FQSSMS Summer 2004 Food Quality Safety Security Management System

FQSSMS Summer 2004Food Quality Safety Security Management System Phase II Jim Gallagher, Ted Lippert, Roger Newhouse, Dennis Rogers, Troy Shrider

Project Focus • There are many diverse Safety and Quality Standards which the food industry is barraged by while trying to conduct business. At this time there is no one place where a company in the food business can go to and compare the differences and likes between the different standards.

Project Objectives • Objective 1:Complete five toolkit assignments, assessing four SDA’s in each toolkit against comparable elements of a (real or simulated) organizational quality system, or modifying tools to enhance organizational quality system, presenting findings, recommendations as phase reports.

Project Objectives • Objective 2: Develop team portfolio incorporating the evolution of the 3 Regular Critique Assessments (RCA’s), 20 required Standard Dedicated Audits (SDA’s), and 20 optional Standard Dedicated Audits (SDA’s) found in Tools 29 – 33 and 36 - 40.

Project Objectives • Objective 3: Replace Compiler Responsibilities in tables with FACR (Findings, Analysis, Conclusions, Recommendations)

Project Objectives • Objective 4: Complete Table Cross Referencing: • ISO 9001 • GFSI (General Food Safety Initiative) • NFPA/SAFE (National Food Processors Association/ Supplier Audits for Food Excellence) • HACCP (Hazard Analysis Critical Control Point) • CODEX (European Food Safety Standard) • GMP • SDA/Tools (Industrial Technologists Standard Dedicated Audits)

Project Objectives • Objective 5: Redesign, and complete several examples of an OPCP and FMEA for Food Industry using Hirzel’s process as example

Methodology • Research data and process insight were gathered by working on toolkits 29-33 and 36-40 from The Industrial Technologist’s Toolkit for Technology Management (Dr. John Sinn, 2003). • On-line meetings were held bi-weekly to discuss and evaluate the progress of the project, with guidance from Dr. Sinn. • Course Discussion boards and e-mails were used to communicate. • The team brainstormed potential projects and approaches.

Project Organization Chart

Tool kit 29 Summary • ISO and QS are introduced, with reference to Baldrige criteria. • ISO 9000 is reviewed and requirements and QS needs discussed. • Item 4 in QS9001-2002 addresses the development of a Quality Management System. • ISO 9001 is streamlined with TS 16949 2002. • The Environmental 14000 standard has six elements • The need and benefits of Auditing Quality Systems is reviewed. • Kaizen, six sigma and lean relationships are briefly reviewed.

Tool kit 30 Summary • Focus on Change Improvement SOP’s, Kaizen, Internal and External Customers • Defining the Meeting and Culture • how to conduct productive project meetings • Problem Solving • Cause and Effect • Brainstorming • Team Behaviors • Forming • Storming • Norming • Performing

Tool kit 31 Summary • Problem solving, documentation, lean foundations, quality systems • Corrective actions, 8-D approach • Ongoing process control plan (OPCP) and standard operating procedures • Time study, work methods and work sampling • Operation, process, capacity determination • Plant layout and flow diagramming • Man-machine analysis--common sense approach • Failure mode and effects analysis (FMEA) • Kaizen, costs and planning for lean

Tool kit 32 Summary • Statistical principles • Quality system standards • Six sigma • Charts, graphs • Attribute charting systems • P charts • Attributes, checklists and charting • SPC, X-bar and variable charting • Cp and Cpk • Quality characteristic foundations, changing relationships • Metrology and Inspection

Tool kit 33 Summary • Basic requirements for E-commerce, information and service • Information technology, automated electronic push: Traditional services • Information shared for work cells, analysis and control, flexible services • Types of maintenance: service underpinnings for waste reduction • Total productive maintenance for lean • Selected troubleshooting fundamentals • Safety services

