CHECKLIST FOR INTERNAL QUALITY AUDITING
The checklist suggested here is indicative only. The internal auditors have to develop their own checklist considering applicable clauses to the identified processes within the Quality Management System. The reading, understanding & co-relating of the documented system with the requirements mentioned in quality manual would facilitate the auditors to be effective & efficient. 1.0 TOP MANAGEMENT Clause Audit Questions No. 5.1 a) What are the inputs used for establishing Quality Policy and Quality Objectives? i.e. Mission, Vision, Corporate Policy, Top Management interests and priorities etc. b) How continual improvement of effectiveness of QMS is ensured? c) How do you communicate to the organization the importance of meeting the customer requirements including the statutory and regulatory requirements? i.e. Memos, Displays, Meetings etc. 5.2 a) What are the inputs provided to you so that the customer requirements are determined and met? i.e. order review meetings, random checking of customer correspondence, customer meetings and feedbacks etc. b) What are the inputs do you get to ensure enhancement in customer satisfaction? i.e. customer feedback, customer audits, customer, survey, feedback to obtain product image in the market, handling customer complaints, repeat orders, cost effectiveness, enhancement in product properties, product development and innovations etc. 5.3 Is Quality Policy: a) Appropriate to the purpose of the organization? i.e. Policy should be in line with the current business priorities such as Increase in market share, Reduction in waste / rejection, cost, Customer satisfaction etc. b) Includes the commitment to comply with requirements and continually improve the effectiveness of QMS. c) Provide the framework for establishing Quality Objectives? d) How is it ensured that the Quality Policy is communicated and understood within the organization? e) How is the Quality Policy reviewed for continuing suitability? i.e. Policy shall be under “Control of Documents.” 5.4.1 a) Are the Quality Objectives consistent with the Quality Policy and are measurable? b) Are objectives deployed at relevant functions and levels within the organization? 5.5.1 a) How do you ensure that the responsibilities and authorities are defined? b) How are these communicated within the organization? i.e. documented by means of manuals, meetings, training, appraisals etc.
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Clause No. 5.5.2 5.5.3
5.6
5.6.2
5.6.3
6.0 8.5.1
CHECKLIST FOR INTERNAL QUALITY AUDITING Audit Questions Is M.R. being appointed? a) What is the process of communication established in your organization? i.e. Procedures, meetings, notice board, electronic media etc. b) Is the communication covers effectiveness of QMS? i.e. Process performance, product conformance, Business performance, deployment of Quality Objectives. a) Are management reviews done at planned intervals? b) Are records of management review maintained? c) Are criterions determined to check the effectiveness of Management Reviews? i.e. on time implementation of actions, follow ups required etc. d) Are the decisions and actions communicated to the various departments? Are following inputs reviewed in the management reviews: a) Result of audits b) Customer feedback c) Process performance i.e. criterions for the processes and objectives. d) Product conformity e) Status of corrective and preventive actions i.e. customer complaints, internal rejections, process trends etc. f) Follow up of last management reviews g) Changes that could affect QMS i.e. reorganization, new products, new markets, revised procedures. h) Recommendations for improvement i.e. Quality Policy, Objectives, Audit result, Analysis of data, Preventive & Corrective action and any other business requirements. Are actions and decisions included in the records for the following three outputs: a) Improvement of the effectiveness of QMS and its processes. b) Improvement of product related to customer requirements. c) Resource needs. How do you ensure availability of resources, infrastructure and work environment? i.e. environment related to product conformity. a) What are the inputs to you for identification of areas for continual improvement? i.e. Quality Policy, Objectives, Audit result, Analysis of data, Preventive & Corrective action and management review. b) What is the area for continual improvement?
