The current issue and full text archive of this journal is available at www.emeraldinsight.com/1463-5771.htmBIJ18,1 Component part quality assurance concerns and standards128 Comparison of world-class manufacturers Alan D. Smith Department of Management and Marketing, Robert Morris University, Pittsburgh, Pennsylvania, USA Abstract Purpose – The purpose of this paper is to provide practitioners of management with a comparative analysis of how two global ﬁrms ensure quality standards in new product development/new product manufacturability processes and manage design changes in reduced product life cycles in the current economic recession. Design/methodology/approach – The ﬁrms selected were: Newell Rubbermaid, a high-volume manufacturer with a diverse product offering, designing and manufacturing consumer products for large retail customers, and General Electric Healthcare Coils, a low-volume manufacturer of a niche product for the magnet resonance imaging medical diagnostic systems. This case study presented a review of the quality steps performed when they are faced with a design change to a part, benchmarking their quality processes with the highest industrial standards possible. Findings – The effective managing of engineering change has always been difﬁcult, time consuming, and a regular source of inefﬁciency and irritation for manufacturers. Best-in-class companies understand that better change processes can drive top-line beneﬁts and the two distinct companies have developed very similar processes through effective industrial benchmarking activities that result in improving speed to market while maintaining high-quality standards. Practical implications – The component part design revision processes are well documented between the two ﬁrms, with an appropriate comparative analysis. Originality/value – Corporate management has demonstrated a commitment to component part quality throughout the development and redesigns processes and has earned and maintained the reputation of best-in-class manufacturing in their respective ﬁelds. Through successful quality assurances and collaboration processes, the companies studied found stability in a very turbulent ﬁnancial and service-orientated marketplace. Keywords Benchmarking, Corporate strategy, Competitive advantage, World class manufacturing, Product development Paper type Research paper 1. Introduction 1.1 Quality assurances through the product life cycle One of the key strategic decisions in operations management and in providing a competitive product is applying the correct quality techniques to assure that partsBenchmarking: An InternationalJournalVol. 18 No. 1, 2011 The author wishes to thank, most heartedly the reviewers for their valuable contributions andpp. 128-148 input into the ﬁnal paper. Peer reviewing and editing are commonly tedious and thankless tasks.q Emerald Group Publishing Limited1463-5771 The author equally thanks the management teams of HR and GEHCC for demonstrating aDOI 10.1108/14635771111109850 willingness to share in their world-class processes of manufacturing.
continue to meet the speciﬁed quality and design requirements throughout the product’s Componentlife cycle in a lean management fashion (Biswas and Sarker, 2008; Browning and Heath, part quality2009; Chan and Kumar, 2009; Grewal, 2008). As suggested by Butcher (2006), a greatfunction of product design is to be able to project and embody the future rather than the assurancepresent, where true added value comes from. Competition in the marketplace demandsthat companies develop and manufacture complex products with higher performanceand quality at a lower price than before to stay competitive. Product life cycles have 129decreased, thus creating the need to develop new product development/new productmanufacturability (NPD/NPM) processes and manage design change in a shorter periodof time with no compromise on quality assurance (Pikosz and Malmqvst, 2000; Summersand Scherpereel, 2008; Swink, 1999, 2000). Leading manufacturers in their respectiveﬁelds understand the importance of this and have developed new product and changequality control systems that maximize proﬁtability for their organization. Song andParry (1999), for example, created and tested a contingency model is used to examine themoderating affects of product innovativeness on new produce performance. Their modellinked measures of product innovativeness, product synergy, development proﬁciency,product competitive advantage, and product performance. The model performancesuggested that increases in product innovativeness weaken the inﬂuence of productsynergies and development proﬁciencies on product performance. Through the four phases of the product’s life cycle different types of qualitytechniques will be required. In the development phase, extensive reliability testingand research will be required to assure design compliance to the quality and designrequirements. As the product moves into the growth cycle, more focus will be placed onprocess quality and supplier quality. In the mature product phase and the end of lifephase, quality becomes a process of optimization and cost reduction. As suggested byDudek-Burlikowska and Szewieczek (2007), through all four cycles a critical aspect ofproduct quality is determining the part quality sensitivity to minor changes and howthose changes affect product quality and reliability. Competitive advantage goes deeper than just the quality of parts and products.Summers and Jones (2002) pointed to several areas to address when developingcompetetive advantage but for this comparison analysis, the author of the present studywill only focus on the process of maintaining part quality and reliability as thecomplonent travels through a design change process.1.2 Top management’s involvement is associated with innovative NPD/NPM processesthat result in redeﬁning manufacturing cultureTop management involvement is essential in promoting product design initiatives ¨common to successful NPD/NPM processes (Toremen et al., 2009; Tripathi and Jeevan,2009; Vinodh et al., 2008; Wan and Chen, 2008). As McDermott (1999, p. 638) commented,“Across all the projects, there was a persistence among team believers that simply wouldnot let the projects die”. There appeared to be both a strong champion as well as a strongsponsor, usually a director through the CEO that provided the encouragement and/orﬁnancial backing to the projects when traditional sources were eliminated. This trendwas especially true in product developments requiring long payback periods. Unfortunately, many product development and innovations that are viable andpossibly essential for the long-term survival of the ﬁrm may be denied due to the need forshort-term high rate of return mentality exhibited by many manufacturing ﬁrms:
BIJ Rather than based on promises of speciﬁc economic payback hurdles, sponsors commonly cited continued investment on a gut feel that the project could have signiﬁcant impact on the18,1 long-term success of the ﬁrm. Without a sponsor, many of the projects would have “fallen between the cracks” of the existing businesses of their corporations. The sponsor of each of these projects worked to keep them alive (even unofﬁcially), and encourage business units to adopt them (McDermott, 1999, pp. 638-9).130 It is critical, regardless of all the other factors that someone within the ﬁrm with a position of power must be willing to identify and promote high-risk and high-potential projects. Concepts of ﬁnancial and upper management support are important for promoting the positive effects of development team integration on successful NPD/NPM processes. Quinn et al. (1996, p. 71) suggested that “the success of a corporation lies more in its intellectual and systems capabilities than in its physical assets”. The traditional method of management of human capital, creativity, innovation, and the learning culture within an organization has long over-shadowed the management of the professional intellect. As with the tenets of resource-based view, strategic philosophy (Michalisin et al., 1997, 2000), the intangible strategic intelligence creates most of professional intellect of an organization, and operates on the following four levels (in increasing importance): cognitive knowledge or basic mastery of a professional discipline, advanced skills or the ability to translate theory into effective execution or practice, systems understanding or the deep knowledge of the cause and effect relationships underlying the professional discipline, and self-motivated creativity or the motivation and adaptability for success. The interaction of these factors allow nurturing organizations the ability to “simultaneously thrive in the face of today’s rapid changes and renew their cognitive knowledge, advanced skills, and systems understanding in order to compete in the next wave of advances” (p. 72). Quinn et al. (1996) also noted that the professional intellect within an organization frequently becomes isolated inside the organization. As shown in the present study, any attempts to isolate product development teams from the rest of the organization were viewed very negatively in terms of its impacts on achieving the ﬁrms’ manufacturing goals in the present study. It is a fact that the existence of a large organizational culture creates conﬂict with other groups, such as marketing or manufacturing conﬂicting with R&D departments. Thus, at the heart of an effective manufacturing organization, managing and developing the professional intellect is critical for sustained competitive advantage. The authors suggested the following successful practices to ensure the development and growth of the professional intellect: recruit the best, force intensive early development, constantly increase professional challenges, and evaluate and weed. As the authors point out, “heavy internal competition and frequent performance appraisal and feedback are common in outstanding organizations” (p. 74). Organizations constantly need to leverage their professional intellect for sustainable competitive advantage. This leveraging of professional intelligence can be accomplished by capturing knowledge in systems and software, overcoming reluctance to share information, and organizing around reinvestment in intellectual capital through relinquishing managerial control and empowering product development teams to mitigate the potential threats to manufacturability. Unfortunately, to accomplish these important objectives, organizations may have to abandon their familiar hierarchical structures
and reorganize in patterns that best suit their professional intellect to create value within Componentthe organization. By creating intellectual webs and connectivity within the organization, part qualitynetworking and culture, and incentives for sharing, managers have the keys to successwithin these organizations. Just as important, how the various product team members assuranceinteract and communicate within the organization is as critical as the actual knowledgethat is created and transferred. Business-decision support systems within manufacturing environments must take 131advantage of the professional intellect that are found in technical project teams andleverage the power of interactive computer-based systems directed toward the complexand dependent decision problems found in strategic manufacturing management.Team integration and NPD/NPM processes must be included in any system that isdesigned to help domestic manufacturing ﬁrms to formulate generic competitivenessstrategies, to test them, and to establish when and how to make a speciﬁc plan or acombination of actions. It is becoming increasingly apparent that an organization shouldbe a catalyst for such networking, instead of creating barriers for its development. Onlythrough sincere sharing of information and the development of the professional intellectwithin the organizations’ product team culture can sustainable strategic advantage becreated in a meaningful way. The formulation of product development team culturemust support the achievement of long-term directions and mission, key strategic andﬁnancial objectives, overall business strategies, speciﬁc functional strategies, andtactical decision making. Hence, sincere sharing of information and the development of acollaborative environment may be created. As noted by Rondeau et al. (2002) and Smith (2006a, b), manufacturingpractices that reduce response time and enhance customization capabilities require aninformation-rich internal environment that is capable of ﬂexible resource deploymentand direct and continuous feedback. Especially, in a post-industrial environment,manufacturing organizations have been searching for ways to reduce time to market,while meeting stringent cost and quality targets in team integration and successfulmanagement of new product initiatives. As previously discussed, research efforts by Swink (1999, 2000) reinforces the notionthat development team integration processes are important to manufacturability andresolving production problems. In general, project complexity and design appear to raisethe level of difﬁculty in manufacturing, but development team integration outweighsand may alleviate the negative aspects of these inﬂuences, which was reafﬁrmed in thepresent case study. Hout (1999) argued that good management practices should provideinsight to the complexity and interaction of traditional manufacturing variables withthe desire to promote a positive organizational culture of sharing and improvement.Speciﬁcally, strategic management through management’s involvement in productteam integration activities should be studied in more detail. It is proposed that suchmanagerial support of involvement in innovative NPD/NPM processes will result inre-deﬁning the form’s manufacturing culture.2. Case studies of product quality revision and adaptability2.1 MethodologyAs the previous studies reviewed on the tactical and strategic importance of qualitybenchmarking processes in its various forms and its associated implementationproblems (Smith and Offodile, 2007, 2008a, b), the author of the present study decided
