Information
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Audit Title
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Site
- Newcastle
- Manchester
- Dublin
- Purley
- Witney
- Petersfield
- Winnersh
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Process Type
- Business Services
- Customer Services
- Fulfilment/Dispatch
- Marketing/Commercial
- People Services
- Product Realisation
- Sales
- Supply Chain
- Training
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Conducted on
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Auditee (s)
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Prepared by
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Document No.
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All evidence to be attached in the relevant section/clause. All photographic evidence must have its original location noted i.e \\filencl01\SSB Marketing\Analysis\Records.
Overview
Audit Preparation / Pre Meeting
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Review corrective actions for previous IA findings
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Review corrective actions for previous EA findings
4.2.1 Documentation Requirements - General
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Process has all Documents, including records, determined by the organisation to ensure the effective planning, operation and control of its processes?<br>
4.2.3 Control of Documents (Mandatory Evidence needed)
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Documents are approved? If reviewed and updated, re-approved?<br>
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Are all documents required by the quality management system controlled?<br>
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Changes and the current revision status of documents are identified?<br>
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Relevant versions of applicable documents are available at points of use?<br>
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Documents remain legible and readily identifiable?<br>
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Ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled?<br>
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Prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose?<br>
4.2.4 Control of Records (Mandatory Evidence needed)
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Have records been established to provide evidence of conformity to requirements and of the effective operation of the quality management system?<br>
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Are they controlled?<br>
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Storage of records?<br>
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Protection of records?<br>
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Are records legible?<br>
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Are records readily identifiable?<br>
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Are records readily retrievable?<br>
6 Resource Management
6.1 Provision of Resources
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Has the process determined and provided the resources needed to implement and maintain the QMS and continually improve its effectiveness?<br>
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Does the provision of resources allow the process to meet customer requirements?<br>
6.2.1 Human Resources - General
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Are personnel performing work affecting conformity to product requirements competent on the basis of appropriate education, training, skills and experience?<br>
6.2.2 Competence, Awareness & Training (Mandatory Evidence needed)
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Has the organization determined the necessary competence for personnel performing work affecting conformity to product requirements?<br>
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Provided training or taken other actions to achieve the necessary competence? (where applicable) <br>
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Evaluated the effectiveness of the actions taken?<br>
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Ensured that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives?<br>
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Maintained appropriate records of education, training, skills and experience (see 4.2.4)?<br>
6.3 Infrastructure
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Has the organization determined, provided and maintained the infrastructure needed to achieve conformity to product requirements?<br>
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Does this infrastructure include, as applicable buildings, workspace and associated utilities?<br>
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Does it include process equipment (both hardware and software)?<br>
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Does it include supporting services (such as transport, communication or information systems)?<br>
6.4 Work Environment
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Has the organization determined and managed the work environment needed to achieve conformity to product requirements?<br>
7 Product Realisation (excluding 7.5.2 and 7.6)
7.1 Planning of Product Realisation
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Has the organization planned and developed the processes needed for product realization?<br>
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Is planning of product realization consistent with the requirements of the other processes of the quality management system (see 4.1)?
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In planning product realization, has the organization determined the following, as appropriate: quality objectives and requirements for the product?
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the need to establish processes, documents, and provide resources specific to the product?
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required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance?
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records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4)?
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Is the output of this planning in a form suitable for the organization's method of operations?
7.2 Customer-related Processes
7.2.1 Determination of Requirements Related to the Product
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Has the organization determined requirements specified by the customer, including the requirements for delivery and post-delivery activities?
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requirements not stated by the customer but necessary for specified or intended use, where known?
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statutory and regulatory requirements related to the product?
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any additional requirements considered necessary by the organization?
7.2.2 Review of Requirements Related to the Product
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Does the organization review the requirements related to the product?
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Is this review conducted prior to the organization's commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders)?
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Does this review ensure that product requirements are defined?
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contract or order requirements differing from those previously expressed are resolved?
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the organization has the ability to meet the defined requirements?
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Have records of the results of the review and actions arising from the review been maintained (see 4.2.4)?
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Where the customer provides no documented statement of requirement, have the customer requirements been confirmed by the organization before acceptance?
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Where product requirements are changed, does the organization ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements?
7.2.3 Customer Communication
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Does the organization determine and implement effective arrangements for communicating with customers in relation to product information?
