Developing an Integrated Sanitation Program Using Innovative Techniques
By C. Michael Nolan
The strength of teamwork cannot be underestimated in any situation. When a food company begins to develop an integrated sanitation program to better ensure the quality and safety of its products, teamwork is essential to the program’s success. At Tropicana, a multidisciplinary Sanitation Core Team comprised of highly experienced professionals from operations, purchasing, research, engineering, statistical, quality assurance (QA) and quality control (QC) has developed a successful integrated sanitation program using innovative sanitation techniques.
Some of the proven techniques used by Tropicana to improve its processes include the development of methods that can aid in the creation of a “sanitation score card,” and implementing measures to develop synergy between operators and sanitation/Good Manufacturing Practices (GMPs) to establish accountability, as well as ways to develop an auditing program that captures real-time data that can be used in training and to increase accountability.
BUILDING TRUST FIRST
The first essential element of putting together an integrated sanitation program within a food processing facility is building trust, which is the basis of a partnership with your “customers,” the facility employees in manufacturing with whom you are working. It is extremely important that everyone in the facility understands why the Sanitation Core Team is doing what it is doing to achieve the company’s sanitation goals.
There are five elements that must be in place to build this trust and thus achieve buy-in from customers, presented here in order of importance:
1. Image. Does your company actually “walk the talk?” If you talk about good sanitation protocols and procedures hut don’t follow through in actions that support what you communicate, your customers will not trust in the program.
2. Competence. Do the personnel who you are utilizing to introduce the integrated sanitation program have the necessary and proper skills? If your customers do not believe in the expertise of the Sanitation Core Team, they will not buy into the program.
3. Commonality. Do we share the same values, beliefs and goals? Have you talked with your customers to identify their values and core beliefs? Having a conversation with the manufacturing personnel will aid in understanding how the company can achieve its sanitation goals.
4. Intent. Personnel in manufacturing are going to ask two age-old questions: Why am I here and what’s in it for me? The team must outline the benefits of the program to the customers to establish trust.
5. Versatility. If QA/QC personnel go into an area and say, “Here’s the specifications, now do it,” with an “it’s my way or the highway” attitude, the customer will likely respond with resistance. Building trust means maintaining a less rigid approach with customers.
If you haven’t built trust with customers, you will have problems in your efforts to achieve integration of the sanitation program. If your customers don’t trust what you’re doing or why you’re doing it, if you have not taken the time to understand your customers’ needs or challenges in manufacturing, or if you have not involved them in your plans to develop an integrated program, you will not gain acceptance and your efforts will fail.
By establishing a partnership, manufacturing personnel will understand that your motivation is to improve their processes, that what they do is important and that you are there to help and support them in achieving sanitation goals.
THE PROACTIVE APPROACH: TRIED-AND-TRUE TECHNIQUES
Tropicana’s Sanitation Core Team utilizes two tried-and-true proactive methods in developing the integrated sanitation program: failure, mode and effect analysis (FMEA) and quality function deployment (QFD). The team also uses several recognized quality techniques to identif5r root causes of potential challenges or identified problems, such as brainstorming, flow-charting and cause- and-effect diagramming, or “fishboning.” Since quality sanitation equals quality flavor, the team wanted to have a positive impact on sanitation as early in the process as possible, rather than relying on customer complaints pertaining to finished product when it is too late for effective sanitation solutions.
Failure, Mode and Effect Analysis. The use of this very proactive method began in the space industry, similar to the development of the Hazard Analysis & Critical Control Points (HACCP) model. There are several types of FMEAs addressing process, design and systems in the manufacturing facility. An FMEA is a documented, disciplined, team-oriented approach to preventing process problems, which allows you to effectively prioritize the multitude of data that is collected. Of course, to be effective the team must consist of personnel who are able to implement preventive recommendations and are committed to taking the time to closely study the process. The team should number between five and nine members to maintain manageability. If successfully implemented, the team itself will go unnoticed.
The column format for the FMEA document contains a checklist of items such as the product process and function (e.g., juice supply); the process line; requirements (e.g., supply juice meets specifications, flavor, or volume); potential failure modes, including chemical contamination foreign objects, or high temperature; potential effects of the failure (e.g., chemical contamination is a food safety issue); the assignment of a severity rating; potential cause(s) of failure; design verification (e.g., QC flavor checks, processing HACCP standard operating procedures [SOPs]); task priority; recommended actions; responsible personnel and target completion date; and actions taken and results.
