recurrence of similar problems. Audit findings need to be documented and any non-conformances found should be reported for further action. A date should be established for the correction, a follow up audit should be carried out to ensure that the non-conformance has been fixed. 4.4.7. Preparing audit conclusion The audit team should confer prior to the closing meeting : To review the audit finding and any other appropriate information collecting during the audit, against the audit objectives To agree on the audit conclusions, atking into account the uncertainty inherent in the audit process To prepare recommendations, if specified by the audit objectives, and To discuss audit follow up, if included in the audit plan. Audit conclusions can address issues such as: The extent of conformity of GMP implementation with the audit criteria The effective implementation, maintenance and improvement of the GMP implementation, and The capability of the management review process to ensure the continuing suitability, adequacy, effectiveness, and improvement of the GMP
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Define expectations and rating system (Critical/Major/Minor Deficiency, and Satisfactory or Outstanding) The inspectors from US FDA classify their findings (FDA Form 483) into compliance or non-compliance. It is possible to further categorise into five groups: Critical deficiency Major deficiency Minor deficiency Satisfactory / adequate Outstanding
Non-compliance Compliance
Detail explanation of these 5 categories: Critical deficiency: Deficiency that seriously violates the safety, identity, and quality of the product, resulting in a product recall, regulatory action or harm to consumer, such as mislabelling; microbial contamination, etc. Major deficiency: Deficiency that can have an impact on the safety and quality of the products. eg. non validated cleaning procedure; undocumented preparation of laboratory reagents; reduced QC testing of raw materials etc. Minor deficiency: Deficiency that is not likely to affect the safety and quality of the product, but does not meet the GMP expectations. eg. record keeping errors; overdue SOP reviews; equipment is not calibrated by due date; use of white-out correction liquid on documents etc. Satisfactory / adequate: The GMP requirements are met. Outstanding: The GMP requirements have been met more than required and excellence is displayed.
4.4.7. Conducting the closing meeting
INTERNAL AUDIT
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A closing meeting, chaired by the audit team leader, should be held to present the audit findings and conclusions in such manner that they are understood and acknowledged by the auditee, and to agree, if appropriate, on the timeframe for the auditee to present a corrective and preventive action plan. Participants in the closing meeting should include the auditee, and may also the audit client and other parties. If necessary, the audit team leader should advise the auditee of situations encountered during the audit that may decrease the reliance that can be placed on the audit conclusions. In many instances, for example internal audit in a small organization, the closing meeting may consist of just communicating the audit findings and conclusions. While for other audit situation, the meeting should be formal and minutes, including records of attendance, should be kept. Any diverging opinion regarding the audit findings and/or conclusions between the audit team and the auditee should be discussed and if possible resolved. If not resolved, all opinions should be recorded. If specified by the audit objectives, recommendations for improvements should be presented. It should be emphasized that recommendations are not binding.
4.5.
Preparing, approving and distributing the audit report
4.5.1. Preparing audit report The audit team leader should be responsible for the preparation and the contents of the audit report. The report should provide a complete, accurate, concise and clear record of the audit and should include or refer to the following: The audit objectives The audit scope, particularly identification of the organizational and functional units or processes audited and the time period covered. Identification of the audit clients, audit team leader and the members.
INTERNAL AUDIT
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The date and places where the on-site audit activities were conducted The audit criteria and its findings The audit conclusions The audit report performance Various formats can be used depending on the auditee (vendors, management or auditee) (Refer to Figure 7). Usually include the name and location of the auditee, date of audit, audit plan, audit observations, classification of noncompliances, recommendation or expectations. The report should write against a standard. It should focus on deficient conditions and not people. Include any positive observations. Keep the audit report simple, clear and straight to the point.
INTERNAL AUDIT REPORT

