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Checklist ISO 15378

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Checklist ISO 15378

  1. 1. 501.12 Checkliste ISO 15378:2011 (DIN EN ISO 15378:2012) Checklist ISO 15378:2011 (DIN EN ISO 15378:2012) Ref.No: _______________________ Organization: ________________________________ Audit period / date Name of lead auditor Signature of lead auditor Instructions for using the DQS-audit checklist 1. Normative references and identification The ordered QM-elements from the standard are preceded by numbers. The additional requirements of ISO 15378:2011 are post-positioned. Special additional questions from Annex A of the standard can be found at the end of this checklist and only need to be answered if they are applicable 2. Application of the assessment checklist The checklist serves for the evaluation of audit results. Every audit requirement should be evaluated separately. The applicability of Annex A (normative) for the organization is to be determined at the beginning of the audit. The evaluation of the documentation and implementation of a standard's requirement should be documented in the following way: 1 = fulfilled 2 = partially fulfilled, still acceptable 3 = partially fulfilled, not acceptable 4 = not fulfilled na = not applicable 0 = not audited Auditor remarks: Checklist ISO 15378:2011 1 / 20
  2. 2. 501.12 Checkliste ISO 15378:2011 (DIN EN ISO 15378:2012) ISO 15378:2011 / DIN EN ISO 15378:2012 Additional requireme nts for ISO:9001 Assess ment 4 Quality management system 4.1 General requirements 4.1-1 Has the organization established and documented a quality management system that fulfils the requirements of ISO 15378? 4.1-2 Does the organization implement, maintain and continually improve the effectiveness of this QM- system? 4.1-3 Has the organization determined the processes necessary for the QM-system and its application in the whole organization? 4.1-4 Has the organization determined the sequence and interaction of these processes? 4.1-5 Has the organization determined criteria and methods needed to ensure that both the operation and control of these processes are effective? 4.1-6 Does the organization ensure the availability of resources and information necessary to support the operation and monitoring of these processes? 4.1-7 Are these processes monitored, measured and analyzed? 4.1-8 Are actions necessary to achieve planned results and continual improvement of these processes implemented? 4.1-9 Does the organization manage these processes in accordance with the requirements of ISO 9001:2008? 4.1-10 Does the organization ensure control over outsourced processes that affect product conformity with requirements? 4.1-11 Is the control of such outsourced processes identified within the quality management system? 4.1-12 Does the overall policy describe the intentions and approach to assurance of product quality? 4.1 g) 4.2 Documentation requirements 4.2.1 General Does the quality management documentation include… 4.2-1 a) documented statements of a quality policy and quality objectives? 4.2-2 b) a quality manual? 4.2-3 c) documented procedures required by ISO 9001:2008? 4.2-4 d) documents needed by the organization to ensure the effective planning, operation and control of its processes? 4.2-5 e) records required by ISO 15378? 4.2-6 f) the documented overall policy of the organization, its intentions and approach for validation? 4.2.1.1 4.2.2 Quality manual 4.2-8 Has the organization established and maintained a quality manual? Does the quality manual include… 4.2-9 a) the scope of the quality management system, including details of and justification for any exclusions? 4.2-10 b) documented procedures for the quality management system, or reference to them? 4.2-11 c) a description of the interaction between the processes of the quality management system? 4.2-12 d) the extent to which this international standard is applicable to Your processes? 4.2.2.1 Checklist ISO 15378:2011 2 / 20
  3. 3. 501.12 Checkliste ISO 15378:2011 (DIN EN ISO 15378:2012) 4.2-13 e) the structure of the documentation used in the quality management system? 4.2.2.2 4.2.3 Control of documents 4.2-14 Are the documents required by the quality management system controlled? 4.2-15 Are records controlled according to the requirements given in 4.2.4 "Control of records" of the standard? 4.2-16 Is a documented procedure established to define the controls needed for… 4.2-17 a) approving documents for adequacy prior to issue? 4.2-18 b) reviewing and updating as necessary and re-approving documents? 4.2-19 c) ensuring that changes and the current revision status of documents are identified? 4.2-20 d) ensuring the prevention of unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose? 4.2-21 e) ensuring that documents remain legible and readily identifiable? 4.2-22 f) ensuring that documents of external origin are identified and their distribution controlled? 4.2-23 g) ensuring the prevention of unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose? 4.2-24 Does the organization ensure that changes to documents are reviewed and approved either by the original approving function or another designated function which has access to pertinent background information upon which to base its decisions? 4.2.3.1 4.2-25 Has the organization defined the period for which at least one copy of obsolete, controlled documents is to be retained? 4.2.3.2 4.2-26 If electronic signatures are used on documents, are the documents controlled to provide equivalent security to that given by a hand-written signature? 4.2.3.3 4.2-27 Do controlled documents include a unique identification? Do controlled documents contain a unique identification on each page (eg documents /-number, issue and page number)? 4.2.3.4 4.2.4 Control of records 4.2-27 Are records established and maintained to provide evidence of conformity to requirements and to the effective operation of the quality management system? 4.2-28 Are the records maintained so as to be legible, readily identifiable and retrievable? 4.2-29 Is a documented procedure established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records? 4.2-30 Are electronic records subject to the same controls as those required for other records (See 4.2.4 and 7.5.2.9)? 4.2.4.1 4.2-31 Are entries in records • clear and indelible? • made directly after performing the activity (in the order performed)? • dated and initialed or signed by the person making the entry? • with corrections dated and initialed or signed and, where appropriate, explained? Is the original entry still legible? 4.2.4.2 4.2-32 Does the organization define the quality critical processes and parameters where a double check is necessary for the release of a batch? If either check is carried out electronically, is this clearly defined? 4.2.4.3 4.2-33 Is each quality critical stage and parameter in production and control processes identified and double-checked? 4.2.4.4 4.2-34 For each batch of primary packaging material, does the organization establish and maintain a record that proves traceability and identifies the quantity manufactured and quantity approved for distribution? 4.2.4.5 4.2-35 Has the organization defined those parameters of the batch documentation that need to be verified? 4.2.4.6 4.2-36 Is the batch documentation verified and approved? 4.2.4.7 Checklist ISO 15378:2011 3 / 20