BIJ to review such parts revision processes from world class, global ﬁrms that are accessible18,1 and have open-minded approaches to new product design and development. The two manufacturing-orientated companies that were selected were Northeast Ohio based, with global operations and reach capabilities, which were within relatively easy access and can be reviewed for the principles of the strategic, ﬁnancial, informational, and operational viewpoints. Such organizations are mainstream economic drivers of the132 Midwestern USA and provide an opportunity to review manufacturing ﬁrms that closely link strategy with service marketing of quality and NPD/NPM processes. While these ﬁrms are quite similar in nature and scope, especially in terms of their desire to serve clientele, each ﬁrm faces unique challenges in utilizing its reputation for quality and expertise in a highly competitive and cost-sensitive environment, with signiﬁcant consequences for getting it wrong in a recessionary economy (Hsu et al., 2009; Kanniainen et al., 2009). Commonly established case study procedures associate with quality initiatives and improvements were followed in the present study (Nonthaleerak and Hendry, 2008; Smith, 2008, 2009). 2.2 Sample selection The two relatively large organizations analyzed from a case study perspective in terms of product design initiatives followed in the order of Newell Rubbermaid (NR) and General Electric Healthcare Coils (GEHCC), two world-class design and manufacturing companies perform changes to existing parts continuously to comply with suppliers requests, part cost optimization, and part obsolescence to name a few. The leaders in the industry must maintain part quality and product reliability without spending excessive amounts of cash and without shutting down production while the part design is changing. They accomplish this task by implementing design and quality procedures, which allow for quicker implementation and add competitive advantage through quality by employing quality function development scenarios and focus on positive quality outcomes. Combinations of personal interviews of upper to middle management, as well as comments from convenient samples of employees were used to gather perceptions of the accuracy of the various managements’ perceived metric-based product quality initiatives and the associated strategic initiatives that support their efforts for operational effectiveness. In essence, much of the factual information, not just personal experiences, were obtained either directly from management’s permission, interviews, and/or from the ﬁrms’ web sites, or a combination of all named sources. The following section begin with a brief introduction to its general operating environment followed by sections describing its goals for implementing incremental and/or radical product design and related offers, and speciﬁc information concerning the construction and delivery systems of these systems. Discussion of the practical applications of lessons learned from the case studies follow these sections. 3. Company case studies Rubbermaid is a high-volume manufacturer with a diverse product offering, designing, and manufacturing consumer products for large retail customers, such as Wal-Mart Co., and they design and manufacture products for regulated industries. Each of these customers expects the highest quality product at the lowest possible price. GEHCC is a low-volume manufacturer of a niche product for the magnet resonance imaging medical
diagnostic systems. GEHCC designs and manufactures products under Food and Drug ComponentAdministration (FDA) regulatory requirements, with their customers demanding part qualityextremely high quality and high reliability. This case study will present a review of thequality steps performed by appropriate management of Rubbermaid and GEHCC when assurancethey are faced with a design change to a part, benchmarking their quality processes withthe highest industrial standards possible. The process identiﬁed for each company is arepresentation of the actual process used and in no way implies the complete compliant 133process.3.1 Case 1: GEHCC3.1.1 Part quality process at GEHCC. As with many benching companies, managementat both the parent company, General Electric, and GEHCC have developed local andglobal written Quality Policies, Procedures and Work Instructions (2009) to facilitatea compliant methodology in maintaining part quality and reliability as the part goesthrough redesign. A part design change starts with the initial engineering change request(ECR) document, which provides the proper rationale for the change request. Somepossible reasons for a change request are; supplier requests, cost reductions, and/or toimprove manufacturability. This process is a fairly standardized process and normallyfollows recognized standards such as ISO 9000 published guidelines on engineeringchange order (ECO) systems (“Engineering Change Order System”, 2010). For the purposeof this case study, the GEHCC evaluation will be based an internal ECR to improvemanufacturability. Once the Change Control Board approves the ECR, it is sent to the appropriateengineering department to be implemented. The eight steps involved in processingan ECR are very similar to the steps are similar to both companies, GEHCC and NR, andare shown in Figure 1. These steps are further broken down into key tasks, which requirecompletion before moving to the next step. Each of these steps will be evaluated tohighlight the importance they play in assuring that the original quality and designrequirements are met during the implementation of the design change. 3.1.2 Supplier notiﬁcation of change phase. The initial contacting of the supplier is todiscuss the change and it allows the engineer an opportunity to determine if the supplieris capable of performing the design change. During the supplier review, alternativesolutions and methods can be discussed. In a complex design change, it may be necessaryto identify alternative suppliers to manufacture the part. 3.1.3 Drawing revised phase. During this process, the engineer makes the changesto the design and evaluates the design for features critical to quality (CTQ), whichincludes design characteristics, manufacturing, and quality requirements. Determiningthe design characteristics involves a thorough review and understanding of thedesign and the original quality and design requirements. The assigned engineers reviewwith established manufacturing and quality to determine if these disciplines haverequirements for additional CTQ’s. These engineers typically discuss the CTQ’s with thesupplier. Once the CTQ’s are identiﬁed the drawing can be revised. 3.1.4 First article parts phase. Before the revised drawing is released tomanufacturing the revised parts are ordered from the supplier; these parts are knownas ﬁrst article parts. In this step of the process, the ability of the supplier to manufactureparts to the revised drawing is evaluated. This evaluation is called a First ArticleInspection (FAI). To conduct the FAI, an appropriate evaluation form is prepared by