Tool kit 36 Summary • ISO and QS Introduced • Process and level classifications, tiers • Launch systems for quality • Fundamental definitions, classifications, phases • The Service Function • Service as upstream function, value added • Understanding customers and suppliers • Kaizen • Serving External Customers

Tool kit 37 Summary • Teams, Kaizen, problem solving • Materials • Classification • Considerations • Characteristics • Material and process testing • Technological Processes • Enhanced Design, • Creativity and The Five Why's • Innovation and Management strategies • Implementing Innovation and Change • Applied Technical Research

Tool kit 38 Summary • Launch data and documentation systems – production qualification • Feasibility Analysis – production capability • Sampling and Inspection Procedures • Short Run Systems – mini run, pre-control, trending

Tool kit 38 Summary • Quality Characteristics – statistical indexes • Engineering Design Change Documentation • PSDOE (Preliminary Design of Experiment) • Reliability – Design FMEA • PPV (Production Part Verification) • Certificate of Compliance

Tool kit 39 Summary • New product development, life cycle • DOE and FEA • Separate and in-tandem • Advanced technological problem solving: • DOE Taguchi style • Reliability • issues and relationships to robust design • Selected reliability measures • Finite Element Analysis (FEA) • General FEA procedures • Garage Door Bracket Case Study: • Integrated DOE and FEA systems • Applying DOE methods to FEA

Tool kit 40 Summary • Automation, computer integration and the electronic push • CAD-CAM systems plus • Data acquisition for quality improvement • Concurrent design and geometric dimensioning • Local area networks • Group technology, work cells and flexibility • Computer analysis and control • Effects of computer integration on production

FACR PPDPOA • Findings: • ISO 15161 already exist as pertaining to the food industry and HACCP • There are numerous codes or standards by which the world wants to guarantee the integrity of it’s food supply. All have the same basic goal of safety and security when it comes to microbial, disease or foreign objects in the food. • Team has found project focus • New documents uncovered for team to study –Global Food Safety Initiative and add to our cross-reference table. • We have standards covering the safety side, need standards to ensure product quality • Evaluation of tools and their applicability to the FQSSMS project seems to be emerging. The team has great momentum, experience, enthusiasm and curiosity. A lot of work has been accomplished in a short period of time, on many levels. The challenge of on-line communication, in a very short period of time, has been met with success. Final objective is in sight, and Phase II should be solid. • Two weeks left in class, time is a major issue.

FACR PPDPOA • Findings continued: • http://www.statease.com/pubs/foodtech.pdf • The teams focus is on Phase ll and cleaning up Phase l. • Tool 32 and 39 add additional value to the FQSSMS by giving us the ability to uses variable and attribute data to measure process capabilities. Reliability data is a little beyond the scope of the project at this time but will be a powerful tool once the system matures. • Goals are now clear, a cross reference table relating several quality systems to food service industry and an FMEA OPCP that the industry can utilize • There has been less focus on what Hirzel does, and increased focus on the quality issues in food processing. This has been a positive shift, allowing researchers to develop a core understanding of the regulatory compliance issues with regard to quality. • As long as the team communicates and posts on a timely manner we should be able to finish the final projects with strong presentations. • The team focus is finally clear.

FACR PPDPOA • Analysis: • ISO 15161 unavailable to team at this time. • The common elements of these standards can be assessed and presented in a tabular format to allow food industries to more readily assess their compliance on a global scale. • Research is needed. • Still need a copy of ISO 15161.ISO standard has been proven over time to increase product quality. Not all sections apply to food industry however. • It will be better judged after Sunday and Monday night chats, spooling into table, last tools, and final portfolio. Understandably, a lot on the plate for the team right now. • Most of time is being spent doing forms and compiling.

