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aar_m-1003-2019_requirements_for_documentation_-_records [2019/10/31 11:12]
rrandall
aar_m-1003-2019_requirements_for_documentation_-_records [2019/10/31 11:33] (current)
rrandall
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 |  9  | Maintain <wrap hi>​documented procedures</​wrap>​ for the verification,​ storage, and preservation of the customer-supplied materials. ​ |  2.11.5 ​ | |  9  | Maintain <wrap hi>​documented procedures</​wrap>​ for the verification,​ storage, and preservation of the customer-supplied materials. ​ |  2.11.5 ​ |
 |  10  | Adhering to <wrap hi>​documented procedures</​wrap>​ defining the work process where the absence of such procedures could adversely affect quality. ​ |  2.15.1 ​ | |  10  | Adhering to <wrap hi>​documented procedures</​wrap>​ defining the work process where the absence of such procedures could adversely affect quality. ​ |  2.15.1 ​ |
-|  11  | Identifying and maintaining equipment with <wrap hi>​documented</​wrap>​ preventive maintenance to ensure continuing conformity to specified requirements. ​ |  2.15.7 ​ | +|  11  | Establish and maintain <wrap hi>​documented procedures</​wrap>​ for handling, storage, preservation,​ and delivery of materials, products, and services (activities). ​ |  2.16.1 ​ | 
-|  12  | Establish and maintain <wrap hi>​documented procedures</​wrap>​ for handling, storage, preservation,​ and delivery of materials, products, and services (activities). ​ |  2.16.1 ​ | +|  ​12  | The facility shall maintain <wrap hi>​documented procedures</​wrap>​ to implement and control the application of the statistical methods. ​ |  2.20.5 ​ | 
-|  ​13  | The facility shall maintain <wrap hi>​documented procedures</​wrap>​ to implement and control the application of the statistical methods. ​ |  2.20.5 ​ | +|  ​13  | The internal audits shall be performed in accordance with <wrap hi>​documented procedures</​wrap>​ (using appropriate checklists) by trained personnel who have the organizational freedom to document results. ​ |  2.21.3 ​ | 
-|  ​14  | The internal audits shall be performed in accordance with <wrap hi>​documented procedures</​wrap>​ (using appropriate checklists) by trained personnel who have the organizational freedom to document results. ​ |  2.21.3 ​ | +|  ​14  | //The facility shall establish and maintain <wrap hi>​documented procedures</​wrap>​ for contract review such that, before submission of an offer by the facility or at the acceptance of a contract or order (statement of requirement),​ the offer, contract, or order shall be reviewed by the facility to ensure the following://​ the requirements contained in the subsections of 2.23.1 |  2.23.1 ​ | 
-|  ​15  | //The facility shall establish and maintain <wrap hi>​documented procedures</​wrap>​ for contract review such that, before submission of an offer by the facility or at the acceptance of a contract or order (statement of requirement),​ the offer, contract, or order shall be reviewed by the facility to ensure the following://​ the requirements contained in the subsections of 2.23.1 |  2.23.1 ​ | +|  ​15  | When servicing is specified in the contract or order, the facility shall establish and maintain <wrap hi>​documented procedures</​wrap>​ for performing, verifying, and reporting that the servicing meets the specified requirements. ​ |  2.23.2 ​ | 
-|  ​16  | When servicing is specified in the contract or order, the facility shall establish and maintain <wrap hi>​documented procedures</​wrap>​ for performing, verifying, and reporting that the servicing meets the specified requirements. ​ |  2.23.2 ​ | +|  ​16  | The facility shall establish and maintain <wrap hi>​documented procedures</​wrap>​ to control and verify the design and development planning of the product in order to ensure that the specified requirements are met. Where product design, redesign, or modifications are not usually performed, the design procedures must address how adherence to existing design criteria is maintained. The facility must define the procedure when a design change is required. ​ |  2.24.1 ​ |  
-|  ​17  | The facility shall establish and maintain <wrap hi>​documented procedures</​wrap>​ to control and verify the design and development planning of the product in order to ensure that the specified requirements are met. Where product design, redesign, or modifications are not usually performed, the design procedures must address how adherence to existing design criteria is maintained. The facility must define the procedure when a design change is required. ​ |  2.24.1 ​ |  +|  ​17  | The facility shall prepare plans for each design and development activity. The plans shall include the review, verification,​ and validation requirements that are appropriate to each design and development activity. The plans shall describe or reference these activities and define responsibility for their implementation. The design and development activities shall be assigned to qualified personnel equipped with adequate resources. The <wrap hi>​plans</​wrap>​ shall be updated as the design evolves. ​ |  2.24.2 ​ | 