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CHECKLIST FOR INTERNAL QUALITY AUDITING 2.0 MANAGEMENT REPRESENTATIVE Clause Audit Questions No. 4.1 a) Which are the processes identified in the QMS in the organization? i.e. for management activities, outsourced activities, provision of resources, product realization and measurement. b) How do you ensure that these processes are established? i.e. verbal or documented based on the complexity of the process. c) Is the sequence and interaction of these processes determined? d) Which processes are you directly responsible for? i.e. Internal audits, Management reviews, Documentation, Customer complaints, Identification of resources, Continual improvement etc. 4.2.1 a) Are documented statements of Quality Policy and Objectives available? b) Are other documents needed by the organization to effective planning, operation and controls of processes are identified? i.e. additional processes / procedures required, Organization charts, Work Instructions, Quality Plans, Specifications, Internal communication, List of Approved Suppliers etc. c) Are records specified in the International Standard identified? 4.2.2 Does a Quality Manual includes: a) Scope of QMS? i.e. activities, processes, product profile, sites, certification scope. b) Justification of exclusions? c) Documented procedures? i.e. Control of Documents, Control of Records, Control of Non – conforming products, Corrective & Preventive actions, Internal audits, Management review and Methodology for process measurements and status of objectives. d) Description of interaction of processes? i.e. Process Flow Charts, Process Description / Matrix. 4.2.3 Is documented procedure available to define controls for: a) Approval? b) Review, Update and Re - approve? c) Changes and current revision status of documents are identified? d) Relevant versions of applicable documents are available at point of use? e) Legible and readily identifiable? f) External origin documents are identified and their distribution controlled? g) Prevent unintended use of obsolete documents and to apply suitable identification to them, if retained? 4.2.4 Is a documented procedure available for controls needed for identification, storage, protection, retrieval, retention time and disposition of records? 5.5.3 How are the changes in documents communicated to various departments?
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Clause No. 8.2.2
CHECKLIST FOR INTERNAL QUALITY AUDITING Audit Questions a) Is documented procedure available for internal audits? b) Does the procedure contain responsibility of planning & conducting the audits, reporting results and record maintenance? c) Are inputs identified to execute the complete audit process? i.e. Status and importance of process of the area to be audited, results of previous audits to determine he frequency of audits, checklist, Auditor competence, Scope etc. d) Are internal audits conducted as per plan? e) Is the criterion of internal auditor’s competence defined? f) Are auditors not auditing their own work? g) Are the actions taken without undue delay by the area being audited? h) Are causes detected and non – conformities eliminated? i) Are follow up activities done? j) Are the audit results including the verification results are reported and records maintained? k) Is the criterion determined for checking the effectiveness of internal audit? l) Are corrections and corrective actions taken if the criterions are not met?
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CHECKLIST FOR INTERNAL QUALITY AUDITING 3.0 SERVICE PROVISION Clause Audit Questions No. 4.1 a) How many processes are identified in the support department? i.e. various support stages can be taken as processes, identification & traceability, customer property, preservation of product etc. b) Are criterions determined to ensure that the support process is effective? i.e. % rejection, achievement of targets, costs etc. c) Are the methods available for above criterions? d) Are controls of processes determined? e) Are process monitored, measured and analyzed? 5.4.1 Are the Quality Objectives deployed in the support department? 6.1 Are the resources required for the process available? 6.2 a) Is the competence defined for the personnel performing support process? b) Are these competence requirements complied with? 6.3 Is infrastructure required for the conformity of the product (service) determined and maintained? i.e. Buildings, workspace etc. 6.4 Is the work environment needed for the conformity of the product (service) determined and managed? 7.5.1 Are the inputs identified for carrying out the production & service provisions under controlled conditions? a) Characteristics of product (service). b) Work instructions or procedures, if necessary. c) Suitable equipment. d) Availability and use of monitoring & measuring devices. e) Implementing, monitoring and measurement. f) Implementation of release, delivery and post delivery activities. 7.5.3 a) Are products (service) identified by suitable means at all stages? b) Is the product (service) inspection status identified at all stages? c) Is product traceability maintained during all phases, if required? 7.5.4 a) Are customer properties identified, verified, protected and safe guarded? b) Are records maintained for the customer property that is lost, damaged and is reported to the customer? i.e. also includes intellectual property. 7.5.5 Are the products and their constituents identified, handled, packed, stored and protected to preserve conformity? 7.6 Are the instruments used calibrated or verified? 8.2.2 Are actions taken for the non – conformities identified in internal audit without any undue delay? 8.2.3 Are correction and corrective actions taken in case the criterions are not met? 8.3 Is there a documented procedure available for non – conforming product (service)? 8.4 Is data generated for monitoring and measurement of the process?
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Clause No. 8.5 8.5.2
8.5.3
CHECKLIST FOR INTERNAL QUALITY AUDITING Audit Questions Are areas of continual improvement identified for improving effectiveness of QMS in support department? Are non – conformities of products, processes including customer complaints: a) Reviewed. b) Analyzed for determining cause. c) Evaluated for the need of action. d) Determining and implementing actions. e) Reviewing the action taken. f) Are the records of results of action taken maintained? Are potential non – conformities determined and a) Reviewed. b) Analyzed for determining cause. c) Evaluated for the need of action. d) Determining and implementing action. e) Reviewing the action. f) Are records of results of action taken maintained?