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enquiries, contracts or order handling, including amendments?
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customer feedback, including customer complaints?
7.3.1 Design and Development Planning
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Does the organization plan and control the design and development of product?
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During the design and development planning, does the organization determine the design and development stages?
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the review, verification and validation that are appropriate to each design and development stage?
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the responsibilities and authorities for design and development?
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Does the organization manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility?
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Is planning output updated, as appropriate, as the design and development progresses?
7.3.2 Design & Development Inputs
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Are inputs relating to product requirements determined and records maintained (see 4.2.4)?
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Do these inputs include functional and performance requirements?
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applicable statutory and regulatory requirements?
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where applicable, information derived from previous similar designs?
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other requirements essential for design and development?
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Are these inputs reviewed for adequacy?
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Are requirements complete, unambiguous and not in conflict with each other?
7.3.3 Design & Development Outputs
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Are the outputs of design and development provided in a form suitable for verification against the design and development input?
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Are the outputs of design and development approved prior to release?
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Do design and development outputs meet the input requirements for design and development?
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provide appropriate information for purchasing, production and for service provision?
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contain or reference product acceptance criteria?
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specify the characteristics of the product that are essential for its safe and proper use?
7.3.4 Design & Development Review
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At suitable stages, are systematic reviews of design and development performed in accordance with planned arrangements (see 7.3.1)?
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At suitable stages, are systematic reviews of design and development performed in accordance with planned arrangements (see 7.3.1)?
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to evaluate the ability of the results of design and development to meet requirements?
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to identify any problems and propose necessary actions?
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Do participants in such reviews include representatives of functions concerned with the design and development stage(s) being reviewed?
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Are records of the results of the reviews and any necessary actions maintained (see 4.2.4)?
7.3.5 Design & Development Verification
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Is verification performed in accordance with planned arrangements (see 7.3.1) to ensure that the design and development outputs have met the design and development input requirements?
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Are records of the results of the verification and any necessary actions maintained (see 4.2.4)?
7.3.6 Design & Development Validation
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Is design and development validation performed in accordance with planned arrangements (see 7.3.1) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known?
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Wherever practicable, is validation completed prior to the delivery or implementation of the product?
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Are records of the results of validation and any necessary actions maintained (see 4.2.4)?
7.3.7 Design & Development Changes
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Are design and development changes identified and records maintained?
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Are the changes reviewed, verified and validated, as appropriate, and approved before implementation?
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Does the review of design and development changes include evaluation of the effect of the changes on constituent parts and product already delivered?
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Are records of the results of the review of changes and any necessary actions maintained (see 4.2.4)?
7.4.1 Purchasing Process
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Does the organization ensure that purchased product conforms to specified purchase requirements?
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Is the type and extent of control applied to the supplier and the purchased product dependent upon the effect of the purchased product on subsequent product realization or the final product?
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Does the organization evaluate and select suppliers based on their ability to supply product in accordance with the organization's requirements?
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Have criteria for selection, evaluation and re-evaluation been established?
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Are records of the results of evaluations and any necessary actions arising from the evaluation maintained (see 4.2.4)?
7.4.2 Purchasing Information
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Does purchasing information describe the product to be purchased, including where appropriate requirements for approval of product, procedures, processes and equipment?
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requirements for qualification of personnel?
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quality management system requirements?
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Does the organization ensure the adequacy of specified purchase requirements prior to their communication to the supplier?
7.4.3 Verification of Purchased Product
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Has the organization established and implemented the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements?
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Where the organization or its customer intends to perform verification at the supplier's premises, has the organization stated the intended verification arrangements and method of product release in the purchasing information?
7.5.1 Control of Production & Service Provision
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Has the organization planned and carried out production and service provision under controlled conditions?
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Do controlled conditions include, as applicable the availability of information that describes the characteristics of the product?
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the availability of work instructions, as necessary?
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the use of suitable equipment?
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the availability and use of monitoring and measuring equipment?
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the implementation of monitoring and measurement?
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the implementation of product release, delivery and post-delivery activities?
7.5.3 Identification and traceability
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Where appropriate, does the organization identify the product by suitable means throughout product realization?
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Does the organization identify the product status with respect to monitoring and measurement requirements throughout product realization?
