Audit Report – Realization Planning 4.1a-d, 4.1f, 4.1 (control of outsourced processes), 4.2.1e, 5.1e, 6.3, 6.4 & 7.1
© 2003 – 2004 Practical Perspectives
When Printed, this copy is for reference purposes only! Check for current revision before using.Scope: Realization Processes
Date: / Auditor(s): / Witness(es):
SECTION 2
2-1
/The realization process includes determination of product-related quality objectives and requirements, as applicable. 7.1a
/J
/ /L
/ /Comments:
2-2
/The realization process supports the establishment of processes, documents, and the need to provide product-specific resources. 4.1a, 4.1b, 4.1d & 7.1b
/J
/ /L
/ /2-3
/Methods for determining, providing for, and maintaining the building, workspace, and associated utilities needed to achieve product conformity are in place. 4.1d, 4.1f, 5.1e & 6.3a
/J
/ /L
/ /2-4
/ Methods for determining, providing for, and maintaining process equipment (hardware and software) needed to achieve product conformity are in place. 4.1d, 4.1f, 5.1e & 6.3b /J
/ /L
/ /2-5
/ Methods for determining, providing for, and maintaining supporting services (outsourced processes) needed to achieve product conformity are in place. 4.1d, 4.1f, 5.1e & 6.3c /J
/ /L
/ /2-6
/ Where a process affecting product conformity is outsourced, the realization process ensures controls needing to be fulfilled to live up to the organization’s quality management system are in place and being followed by the supplier. 4.1 (control of outsourced process) /J
/ /L
/ /2-7
/ Methods for determining, providing for, and managing the work environment needed to achieve product conformity are in place. 4.1d, 4.1f, 5.1e & 6.4 /J
/ /L
/ /2-8
/ The realization process determines product-specific verifications, validations, monitoring, inspections, and testing including criteria for acceptance. 4.1c & 7.1c /J
/ /L
/ /2-9
/The realization process identifies the records needed for validating or qualifying new processes, as applicable, and for providing evidence of the product’s ability to meet requirements. 4.2.1e & 7.1d
/J
/ /L
/ /2-10
/Planning outputs are in a form suitable for the methods of operation in use, and support the identification, planning, development, and implementation of processes needed for product or service realization. 7.1
/J
/ /L
/ /Clarifications: / Outsourced processes – While this can be any process, the only ones we are concerned with are those related to meeting customer requirements. If an outsourced process affects the quality of the product, it falls under the controls outlined in ISO 9001:2000 and the organization has to ensure the supplier of the outsourced process has those controls in place or has to establish additional controls to ensure compliance with requirements. Planning outputs – Typically in the form of product-specific work instructions, but could be process work instructions. Can also be an implementation plan (time line, flowchart, etc.) Product-related objectives – Product-specific targets needing to be fulfilled, as deemed necessary by the organization. In some cases, the objectives are more process driven. Realization process – Develop a plan for providing a product or service. Work environment – Environmental consideration related to producing a product or providing a service to meet requirements. An example of this would be controlling temperature and humidity to reduce the impact they have on the product.
Add-on questions identified as part of document review (section 1) can be attached to this form or added on the back, as long as the questions include conclusions (J & L).
Audit Report - Realization Planning Revision: 2/12/2004 Page 1 of 1