  4. 4. 501.12 Checkliste ISO 15378:2011 (DIN EN ISO 15378:2012) 4.2-37 Are all manufacturing, control, testing, distribution and investigation records retained: for at least five years after the date of manufacture, or as agreed with the customer, or for at least one year after the expiration date of the primary packaging material assigned by the organization, unless agreed otherwise with the customer? 4.2.4.8 5 Management responsibility 5.1 Management commitment Does top management provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by… 5.1-1 a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements? 5.1-2 b) establishing the quality policy? 5.1-3 c) ensuring that quality objectives are established? 5.1-4 d) conducting management reviews? 5.1-5 e) ensuring the availability of resources? 5.2 Customer focus 5.2 Does top management ensure that customer requirements are determined and met with the aim of enhancing customer satisfaction? 5.2.1 Customer audits 5.2-2 Does the organization permit the customers or their representatives to conduct audits to review the quality management system? 5.2.1 5.3 Quality policy Does top management ensure, that the quality policy… 5.3-1 a) is appropriate to the purpose of the organization? 5.3-2 b) includes a commitment to comply with the requirements and continually improve the effectiveness of the QM system? 5.3-3 c) provides a framework for establishing and reviewing quality objectives? 5.3-4 d) is communicated and understood within the organization? 5.3-5 e) is reviewed for continuing suitability? 5.4 Planning 5.4.1 Quality objectives 5.4-1 Does top management ensure that quality objectives, including those needed to meet requirements for product are established at relevant functions and levels within the organization? 5.4-2 Are the quality objectives measurable and consistent with the quality policy? 5.4.2 Quality management system planning Does top management ensure that... 5.4-3 a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1 "General requirements" as well as the quality objectives? 5.4-4 b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented? 5.5 Responsibility, authority and communication 5.5.1 Responsibility and authority 5.5-1 Does top management ensure that the responsibilities and authorities are defined and communicated within the organization? 5.5-2 Does the organization maintain a current record of signatures of responsible persons? 5.5.1.1 5.5-3 Do quality units with responsibility for quality critical decisions have the authority to make these decisions independently from production? 5.5.1.2 5.5.2 Management representative Checklist ISO 15378:2011 4 / 20
  5. 5. 501.12 Checkliste ISO 15378:2011 (DIN EN ISO 15378:2012) Has top management appointed a member of management who has responsibility and authority that includes: 5.5-4 a) ensuring that processes needed for the quality management system are established, implemented and maintained? 5.5-5 b) reporting to top management on the performance of the quality management system and any need for improvement? 5.5-6 c) ensuring the promotion of awareness of customer requirements throughout the organization? 5.5.3 Internal communication 5.5-7 Has top management ensured that appropriate communication processes are established within the organization? 5.5-8 Does top management ensure that communication regarding the effectiveness of the QM-system takes place? 5.5-9 Are Good Manufacturing Practices (GMP) in this international standard and requirements stated by laws and regulations communicated, as appropriate, to each level of the organization? 5.5.3.1 5.5-10 Is top management notified of quality critical situations in a timely manner? 5.5.3.2 5.6 Management review 5.6.1 General 5.6-1 Does top management review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness? 5.6-2 Does this review include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and the quality objectives? 5.6-3 Are records from management reviews maintained? 5.6.2 Review input Does the input to management review include information on… 5.6-4 a) results of audits? 5.6-5 b) customer feedback? 5.6-6 c) process performance and product conformity? 5.6-7 d) status of preventive and corrective actions? 5.6-8 e) follow-up actions from previous management reviews? 5.6-9 f) changes that could affect the quality management system? 5.6-10 g) recommendations for improvement? 5.6.3 Review output Does the output from the management review include any actions and decisions related to: 5.6-11 a) improvement of the effectiveness of the quality management system and its processes? 5.6-12 b) improvement of product related to customer requirements? 5.6-13 c) resource needs? 6 Resource management 6.1 Provision of resources Does the organization determine and provide the resources needed to… 6.1-1 a) implement and maintain the quality management system and continually improve its effectiveness? 6.1-2 b) enhance customer satisfaction by meeting the customer requirements? 6.2 Human resources 6.2.1 General 6.2-1 Are the personnel performing work affecting product quality competent on the basis of appropriate Checklist ISO 15378:2011 5 / 20
  6. 6. 501.12 Checkliste ISO 15378:2011 (DIN EN ISO 15378:2012) education, training, skills and experience? 6.2.2 Competence, awareness and training 6.2-2 a) Has the organization determined the necessary competence or personnel performing work affecting product quality? 6.2-3 b) Does the organization provide training to satisfy these needs or take other actions to provide the necessary competence? 6.2-4 c) Does the organization evaluate the effectiveness of actions taken? 6.2-5 d) Does the organization ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of quality objectives? 6.2-6 e) Does the organization maintain appropriate records of education, training, skills and experience? 6.2.2.1 GMP training 6.2-7 Is addition training conducted regularly and include awareness of applicable GMP and all procedures and policies that affect product quality and the quality management system? Does thins training include: a) the risk of contamination and cross-contamination? b) the potential hazard to end user/patient if product is contaminated? c) the impact of any deviations from specified procedures, processes or specifications on customer's product quality or the end user? 6.2.2.1.1 6.2-8 Is particular attention given to training of the personnel involved with the manufacture of sterile components or components to be subsequently sterilized? 6.2.2.1.2 .2-9 Is specific training on microbiological and particulate contamination and the potential risk to the patient of such contamination provided? 6.2.2.1.3 6.2-10 Is additional refresher training carried out at defined intervals? 6.2.2.1.4 6.2-11 Are temporary personnel trained or under supervision of a trained person? 6.2.2.2 6.2-12 Where consultants are employed to advise on quality matters, are records of their qualifications and type of service(s) provided maintained? 6.2.2.3 6.3 Infrastructure 6.3-1 Has the organization determined, provided and maintained the infrastructure needed to achieve conformity to product requirements? Does it include, as applicable... 6.3-2 a) buildings, workspace and associated utilities? 6.3-3 b) process equipment (both hardware and software)? 6.3-4 c) supporting services (such as transport and communication)? 6.4 Work environment 6.4-1 Has the organization determined and managed the work environment needed to achieve conformity to product requirements? 6.4-2 Has the organization established documented requirements for health, cleanliness, clothing and access control of personnel, if contact between such personnel and the primary packaging material or work environment could adversely affect the quality of the primary packaging material? 6.4.1.1 6.4-3 If work conditions can have an adverse effect on primary packaging material quality, has the organization defined the appropriate work environment conditions and established a system for their effective monitoring and control? 6.4.1.2 6.4-4 If appropriate, are special conditions established and documented for the control of contaminated or potentially contaminated primary packaging material to prevent contamination of other primary packaging material, the work environment or personnel? 6.4.1.3 6.4.2 Classification of clean areas/cleanrooms 6.4.2 Are clean areas/cleanrooms classified according to ISO 14644-1 and monitored/operated according to ISO 14644-2, ISO 14644-3 and ISO 14644-5 or equivalent? 6.4.2 6.4.3 Risk control of contamination 6.4.3 Checklist ISO 15378:2011 6 / 20