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CHECKLIST FOR INTERNAL QUALITY AUDITING 4.0 SALES Clause Audit Questions No. 4.1 a) Are criterions determined to ensure that the sales process is effective? i.e. sales target, customer satisfaction, delivery compliance, customer complaints, customer returns etc. b) Are the methods available for above criterions? c) Are controls of processes determined? d) Are process monitored, measured and analyzed? 5.4.1 Are the Quality Objectives deployed in the sales department? 6.1 Are the resources required for the process available? 6.2 a) Is the competence defined for the personnel performing support process? b) Are these competence requirements complied with? 7.1 How is customer related process identified and established? 7.2.1 How are requirements related are identified as an input? a) Stated delivery, post delivery customer requirements. b) Unstated requirements i.e. identified unstated requirement dictated by the end use of the product. c) Statutory & regulatory requirements related to the product. d) Any additional requirements i.e. pre dispatch information, pre dispatch inspection etc. 7.2.2 a) Are the requirements reviewed and necessary inputs from the various departments obtained prior to organization commitment? b) Are the records of above reviews and actions arising due to this review maintained? c) Are the relevant documents amended and communicated to the relevant departments in case of amendment to the order? d) Are verbal orders confirmed to the customer before acceptance? e) Is the output from the sales department communicated to the relevant departments? 7.2.3 Are arrangements for communicating to the customer for product information, inquiries, customer feedback including customer complaints determined? 8.2.1 a) Is method of measurement of customer satisfaction / perception determined? b) Are corrective actions identified if the customer requirements are not full filled? 8.2.2 Are actions taken for the non – conformities identified in internal audit without any undue delay? 8.2.3 Are correction and corrective actions taken in case the criterions are not met? 8.4 Is data generated for monitoring and measurement of the process? 8.5 Are areas of continual improvement identified for improving effectiveness of QMS in sales department?
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CHECKLIST FOR INTERNAL QUALITY AUDITING 5.0 PROCUREMENT & LOGISTICS Clause Audit Questions No. 4.1 a) Are criterions determined to ensure that the procurement process is effective? i.e. % rejection, material cost targets etc. b) Are the methods available for above criterions? c) Are controls of processes determined? d) Are process monitored, measured and analyzed? e) Are there any outsourced process identified in the organization? f) Are controls of these outsourced processes identified in the QMS? 5.4.1 Are the Quality Objectives deployed in the procurement & logistics department? 6.1 Are the resources required for the process available? 6.2 a) Is the competence defined for the personnel performing support process? b) Are these competence requirements complied with? 7.1 a) What are the processes identified and established? i.e. Procurement – Local, Imported, Vendor selection & evaluation etc. b) Are the inputs identified for the purchasing process? i.e. Despatch plan, Bill of material, selected suppliers etc. 7.4.2 Does purchase information contain: a) Product description. b) Where ever appropriate, requirement / criterion for approval of a product, procedures, processes. c) Requirement of qualification of personnel. d) QMS requirements. e) Are requirements contained in the purchasing information is checked for adequacy prior to communication to the supplier? 7.4.3 a) Is the acceptance criteria established and implemented to ensure that purchase product meets specified purchase requirements? b) Does the purchasing information contain the intent of customer or organization, if required? c) Are criterions established for selection, evaluation and re – evaluation of suppliers? d) Are records of evaluation maintained? 7.5.5 Are the products received identified, handled, packed and stored adequately to preserve the conformity of the product? 8.2.2 Are actions taken for the non – conformities identified in internal audit without any undue delay? 8.2.3 Are correction and corrective actions taken in case the criterions are not met? 8.4 Is data generated for monitoring and measurement of the process? 8.5 Are areas of continual improvement identified for improving effectiveness of QMS in procurement & logistics department?
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CHECKLIST FOR INTERNAL QUALITY AUDITING 6.0 HUMAN RESOURCE & ADMINISTRATION Clause Audit Questions No. 4.1 a) Are criterions determined to ensure that the HRD process is effective? i.e. trainings required, training hrs per employee, gaps between competence required and actual etc. b) Are the methods available for above criterions? c) Are controls of processes determined? d) Are process monitored, measured and analyzed? 5.4.1 Are the Quality Objectives deployed in the HRD department? 6.1 Are the resources required for the process available? 6.2 a) Is necessary competence on the basis of education, training, skill & experience determined for various personnel? b) Are these competence requirements complied with? c) Are there any gaps between the above needs and actual? 7.1 How is HRD process established? 8.2.2 Are actions taken for the non – conformities identified in internal audit without any undue delay? 8.2.3 Are correction and corrective actions taken in case the criterions are not met? 8.4 Is data generated for monitoring and measurement of the process? 8.5 Are areas of continual improvement identified for improving effectiveness of QMS in HRD?
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