Your browser does not support JavaScript! September 2016 ⋆ The BioExpert

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What is CAPA?

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By Mohamed Anvar Deen

CORRECTIVE ACTION & PREVENTIVE ACTION

What are Corrective Action and Preventive Action? Corrective action is an action taken to prevent the re-occurrence, Whereas Preventive action is an action to prevent the occurrence. FDA investigators focus on CAPA during inspections because it is a roadmap to identify potential and existing problems at a company. CAPA documentation provides FDA investigators, auditors, and executive management a means to review problems. Therefore, effective management of the CAPA syscapatem is critical to compliance. By following five essential steps, companies can be CAPA compliant and ensure a successful audit or inspection. The failure to either have a CAPA process, or failing to document or establish CAPA procedures, is one of the most common issues noted by the FDA. The lack of a documented CAPA system was the second most common observation by FDA investigators and was noted in more than half of all Warning Letters citing a CAPA violation.

1. IDENTIFICATION

The first step may seem obvious, but it is essential to Identify/ establish a CAPA system. Non-conformities requiring CAPA can arise from various situations and can include, but are not limited to, internal audits, external audits, regulatory Inspections, customer complaints, staff observations, trending data risk assessments, process performance monitoring, management review, etc. During this initial step of the process it is important to list the specific information available that demonstrates that the problem does exist. This description should be concise, but with sufficient information to assure that the problem is well detailed and can be easily understood from reading the explanation. Key areas to focus on are:
  • What EXACTLY went wrong?
  • How often has it occurred?
  • How big is the problem?
  • What impact does the event create?
  • Who has more information?
Common pitfalls at this stage are, for instance, failing to confirm understanding, accepting opinions as facts, failing to record information.

2. EVALUATIONtable1

Once the Identification phase is closed, the second step to CAPA compliance is to use statistical methodology to evaluate quality data and identify quality problems. The non-conformance is required to be assessed in terms of the potential impact, for instance in related to safety, reliability, costs, or customer satisfaction, quality audit reports, quality records, service records, complaints, returned products,. Utilizing a risk assessment tool, such the matrix in Table .1, is a recommended and suitable tool. Additionally, remedial actions might need to be implemented during this phase until the investigation is closed and the corrective action defined and implemented.

3. INVESTIGATION (RCA)table2-capan

The third step to CAPA compliance is Investigation. With the further knowledge gained through the first two steps of the process, it is now time to prepare the investigation plan by reviewing the circumstances related to the issue. By applying certain techniques as described in Table 2, a list of all possible causes can be created. This will form the basis for collecting relevant information and further evidences, like test data, that will be required to drill down to the root cause of the issue. It is important to consider all possible causes (and not only focusing on one), the appropriate associated information and supplementary data to determine the root cause of the non-conformance. It is strongly recommended to consider equipment, materials, personnel, procedures, design, training, software, and external factors, and list all possible root causes to define which data must be collected for the assessment. Brainstorming sessions, Process Mapping, Value Stream Mapping, Interviews and applying the 5 Whys are the most common techniques. However it is imperative to recall that “we can’t solve problems by using the same kind of thinking we used when we created them.” (Albert Einstein) Therefore, approaching the problem from a different angle, involving a team and exploring different and/or new options is the key for an effective Investigation and root cause analysis.

4.   IMPLEMENTATION   

The fourth step in CAPA compliance is implementation, after the investigation is closed and the potential root cause identified, the CAPA needs to be implemented. In order to proceed, a CAPA plan should be developed and should include, as appropriate:
  • All actions to be completed, for example review of other batch records
  • Required documents (e.g., SOPs) to be changed
  • Process / Procedure changes – Process changes should be described in sufficient detail so that it is clearly understood what needs to be done (avoid generic statements). The expected outcome must be clarified and described
  • Employee training
  • Monitors / Controls to be implemented to prevent the problem to reoccur.
The CAPA plan must also identify the person responsible for completing each task, including time lines and further resources needed, if applicable. To identify and implement a plan is simply not enough; effective follow-up to ensure that the plan is addressing the problem and is not creating any new problems is indispensable. Companies should always be cognizant that fixing one problem may create another. With this in mind, any changes to the production process that fix an issue should also be viewed as a potential source of new problems. Therefore, after preventive or corrective actions have been taken, companies must ensure that not only the original problem has been solved but also that no new problems have arisen as a result of that action