  7. 7. 501.12 Checkliste ISO 15378:2011 (DIN EN ISO 15378:2012) Has the organization determined and controlled the risks that may result in contamination of primary packaging materials, for example: a) personal hygiene and health? b) personal clothing, jeweler including piercing and make-up? c) smoking, eating, chewing, drinking and personal medication? d) handling and disposal of waste? e) microbiological contamination? 6.4.3 6.4.4 Pest control Is an effective, documented pest control program implemented and maintained? 6.4.4 6.4.5 Utilities (ancillary services) Are all utilities (e.g. air, gases, steam water) assessed for their potential impact on the quality of the primary packaging materials and any associated risks? Are records of the assessments maintained? (see 4.2.4) 6.4.5.1 Are appropriate ventilation and exhaust systems provided, where necessary, to minimize contamination? Is particular attention given to recirculation systems? 6.4.5.2 If water comes into direct contact with the primary packaging material, or its starting material or is used for cleaning the equipment in contact with the product, it its quality determined and controlled? 6.4.5.3 6.5 Maintenance activities Has the organization established documented requirements for maintenance activities (e.g. production processes, systems and equipment), when such activities or lack thereof may affect product quality? 6.5.1 Are records of such maintenance activities maintained (see 4.2.4)? 6.5.2 Has the organization ensured that the infrastructure is managed, operated, cleaned and, where appropriate, maintained in accordance with GMP and to avoid product contamination (including control of particulate matter and microbiological control where applicable)? 6.5.3 Do computerized systems that may impact upon primary packaging material quality have sufficient controls for installation, operation, maintenance, modification and security? 6.5.4 Is a set of technical documentation for quality critical equipment and installations maintained? 6.5.5 7 Product realization 7.1 Planning of product realization 7.1-1 Does the organization plan and develop the processes needed for product realization? 4.2.3 7.1-2 Is the planning of product realization consistent with the requirements of other processes of the quality management system? In planning product realization, has the organization determined the following, as appropriate: 7.1-3 a) Quality objectives and requirements for the product? 7.1-4 b) The need to establish processes, documents, and provide resources specific to the product? 7.1-5 c) Required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance? 7.1-6 d) Records needed to provide evidence that the realization processes and resulting product meet requirements 7.1-7 Is the output of this planning in a form suitable for the organization's method of operations? 7.1-8 Does product realization planning consider the requirement for consistent processing of primary packaging materials? Does planning also take account of the need for taking and retaining samples in appropriate conditions? 7.1.1 7.1-9 Does the organization ensure that risk management processes are included in the planning and implemented throughout product realization? Are records maintained? 7.1.2 7.2 Customer-related processes Checklist ISO 15378:2011 7 / 20
  8. 8. 501.12 Checkliste ISO 15378:2011 (DIN EN ISO 15378:2012) 7.2.1 Determination of requirements related to the product Does the organization determine… 7.2-1 a) requirements specified by the customer, including the requirements for delivery and post- delivery activities? 7.2-2 b) requirements not stated by the customer but necessary for specified or intended use, where known? 7.2-3 c) statutory and regulatory requirements related to the products? 7.2-4 d) any additional requirements determined by the organization? 7.2-5 Are requirements related to the product, including changes requiring notification, determined and documented? 7.2.1.1 7.2-6 Are customer requirements to avoid unauthorized use of waste primary packaging material (including samples, print media, and labels) determined and documented? 7.2.1.2 7.2.2 Review of requirements related to the product 7.2-7 Does the organization review the requirements related to the product? 7.2-8 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)? Does this review ensure that ... 7.2-9 a) product requirements are defined? 7.2-10 b) contract or order requirements differing from those previously expressed are resolved? 7.2-11 c) the organization has the ability to meet the defined requirements? 7.2-12 Are records of the results of the review and of actions arising from the review maintained? 7.2-13 Does the organization confirm the customer requirements before acceptance, where the customer provides no documented statement of requirement? 7.2-14 Does the organization ensure that relevant documents are amended, where product requirements are changed? 7.2-15 Does the organization ensure that relevant personnel are aware of the changed requirements? 7.2.3 Customer communication Has the organization determined and implemented effective arrangements for communication with customers in relation to ... 7.2-16 a) product information? 7.2-17 b) enquiries, contracts or order handling, including amendments? 7.2-18 c) customer feedback, including customer complaints? 7.2-19 Has the organization established and does it maintain a documented feedback system to provide early warning of potential and actual quality problems and to facilitate customer input into the corrective and preventive action system? 7.2.3.1 7.2-20 When required by the customer, does the organization agree with the customer, which changes require written confirmation prior to approval and which changes require notification only? Are proposed changes communicated in a timely manner and the process for introducing changes agreed? 7.2.3.2 7.3 Design and development 7.3.1 Design and development planning 7.3-1 Does the organization plan and control the design and development of product? During the design and development planning, does the organization determine... 7.3-2 a) the design and development stages? 7.3-3 b) the review, verification and validation that are appropriate to each design and development stage? Checklist ISO 15378:2011 8 / 20