BIJ 3 First article 2 Drawing revised18,1 4 Product test parts In-house FAI Develop CTQs 1 Supplier Test plan Supplier FAI & notification 8 Update cert of change Run test Determine production inspection Assembly Test report code Initial134 discussion In process inspection Quality 7 Update part change inspection New 6 Release documents revised 5 Manufacturing documents and Training drawing quality process review Engineering Manufacturing review and review approve Manufacturing Quality review review and approve Production review and approve Sourcing review and approveFigure 1. Service reviewTypical change evaluation and approveworkﬂow at GEHCC Quality review and approve the engineer, which identiﬁes those criteria that require proof of compliance before the part can be accepted for product testing. The FAI is also used to determine if the inspection code for the part needs to be modiﬁed. The inspection code provides information to quality control to identify inspection requirement for production parts. 3.1.5 Product test phase. Medical products fall under strict design and manufacturing requirements regulated by the US FDA. Every evaluation must comply with the design control requirements in FDA-based quality system regulation (21 CFR Part 820). The general guidelines are outlined by Matlis and Rubin (2009). To evaluate and demonstrate that the revised part is reliable and can meet the original quality and design requirements, a product test program must be developed. An engineering team will review the original product evaluation and test documents and determine what types of tests are required for the new part to show continued product compliance to the original quality and design requirements. The testing requirements for the revised product are documented in a test plan, which must be reviewed and approved by engineering and quality departments prior to implementing the test. Testing is typically performed by speciﬁcally training technicians who understand and follow the test plan requirements and provide the necessary documentation the data sheets. After completion of each test, the test data sheets are reviewed and approved by engineering and quality. An assigned engineer prepares a test report after all testing is completed. The test report documents the results of the tests, identiﬁes if the product passed the testing, and provides a written conclusion and recommendation on the use of the product. The report is reviewed for compliance to the original quality and design requirements and approved by engineering and quality prior to implementing the part change.
3.1.6 Manufacturing and quality process review phase. The manufacturing and Componentquality processes used in the manufacture of the product will be reviewed to assure part qualitythat the part change did not affect these documents. Any documents affected by thechange must be revised and approved and the revised documents will be released when assurancethe revised drawing is released. 3.1.7 Release revised documents and drawing phase. All revised documents and thedrawing will be listed on an ECO form. The ECO identiﬁes the reason for change, the 135revision level of each document and drawing, it provides instructions on whichdocuments must be supplied to the supplier and which documents must be updated inmanufacturing and quality, it provides corrective action for parts in inventory, work inprocess, ﬁnished goods and on order, and the ECO provides service rework instructionif required. The overall ECO packet consisting of the revised documents, drawing, andsupport documentation will be electronically routed for ﬁnal approval for complianceto the quality and design requirements before release. Once the ECO is approved forrelease, the implementation date for the ECO will be added to the ECO. 3.1.8 Update inspection phase. Prior to the implementation of the ECO, all thedocuments and drawing will be reviewed with the inspection department to updatethem on any new quality requirements and to assure that the inspection code for thepart is updated when the ECO is implemented. Also, any new training will be identiﬁedat this time. 3.1.9 Update production phase. Prior to the implementation of the ECO, thedocuments and drawings will be reviewed with the product assemblers to update themon any new manufacturing and quality requirements. Any new training will beidentiﬁed at this time. This entire quality revision processes is shown in Figure 1, whichshows the typical change workﬂows for GEHCC.3.2 Case 2: NR3.2.1 Part quality process at NR. At the heart of the corporate quality initiatives at NR istheir new product and product change quality control system is what the organizationrefers to as the consumer-driven innovation (CDI) process. This process was designedin order create a robust procedure for generating, evaluating and launching newproducts and product updates, and consists of ﬁve milestones; discovery, deﬁnition,design, development, deployment, and delivery. Figure 2 is a representation of the basicdecision steps outlined in the CDI process at NR. MS O MS 1 MS 2 discovery GATE 1 definition GATE 2 design GATE 3 Figure 2. New product and product Post- change quality control MS 3 MS 4 MS 5 launch development GATE 4 deployment GATE 5 delivery system, known as the CDI audit process