The application of both a severity rating and an occurrence rating is key to a successful FMEA. Table 1 provides an example of 10 severity ratings, from nonhazardous product/process failures to those considered hazardous. Table 2 provides an example of occurrence ratings, which are rankings based on how frequently a product/process failure occurs. A “risk priority” that provides the team with an indication of where to focus sanitation and other food safety/QA/QC efforts can be established by multiplying the severity rating assigned to a particular product/process by the assigned occurrence rating. The higher the number, the higher the priority.
For example, consider that the product and process function is juice supply and the requirement for the line is that the juice supply meet specifications, flavor and volume requirements. One of the potential failure modes identified in the run is chemical contamination, the potential effect of which is food safety. As such, the severity rating applied is noted as 9, “serious effect.” In this example, the potential cause of failure is identified as miscommunication between the juice supply and diversified, and the subsequent occurrence rating is 8, “high.” The resulting task priority number is 288, which the team then identifies as a high task priority. The design verification for the product/process has been identified as including the use of conductivity meters and application of existing SOPs.
As a result, the appropriate team members would provide recommended actions, such as a review of the current SOPs and the determination of an ideal location for conductivity meters and the steps to be taken if the conductivity set- point is exceeded. Thus, actions taken might include the writing of a draft procedure to include training, the placement of the conductivity meter at supply to raw juice tanks, and instructions that an alarm be issued by the operator, respectively. Following these actions, the team would then be able to reevaluate the process. In many cases (and this is essentially the strength of the FMEA), is that the use of this approach will result in a reduction of the problem. Further, application of a detection rating (Table 3) provides more valuable information to the team as to what controls will most likely detect a failure.
Quality Function Deployment. The other proactive technique utilized by the Sanitation Core Team is the QFD, which is an an approach that identifies five key areas of operational requirements: customer requirements, design requirements, ingredient characteristics, manufacturing operations and production requirements. For each of these areas, the team and the appropriate departments meet to establish goals (Level 1: What is to be accomplished) and strategies to attain those goals (Level 2: How to get goals accomplished). After the initial meetings, the team will meet monthly to review and revisit the set goals and strategies.
Consider the following example: The team establishes a key quality objective goal (the “what”) as a focus on GMP/sanitation. At Level 1, the “hows” are identified as: (1) departmental level focus on GMP/sanitation; (2) quality evaluation process; (3) third-party juice supply; and (4) standardize sanitation practices and procedures. At Level 2, the “hows” become the “whats”: For example, a departmental level focus on GMP/sanitation (what) gives rise to specific ways in which to accomplish such a focus, ranging from the use of internal/external audits and a sanitation scorecard, to establishing more training programs, “Star Point” teams, department micro teams and a GMP website. Individuals are given responsibility for accomplishing these specific goals, which is key to the successful use of the QFD approach in that you’ve not only identified the issues but there is accountability.
DEVELOPING A SANITATION SCORECARD
The Quality/Sanitation Metric scorecard is a valuable tool in a successful sanitation program. While developing such a scorecard can take a significant amount of time depending on the size of the operation, it can provide very useful data to management personnel to identify trends and develop more effective processes. The first step in developing the scorecard is to identify how the data will be kept and tracked and who will be responsible. Second, team members must be selected to be part of the development process, followed by the establishment of departmental core teams. Next, operator responsibility must be assigned. The data must then be quantified statistically. Finally, training must be established.
Going through the process and hard work of developing the sanitation scorecard is as rewarding and informative as the scorecard itself. The format or matrix developed by each company will be based upon the criteria developed for the scorecard. Each company’s scorecard will look different based upon the criteria they identify as meeting their needs. The format should be simple, concise and easily read. Graphs are an excellent tool used to visually represent data that otherwise may not be easily deciphered.