  9. 9. 501.12 Checkliste ISO 15378:2011 (DIN EN ISO 15378:2012) 7.3-4 c) the responsibilities and authorities for design and development? 7.3-5 Does the organization manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility? 7.3-6 Is planning output updated, as appropriate, as the design and development progresses? 7.3-7 Has the organization implemented documented procedures for design and development, which include risk assessment, determination of relevant aspects of GMP and any potential impact on the customer and ultimately the patient? 7.3.1.1 7.3.2 Design and development 7.3-8 Are inputs related to product requirements determined and records maintained? Do these inputs include... 7.3-9 a) functional and performance requirements? 7.3-10 b) applicable statutory and regulatory requirements? 7.3-11 c) where applicable, information derived from previous similar designs? 7.3-12 d) other requirements essential for design and development? 7.3-13 Are these inputs reviewed for adequacy? 7.3-14 Are these requirements complete, unambiguous and not in conflict with each other? 7.3.3 Design and development outputs 7.3-15 Are the outputs of the design and development provided in a form that enables verification against the design and development input? 7.3-16 Are the outputs of the design and development approved prior to release? 7.3-17 a) Do the design and development outputs meet the input requirements for design and development? 7.3-18 b) Do the design and development outputs provide appropriate information for purchasing, production and for service provision? 7.3-19 c) Do the design and development outputs contain or reference product acceptance criteria? 7.3-20 d) Do the design and development outputs specify the characteristics of the product that are essential for its safe and proper use? 7.3.4 Design and development review Are systematic reviews of design and development performed at suitable stages in accordance with planned arrangements to... 7.3-22 a) evaluate the ability of the results of design and development to meet requirements? 7.3-23 b) identify any problems and propose necessary actions? 7.3-24 Do the participants in these reviews include representatives of functions concerned with the design and development stage(s) being reviewed? 7.3-25 Are records of the results of reviews as well as of any necessary actions maintained? 7.3.5 Design and development verification 7.3-26 Is verification performed in accordance with planned arrangements to ensure that design and development outputs have met the design and development input requirements? 4.4.7 7.3-27 Are records of the results of verification as well as of any necessary actions maintained? 7.3.6 Design and development validation 7.3-29 Is the design and development validation performed in accordance with planned arrangements to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known? 7.3-30 Is validation completed prior to the delivery or implementation of the product wherever practicable? 7.3-31 Are records of the results of validation as well as of any necessary actions maintained? 7.3.7 Control of design and development changes 7.3-29 Are design and development changes identified and records maintained? Checklist ISO 15378:2011 9 / 20
  10. 10. 501.12 Checkliste ISO 15378:2011 (DIN EN ISO 15378:2012) 7.3-30 Are the changes reviewed, verified and validated, as appropriate? 7.3-31 Are the changes approved before implementation? 7.3-32 Does the review of design and development changes include evaluation of the effect of the changes on constituent parts and product already delivered? 7.3-33 Are records of the results of the review of changes and any necessary actions maintained? 7.3.7.1 Notification 7.3-34 Is the customer or the control / permitting authority notified of changes if the technical files / reference data have been affected? Are changes that affect any of the data supplied notified to the customer and, if a technical dossier/master file has been supplied by the organization, directly to the regulatory authorities? 7.3.7.1 7.3.7.2 Design changes 7.3-35 When implementing change, are the existing validation and documents affected by the change reviewed and revised? Are personnel trained as appropriate? 7.3.7.2 7.4 Purchasing 7.4.1 Purchasing process 7.4-1 Does the organization ensure that purchased product conforms to specified purchase requirements? 7.4-2 Are 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? 7.4-3 Are suppliers evaluated and selected based on their ability to supply product in accordance with the organization's requirements? 7.4-4 Are criteria established for selection, evaluation and reevaluation? 7.4-5 Are records maintained of the results of evaluations and any necessary actions? 7.4-6 Has the organization approved suppliers of: a) starting materials? b) quality critical process aids? c) packaging materials for use in cleanrooms? 7.4.1.1 7.4-7 Does the organization notify the customer prior to outsourcing any part of the production process? 7.4.1.2 7.4-8 Are all outsourced services, that can affect product quality, controlled including origination, laboratory services, sterilization, calibration services and qualification services, maintenance, cleaning, haulage, pest control and waste contractors, depending on the risks involved? 7.4.1.3 7.4-9 Are consultants advising on the manufacture and control of primary packaging materials considered as suppliers? 7.4.1.4 7.4-10 Are suppliers of quality critical materials and services approved by the quality unit(s) or a person assigned by the quality unit(s)? 7.4.1.5 7.4-11 Has the organization evaluated and recorded the competence of laboratories to perform quality critical activities? Does the organization only use laboratories that it has accepted as being competent to perform quality critical activities? 7.4.1.6 7.4-12 If the sterilization process is outsourced, does the organization ensure that the process complies with the requirements of 7.5.1 and 7.5.2? 7.4.1.7 7.4-13 Is changing the source of quality critical raw materials handled as part of the Change Control process? 7.4.1.8 7.4.2 Purchasing information 7.4-14 Does purchasing information describe the product to be purchased? Does it include, where appropriate... 7.4-15 a) requirements for approval of product, procedures, processes and equipment? 7.4-16 b) requirements for qualification of personnel? Checklist ISO 15378:2011 10 / 20
  11. 11. 501.12 Checkliste ISO 15378:2011 (DIN EN ISO 15378:2012) 7.4-17 c) QM system requirements? 7.4-18 Does the organization ensure the adequacy of specified purchase requirements prior to their communication to the supplier? 7.4-19 Does the organization maintain relevant purchasing information to the extent required for traceability as given in 7.5.3, i.e. documents (see 4.2.3) and records (see 4.2.4)? 7.4.2 7.4.3 Verification of purchased products 7.4-20 Has the organization established and does it implement inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements? 7.4-21 Does the organization state the intended verification arrangements and method of product release in the purchasing information, where the organization or its customer intends to perform verification at the supplier's premises? 7.4-22 Are incoming materials physically or administratively quarantined until they have been approved and released for use? 7.4.3.1 7.4-23 Are records of the verification maintained (see 4.2.4)? 7.4.3.2 7.4-24 Are sampling activities conducted in accordance with a sampling method, using procedures, facilities and equipment designed to avoid contamination? 7.4.3.3 7.5 Production and service provision 7.5.1 Control of production and service provision 7.5-1 Does the organization plan and carry out production and service provision under controlled conditions? Do these controlled conditions include, as applicable... 