5.  VERIFICATION 

The Final step in CAPA compliance is verification. One of the most fundamental steps in the process is to provide evidence that the CAPA has finally been implemented successfully. This assessment must allow answering several key questions:
  • Has the root cause been tackled appropriate to prevent the issue from recurring?
  • Have all defined actions and changes been completed and verified?
  • Are proper controls in place?
  • Is there any chance that the solution implemented has any adverse effect on the product, process, or service?
  • Is everything well documented?
CAPA systems are not only a regulatory requirement; they make good business sense to secure the patient’s life. Companies must ensure that appropriate corrective actions include both short-term actions to address the immediate problem and long-term actions to prevent the recurrence of a problem. In order to successfully manage the CAPA system, we need to simplify the procedures, and to filter and prioritize the corrective and preventive actions. Senior management must allocate proper resources to identify and remove the root causes of recurring problems. The most complex CAPA issues may be found in non-routine channels, such as customer surveys. Companies have to uncover and rectify the tough-to-spot problems, before they trigger an FDA warning letter. By removing the root causes of recurring problems, companies will benefit twice – by meeting the regulatory expectations as well as business requirements.
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Why are there More Recalls Due to Listeria monocytogenes

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listeria-plate In the past few months there have been a number of recalls due to L. monocytogenes. Just in the month of September there were four recalls. The question is why are we seeing this increase in recalls? Is it a sign of more problems or a sign of the industry getting better in catching the problems earlier? Let’s review the following cases:  

Blue Bell Ice cream

September 21: FDA announced that the company is voluntarily recalling some half-gallon and pint-sized chocolate chip cookie dough and half-gallon “Cookie Two Step” products because they were made with a chocolate chip cookie dough ingredient supplied by a third party supplier Aspen Hills, Inc., due to the potential of being contaminated with – Listeria monocytogenes. The products were produced with the chocolate chip cookie dough pieces and were distributed in Alabama, Georgia, Kentucky, Louisiana, Mississippi, North Carolina, South Carolina, Tennessee and Virginia. No illnesses have been reported to date. Blue Bell identified a potential problem through intensified internal testing and notified Aspen Hills. Although the products in the marketplace hblue-bell-ice-creamave passed the test and hold program, which requires that finished product samples test negative for Listeria monocytogenes, Blue Bell is still initiating this recall out of an abundance of caution. It is important to mention that last year, Blue Bell had to halt production and issue a massive recall of its products due to a Listeria outbreak .. According to CNN the company had spent 2016 getting its products back in stores. It just delivered tubs to Raleigh, North Carolina, for the first time two days before the latest recall was announced. It seems as if the enhanced safety screenings the company adopted after the last year’s catastrophe may be what caught the issue. The company had identified the problem through “intensified internal testing” the company reported.

Apple Tree Goat Dairy

apple-tree-goat September 20: FDA announced that the company is recalling Feta cheese, Gouda Cheese, French Herb Chevre because it has the potential to be contaminated with Listeria monocytogenes.  These products may have been distributed in Washington DC, New Jersey, Delaware, Maryland and Virginia. No illnesses have been reported to date. The recall was the result of a routine sampling program by Pennsylvania Department of Agriculture. The samples collected by Pennsylvania were found to be contaminated with Listeria Monocytogenes.  

Kellogg’s® Eggo® Nutri-Grain® Whole Wheat Waffles

September 19: We reported in a previous blog about the Eggo recall of 10,000 cases of Kellogg’s® Eggo® Nutri-Grain® Whole Wheat Waffles because they have the potential of being  contaminated with Listeria monocytogenes. No other Eggo products are implicated and there were no reports on of illness to date. Kellogg announced that the recall was a result of routine tests that the company conducted which identified the potential for contamination. 

SM Fish

September 8: FDA announced the voluntary recall of OSSIE’S brand ready-to-eat salads because they have the potential to be contaminated with Listeria monocytogenes. These products were sold at the firm’s seven retail outlets located in New York and New Jersey between August 1, 2016 and September 9, 2016. No illnesses have been reported to date. The recall was the result of sampling and inspectional findings by the US Food and Drug Administration (FDA).  FDA found Listeria monocytogenes in multiple locations throughout the facility.  SM Fish Corp. has ceased production and distribution of products.

Why Do We See More Recalls?