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Where traceability is a requirement, does the organization control and record the unique identification of the product and maintain records (see 4.2.4)?
7.5.4 Customer property
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Does the organization exercise care with customer property while it is under the organization's control or being used by the organization?
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Does the organization identify, verify, protect and safeguard customer property provided for use or incorporation into the product?
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If any customer property is lost, damaged or otherwise found to be unsuitable for use, is this reported to the customer by the organization?
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If any customer property is lost, damaged or otherwise found to be unsuitable for use, are records maintained (see 4.2.4)?
7.5.5 Preservation of product
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Does the organization preserve the conformity of product during internal processing and delivery to the intended destination in order to maintain conformity to requirements?
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As applicable, does this preservation include identification, handling, packaging, storage and protection?
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Does preservation also apply to the constituent parts of a product?
8 Measurement, Analysis and Improvement
8.1 General
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Has the process planned and implemented the monitoring, measurement, analysis and improvement procedures needed<br>to demonstrate conformity to product requirements?<br>
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To ensure conformity of the quality management system?<br>
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To continually improve the effectiveness of the quality management system?<br>
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Does this include determination of applicable methods, including statistical techniques, and the extent of their use?<br>
8.2.1 Customer satisfaction
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As one of the measurements of the performance of the quality management system, does the organization monitor information relating to customer perception as to whether the organization has met customer requirements?<br>
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Have the methods for obtaining and using this information been determined?<br>
8.2.2 Internal Audit
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Has the process been audited on time and in an effective manner?
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Have the results of previous audits been considered?<br>
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Have the audit criteria, scope, frequency and methods been clearly defined? Enter procedure name (s)<br>
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Does the selection of auditors and conduct of audits ensure objectivity and impartiality of the audit process?<br>
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Does the management responsible for the area being audited ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes?
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Do follow-up activities include the verification of the actions taken and the reporting of verification results (see 8.5.2)?<br>
8.2.3 Monitoring and measurement of processes (Mandatory Evidence needed)
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Does the organization apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes?<br>
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Do these methods demonstrate the ability of the processes to achieve planned results?<br>
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When planned results are not achieved, is correction and corrective action taken, as appropriate?<br>
8.2.4 Monitoring and measurement of product
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Does the process monitor and measure the characteristics of the product to verify that product requirements have been met?<br>
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Is this carried out at appropriate stages of the product realization process in accordance with the planned arrangements (see 7.1)?<br>
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Has evidence of conformity with the acceptance criteria been maintained?<br>
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Do records indicate the person(s) authorizing release of product for delivery to the customer (see 4.2.4)?<br>
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Does the organization ensure that the release of product and delivery of service shall not proceed until the planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer?<br>
8.3 Control of nonconforming product
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Does the organization ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery?<br>
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Have the controls and related responsibilities and authorities for dealing with nonconforming product been defined in a documented procedure?<br>
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Does the process/organisation deal with nonconforming product by one or more of the following ways: by taking action to eliminate the detected nonconformity?<br>
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By taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started?
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By authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer?<br>
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By taking action to preclude its original intended use or application?<br>
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When nonconforming product is corrected is it subject to re-verification to demonstrate conformity to the requirements?<br>
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Are records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, maintained (see 4.2.4)?<br><br>
8.4 Analysis of data (Mandatory Evidence needed)
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Does the Process determine, collect and analyse appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made?<br>
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Does this include data generated as a result of monitoring and measurement and from other relevant sources?<br>
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Does the analysis of data provide information relating to customer satisfaction (see 8.2.1)?<br>
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Conformity to product requirements (see 7.2.1)?<br>
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Characteristics and trends of processes and products including opportunities for preventive action (see 8.2.3 and 8.2.4)?<br>
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Suppliers (see 7.4)?<br>
8.5.2 Corrective action
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Does the process/organization take action to eliminate the causes of nonconformities in order to prevent recurrence?<br>
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Are corrective actions appropriate to the effects of the nonconformities encountered?<br>
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Review the effectiveness of the corrective action taken?<br><br><br><br><br><br>
8.5.3 Preventive action
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Are preventive actions appropriate to the effects of the potential problems?<br>
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Evaluating the need for action to prevent occurrence of nonconformities?<br>
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Reviewing the effectiveness of the preventive action taken?<br>