BIJ As shown in Figure 2, the concepts behind the CDI process are that work is done to18,1 understand the potential costs and beneﬁts in the milestone processes, then evaluated by key decision makers at each gate in order to ensure that only projects with adequate returns are selected and implemented. In addition to this beneﬁt, the milestone and gate procedure creates buy-in from top management and helps to expedite the implementation of project proposals. This process gives the ﬁrm the ability to136 concentrate on quality at many levels, as they are not solely focused on part quality, but the quality of ideas, and of the process as a whole. 3.2.2 MS-0-discovery phase. Members of the NR Innovation University, the major corporate training center for the company, lead the deﬁnition phase. These team members are responsible for gathering and ﬁltering concepts at a very high level. In this phase, ideas are very broad, and are generally not linked to metrics that measure success. In order to generate ideas, the team members hold regular brainstorming meetings with players from across the supply chain and internal departments; typically, these meetings are held bi-weekly. In addition to this method, ideas can be generated via a product creation request (PCR) or ECR. These can be submitted anytime by individuals within the organization or by key individuals within the supply chain by visiting the CDI intranet site. These ideas are evaluated on a daily basis for linkage to strategy, market attractiveness, and potential unmet customer/consumer needs (“CDI Process Overview”, 2007). If an idea is deemed viable, it is moved from MS0 to MS1, the deﬁnition phase. 3.2.3 MS-1-deﬁnition phase. In this phase, the high-level ECR begins to route to key individuals in the business. These individuals are tasked with verifying and deﬁning the opportunity. In this phase, the focus is more on the quality of the idea, rather than the part quality, so it will be discussed only brieﬂy. In this phase, the ECR is routed to individuals that will put the project in perspective, and a project manager is assigned. They will put together their thoughts on the strategic ﬁt, market potential, conduct consumer research, provide a competitive assessment, and specify resources. At the conclusion of this step, projects will either be terminated or moved to MS-2, the design phase. In order to move to the next phase, the project manager and innovation team members must be satisﬁed that the change will positively impact the ﬁrm’s bottom line, and align with business goals and values. In order to keep tabs on the process, all ECR’s are entered into our product life cycle management (PLM) software. The software keeps tabs on the routing process, assigns time limits to individual tasks and allows us to centralize all information regarding the proposed change. Based on inputs from the project manger, applications of the software will automatically determine the routing sequence, and move the project through the milestone process as tasks are completed. In addition to this automated functionality, NR employs several database administrators tasked with making sure the tasks are completed correctly and on time. Individuals critical to the process are tied to the performance of the system through their yearly performance evaluations. 3.2.4 MS-2-design phase. The design phase is where things ﬁnally start to come together, and where the part quality procedures start to weigh heavily on the concept moving forward. The part quality process is referred to as the production part approval process (PPAP), and integrates with the CDI process as shown in Figure 3. As typical of most manufacturing companies, management at NR seeks to be constantly competitive, remaining lean and high quality. For these reasons, the leadership team treats all manufacturing sites as an external supplier. Manufacturing sites within
Milestone Component 0 part quality discovery assurance Milestone 1 definition 137 Milestone Step 1, PPAP 2 supply kickoff design meeting Step 2, documentation review Milestone Step 3, PPAP submission 3 request development Step 4, PPAP Milestone warranty 4 submission deployment Figure 3. PPAP in terms Milestone preparation and timing 5 activities deliverythe ﬁrm are forced to compete for business with outside suppliers every time a productchanges or a new product is introduced. For that reason, the PPAP process is the sameregardless of who actually does the manufacturing. Therefore, moving forward, we willrefer to Newell manufacturing sites and outside contractors as suppliers. At this point in the process, there are many activities moving forward in concert asthe various functional departments tackle their respective tasks. In MS-2, the PPAPstarts with a supplier kick-off meeting. Pre-requisites to the meeting include theﬁnalization of product concept, revised drawings, an approved business plan, and amanufacturing/sourcing evaluation where we send the revised prints out for quotation.Upon receipt of the quotes, the strategic sourcing team will determine where the partwill be manufactured and the PPAP process can begin. The PPAP process consists ofthe following steps: supplier kick-off meeting (MS-2), documentation review (MS-3),PPAP submission request (MS-3), and PPAP submission warrant (MS-4). The supplierkick-off meeting is designed in order to communicate the goals, objectives, timeline,and requirements of the PPAP process. The process at NR also relays corrective actionrequirements and potential repercussions that can exist if the process is not followed
BIJ in a timely manner and in accordance with all standard operating procedures. Objectives18,1 of the meeting and high-level PPAP requirements can be found in Figure 4. 3.2.5 MS-3-development phase. MS-3 phase occurs when the PPAP process starts to unfold, after the initial test run of the product is completed, along with all the required documentation. The PPAP documentation required by suppliers is found in Figure 5. All documents are considered critical to the success of the launch, for simplicity138 sake; however, only a few of the more critical documents are discussed as they SUPPLIER KICKOFF MEETING Work instructions A supplier kickoff meeting is performed in preparation for PPAP submission for any new product launch. 1. Review the Program information and PPAP submission date. 2. Review the Checklist for the topics to be reviewed during the supplier kickoff. 3. Review the Special instructions for any additional PPAP requirements. Program information Program name Description Supplier name Part name(s) RFP product engineer PPAP Submission date Checklist What is PPAP? Review the purpose of the production part approval process. What are the keys to PPAP? 1. Supplier kickoff meeting - Occurs when supplier is awarded business. 2. Documentation request - Occurs immediately following T1 trial run. 3. PPAP submission request - Sent to supplier 4 weeks prior to PPAP. 4. PPAP submission - Submitted by supplier immediately following Pilot Run. What is a pilot run? The initial production trial run from which the PPAP samples are taken. When is a pilot run performed? When the process is 100% production representative. PPAP general requirements PPAP approval must happen before first shipment. PPAP samples mustcome from a 300 piece production Pilot Run. PPAP submission includes 6 dimensional samples with 100% layout. (Minimum) PPAP must be run on 100% production process at production rate. Suppliers production run at rate will be verified during the PPAP Pilot Run. RFP product engineer and supplier quality give PPAP approval. Review PPAP Submission documentation. Key program & PPAP dates Review the target pilot run and PPAP submission dates for the program.Figure 4.General objectives of themeeting and high-levelPPAP requirements Source: “PPAP quality procedures” (2008)