-|  ​18  | The facility shall prepare plans for each design and development activity. The plans shall include the review, verification,​ and validation requirements that are appropriate to each design and development activity. The plans shall describe or reference these activities and define responsibility for their implementation. The design and development activities shall be assigned to qualified personnel equipped with adequate resources. The <wrap hi>​plans</​wrap>​ shall be updated as the design evolves. ​ |  2.24.2 ​ | +|  ​18  | The facility shall define organizational and technical interfaces between different groups who contribute to the design process and shall <wrap hi>​document</​wrap>,​ transmit, and regularly review the necessary information. The facility shall manage the interfaces between the different groups to ensure effective communication and clear assignment of responsibility. ​ |  2.24.3 ​ | 
-|  ​19  | The facility shall define organizational and technical interfaces between different groups who contribute to the design process and shall <wrap hi>​document</​wrap>,​ transmit, and regularly review the necessary information. The facility shall manage the interfaces between the different groups to ensure effective communication and clear assignment of responsibility. ​ |  2.24.3 ​ | +|  ​19  | The facility shall identify and <wrap hi>​document</​wrap>​ design and development input requirements relating to the product, including applicable statutory and regulatory requirements,​ functional and performance requirements,​ and, where applicable, information derived from previous similar designs and other requirements essential for design and development ​ |  2.24.4 ​ | 
-|  ​20  | The facility shall identify and <wrap hi>​document</​wrap>​ design and development input requirements relating to the product, including applicable statutory and regulatory requirements,​ functional and performance requirements,​ and, where applicable, information derived from previous similar designs and other requirements essential for design and development ​ |  2.24.4 ​ | +|  ​20  | The facility shall <wrap hi>​document</​wrap>​ the design and development output and express it in terms that can be verified against design-input requirements and validated (see paragraph 2.24.9). ​ |  2.24.5 ​ |
-|  ​21  | The facility shall <wrap hi>​document</​wrap>​ the design and development output and express it in terms that can be verified against design-input requirements and validated (see paragraph 2.24.9). ​ |  2.24.5 ​ |+
  
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 |  1  | //Maintain calibration documents that include...//​ all of the requirements identified in the subsections of 2.8.4 <wrap em>​**[Actually,​ a record]**</​wrap> ​ |  2.8.4  | |  1  | //Maintain calibration documents that include...//​ all of the requirements identified in the subsections of 2.8.4 <wrap em>​**[Actually,​ a record]**</​wrap> ​ |  2.8.4  |
 |  2  | Assess and document the validity of previous inspection and test results when measuring and testing equipment are found to be out of calibration. <wrap em>​**[Actually,​ a record]**</​wrap>​| ​ 2.8.7  | |  2  | Assess and document the validity of previous inspection and test results when measuring and testing equipment are found to be out of calibration. <wrap em>​**[Actually,​ a record]**</​wrap>​| ​ 2.8.7  |
-|  3  | Evaluate and select subcontractors based on <wrap hi>​documented assessments</​wrap>​ of their ability to meet contract and quality requirements.<​wrap ​hi>​**[Actually,​ a record]**</​wrap>​ |  2.9.1.3 ​ |+|  3  | Evaluate and select subcontractors based on <wrap hi>​documented assessments</​wrap>​ of their ability to meet contract and quality requirements.<​wrap ​em>​**[Actually,​ a record]**</​wrap>​ |  2.9.1.3 ​ |
 |  4  | //​Purchasing documents shall contain data clearly describing the items ordered, including...//​ the requirements contained in the subsections of 2.9.2 <wrap em>​**[Actually,​ a record]**</​wrap>​ |  2.9.2  | |  4  | //​Purchasing documents shall contain data clearly describing the items ordered, including...//​ the requirements contained in the subsections of 2.9.2 <wrap em>​**[Actually,​ a record]**</​wrap>​ |  2.9.2  |
-|  5  | Ensuring that documentation for currently qualified personnel, processes, or equipment is maintained in accordance with the requirements of pertinent codes, standards, and specifications. <wrap em>​**[Actually,​ a record]**</​wrap>​ |  2.15.10 ​ | +|  5  | Identifying and maintaining equipment with <wrap hi>​documented</​wrap>​ preventive maintenance to ensure continuing conformity to specified requirements. ​ |  2.15.7 ​ | 
-|  ​ | The facility shall maintain records identifying nonconforming materials, products, and services (activities),​ the nature and extent of nonconformance,​ its disposition,​ and evidence that repaired and reworked materials, products, and services (activities) have been inspected or tested in accordance with applicable documented procedures. ​ |  2.18.5 ​ | +|  6  | Ensuring that documentation for currently qualified personnel, processes, or equipment is maintained in accordance with the requirements of pertinent codes, standards, and specifications. <wrap em>​**[Actually,​ a record]**</​wrap>​ |  2.15.10 ​ | 