7.5-2 a) the availability of information that describes the characteristics of the product? 7.5-3 b) the availability of work instructions, as necessary? 7.5-4 c) the use of suitable equipment? 7.5-5 d) the availability and use of monitoring and measuring devices? 7.5-6 e) the implementation of monitoring and measurement? 7.5-7 f) the implementation of product release, delivery and post-delivery activities? 7.5-8 g) the definition of the date of manufacture taking into account the processes involved? 7.5.1 7.5-9 h) special attention to marking, labeling and packaging operations to provide effective control and to prevent errors? 7.5.2 7.5-10 i) a documented procedure defining the management of process deviations? Are quality critical deviations investigated and the outcome recorded (see 4.2.4)? 7.5.3 7.5.1.1 Cleanliness of product and contamination control 7.5-11 Does the organization establish and maintain documented requirements for cleanliness of primary packaging materials and procedures to prevent contamination of equipment or product? 7.5.1.1.1 7.5-12 Do all production processes in clean areas or in controlled areas, including environmental controls, production, in-process controls and packaging of primary packaging materials comply with the specified area conditions and operating criteria? Do cleanrooms have air- locks? 7.5.1.1.2 7.5-13 Are production processes in controlled environmental conditions agreed between customer and organization? 7.5.1.1.3 7.5-14 Does the organization establish documented cleanliness requirements for primary packaging materials? a) when primary packaging material is cleaned by the organization prior to sterilization by the organization and / or its use, or b) when primary packaging material is to be supplied non-sterile and its cleanliness is of significance in use, or c) when process agents are to be removed from product during manufacture? 7.5.1.1.4 Checklist ISO 15378:2011 11 / 20
  12. 12. 501.12 Checkliste ISO 15378:2011 (DIN EN ISO 15378:2012) 7.5-15 Are storage containers and their attendant manifolds, filling and discharge lines identified? 7.5.1.1.5 7.5-16 Is special attention (e.g. identification, security, cleanliness) given prior to discharge in and out of bulk containers/silos? 7.5.1.1.6 7.5-17 Are written procedures established for the cleaning of equipment used in the manufacture of primary packaging materials? Are records of cleaning equipment that are critical to the quality of primary packaging materials maintained? 7.5.1.1.7 7.5-18 Is production equipment/area identified as to its content and cleaning status? 7.5.1.1.8 7.5-19 Is the incorporation of reprocessed materials inherent in the manufacture of some materials (e.g. glass, aluminum, paper)? Are reprocessing parameters defined and agreed with the customer? 7.5.1.1.9 7.5-20 Is it ensured that thermoplastic waste materials are not reground and reused in primary packaging materials, unless agreed with the customer? 7.5.1.1.10 7.5-21 Is there a line clearance inspection of packaging and labeling facilities between packaging operations to remove all materials and documentation not required for the next operation? Are line clearance activities recorded (see 4.2.4)? 7.5.1.1.11 7.5.1.2 Change control 7.5-22 Has the organization implemented a process for effective and efficient control of changes to ensure that changes do not affect product quality, and do satisfy the needs and expectations of interested parties? 7.5.1.2.1 7.5-23 Are changes identified, recorded, evaluated, reviewed and controlled in order to understand the effect on other processes? 7.5.1.2.2 7.5-24 Is authority for initiating, review and approval of changes defined in order to maintain control? 7.5.1.2.3 7.5.1.3 Particular requirements for sterile primary packaging materials 7.5-25 Does the organization maintain records (see 4.2.4) of the process parameters for the sterilization process, which was used for each sterilization batch? Are sterilization records traceable to each batch of primary packaging material? 7.5.1.3 7.5.2 Validation of processes for production and service provision 7.5.2-1 Does the organization validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement? 7.5.2-2 Does this include any processes where deficiencies may become apparent only after the product is in use or the service has been delivered? 7.5.2-3 Does the validation demonstrate the ability of these processes to achieve planned results? Has the organization established arrangements for these processes including, as applicable... 7.5.2-4 a) defined criteria for review and approval of the processes? 7.5.2-5 b) approval of equipment and qualification of personnel? 7.5.2-6 c) use of specific methods and procedures? 7.5.2-7 d) requirements for records? 7.5.2-8 e) revalidation? 7.5.2-9 Does the organization identify the quality critical processes within its operations, namely those that influence the quality of the primary packaging material? Is control over any of these processes where the resulting output cannot be verified by subsequent monitoring or measurement demonstrated through validation and documented? 7.5.2.1 7.5.2-10 Is risk assessment used to determine which processes are quality-critical, and to determine the extent of the validation work necessary to demonstrate control of these processes? Is risk analysis related to product quality related attributes? 7.5.2.2 7.5.2-11 Are technical systems (e.g. machines, lines, structural production components, etc.) used for manufacturing and testing of primary packaging materials verified and/or qualified/validated in accordance with a documented risk assessment? 7.5.2.3 7.5.2-12 Is verification and qualification/validation performed when significant changes to the 7.5.2.4 Checklist ISO 15378:2011 12 / 20
  13. 13. 501.12 Checkliste ISO 15378:2011 (DIN EN ISO 15378:2012) facilities, equipment and process occur which may affect the quality of the product? 7.5.2-13 Where appropriate, is validation of individual product carried out as agreed with the customer? 7.5.2.5 7.5.2-14 Are the results of validation recorded (see 4.2.4)? Are validation records maintained throughout the life of the equipment, process and/or product for a period of two years beyond retirement or as agreed with the customer? 7.5.2.6 7.5.2-15 For software used in quality critical processes, are functional tests to verify the traceability, transfer, accuracy and retention of data performed in sufficient number and under appropriate conditions? Is the system checked e. g. by entering correct and incorrect data in order to detect the traceability, transfer accuracy and retention of data or records? 7.5.2.7 7.5.2.16 Are the results of these tests and checks recorded (see 4.2.4)? 7.5.2.8 7.5.2-17 Are electronic records secured and protected against loss and accidental corruption and in form that will permit regeneration; if this is not possible, are hard copy prints retained for a period of two years beyond retirement or agreed with the customer? 7.5.2.9 7.5.2-18 If any quality critical process is outsourced, does the organization ensure that the process complies with the requirement of ISO 15378? 7.5.2.10 7.5.2-19 If sterilization is a requirement, has the organization established documented procedures for the validation of sterilization processes? Are sterilization processes validated prior to initial use? Are records of the results of sterilization process validation maintained (see 4.2.4)? 