10 15 August 2004
No
1.
GMP. Ref.
2.1.1
Finding IQA
Production and QC sections are headed by the same person Consideration should be given to define in system more clearly regarding thermometer used in the liquid mixer The quality system does not consistently ensure that control over subcontractor is adequately identified in the system.
F/O
F
Locatio n
Head office Liquid production
Audite e
Abas
Auditor
Budi
2.
4.3
Tuti
May Lin
11
Supply chain
Herman
Ida
Figure 7.
INTERNAL AUDIT
Prepared by Lam Kok Seng - Singapore EC-ASEAN Economic Cooperation Programme on Standards, Quality and Conformity Assessment Cosmetic Sub-Programme Various types of audit reports
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4.5.2. Approving and distributing the audit report The audit report should be dated, reviewed aand approved in accordance with the audit program and issued within the agreed time period. The approved audit report should then be distributed to recipients designated by the audit client. This report is the property of the audit client. The audit team members and all recipients should respect and maintain the confidentiality of the report 4.6 Follow-up and closing up the loop: The conclusion of the audit may indicate the need for corrective, preventive or improvement actions, as applicable. Such actions are ussualy decided and undertaken by the auditee within an agreed timeframe and are not considered to be part of the audit. Receive a satisfactory response from auditee and their commitment to correct for any deficiency (Refer to Figure 5). Confirm CAPA are satisfactory, accomplished and documented. Verify and track for CAPA by scheduling a follow-up audit and/or requesting for an updated SOP. Ensures that the CAPA are completed and effective.
I tem 1 Audit observation Our response
The current version of SOPs is The department had not not consistently available in designated someone to the packaging department maintain the SOP binders as other departments had. A clerk has now been assigned to this task, the task has been added to the job description
Figure 8. Example of audit responses
INTERNAL AUDIT
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5.
Conclusions Nobody likes to be audited. It is a means to have continuous improvement. This is especially when it involves giving your company the license to manufacture or shutdown. But, if a person is prepared and a functional quality system is in place, one can see it as a way for continuous improvement.
6.
References a. ASEAN Guidelines for Cosmetic GMP. b. International standard ISO 19011:2002 (E), Guidelines for quality and/or environmental management system auditing, 1st Edition, 2002 c. www.cityu.edu.hk., Internal Quality Audit Scheme. d. www.fineprint.com, Internal Audit Procedure e. Stimson W.A., Internal Quality Auditing, Meeting the challenge of ISO 9000:2000, Paton Press, 2001 f. WHO EDM, Basic Principle of GMP: Self-Inspection.

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ASEAN COSMETIC GMP Training Manual Module 9

Project cofinanced by European Union

Project cofinanced by Asean

Date: 15 2005 Rev. : 00

ASEAN COSMETIC GMP Training Manual Module 9

Project cofinanced by European Union

Project cofinanced by Asean

Date: 15 2005 Rev. : 00

ASEAN COSMETIC GMP Training Manual Module 9

Project cofinanced by European Union

Project cofinanced by Asean

Date: 15 2005 Rev. : 00

ASEAN COSMETIC GMP Training Manual Module 9

Project cofinanced by European Union

Project cofinanced by Asean

Date: 15 2005 Rev. : 00

The key principles of the internal quality audit are:

ASEAN COSMETIC GMP Training Manual Module 9

Project cofinanced by European Union

Project cofinanced by Asean

Date: 15 2005 Rev. : 00

ASEAN COSMETIC GMP Training Manual Module 9

Project cofinanced by European Union

Project cofinanced by Asean

Date: 15 2005 Rev. : 00

ASEAN COSMETIC GMP Training Manual Module 9

Project cofinanced by European Union

Project cofinanced by Asean

Date: 15 2005 Rev. : 00

ASEAN COSMETIC GMP Training Manual Module 9

Project cofinanced by European Union

Project cofinanced by Asean

Date: 15 2005 Rev. : 00

Improving the audit programme

competence and evaluation of auditors Audit activities

Figure 1. Illustration of the process flow for internal audit

ASEAN COSMETIC GMP Training Manual Module 9

Project cofinanced by European Union

Project cofinanced by Asean

Date: 15 2005 Rev. : 00

ASEAN COSMETIC GMP Training Manual Module 9

Project cofinanced by European Union

Project cofinanced by Asean

Date: 15 2005 Rev. : 00

ASEAN COSMETIC GMP Training Manual Module 9

Project cofinanced by European Union

Project cofinanced by Asean

Date: 15 2005 Rev. : 00

ASEAN COSMETIC GMP Training Manual Module 9

Project cofinanced by European Union

Project cofinanced by Asean

Date: 15 2005 Rev. : 00

ASEAN COSMETIC GMP Training Manual Module 9

Project cofinanced by European Union

Project cofinanced by Asean

Date: 15 2005 Rev. : 00

ASEAN COSMETIC GMP Training Manual Module 9

Project cofinanced by European Union

Project cofinanced by Asean

Date: 15 2005 Rev. : 00

ASEAN COSMETIC GMP Training Manual Module 9

Project cofinanced by European Union

Project cofinanced by Asean

Date: 15 2005 Rev. : 00