How do you develop the tracking program? First, set limits on the amount of data to be collected. It is impossible to collect data from everywhere. Identify what is important to your operations, and keep in mind that you have to identify these early on in a process, proactively. Also, perform trending analysis; for example, by training the micrographs. Next, consolidate the information you’ve gathered, and decide how you will put it all together. Identify distribution among the various levels of management. One of the keys to the success of the Tropicana program is that this goes to every senior level management personnel.
How do you collect the data? As an example, say that you are measuring the effectiveness of the clean-in-place (CIP) environmental swabbing program. To collect usable data, a manageable sampling plan must be developed that takes into account cost, manpower, ease of use and training needs. Make sure that once you’ve identified who is going to take the samples that these individuals, often operators and leads, have the training to perform the task required and are not faced with overly difficult paperwork once the samples are taken. Make sure you are utilizing the advantages of technology; in this case, luminometry. This is an excellent tool that provides real-time results—rather than waiting up to five days for conventional swab data—and the information is readily available in a “go/no go” format so that the operator knows what action to take immediately based on the number appearing on the meter.
THE ELEVATIONS OF TEAM DEVELOPMENT
There are three “elevations,” if you will, in team development that allow for the top-down success of a sanitation program. At the 10,000-ft. level, team development begins with selecting the right team members. The team should be comprised of personnel from several different disciplines and departments to ensure cross-functionality. At this level, a mission for the team should be developed, as well as the goals to be achieved, including management and manufacturing goals. A management support team should be created.
At the 1,000-ft. level, the main aim should be developing departmental sanitation teams, as discussed earlier. One of the best ways to create a good, working partnership with senior management is to involve them with this team. Also, this is the level at which you can attain department buy-in by showing the need for the policies and procedures to be enacted. These teams are led by QC and department supervisors, acting primarily as facilitators, and include operators, hourly wage earners and chemical suppliers. (The latter can provide valuable information on technology and state-of-the-art uses early on in a process.) At this level, teams can discuss current trends and issues identified throughout a work day. Again, training is key and the needs in this regard should be identified and provided so that all members of the team can fully participate in decisions. At this level, the ongoing continuous improvement plans are developed.
At the 50-ft. level, operator responsibility is paramount. The operators are held accountable for sanitation, but in too many instances they hear “production, production, production is the backbone of the company,” rather than “sanitation goes hand-in-glove with production goals.” At this level, operators must have good checklists for required daily sanitation practices. Operators should be responsible to conduct internal GMP audits and environmental swabbing, which will be discussed later. Finally, operators are responsible to document sanitation efforts and results.
The Quality/Sanitation Metric Scorecard gives management the data to identify trends and develop more effective processes. The Tropicana Sanitation Core Team developed interlocking sanitation control methods that affect the product early in the juice making process, as well as a method of trending and tracking data to be presented to senior management. The scorecard allows the team to quantify, with an actual number, the efficacy of the sanitation program. The interlocking control methods are: (1) clean-in-place /sanitation-in-place (CIP/SIP) tracking; (2) environmental tracking; and (3) GMP tracking. These methods will be used here to illustrate how such a process works.
CIP/SIP Tracking: Identifying Flow Rate. To achieve the CIP/SIP tracking, the team first had to identify the current system capabilities to determine whether the process had the ability to meet the established standards. Since the facility has grown over the past 50 years at its location, with multiple systems in place and an estimated seven miles of pipe, this required extensive tracking and identification of all of the process lines. It was necessary to identify the line flow in order to find out whether or not the capability could be assessed. This required the attachment of a high-tech portable flow meter in hundreds of locations. A matrix was developed that identified all of the lines in packaging and processing that outlined the capabilities. Steps were then put in place to manage this process.
In total, the tracking process took between six to eight months to complete, and all of the data were collected by operators. Although there is a mathematical formula that can be used to determine flow based upon gallons per minute of the pump and the size and diameter of the pipe, we wanted to validate the flow meter with the formula. What we found was that this procedure helped us to track the pumps that were pumping to their full capacity according to the specifications and to identify pumps that were out-of-specification. In addition, CIP tracking showed whether activities had been completed, such as whether clean-ups were conducted in the past 24 to 48 hours, depending on a specific system’s individual QA specification.