7.5.2.11 7.5.2-20 Where sterilization is a requirement, does the organization subject the primary packaging materials to a validated sterilization process and record all the control parameters of the sterilization process? If the sterilization process is outsourced, does the organization ensure that the process complies with the above requirements (see 7.5.2)? 7.5.2.12 7.5.3 Identification and traceability 7.5.3-1 Does the organization, where appropriate, identify the product by suitable means throughout product realization? 7.5.3-2 Does the organization identify the product status with respect to monitoring and measurement requirements? 7.5.3-3 Does the organization control and record the unique identification of the product, where traceability is a requirement? 7.5.3-4 Has the organization established and maintained a system to trace all materials from source to product realization defining the extent and the records required based on risk assessment (see 4,2.4, 8.3 and 8.5)? 7.5.3.1 7.5.3-5 Are batch production records numbered with a unique batch or identification number? 7.5.3.2 7.5.3-6 Are records of the use of quality critical equipment retained (see 4.2.4)? Do these records also include cleaning and maintenance activities in sequence with the manufacturing operations? Are maintenance activities documented and traceable to a particular manufacturing operation or piece of equipment? 7.5.3.3 7.5.3-7 Has the organization established and does it maintain documented procedures? Do these ensure that primary packaging materials returned to the organization for e.g. reprocessing to specified requirements, are identified and distinguished from normal production at all times? 7.5.3.4 7.5.4 Customer property 7.5.4-1 Does the organization exercise care with customer property while it is under the organization's control or being used by the organization? 7.5.4-2 Does the organization identify, verify, protect and safeguard customer property provided for use or incorporation into the product? 7.5.4-3 Does the organization report to the customer and maintain records if any customer property is lost, damaged or otherwise found to be unsuitable for use? 7.5.5 Preservation of product 7.5.5-1 Does the organization preserve the conformity of product during internal processing and delivery to Checklist ISO 15378:2011 13 / 20
  14. 14. 501.12 Checkliste ISO 15378:2011 (DIN EN ISO 15378:2012) the intended destination? 7.5.5-2 Does this preservation include identification, handling, packaging, storage and protection? 7.5.5-3 Does this preservation also apply to the constituent parts of a product? 7.5.5-4 Does the organization establish and maintain documented procedures for the control of product with a limited shelf-life or requiring special storage conditions? Are such special storage conditions controlled and recorded (see 4.2.4) and are shelf lives justified by data? 7.5.5.1 7.5.5-5 Is product clearly identified, segregated and securely stored, and protected from extraneous matter or contamination? Is packaging used to produce and contain the product clean and suitable? Are deliveries accompanied by appropriate documentation? (The delivery documentation should be batch-specific)? 7.5.5.2 7.5.5-6 If packaging containers are reused, are previous labels removed or defaced? Are they cleaned or verified as clean, in accordance with a documented procedure? 7.5.5.3 7.5.5-7 Are any special transport or storage conditions for primary packaging materials stated on the label and complied with? 7.5.5.4 7.6 Control and monitoring of measuring devices 7.6-1 Does the organization determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements? 7.6-2 Has the organization established processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements? Is the measuring equipment, where necessary to ensure valid results,... 7.6-3 a) calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards? 7.6-4 b) Is the basis used for calibration or verification recorded, where no such standards exist? 7.6-5 c) adjusted or re-adjusted as necessary? 7.6-6 d) identified to enable the calibration status to be determined? 7.6-7 e) safeguarded from adjustments that would invalidate the measurement result? 7.6-8 f) protected from damage and deterioration during handling, maintenance and storage? 7.6-9 Is the validity of previous measuring results assessed and recorded, when the measuring equipment is found not to conform to requirements? 7.6-10 Does the organization take appropriate action on the measuring equipment and any product affected? 7.6-11 Are records maintained of the results of calibration and verification? 7.6-12 Is the ability of computer software to satisfy the intended application confirmed, when used in the monitoring and measurement of specified requirements? 7.6-13 Is this undertaken prior to initial use and reconfirmed as necessary? 7.6-14 Are there regular, recorded challenge tests to automatic inspection equipment (e. g. 100% camera inspection systems and barcode readers) to verify the continued functionality? 7.6.1 7.6-15 Are production and control data related to the customer's product (excluding the organization's confidential intellectual property) made available when required by the customer or customer's representative, for verification that the production process, in- process and final control and test equipment are functionally adequate? 7.6.2 7.6-16 Is test equipment used in determining the acceptance of quality critical starting materials, intermediate/in-process or finished product, calibrated and additional qualification tests performed, if appropriate? 7.6.3 8 Measurement, analysis and improvement 8.1 General Does the organization plan and implement the monitoring, measurement, analysis and improvement Checklist ISO 15378:2011 14 / 20
  15. 15. 501.12 Checkliste ISO 15378:2011 (DIN EN ISO 15378:2012) processes needed to... 8.1-1 a) demonstrate conformity of the product? 8.1-2 b) ensure conformity of the QM system? 8.1-3 c) continually improve the effectiveness of the QM system? 8.1-4 Does this include determination of applicable methods, including statistical techniques, and the extent of their use? 8.2 Monitoring and measurement 8.2.1 Customer satisfaction 8.2-1 Does the organization monitor information relating to customer perception as to whether the organization has met customer requirements, as one of the measurements of the performance of the QM system? 8.2-2 Are the methods determined for obtaining and using this information? 8.2.2 Internal audit Does the organization conduct internal audits at planned intervals to determine whether the QM system... 8.2-3 a) conforms to the planned arrangements, to the requirements of ISO 9001 : 2008 and to the QM system requirements established by the organization? 8.2-4 b) is effectively implemented and maintained? 8.2-5 Is an audit program planned? 8.2-6 Is the status and importance of the processes and areas to be audited taken into consideration? 8.2-7 Are the results of previous audits taken into consideration? 8.2-8 Are the audit criteria, scope, frequency and methods defined? 8.2-9 Does the selection of auditors ensure objectivity and impartiality of the audit process? Auditors shall not audit their own work. 8.2-10 Does the conduct of audits ensure objectivity and impartiality of the audit process? 8.2-11 Are the responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records defined in a documented procedure? 