ISO9001:2008 How PLM Contributes to Conformity

Transcription

1 ISO9001:2008 How PLM Contributes to Conformity November 2014 Rockwell Consults, LLC Brian Rockwell, PLM Solutions Architect

2 Table of Contents 1 Abbreviations Introduction What is PLM? Initial Design Market Need Sales Identification Management Decision Customer Needs Design Approval Process Product Release Process Engineering Changes Product Retirement ISO 9001 Conformance ISO How PLM Contributes to Conformity.docx 2 of 11

3 1 Abbreviations Abbreviation or Acronym Description Comments ECN Engineering Change Notice ECO Engineering Change Order ERP Enterprise Resource Planning ISO International Standards Organization NPI New Product Introduction PLM Product Lifecycle Management ISO How PLM Contributes to Conformity.docx 3 of 11

4 2 Introduction The International Standards Organization (ISO) is an international standard-setting body composed of representatives from various national standards organizations. 1 The ISO9000 series was created to define, establish, and maintain an effective quality assurance system for manufacturing and service industries. The standards are available through national standards bodies. ISO 9000 deals with the fundamentals of quality management systems, including the eight management principles upon which the family of standards is based. ISO 9001 deals with the requirements that organizations wishing to meet the standard must fulfill. 2 Since PLM is designed to work with and enhance the company s quality assurance plan, this document helps provide a point-by-point analysis of the ISO9001:2008(E) standard as it compares to PLM and compliance ISO How PLM Contributes to Conformity.docx 4 of 11

5 3 What is PLM? PLM, or Product Lifecycle Management, is the business strategy that involves the management of a product from inception through retirement. This document is not designed to explore each step at great lengths suffice it to say there are many sources available through other research channels that can provide infinitely more insight into the marketing, sales and supply chain product strategies. PLM deals with the entire product lifecycle process, however most companies will concentrate on the introduction and design management of a product with little or no thought towards the retirement or supersession of an existing product. This is a debatable subject therefore we will highlight the need to consider the entire lifecycle of a product as just that a lifecycle. How each company deals with that approach is completely discretionary. The different stages are reviewed as follows: Initial Design The initial design of a product or sometimes referred to as New Product Introduction (NPI) is the release process to bring a product to market. There is no set manner to do so, although some common components are identified by the following: Market Need Most new product is the result of some type of market research or through feedback through various channels. Some are mentioned below, however regardless of the means of communication of that product need a decision is made, resources are allocated, and a plan is put into place Sales Identification Management Decision Customer Needs Design Approval Process Eventually a rough design is thought up and the intent to implement that plan comes into being. The design is usually put to paper so to speak and a design is created. Normally this is done through a 3D CAD program to allow certain departments within the company to understand the concept and to determine if the new product idea is marketable and profitable. Product Release Process The release of that product is based on the decision that the product is actually feasible and lucrative. Once that decision has been made and the company decides to move forward, some process is utilized to bring the new product to the knowledge of manufacturing, which in most cases is through some ERP system. Since Infor PLM Discrete is the focus and Infor sells several flavors of ERP, the intent is that PLM be used in conjunction with and interface to some Infor ERP system; although that is not entirely exclusive. Any system with point-to-point connections will work well, depending on the mode of installation. Engineering Changes Once the product has been released, it is almost inevitable there will be some change to manage to the product. Years may pass with no changes whatsoever, however typically there are times when some changes occur ISO How PLM Contributes to Conformity.docx 5 of 11

6 simultaneously. Either extreme can be accommodated if the users and management understand the process and make every effort to adhere to that process. With the correct controls and monitoring in place, this risk can be mitigated through proactive review and user training. Product Retirement Rarely addressed or often overlooked, product retirement is also a process that should be reviewed and defined. Some companies make the conscious decision to not retire product for reasons deemed important to them. Suffice it to say product retirement is an important aspect of a product s lifecycle ISO How PLM Contributes to Conformity.docx 6 of 11

7 4 ISO 9001 Conformance Below is a breakdown of the different sections in the ISO 9001 standard and how PLM adds value to the adherence of that requirement. Section Description PLM Value Comments 4.1 The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard. By using the PLM workflow(s), customers are forced to think and re-think how to incorporate quality into the approval process of product design and the release of information to the internal 4.1(a) 4.1(b) 4.1(c) 4.1(d) 4.1(e) 4.1(f) Determine the processes needed for the quality management system and their application throughout the organization Determine the sequence and interaction of these processes Determine criteria and methods needed to ensure that both the operation and control of these processes are effective Ensure the availability of resources and information necessary to support the operation and monitoring of these processes Monitor, measure where applicable, and analyze these processes Implement actions necessary to achieve planned results and continual improvement of these processes Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in company as well as externally. PLM requires specific processes to release data to and from PLM (normally to ERP) The workflow template uses a step-by-step process to progress the actual workflow Controls and checks are tools available to the user admin when creating the business process. These are typically configured during the template creation process, but some minor changes and tweaks can be made to individual processes once they have been created. Query tools are available to find information within PLM. Reporting tools are also available for identifying processes that may be in progress, suspended, failed, canceled, or completed. Processes should be reviewed periodically to determine if the process is meeting business requirements or if improvements can be made. With the inherent need to check out a document to modify, this requirement is met Records established to provide Since PLM is a document Documentation can be ISO How PLM Contributes to Conformity.docx 7 of 11