FACR PPDPOA • Analysis continued: • This is an article aimed at using DOE software in the food industry. • The quality of our final compilation will depend on our ability to communicate any needed improvements and to post our work in a consistent manner. • Team is becoming more focused and communication has improved. The table is starting to gel. • The communication of the team has been outstanding the last two weeks. One more week and the completed project will exceed initial expectations from such a short time frame. • Lack of intimate knowledge with Hirzel’s operation results in application of tools on broader food production industry issues. • Communication is the key. • Troy and Dennis are working on a side project, which should be beneficial to team.

FACR PPDPOA • Conclusions: • Since this integration of ISO and HACCP has already been done, then team needs to take another look at the project scope. • All global standards have the same basic goal. • Research will need to be done by all on team to accomplish task • Since the whole team is active now –work can be divided up into researching these standards. • ISO 9002 (at least portions) need incorporated into the technical flowchart and quality system at Hirzel. • Solid team growth, communication, and progress on objectives. Need to finish even stronger. • If completion of table is to be done- we must start now.

FACR PPDPOA • Conclusions continued: • Design Expert is the software specifically critiqued in this article. This DOE software is aimed at the food industry and is usable by someone with moderate experience with design of experiments. • We have been working well as a team and should continue to improve. • The original goal of defining the table is achievable. I also think we can stretch the QOS by the incorporation of the FMEA and control plans. • Team summer needs just a little more effort to complete our goal. • This team has set the bar extremely high for future groups. The amount of work produced in a short period of time is impressive in its research and scope of application to the food industry. • We still have quite a bit of work to do. • Once everything is put together information will be useful.

FACR PPDPOA • Recommendations: • Obtain copy of ISO 15161 for teams review. • The team should make it’s best attempt to identify all of the global standards. • Obtain copies of standards and get to studying them. • Have a chat to decide how to divide up the work and continue on project off cross-reference table. • Review the ISO standard and determine which sections are most beneficial to the food industry. • Will wait for Sun/Mon chat and brainstorming to judge.

FACR PPDPOA • Recommendations continued: • Decide on overall format and assign work for everyone to complete table. • Certainly something that someone at Hirzel should be aware of. • Continue moving forward and keep focused. • Continue with additional chats and formulation of FMEA and control plan. • Communicate, communicate, communicate • Continue to focus on the cross-reference table, providing yet another foundation for future groups to build on. • Continue to work hard in this last week. • Finish strong and plan and organize well.

FACR TPPMA • Findings: • Interesting to see three different approaches to TPPMA, all equally valid. It’s a little difficult to come to substantial conclusions this early, but the lack of 40% of the team’s input is definitely a disappointment. • UNIDO United Nations Industrial Development Organization • Project focus and team membership problems • With Jim being sick the team got behind. Also Troy just got back from vacation and Dennis started so team a little in disarray. • Strong team players. Everyone brings something to the table. Given a normal 4 month semester, this team could accomplish amazing things. Good leadership. • The team is now at a point where all are engaged fully and contributing.

FACR TPPMA • Findings continued: • The whole team suffers when all are not able to contribute evenly. • We work together well as a team but we need to stay on track and focus on the same objectives. • Team is doing better job meeting deadlines and holding each other accountable. Team is also communicating more frequently as seen by several chat sessions and thread discussions. I feel that the last tools and Phase II of this project are going to gel and expectations will be exceeded. • Team initially had about 50% participation. • The team is has learned to work together well and if all participate then the last portion of this class should go well. • Everyone worked well for tool 32/39.

FACR TPPMA • Analysis: • Rankings appear to be similar in Ted and Rogers grading. My opinion is that Roger may be most on-track with his evaluation. Although we’re getting started, we still are not hitting our marks as a team. I’m guessing he’s being patient….for now. • This organizations websites offers links and information on the CODEX food safety and quality standard • Chat sessions clearing things up. • Based on the ratings parts of teams are doing well. Considering the chat on Wednesday July 14th everyone is starting to get involved well. Thus ratings for all members should begin to equal out. • Feels like the start of the actual table (w/exception of Ted’s format in Excel) is a little late. • Dennis and Troy have both done a good job at putting team needs first (31-38) and themselves second