8.2-12 Are records of the audits and their results maintained? Does the management responsible for the area being audited ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes? 8.2-13 Do follow-up activities include the verification of the actions taken and the reporting of verification results? 8.2.3 Monitoring and measurement of processes 8.2-14 Does the organization apply suitable methods for monitoring and, where applicable, measurement of the QM system processes? 8.2-15 Do these methods demonstrate the ability of the processes to achieve planned results? 8.2-16 Are correction and corrective action taken to ensure conformity of the product, as appropriate, when planned results are not achieved? 8.2-17 Does/do the quality unit(s) ensure that quality critical deviations are investigated, resolved and documented? 8.2.3 8.2.4 Monitoring and measurement of product 8.2-17 Does the organization monitor and measure the characteristics of the product to verify that product requirements have been met? 8.2-18 Is this carried out at appropriate stages of the product realization process in accordance with the planned arrangements? 8.2-19 Is evidence of conformity with the acceptance criteria maintained? 8.2-20 Do the records indicate the person(s) authorizing release of product? 8.2-21 Is product release and service delivery placed on hold until planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by Checklist ISO 15378:2011 15 / 20
  16. 16. 501.12 Checkliste ISO 15378:2011 (DIN EN ISO 15378:2012) the customer? 8.2.4.1 Investigation of OOS results 8.2-22 Is any out of specification result (OOS) investigated according to a documented procedure and the outcome recorded (see 4.2.4)? 8.2.4.1 8.2.4.2 Incoming inspection and testing 8.2-23 Are requirements established and maintained for all materials used? Are incoming materials inspected or otherwise verified as conforming to specified requirements? 8.2.4.2 8.2.4.3 In-process controls 8.2-24 Does the organization, as required by documented procedures, inspect and test the product during processing? 8.2.4.3.1 8.2-25 Are sampling procedures defined to ensure that samples are representative of the process being assessed? Is it ensured, that samples are not returned to the production area or incorporated into the batch of the primary packaging material? 8.2.4.3.2 8.2-26 Are additional in-process controls carried out after an equipment breakdown or an un- scheduled interruption which stops the process? 8.2.4.3.3 8.2.4.4 Final inspection 8.2-27 If final inspection is a requirement, is it completed prior to batch release? 8.2.4.4 8.2.4.5 Retained samples 8.2-28 Are retained samples taken in accordance with the organizations or the customer requirements? 8.2.4.5 8.2.4.6 Batch release 8.2-29 Is a review of batch documentation performed in order to release the batch? 8.2.4.6 8.3 Control of nonconforming product 8.3-1 Does the organization ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery? 8.3-2 Are the controls and related responsibilities and authorities for dealing with nonconforming product defined in a documented procedure? Where applicable, does the organization deal with nonconforming product by one or more of the following ways... 8.3-3 a) by taking action to eliminate the detected nonconformity? 8.3-4 b) by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer? 8.3-5 c) taking action to preclude its original intended use or application? 8.3-6 d) are actions been taken that are appropriate to the effects and / or potential effect, if a nonconforming product is discovered after it has already been delivered and / or put into use? 8.3-7 e) when nonconforming product is corrected is it subject to re-verification to demonstrate conformity to the requirements? 8.3-8 f) are records of the nature of nonconformities and any subsequent actions taken maintained, including concessions obtained ? 8.3-9 Is a further improved product re-verified to demonstrate conformity to the requirements? 8.3-10 Does the organization take actions that are appropriate to the effects or potential effects of the error if a defective product is detected after delivery or use? 8.3-11 Are nonconforming material or products quarantined pending determination of corrective or other actions? When considering correction via reworking or reconditioning, is a risk assessment of any adverse effects of the reworking on the products performed and documented (see 4.2.3 and 7.5.1) 8.3.1 8.3-12 Are reworking and / or reconditioning in accordance with a documented procedure that has been approved by the quality unit(s)? 8.3.2 Checklist ISO 15378:2011 16 / 20
  17. 17. 501.12 Checkliste ISO 15378:2011 (DIN EN ISO 15378:2012) Is the process of reworking agreed with the customer, if it is a fixed requirement? 8.3-13 If primary packaging material has been produced under cleanroom conditions, is any reworking carried out under the same conditions? 8.3.3 8.3-14 Is any proposal to release nonconforming product via a documented concession, authorized by the customer? 8.3.4 8.3-15 Following rejection, are primary packaging materials disposed of or destroyed according to a documented procedure? 8.3.5 8.4 Analysis of data 8.4-1 Does the organization determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the QM system and to evaluate where continual improvement of the effectiveness of the QM system can be made? 8.4-2 Does this include data generated as a result of monitoring and measurement and from other relevant sources? Does the analysis provide information relating to... 8.4-3 a) customer satisfaction? 8.4-4 b) conformity to product requirements? 8.4-5 c) characteristics and trends of processes and products including opportunities for preventive action? 8.4-6 d) suppliers? 8.4-7 Does the organization establish and maintain documented procedures, including requirements for the analysis of data to identify existing or potential causes of non- conforming product or other quality problems? 8.4 8.5 Improvement 8.5.1 Continual improvement 8.5-1 Does the organization continually improve the effectiveness of the QM system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review? 8.5-2 Are changes proposed as part of continual improvement subject to risk management? 8.5.1 8.5.2 Corrective action 8.5-3 Does the organization take action to eliminate the cause of nonconformities in order to prevent recurrence? 8.5-4 Are corrective actions appropriate to the effects of the nonconformities encountered? Is a documented procedure established to define requirements for... 8.5-5 a) reviewing nonconformities (including customer complaints)? 8.5-6 b) determining the causes of nonconformity? 8.5-7 c) evaluating the need for action to ensure that nonconformities do not recur? 8.5-8 d) determining and implementing action needed? 8.5-9 e) records of the results of action taken? 8.5-10 f) reviewing corrective action taken? 8.5-11 Does the organization investigate all customer complaints in a timely manner and communicate identified corrective action to all production and production-related sites? Are action(s) implemented as soon as practical and to an agreed timetable? Are records of investigation maintained (see 4.3,4)? 8.5.2.1 8.5-12 Is customer complaint not followed by corrective and/or preventive action justified and also recorded? 8.5.2.2 8.5.3 Preventive action 8.5-13 Does the organization determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence? 8.5-14 Are preventive actions appropriate to the effects of the potential problems? Checklist ISO 15378:2011 17 / 20