8 evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled. The organization shall establish a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention and disposition of records. Records shall remain legible, readily identifiable and retrievable. 7.1 The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system 7.1(b) The need to establish processes and documents, and to provide resources specific to the product 7.1(c) 7.1(d) 7.2.3(a) Required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance Records needed to provide evidence that the realization processes and resulting product meet requirements The organization shall determine and implement effective arrangements for communicating with customers in relation to a) product information management system, this is an inherent characteristic of PLM. Although this is really a business directive, PLM again can facilitate the definition and overall scope of the product management process. The Business Process module is designed to create a process that is plan-worthy, configurable, reproducible, consistent, manageable, and adaptable to the overall changing business requirements. Of all the activities noted here, the ones not covered by PLM are measurement, inspection and testing requirements, however that can be performed by another system such as LIMS and the report attached to the approval workflow to support and corroborate sufficient quality standards. This is maintained through quality documentation and procedures, such as SOP s. These would ideally be maintained by PLM where only quality has access. PLM utilizes several methods by which information may be shared outside the company such as: 1. PartnerNet 2. Product Packager 3. Direct access to PLM 4. Reports 5. Excel exports for maintained within PLM to cover how PLM is managed. This will also allow for versioning seeing how the process evolves over time. The quality documentation can be approved using its own process. Conformance reports, assembly instructions, testing results, etc. can all be maintained in PLM under revision control if required. Not all of these methods are acceptable to the company and need to be determined on a caseby-case basis ISO How PLM Contributes to Conformity.docx 8 of 11

9 7.3.1 The organization shall plan and control the design and development of product (a) During the design and development planning, the organization shall determine: This is the exact intent and purpose of PLM. Through the workflow process, PLM allows to control of product development. Each stage of the workflow is design specifically with a task or with tasks in mind. Each requirement will be analyzed separately based on the strengths of PLM and how it actually carries out and satisfies the ISO 9001 standard (b) 7.3.1(c) 7.3.2(a) The design and development stages The review, verification and validation that are appropriate to each design and development stage The responsibilities and authorities for design and development Inputs relating to product requirements shall be determined and records maintained (see 4.2.4). These inputs shall include: Functional and performance requirements The task is designed to require approval for each item attached so the tendency to gloss over a task is not allowed. This creates a validation step that forces the user to physically see and understand that something is attached. Each user who logs in will have a role(s) and group(s) assigned to them that will allow them to perform their specific tasks for each individual workflow. This will allow access to specific information in a read/write mode or as read-only access. CAD templates and other inputs can be created and connected to PLM for ease of access when crating new parts and drawings. Because of the interface from some CAD packages to PLM the ability to specifically identify the data requirements is quite advantageous. Workflow performance can be enhanced by setting criteria to expire a task, allowing the escalation of said task to possibly a manager or someone who motors and controls the process performance. Additionally, reports can be created that will allow the periodic review of processes to see if there are bottlenecks or shortcomings to the process ISO How PLM Contributes to Conformity.docx 9 of 11

10 7.3.2(b) 7.3.2(c) 7.3.2(d) 7.3.3(a) 7.3.3(b) 7.3.3(c) 7.3.3(d) Applicable statutory and regulatory requirements Where applicable, information derived from previous similar designs Other requirements essential for design and development The outputs of design and development shall be in a form suitable for verification against the design and development input and shall be approved prior to release. Design and development outputs shall: Meet the input requirements for design and development Provide appropriate information for purchasing, production and service provision Contain or reference product acceptance criteria Specify the characteristics of the product that are essential for its safe and proper use Depending on the actual requirements, the company will need to assess and determine if PLM conforms. If a part is derived or copied from an existing part, data is tracked to allow the user to recognize the source. This is covered for the most part with the entire concept of PLM. This is more of a catchall phrase that is equivalent to saying whatever else was missed. PLM provides sufficient output information to verify the design against the intended purpose and inputs provided into the system. This allows the 3D design model as well as the 2D drawing to be maintained in a cohesive unit as well as maintaining a full Bill of Material design with all relevant connections and links to reconstruct the design in a consistent, concise manner. Furthermore, any changes made to the product are also tracked in a revision format to allow the user to see previous releases and compare those revisions to each other. This is not normally covered by PLM, although it may be used from a reference standpoint. PLM controls the approval process which contains the acceptance criteria to an extent. Any testing or QA results for testing that have been performed on the product beyond PLM can be attached to the change process for tracking purposes. This is not normally handled by PLM, however any ancillary documentation to determine the use and cautions (such as an MSDS or user s manual) can be attached to either the PLM item It is typical that a blend of systematic controls and processes coupled with enforced company policy provide sufficient coverage for most regulatory requirements ISO How PLM Contributes to Conformity.docx 10 of 11

11 7.3.4 At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements Verification shall be 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. Records of the results of the verification and any necessary actions shall be maintained Design and development validation shall be 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. Wherever practicable, validation shall be completed prior to the delivery or implementation of the product. Records of the results of validation and any necessary actions shall be maintained Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered. Records of the results of the review of changes and any necessary actions shall be maintained or the NPI/ECO Process PLM can only provide a concise, easy to follow workflow using a workflow-style visual diagram. When and how that diagram is reviewed is strictly up to the company. From a product perspective, the design is verified against documentation inside PLM. Any additional documentation resulting from product testing and conformance verification can also be maintained in PLM if another system is not being used to do so. This is the principle purpose of PLM. By allowing changes to be made at certain times and controlling the release of that information to the company (specifically manufacturing), the company assures design matches what is on the plant floor at all times. Errors are reduced and the release process becomes more viable as an integral part of product design, development and management ISO How PLM Contributes to Conformity.docx 11 of 11