FACR TPPMA • Analysis continued: • The analogy of a chain, while overused, is still the best. All links must hold their share or the team will fail. • Team focus and timing are key elements at this point. • Everyone seems to be trying to step up the level of communication. All seem to have a sense of urgency with timing as the semester is about to end. I also believe that all team members now believe in the class format and tool processes. I for one was skeptical at first. But with the growth of the team and the project in just a few short weeks I am a believer. • This was due to sickness, late enrollments and workloads (both academic and professional). • As long as we continue to communicate, the objectives of these final projects should be met. • Team finally got in the groove and everyone contributed their part.

FACR TPPMA • Conclusions: • (Speaking only of myself) Starting with the next tool/s submissions, the TPPMA will be approached with fewer leniencies. • This site is well presented and offers links to the CODEX site, the full text of the standards are available there. • As relationships build among team members – unity to get job done is growing. • Team needs to continue on with project even when all members do not make deadlines. • Cross-reference table must be main priority through this weekend. • Team can really start working together now but how much time is left?

FACR TPPMA • Conclusions continued: • It became apparent that the team would not be able to complete all six sets of tools. • There is little time left in the class but if the team can pull together we still can make these projects happen. • To exceed the expectations of Phase II, we must communicate even more. • People got healthier, dropped some other classes, ect. • Each of the prior projects has become progressively better and the last one should continue along this path. • When team gets to know each other and trust each other to get work done things go better.

FACR TPPMA • Recommendations: • All that I would submit as a recommendation would be the obvious. Put some thought into the TPPMA, honestly express your impressions of the team’s players, and take a look at what your teammates are saying in theirs. I think that the TPPMA is the “glue” of the team in a lot of ways. • The team should consider using this website as a reference source and jump off place http://www.unido.org/en/doc/8689 • Keep chatting and communicating and everyone keep working hard to get postings in on time to stay organized. • At chat on Sunday night we need to really close in on the general direction and who needs to do what. • Have the cross-reference table drafted for completion by Wednesday p.m. at the latest. • Focus on objectives!!

FACR TPPMA • Recommendations continued: • The last tool set (34/41) will be dropped from the course requirements. • Because of the limited amount of time left in the class we have to focus on communicating and planning to move ahead as fast and steady as possible. • Communicate through e-mail or threads and chat nightly, even if only a few participate. Make sure to notify others that a chat has taken place so they can review the chat and keep up to speed. • This is good to keep in mind when accepting assignments, if you’re in that position, not to overstretch yourself. This team was able to survive and even prosper because a core group of people were able to push through the lean times, allowing the others to join in and give above 100% in the homestretch. • The team should not loose focus on these last projects. • Keep same teams together in future if at all possible.

FACR TRIRPA • Findings: • Through the courseware content the ISO elements were defined and explained briefly. Every good company will have an organized Quality system that follows these elements .It starts at the top with management commitments. The project focus is currently to find a way to integrate ISO elements into HACCP and the GMS. During some research by Roger Newhouse he found that the ISO and HACCP standards for food industry have already been integrated via ISO 15161. • Website for the Food and Agriculture Organization of the United Nations. • Team organization and meeting planning are important for any organization including our team. • Many quality tools are available to use for continuous improvement and new product launch. • There are many methods that a company can use to regulate the quality of a product • Statistical Process Control is used through out the quality field. • http://www.nal.usda.gov/foodborne.index/html

FACR TRIRPA • Findings: • The use of FEA is a valuable tool to produce quality cost effective products. • Tool 32/39 is the best tools within the tool set to date. They easily provide examples of how improvement can be obtained through data manipulation and collection. The tool does a very good job of showing how attribute data can be used. Attribute data is often overlooked in today’s industries. • National Alliance for Food Safety and Security • Automation can improve both the speed and accuracy of certain processes. • New technology is out there to benefit a quality system • Obviously an innovative approach, challenging manufacturing paradigms. Thinking out of the box, utilizing modern technology. Almost beating the consumer to the punch with regard to DEMAND. • Tools could relate safety in terms of internet security better. From reading the web article, attack by hackers is much higher than what most people think.