  18. 18. 501.12 Checkliste ISO 15378:2011 (DIN EN ISO 15378:2012) Is a documented procedure established to define requirements for... 8.5-15 a) determining potential nonconformities and their causes? 8.5-16 b) evaluating the need for action to prevent occurrence of nonconformities? 8.5-17 c) determining and implementing action needed? 8.5-18 d) records of results of action taken? 8.5-19 e) evaluation of the effectiveness of the preventive actions taken? Annex A (normative) GMP-requirements for printed primary packaging materials Assess ment A.1 Print impression media A.1.1 General A.1.1-1 Is all print impression media clearly and uniquely identified such that it is traceable to the origination material? A.1.1-2 Is all print impression media produced from and traceable to the master origination material held by the customer? A.1.1-3 Is all print impression media verified against the customer approved hard copy or electronic data and recorded? A.1.1-4 Is all print impression media stored in a secure area with a defined system for authorized issue and return to store? A.1.2 Matched plates a) Where more than one printing plate is required, is there a documented system for ensuring that all plates within the set are used? b) Where a set of plates contains the generic design for several jobs, is each individual plate within the set clearly, uniquely identified and documented? A.1.3 Copy/design change A.1.3-1 Where a design requires several plates and some of them are to be replaced because of a copy/design change, is there a documented procedure to allow for the replacement of the affected plate(s) and the retention of other media within the set? A.1.3-2 Are the original plates subjected to a procedure that allows re-identification? A.1.4 Verification A.1.4-1 Is the verification of the design on print impression media carried out during the printing machine make-ready and before the approval to run the product is given? A.1.4.1 Quarantine and desctruction A.1.4-2 Does the organization have a documented procedure which ensures that origination and print media, for a design undergoing revision, are subject to formal quarantine? A.1.4-3 Is there a documented system detailing the individual procedures for a) Disposal of unwanted origination and b) Unwanted print media? A.1.4-4 Are such items rendered unusable and disposed of in a controlled and secure manner? A.2 Print and conversion processes A.2.1 Print machine set-up (make-ready) A.2.1-1 Is the initial print make-ready performed using unprinted components or materials? A.2.1-2 Is material used for make-ready segregated and then disposed of as production waste? When set up subsequent printing processes, material from the same batch may be used as in the initial make- ready? A.2.2 Changeover systems A.2.2-1 Are changeover systems that are designed to reduce make-ready time (e.g. automated plate changing) and which do not permit a total line clearance subject to a documented risk assessment? A.2.2-2 Are these risk assessments operated with controls to ensure product security? A.2.2-3 Is all print media from the previous job removed from the line prior to formal approval of the print run being given? A.2.2-4 Are all controls recorded? A.2.3 Retained samples Checklist ISO 15378:2011 18 / 20
  19. 19. 501.12 Checkliste ISO 15378:2011 (DIN EN ISO 15378:2012) A.2.3-1 Are all in-process printed samples which are to be retained clearly identified and securely stored? A.2.3-2 Are samples used for other purposes voided if they leave the control of the organization? A.2.4 Replacement print media A.2.4-1 During a production run, if replacement plates are made from an existing fixed approved source, is the job continued only after a new "first off" check has been carried out? A.2.4-2 Are the replacement plates treated as new origination? A.2.4-3 Is the subsequent production treated as a new batch? A.2.4-4 Is the introduction of all new replacement print media recorded? A.2.6 Batch production and stock holding Group print impression Due to the risk of cross-contamination is a grouped print impression (printing more than one design on a print substrate during the same production run) not permitted. A.2.6-1 Does the organization control the storage (to)… a) ensure the security and integrity of the product? b) maintain traceability back to the manufacture? c) maintain traceability back to the materials used? d) and is contracted? A.2.7 Digital printing A.2.7-1 Are the new activities introduced by digital printing controlled and documented? A.2.7-2 Is the use of digital printing and any special requirements for the product agreed with the customer? A.2.7-3 Has the organization established a secure file access system, which is designed to prevent unintentional use of incorrect origination files? A.2.7-4 For the achievement of acceptable colors, are operational processes established through a formal process and recorded? A.3 Security barcode systems A.3.2 Verification methods/equipment A.3.2-1 Is every security barcodes item verified by on-line scanning equipment (where practical)? A.3.2-2 Is the scanning equipment software/control configuration loaded from an independent source? A.3.2-3 Is there an effective locking of the scanner after a code has been already entered once and checked? A.3.2-4 Is there an effective system for rejecting any product that fails the scanning process? A.3.2-5 Is each of these rejected products inspected to determine the cause of rejection and subsequently scrapped? A.3.2-6 Are the findings recorded and reviewed prior to product release? A.3.2-7 Is on-line scanning equipment and its associated reject mechanism subjected to a challenge test during production? A.3.2-8 Does such monitoring take place at the start of the process, at regular intervals, and be recorded? A.3.2-9 a) For any product produced where electronic scanning is specified, but has not been performed, is it properly authorized and recorded in the quality records? b) Is the customer notified and documented approval obtained before product release? A.3.2-10 Are off line measurements and/or verification of sample barcodes from all lanes carried out? A.3.3 "Point of sale" barcodes A.3.3-1 Where "point of sale" barcodes are incorporated into the design, is a documented sample check carried out during the production process? A.3.4 Reel naterials and products A.3.4-1 Unless otherwise specified by the customer, are splices made using a brightly colored adhesive tape on both sides of the web? A.3.4-2 Are both sides of the splice checked to ensure that: a) identical materials are joined? b) mutually fit? A.3.4-3 a) Is the quantity of material (length, weight or numerical) produced on each reel determined within accuracy Checklist ISO 15378:2011 19 / 20
  20. 20. 501.12 Checkliste ISO 15378:2011 (DIN EN ISO 15378:2012) limits agreed with the customer? b) is this quantity recorded on the inner face of each reel A.3.4-4 Are the batch identity, reel number and production date recorded on the inner face of the core of each individual reel? A.3.4-5 Does the web run to the unprinted material at the end of the print ? A.3.4-6 Is there a formal documented procedure for removal and disposal of the material used to pull the new design through the machine? (Required when it is necessary to leave printed material in the converting equipment due to the difficulty in carrying out re-webbing.) A.3.4-7 Does the organization have a secure system for the detection, removal and segregation of product with missing colors or text? Checklist ISO 15378:2011 20 / 20

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