The CIP/SIP process quantifies whether the plant is meeting system requirements for the timing of CIP/SIP activities for each system. Each area looks at the total number of system opportunities, then the total number of systems lyed out, to give the percentage of lye outs completed. The result of this was a more effective identification of problem areas and the implementation of more effective sanitation procedures and tools to address those challenge areas.
The team also looked at the systems that exceed QA specifications. This system check identified our ability to adhere to specifications that are established for all processes. This data is also added to the Quality/Sanitation Metric Scorecard, allowing management to identify areas for increased focus.
Environmental Tracking. The team developed a method of tracking the results of CIP by using luminometry technology, for which minimum guidelines were established. These guidelines are aimed at producing a “go/no go” process based upon the luminometry results. In other words, if the operator sees a certain number, he can go ahead and move on. After every CIP, the operator takes a luminometry swab and identifies whether the process was effective. If ineffective, the tanks or lines are resanitized. All of this data is then tracked and identified on the sanitation scorecard. Each area looks at the percentage complete and the percentage completed within specification. This is what is recorded on the scorecard. Each area can then track the luminometry results, which over time can show trends on specific pieces of equipment.
Sampling is an important part of this tracking process, as well. When selecting sampling sites, consider the areas that have been identified as critical control points and talk to operators to determine whether they have had difficulty cleaning certain areas or equipment in the past. Also, it is a good idea to conduct microbiological investigations in which there is a sampling plan and the finished product is pulled on a regular schedule to gather data. We found that using the data collected from these microbiological investigations helped us not only to identify the microbiological issues but to determine the appropriate places to swab.
During the initial design of the environmental tracking process, operators took conventional microbiological swabs in addition to luminometry swabs to validate the process and to ensure that what was being done would be successful. This was done because luminometry swabs identify only the presence/absence of organic debris, while conventional swabs identify the organism. After the process was validated, the conventional swabs were no longer taken for this purpose.
GMP Tracking. Since the GMPs are the backbone of any successful sanitation program, the team developed a training process and tracking procedure to ensure compliance. The operators and front-line personnel were trained in self-auditing their departments in accordance with the Tropicana GMP Handbook and provided training to render an effective GMP audit.
The key to the process is two-fold. First, there is a requirement for the timely execution of the audits; i.e., first shift audits on Monday, second shift audits on Wednesday; and third shift audits on Friday. Thus, the departments audit themselves three times a week. Second, there is a requirement for the timely completion of any violations noted by the auditor. Supervisors are given the audit results and are required to follow up on completions in a timely manner; if not, the supervisors are held accountable. If the plant sanitarian conducts his audit, notes that issues were raised and not corrected, there is accountability. Similarly, rewards and recognition for excellence in sanitation are also generated by the plant sanitarian’s audits.
An audit form was created to identify GMP standards using the key elements from the GMP Handbook. The department auditors then audit the departments against the established criteria. The departments have the authority to modify or change these criteria to meet the needs within each department.
The data gathered from these interlocking sanitation control methods is shared monthly with top management as part of the Quality/Sanitation Metric Scorecard. This information helps to alert management to areas that need additional support, as well as provides information on areas that deserve recognition for their improvement efforts.
THE GMP/SANITATION QUALITY AUDIT
In addition to the departmental self audits, a standardized and scored audit process was developed for use in all of the Tropicana North American facilities. A trained and qualified individual renders these unannounced audits monthly in all departments. As an ISO-certified facility, the Tropicana GMP/Sanitation Quality Department audits are based on: GMPs, CFR 110; Tropicana’s Employee Handbook, current revision; Tropicana’s Integrated Pest Management Procedure 5008.010; AIB Consolidated Standards for Food Safety; AIB Consolidated Standards for Pack-aging Facilities; and the company’s chemical hygiene plan.
This is a weighted audit, based upon the severity of the violation. The point value system used to determine severity can be customized to meet the needs of individual manufacturing operations. Some examples of point values assigned to typical focus areas might include areas such as housekeeping/chemical hygiene issues (i.e., unlabeled chemical bottles, unlabeled buckets), which are given a severity rating of 3, as compared to critical sanitation issues (i.e., mold inside tanks, lack of asepsis, flaking paint or rust above tanks), which are given a severity rating of 6 (Table 4).