Component DOCUMENTATION REQUEST part quality Work instructions assurance Use this document to request preliminary information during the development process. 1. Review the Program information and submission date. Documentation must be submitted prior to the submission date. 139 2. Review the Checklist for the list of documentation requested. 3. Review the Special instructions for any additional notes. Program information Program name Description Supplier name Part number(s) Documentation requested by Document submission date Checkl ist Request to Submitted by Description Notes submit supplier Preliminary process flow Preliminary control plan Manufacturing floor plan Preliminary testing results Preliminary dimensional results Preliminary capability studies Production gage plan & gage R&R Process validation test plan Preliminary packaging samples Material & color documentation Development drawings Additional documentation 1 Additional documentation 2 SAMPLE REQUEST 1 _____ Pieces per cavity SAMPLE REQUEST 2 _____ Pieces per cavity Figure 5. Required supplier documentation in the PPAP processSource: “PPAP quality procedures” (2008)related to component quality initiatives, namely process ﬂow, control plan, anddimensional results. The process ﬂow is essentially a process map that is a schematic representationof the current or proposed process ﬂow. It can be used to show sources of variation
BIJ in the process such as different machines, the introduction of new material, the methods18,1 used to manufacture product, and the use of manpower. It helps to analyze the entire process of how a speciﬁc product is manufactured and can be used to improve the quality of the product or productivity. The purpose of control plan, on the other hand, is to aid in the manufacturing of quality products according to customer requirements. Control plans provide a written summary description of the systems used in minimizing process140 and product variation. The control plan describes the actions that are required at each phase of the process including receiving; in-process, out-going and periodic requirements to assure that all process outputs are being controlled. During production, the control plan provides the process monitoring and control methods that will be used to control part and process quality. The control plan should be updated and revised as the process changes, as shown in Figure 6. If methods of inspection are improved, it needs to be reﬂected in the control plan, so this document needs to accurately tell the story of the production and inspection process. In terms of the dimensional results, the supplier in question must provide documentation to show that the parts supplied are in accordance with the dimensions called out on the prints. To accomplish this documentation properly, all dimensions, including reference dimensions, on the print are highlighted and numbered by the vendor. The dimensions are measured and compared to what is called out on the print so that everything of value is noted on the dimensional result sheet and a copy of the print with the ballooned numbers is included with the submission and CTQ’s will be called out on the print. An example of the PPAP dimensional report can be shown in Figure 7. Upon receipt of the appropriate documents, management then identiﬁes the areas that need improvement before moving into the pilot runs. The process of reﬁning the documents will continue until the PPAP process is completed and formal parts are submitted. An important aspect of the MS-3 phase involves the formal PPAP submission request. This request instructs the supplier to move forward with a limited, pilot production run of the part. In this step, the vendor is required to submit a minimum amount of product produced in an environment that will exactly mimic the real-world production environment. This request is typically submitted four weeks prior the pilot run in order to give suppliers ample time to work on processing parameters and process documentation. Figure 8 is an example PPAP submission request. 3.2.6 MS-4-deployment phase. In this phase, the pilot production runs and required documents are completed and submitted to the leadership team for approval. Part number/latest change level 1 Process control plan Part name/description By/date 3 Appvd date Page 2 4 Supplier/code: Ref: MFG. appvl/date: QA appvl/date: 5 6 7 Sequence Machine Critical Evaluation Evaluation Reaction to out of Related Specification Authority control conditions # Name number characteristic method frequency documents 8 9 10 11 1 13 1 15 1 17Figure 6.Control planexample format Source: “PPAP quality procedures” (2008)
PPAP DIMENSIONAL REPORT Component Preparer instructions part quality 1. Complete sections 1- 3. 2. Item number should be linked to corresponding ballooned engineering drawing and product specifications. assurance 3. Provide report with PPAP submission to Newell Rubbermaid SQE for approval. Refer to the supplier quality assurance manual (CORP1QA-001) for additional information. 1. General information Description PPAP sample 141 Part number/Rev part number 2. Measurement information Item Zone/ Status Characterstic & tolerance Actual measurement Comments no Page Accept Reject 3. Preparer signature Figure 7. PPAP dimensional report plan example formatSource: “PPAP quality procedures” (2008)The process starts with the submission of the PPAP part submission warrant form. Thesubmissions are reviewed by relevant associates, and hopefully, the product is releasedfor production. As with all of these steps, relevant information including drawings,documents, and communication history are uploaded into the company’s PLM softwarefor easy data sharing and project tracking. 3.2.7 MS-5-delivery phase. During MS-5 phase, the sixth and ﬁnal step in the CDIprocess, production is ramped up and daily quality activities begin. In the case of NR,the critical dimensions are monitored continuously via random product audits. Typicalaudits consist of a ﬁve-piece audit every hour for critical dimensions and for ﬁt/function.