FACR TRIRPA • Analysis: • Management commitment is where Quality has to start’ Especially in any type of a launch. It also appears there is material available relating the ISO standard to the food industry • Very well structured and comprehensive website. • The service sector has the same needs for communication as the manufacturing industry. • Many involve sampling and or short-runs. • A company needs to use these tools. • ISO requires a documentation system such as this. • Wonderful site for exploring the world of Food Safety and Security • FEA is a good tool to compare various design while DOE is important to develop physical testing methods to determine true capabilities that a product has. • In less robust and infant quality systems, attribute data can be an easy way to monitor capability and drive improvements.

FACR TRIRPA • Analysis continued: • Universities participating in this alliance: Auburn University, Iowa State University , Kansas State University , Michigan State University , Mississippi State University , North Carolina State University , North Dakota State University , Purdue University , Texas A&M University , University of Arkansas , University of California-Davis , University of Florida , University of Georgia , University of Idaho University of Illinois , University of Tennessee , University of Wisconsin , Virginia Tech University , Washington State University • While robotics and automation are often intelligent methods of manufacturing, they are not always the best route to go. • Is Hirzel using new technology like The CDS and do they have a TPM team or group? • There is a brief case study included at the end of the article. Team approach, maximize diversity of resources. • With the push toward paperless work, the risk of attack will continue to increase. According to the web article, most viruses attack weakness in Windows operating frames.

FACR TRIRPA • Conclusions: • Is the ISO 15161 standard workable or can we improve on it? • This is a good reference site for our team, it includes links to Codex and HACCP information. • Team FQSSMS is basically working as a service provider and in such need to refine our communications skills. • Working in teams is the best way to approach these tools. • The problem solving and improvement tools that we have covered are necessary to produce quality products. • Need to be sure this is included in other Quality mandates for the food industry. • Multitude of links to tons of HACCP online resources.

FACR TRIRPA • Conclusions continued: • The use of FEA and DOE can help a company produce products that meet their customers needs. • A food service QOS should first work with what they have. That is usually minimal variable data, thus attribute data can provide a means to drive improvements with minimal investment. • Where is Bowling Green State University? • There will be many new automated processes to come in the future. • Every company should use new software and have TPM and safety work together to improve a quality system. • This is a very interesting concept that I had never heard of. I am familiar with Kan Ban, linked cell, and JIT. • Security of web based system has to be a top priority.

FACR TRIRPA • Recommendations: • Have the group review the ISO 15161 standard and see what we can do. Maybe make a cross-reference sheet to examine all parts of ISO 15161 and HACCP. We need to research this more and chat about it. • Team members should review this site. • As we problem solve use the 5-whys and staying in good communication about any topics we research with relevance to our project • Our team needs to communicate more to each other and use the planning techniques. • As a group we can learn to use these methods to create better quality standards. • Review GMP, HACCP, and GFSI. • All involved in HACCP need to have this site bookmarked.

FACR TRIRPA • Recommendations continued: • As these tools become more developed companies from all industries should be able to use the results to help further improve their products. • The tool needs further in depth detail on the six-sigma process. All ingredients are there. The tool also can be enhanced by adding a different format to the formulas, PDF file or scanned test book copies. Some of the formulas are confusing the way they are presented. • That BGSU look into joining this organization. • A company should look at new automation processes, but use these methods only when applicable. • Implement new software and TPM if not already done. • Does not apply well to food production/canning. • Update virus protection daily. Check for Windows updates on a daily basis also. Provide contingency plans in case of intrusion.

FQSSMS Summer 2004 Food Quality Safety Security Management System