According to Steryicycle ExpertSOLUTIONS FDA recalled food units in the second quarter (Q2) of 2016 were more than 80 times higher than the first quarter (Q1), while USDA recalled product pounds more than 45 times higher. FDA contamination recalls alone rose 167 percent from Q1 to Q2 – higher than any quarter in 2014 or 2015. However, this trend is due to advancements in testing, as testing becomes faster, cheaper and more precise, and regulators have also reduced the acceptable levels of pathogens in certain classes of foods. Even foods designated for cooking, which include kill steps, are subject to stricter regulations. Across America Patch interviewed Professor Elliot Ryser (food science at Michigan State University)who claimed that the increase in recalls is actually a sign that food safety measures are getting better, not worse. And, more specifically to Listeria, it is sickening fewer people than ever before. As Ryser explained, our technology for detecting outbreaks has improved. “The CDC [Centers for Disease Control] has gone to what they call ‘whole-genome sequencing’ to identify Listeria and other pathogens. It is more sensitive than what we’ve used in the past,” he said. Perhaps the increase in recalls is because the companies manage better their supply and catch potential problems earlier. According to Dr. Ryser “The number of cases of listeriosis has dropped quite dramatically since the 1990s,” Ryser said. “The estimate back then was 2,500 cases a year, and now we’re down to about 1,500 cases a year.”
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Kellogg recalls Eggo® Nutri-Grain® Whole Wheat Waffles due to Fear of Listeria

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The FDA reports that Kellogg Company voluntarily recalled 10,000 cases of Kellogg’s® Eggo® Nutri-Grain® Whole Wheat Waffles because they have the potential of being  contaminated with Listeria monocytogenes. eggo2 No other Eggo products are implicated and there were no reports on of illness to date. Kellogg announced that the recall is a result of routine tests that the company conducts which identified the potential for contamination As soon as the company learned of a potential concern, it moved quickly to identify any foods that might be impacted and resolve the issue. Recalled product was distributed to customers and retailers in 25 states (CO, CT, DE,GA, IA, IL, IN, KS, MA, MD, ME, MI, MN, MO, ND, NE, NH, NJ, NY, OH, PA, VA, VT,WI, WY).  The Eggo brand has had other recalls due to Listeria contamination: in 2009, the Georgia Agriculture Department inspectors discovered Listeria monocytogenes in a plant for Eggo Buttermilk Waffles (the plant was shut down for “hygienic restoration”), and in 2010 the Food and Drug Administration wrote a letter to Kellogg’s, calling the Atlanta plant was contaminated. All news outlets reported this recall. The question is: are there more outbreaks due to foodborne illnesses? Lena H. Sun from the Washington Post wrote , a few months ago that:”Major foodborne outbreaks in the United States have more than tripled in the last 20 years, and the germs most frequently implicated are familiar to most Americans: Salmonella, E. coli and Listeria.” increase-foodborne-outbreaks Another question is: Are the new FSMA regulations helping in early detection of contamination and as a result avoiding illnesses?
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Validation of RapidCheck Select Salmonella Test Method for Detecting Low Levels of Salmonella species in Palm Oil

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Authors Meredith I. Sutzko and Ann Allen;  Romer Labs 130 Sandy Drive  Newark, DE 19713 U.S.A   [https://www.romerlabs.com/]

Objective

The RapidChek SELECT Salmonella test system (RC SS) is designed to detect Salmonella species in a variety of foods and environmental surfaces, and is now also validated to detect low levels of Salmonella spp. in palm oil. The test kit permits the presumptive detection and identification of Salmonella spp. in a minimum of 22 hours when the pathogen is present at low levels in food and environmental surfaces.

Challenges

Method Comparison Study (FDA BAM versus RapidChek) Salmonella Typhimurium ATCC 14028 spiked at 2.5 cfu/25g sample (n=20 per method) + 5 unincculated negative controls. Cultural confirmation of all samples regardless of presumptive results on XLD and HE agars (FDA BAM) FDA BAM Chapter 5: Salmonella     rc-pic  

Results

t1     t2   t3

Conclusion

  • RapidChek Select Salmonella detected Salmonella in palm oil with 100% sensitivity and specificity within 22 hours
  • Proved equivalent to FDA BAM cultural method RapidChek will provide users with a rapid, reliable, cost effective tool for monitoring and controlling Salmonella species in palm oil
This poster was presented at the IAFP 2016 Annual meeting
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FSMA Compliance Starts Now- Are we Ready?