BIJ18,1 PPAP SUBMISSION REQUEST PPAP instructions Use this document to request preliminary information during the development process. 1. Review the PPAP information and submission date. PPAP samples and PPAP documentation142 must be submitted prior to the submission date. 2. Review the PPAP submission checklist for the list of PPAP submission requirements. 3. Review the Special instructions for specific PPAP requirements. 4. To submit PPAP first sign and complete a PPAPP art submission warrant. The warrant should be the first document in the PPAP submission. Program information Program name Description Supplier name Part name(s) PPAP Submission requested by Required submission date PPAP submission checklist Request to Document description Approved submit PPAP part submission warrant NR engineering drawing(s) NR enters number & revision level NR product specification(s) NR enters number & revision level NR test specifications(s) NR enters number & revision level NR packaging specification(s) NR enters number & revision level PPAP dimensional report PPAP 100% layout samples 6 Parts or __________ Parts per cavity Process capability studies Process flow chart Process control plan Gage R&R study Supplier PPAP testing report NSF and/or FDA approval Newell Rubbermaid approval documents Received Approved NR material & color approval NR materials is responsible for material and color approval. NR packaging approval NR packaging is responsible for packaging approval. NR test report NR test lab is responsible for the production test lab report. NR process sign off results NR product engineer & supplier quality. Production run at rate results NR / GSA representative. Special instructionsFigure 8.MS-3 phase the formalPPAP submissionchecklist example format Source: “PPAP quality procedures” (2008) Dimensions that prove to be difﬁcult to control will be tracked on control charts, and periodic capability studies will be performed. In addition to these steps, management closely tracks other critical metrics; such as utilization, cycle time, material/labor usage and tool wear among others. Upon successful launch of the product, the documentation will be reviewed one ﬁnal time and the ECR/PCR will be closed by the relevant
project manager. All information regarding the launch will remain available to the Componentmasses for the life of the product. part quality assurance4. Discussion and implications4.1 Comparison of component quality processesBoth Rubbermaid and GEHCC have very structured processes for ensuring thatpart quality is included in its part design methodology. While at ﬁrst glance there 143seems to be major differences in their methodologies, there are many similarities witheach organization’s approach to part quality. It is also interesting to note where theorganizations have differences as it pertains to each process. This comparison is notmeant to endorse one process over another, but rather to show how two organizationsare similar with their processes and to note where they differ. At GEHCC, the part change process begins with the ECR as it does with Rubbermaid,but it is interesting to note how the two organizations are different in their approaches.At GEHCC, the initiation of an ECR tends to be driven by cost reductions, supplierrequests, or to improve manufacturability. These initiations tend to be driven by verytactical decision-making criteria. NR has a very different organizational mindset when itcomes to ECR, and management appears to place signiﬁcant emphasis on ensuring thepart and its quality is aligned with high-level organizational mission and goals beforecreating the ECR. This is an interesting contrast to how organizations view quality froma high level. It seems like GEHCC is very tactical and in the trenches when it comes tousing quality to drive part-making decisions. Quality at this stage for NR focuses onensuring the ECR request is going to meet all organizational goals. This is not to saymanagement does not look at changing parts for the reasons listed for GEHCC, butrather to point out where the general emphasis is focused. Once an ECR has been approved to move forward in the process, the next step is tobegin designing the actual part. It is at this point that both ﬁrms really start to focuson part quality from a production standpoint as both ﬁrms start with a design andhave to consider if internal or external suppliers will be producing the part. It isinteresting to note both ﬁrms are willing to use a supplier regardless if it is internal orexternal to the organization. They both evaluate the ability of the supplier on how theycan deliver the parts, not if the supplier is with the parent company or not. One of the major differences in how each company addresses development is howthey handle the upfront decision-making process of determining if the supplier iscapable of making the part according to the speciﬁcations. GEHCC has incorporateda ﬁrst article part process that requires the suppliers to prove they can make theparts to the quality and other speciﬁcations previously determined. Only upon passingthis initial test will the drawing be released to manufacturing for full-product testing.NR puts its process ﬂow, control plan, and manufacturing ﬂoor plan together beforedoing actual product testing. Both organizations require that suppliers showdocumentation that they are able to produce the part to the speciﬁcations set forth inthe design documents. GEHCC takes a bit more cautious approach to the developmentbefore going to a full production run, but this situation may be due that the company is inthe medical-device industry and they have more regulations they must meet beforecommitting to a full production run. Additionally, GEHCC breaks the part design andtesting down to four milestones (ﬁrst article parts, product test, manufacturing qualityprocess review, and release revised documents and drawing) while NR has this one step
BIJ listed as development. Again, this difference in emphasis ties back to the overall18,1 organizational philosophy. Management at GEHCC tends to be a very tactical when it comes to part quality and design and it shows by breaking the process down to several major milestones. NR’s management tends to focus on products and quality from an organizational level and thus has more emphasis on upfront process of the discovery and deﬁnition phases. While both are very good at producing high-quality products, they144 come to this end through very different means. Another notable difference between the two is that GEHCC has built a training component into its quality part change process as it sees the training of its people as a critical step in ensuring quality. The corporate structures for quality benchmarking at NR and GEHCC have similar processes in place to identify quality issues that need to be improved upon before going into full production. In essence, NR uses its PPAP checklist to capture and track quality issues, while GEHCC uses a test plan and report model to do the same