-|  ​ | The facility shall maintain a completed Quality Assurance Program Evaluation Checklist, documenting the corresponding line item from the facility’s Quality Assurance Manual and supporting Quality Assurance Program procedure(s) that address each requirement in the current Specification M-1003. <wrap em>​**[Actually,​ a record]**</​wrap>​ |  2.19.1.1 ​ | +|  ​ | The facility shall maintain records identifying nonconforming materials, products, and services (activities),​ the nature and extent of nonconformance,​ its disposition,​ and evidence that repaired and reworked materials, products, and services (activities) have been inspected or tested in accordance with applicable documented procedures. ​ |  2.18.5 ​ | 
-|  ​ | Internal audit results shall be documented and include evidence of conformance and/or nonconformance of materials, products, and services (activities) to specified requirements. <wrap em>​**[Actually,​ a record]**</​wrap> ​ |  2.21.4 ​ | +|  ​ | The facility shall maintain a completed Quality Assurance Program Evaluation Checklist, documenting the corresponding line item from the facility’s Quality Assurance Manual and supporting Quality Assurance Program procedure(s) that address each requirement in the current Specification M-1003. <wrap em>​**[Actually,​ a record]**</​wrap>​ |  2.19.1.1 ​ | 
-|  ​ | The requirements are adequately defined and <wrap hi>​documented</​wrap>​. Where no written statement of requirement is available for an order received by verbal means, the facility shall ensure that the order requirements are agreed to before acceptance and subsequently documented. <wrap em>​**[Actually,​ a record]**</​wrap> ​ |  2.23.1.1 ​ | +|  ​ | Internal audit results shall be documented and include evidence of conformance and/or nonconformance of materials, products, and services (activities) to specified requirements. <wrap em>​**[Actually,​ a record]**</​wrap> ​ |  2.21.4 ​ | 
-|  ​10  | The facility shall maintain <wrap hi>​records</​wrap>​ of contract reviews. ​ |  2.23.4 ​ | +|  ​10  | The requirements are adequately defined and <wrap hi>​documented</​wrap>​. Where no written statement of requirement is available for an order received by verbal means, the facility shall ensure that the order requirements are agreed to before acceptance and subsequently documented. <wrap em>​**[Actually,​ a record]**</​wrap> ​ |  2.23.1.1 ​ | 
-|  ​11  | At appropriate stages of design, formal reviews of the design and development results shall be planned and conducted to evaluate the ability of the results to meet design and development input requirements. The review shall identify any problems and shall propose appropriate resolution actions. Participants at each design review shall include representatives of functions concerned with the design and development stage(s) being reviewed. <wrap hi>​Records</​wrap>​ of such reviews shall be maintained and necessary actions shall be documented. ​ |  2.24.7 ​ | +|  ​11  | The facility shall maintain <wrap hi>​records</​wrap>​ of contract reviews. ​ |  2.23.4 ​ | 
-|  ​12  | At appropriate stages of design, design verification shall be performed to ensure that the design and development output meets the design and development input requirements. The design and development verification measures and any necessary actions shall be <wrap hi>​recorded</​wrap>​. ​ |  2.24.8 ​ | +|  ​12  | At appropriate stages of design, formal reviews of the design and development results shall be planned and conducted to evaluate the ability of the results to meet design and development input requirements. The review shall identify any problems and shall propose appropriate resolution actions. Participants at each design review shall include representatives of functions concerned with the design and development stage(s) being reviewed. <wrap hi>​Records</​wrap>​ of such reviews shall be maintained and necessary actions shall be documented. ​ |  2.24.7 ​ | 
-|  ​13  | All design and development changes and modifications shall be identified, documented, reviewed, verified, and validated as appropriate and then approved by authorized personnel. ​ |  2.24.10 ​ | +|  ​13  | At appropriate stages of design, design verification shall be performed to ensure that the design and development output meets the design and development input requirements. The design and development verification measures and any necessary actions shall be <wrap hi>​recorded</​wrap>​. ​ |  2.24.8 ​ | 
-|  ​14  | The facility shall maintain <wrap hi>​records</​wrap>​ of the review of changes and any necessary actions. ​ |  2.24.10.2 ​ |+|  ​14  | All design and development changes and modifications shall be identified, documented, reviewed, verified, and validated as appropriate and then approved by authorized personnel. ​ |  2.24.10 ​ | 
 +|  ​15  | The facility shall maintain <wrap hi>​records</​wrap>​ of the review of changes and any necessary actions. ​ |  2.24.10.2 ​ |