Following the audit, the points are totaled and deducted from a possible score of 1,000. For example, if a department scores 75 points, that number is deducted from 1,000 for a department score of 925. Based upon the scores achieved, departments are rated according to the following: 970-1,000, Excellent; 925-969, Good; 900-924, Poor; 0-899, Unsatisfactory. At Tropicana, the target set by senior management is 970, and if a department fails to meet this target, the e-mails from management begin to fill computer screens.
Corrective action is taken according to the points awarded on the audit. For example, if a 6-point issue is noted in the audit (i.e., critical sanitation issues), the problem must be corrected immediately and a written response sent to the auditor within 24 hours. The response will also outline corrective measures to alleviate the issue from occurring in the future. Five-point issues must be corrected within seven working days of the closing meeting and the notification of correction must be provided to the auditor and contain the date corrected. Three- and four- point issues must be corrected prior to the next audit. If the issues are not corrected, the score is doubled. If 2-point issues are not corrected immediately, an approved “Unsafe Condition Report” may be issued by the department.
In order to achieve timely resolution of identified problems from the audit, points are doubled if the issue is not corrected by the next month’s audit. For example, if a department is doing well and scoring in the 980s, but any issues identified by the plant sanitarian are not corrected the next month, that score will drop to the 950s and the department will begin to receive phone calls from management. By doubling the points, the focus is raised to a priority level on issues that aren’t being corrected in a timely manner.
An established framework for communication is vital. Audit responses are sent via e-mail in the same format as the audit format. Departments are required to fill in the appropriate areas and e-mail the information back to the auditor, noting work order number and date for the issue(s) corrected. If the work order is provided to the auditor, the points assessed are removed. This is to facilitate better tracking of timely corrective actions. Post-audit meetings are conducted and may be scheduled with the supervisor or manager of the area. Any issues found during the audit are discussed and the corrective procedures outlined.
Audits are published to all levels of management, and results often are shared at shift meetings. The plant sanitarian takes digital photos of every issue found during the audits, which have been used successfully at shift meetings to train personnel visually about what “wrong” looks like, paving the way for better understanding of what needs to be prevented or corrected and why. The auditor also takes photos of examples of excellence in the sanitation program, and shares this at shift meetings to bring a positive reinforcement aspect to training against the audit. All photographs and audit summaries are posted on the company’s GMP intranet website, which further facilitates focus from all levels on the sanitation program. Departments can access the intranet site and track their historical performance, as well as perform trending on the data to conduct such activities as recall analyses. As a result, these audits have significantly improved the sanitation and housekeeping within the facility.
REAL COMMITMENT, REAL SUCCESS
The Sanitation Core Team has been diligent in its efforts to improve the overall sanitation in the Tropicana facility. The team meets weekly to identify the issues and to create timely solutions. The success of the team approach has been remarkable in its breadth and scope, impacting many areas of the facility from the CIP/SIP processes to the ultimate determiner of the teams’ skills, the consumer. The fact that consumer complaints are at an all- time low indicates the power of the team’s efforts and abilities. Not only are consumer flavor and spoilage complaints down (38% and 20%, respectively), but microbiological counts have been reduced in packaging (51%) and fruit processing (75%). Improved audit scores in manufacturing have increased by 40%.
As the food processing industry develops increasingly streamlined, team-oriented approaches to sanitation programs, more effective assurance of the quality and safety of products will be the successful result of its efforts.
C. Michael Nolan is Plant Sanitarian for Tropicana Products, Inc. He has been with Tropicana for nine years. Nolan is an ISO Lead Auditor.
The author would like to thank the highly trained, motivated and experienced Tropicana Sanitation Core Team: Doug Van Strijp, Manager Quality Control; Tammy Foster, Food Safety Systems Manager, QA; Dan Fisher, Quality Systems Facilitator, Packaging; Vic D’Angiolillo, Supply Train Coordinator; Tammy Parrot, Manufacturing Quality Systems Coordinator; Renee Fenton, Technical Services Coordinator; Julie Thomas, Technical Services Quality Systems Facilitator; Barbara Stewart, Buyer, Maintenance, Repair & Operations; and Tom Conradi, Quality Systems Coordinator, Packaging.
Categories: Management: Case Studies, Training; Sanitation: CIP/COP, Environmental Monitoring, SSOPs