function. It is after passing through these processes that GEHCC and NR will begin a full production run of the indicated parts. Both organizations have set monitoring processes to address quality issues throughout the product life cycle, as illustrated in Table I. 4.2 Management recommendations In most organizations, product quality and reliability is a measurement of success. The management of the two organizations discussed in the present case study must continue to utilize various methods to maintain a level of success. Developing high-quality products is the objective of management at GEHCC and Rubbermaid. Moving forward to achieve this goal requires continued engagement by all levels of each ﬁrm, as management oversees the design of parts and products, it will also need to provide leadership. It is essential to follow the processes in place to accomplish a long-term return on investment, but both companies have proven to be elite and world class in their respective marketplaces by demonstrating their profound commitment to offer quality products. Their management must maintain a critical analysis of performance in order to assess continued process improvement. Without continuous quality improvement initiatives, the management team minimizes the opportunity for their company to be competitive. Continuous evaluation of critical success factors is signiﬁcant in continued proﬁtability, as well as consistent evaluation also includes the supply chain network. The supply management connectivity is vital for both ﬁrms. As mentioned earlier, GEHCC engineers develop a rapport with their suppliers keeping communication lines Part design change process comparison Activities Rubbermaid GEHCC Supplier notiﬁcation X X Drawing revisions X X First article inspection X X Product test X X Manufacturing and quality process review X X Release revised documents and drawing X XTable I. Update inspection X XGEHCC and Rubbermaid Update production X Xparts’ production qualitycomparisons Note: X indicates active involvement and requirements
open for frequent change. They function as a team to collaborate on the goals of the ﬁrm. ComponentOn the other hand, NR has a process by which the suppliers are included in milestone part qualitynumber two, the design phase. In a comparison of both methods, the key element is thatmanagers need to routinely assess the ﬁrm’s relationship with their suppliers, since assuranceestablishing or sustaining a competitive advantage is at stake and should be at theforefront of management. As presented in the present study, component or part quality is echoed throughout 145both of the company’s organizational goals. Deﬁnitively outlined with NR, managersmust continually take in consideration the ﬁve milestones of the CDI process. The missionat GEHCC essential objectives varies, but it also focuses on a standardized processfor part quality. A diverse set of tools is at the disposal of managers to achieve long-termcompetitive strategy. One of those tools that management uses is of cost and beneﬁtanalysis in developing strategies for future production that will assist managers inknowing their strengths and weaknesses. Management’s theoretical approach forNPD/NPM should always be one of value added to the ultimate customer. Effectiveutilization of resources is on the shoulders of the professional managers. Management atboth NR and GEHCC management must be clear about responsibilities, have good businesspractices, and implement timely reporting systems of performance for continuity of successin the marketplace (Hu et al., 2008; Jain et al., 2008; Smith, 2006a, b; McDermott, 1999).5. General conclusions on quality assurance standardsManaging engineering change has always been a difﬁcult and time-consuming task andis a regular source of inefﬁciency and irritation for manufacturers. Best-in-classcompanies understand that better change processes can drive top-line beneﬁts and as aresult are developing these processes with a focus on improving speed to market whilemaintaining high-quality standards. Quality, or the lack of quality, affects the entireorganization from supplier to customer and from product design to maintenance.Quality has implications beyond those related to operations including; companyreputation, product liability, and global implications. All serve as strong arguments foran organization to understand quality and build a total quality management systemwith the focus of identifying and satisfying customers needs. The cost of quality for any organization consists of four major categories, includingprevention costs, appraisal costs, internal failure, and external costs. The cost of the ﬁrstthree factors can be reasonably estimated (Kennedy and Widener, 2008), but the externalcosts which are incurred after delivery of defective parts or services can be very hard toquantify and can exceed the value of revenues associated with a product, if proper qualitymanagement is not in place for an organization. In the present case study, management atboth NR and GEHCC have shown a commitment to part quality throughout thedevelopment and redesign processes in place at each organization and have earned andmaintained the reputation of best-in-class manufacturing in their respective ﬁelds.ReferencesBiswas, P. and Sarker, B.R. (2008), “Optimal batch quantity models for a lean production system with in-cycle rework and scrap”, International Journal of Production Research, Vol. 46 No. 23, pp. 6585-610.Browning, T.R. and Heath, R.D. (2009), “Reconceptualizing the effects of lean on production costs with evidence from the F-22 program”, Journal of Operations Management, Vol. 27 No. 1, pp. 23-35.
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BIJ Further reading18,1 Cavaleri, S.A. (2008), “Are learning organizations pragmatic?”, The Learning Organization, Vol. 15 No. 6, pp. 474-81. Scherrer-Rathje, M., Boyle, T.A. and Deﬂorin, P. (2009), “Lean, take two! Reﬂections from the second attempt at lean implementation”, Business Horizons, Vol. 52 No. 1, pp. 79-85. Sprovieri, J. (2008), “A modest Increase”, Assembly, Vol. 51 No. 13, pp. 22-41.148 About the author Alan D. Smith is presently University Professor of Operations Management in the Department of Management and Marketing at Robert Morris University, located in Pittsburgh, PA. Previously, he was Chair of the Department of Quantitative and Natural Sciences and Coordinator of Engineering Programs at the same institution, as well as Associate Professor of Business Administration and Director of Coal Mining Administration at Eastern Kentucky University. He holds concurrent PhDs in Engineering Systems/Education from The University of Akron and in Business Administration (OM and MIS) from Kent State University, as well as being author of numerous articles and book chapters. Alan D. Smith can be contacted at: email@example.com To purchase reprints of this article please e-mail: firstname.lastname@example.org Or visit our web site for further details: www.emeraldinsight.com/reprints