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fda_fsma_act1FSMA represents the most sweeping change to U.S. food regulations in over 70 years. It represents a radical change for food safety in US and its suppliers abroad, bringing a new focus on prevention. It is a fundamental change in food regulations affecting the entire food supply chain. Now, all seven rules of FSMA (Food safety Modernization Act)  are now final and implementation for the large companies starts now. Below is a quick overview of the new rules provided by the FDA. The final rules are:
  1. Preventive control for human food
  2. Preventive control for animal food
  3. Accredited third-party certification
  4. Foreign supplier verification programs for importers of food for humans and animals
  5. Produce safety
  6. Sanitary transportation of human and animal food
  7. Mitigation strategies to protect food against international adulteration

Preventative control human food and animal food

The FSMA transforms the FDA’s approach from a reactive system that responds to outbreaks (rather than prevents them) to a preventative system based on controls across the food supply. Animal food manufacturers must implement current Good Manufacturing Practices and Preventive Controls. The plan also involves the following:
  • Food facilities must establish and implement a food safety system that includes analysis of hazards and risk-based preventive controls.safe-food-category-stamp
  • Establish preventative controls including process, food allergen, and sanitation controls, as well as supply-chain controls and recall plans.
  • Management oversight of preventive control, including corrective actions, documented corrections and verification that the corrective action is working. Verification could include validating, with scientific evidence, that a preventive control is capable of effectively controlling an identified hazard.
The company must maintain and implement a written food safety plan.  It must contain elements like hazard analysis, preventative controls, monitoring procedures and corrective action.

Accredited third-party auditors/ certification bodies to conduct audits

FDA would recognize accreditation bodies, which would in turn accredit the third party auditors/certification bodies that would audit and issue certifications to qualifying foreign facilities.  

Requirements of accreditation bodies

In order to be recognized by FDA, the accreditation bodies would have to submit to certain FDA requirements themselves and impose certain requirements on the entities they accredit. FDA would monitor their performance, the accreditation bodies will need to assess and correct any problems in their own performance, submit reports to the US FDA, maintain records of the program and provide US FDA access to them.

Third-party certification bodies

Ensure that their auditors are competent and objective, they need to verify the effectiveness of their corrective actions, assess and correct any problem that they may have, maintain and provide US FDA access to records to the program. The third-party certification bodies can be a foreign government, a third-party entity or individual.

Foreign supplier verification programs for importers of food for humans and animals

Any human or animal food imported into the U.S. must be produced under the same safety standards as food that is produced in the US. It must pass through a risk analysis and the application of preventive controls designed to minimize those risks before it reaches the American consumer. If only manufactured overseas, the importer of the finished product is responsible for insuring that these safety controls have occurred. If manufactured domestically, the U.S. facility must insure these safety controls.

Produce safety

produceThere are 6 key requirements, one that applies to sprouts only. Agricultural water No detectable level of generic E. coli would be allowed in water used for hand washing, food contact surface application, ice that is applied directly to produce and for sprout irrigation. Biological soil amendments dealing with treatment of raw manure and compost. Wild and domestic animals Farmers are required to take measures to identity animal intrusion and not harvest produce that is likely to have been contaminated by animals.  Worker training and health and hygiene–Farm workers need to be trained in basic health and hygiene requirements. Equipment, tools and buildings- establishes rules to prevent these as sources of contamination, and measures to prevent contamination.

Sanitary transportation of human and animal food

The key requirements include: Transporting vehicles- designed and maintained to ensure that it does not cause the food that it transports to become unsafe. Transportation operations- measures are taken during transportation to ensure food safety (e.g. temperature control, cross contamination, unintentional incorporation of allergens). Trainingpersonnel training in sanitary transportation practices and documentation of this training is required. Records- Maintenance of records of written procedures, agreements and training is required.

Mitigation strategies to protect food against intentional adulteration

Under this rule each facility is required to prepare and implement a written food defense plan. The plan must include:
  • Vulnerability assessment– including the following elements: The severity and scale of the potential impact on public health; the degree of physical access to the product; and the ability to successfully contaminate the product.
  • Mitigation strategieseach actionable process step to provide assurances that the identified vulnerabilities will be minimized or prevented.
  • Mitigation strategy management componentsStep taken for proper implementation including monitoring, corrective action, and verification.
  • Training and record keeping: Ensure that personnel assigned to the vulnerable areas receive appropriate training and record keeping.