The beginning of May started with important news for the agribusiness. The House of Representatives approved the bill that shares the responsibility related to sanitary inspection processes with the companies themselves, such as meatpackers and 100% of plant and animal food factories. Now going to the Federal Senate, the Bill (PL 1293/21), which you can access through this link, foresees that the agents of the productive chains in the agriculture and cattle-raising sector can develop self-control programs with the objective of guaranteeing the safety, identity, quality and security of their products.
Along with this, there was excellent news from the Department of Inspection of Products of Animal Origin (DIPOA) with the circular letter nº 21/2022/DIPOA/SDA/MAPA that started to admit computerized forms for the execution records, monitoring and verification of the components that make up the self-control programs, as well as the electronic signature of those responsible for the companies in the animal feed area. It really shows a new tendency in MAPA to create digitalization mechanisms and centralized information platforms (see the Autocontrol Platform that is being developed) that make it possible to combine efficiency, security, and processes without the need for piles of handwritten papers.
The concept of self-control programs are not new, they had already been established by MAPA itself in circulars number 175 and 176 of 2005. Some years later, they were revoked with the decree number 9013 of 2017, which regulated the Autocontrol Programs (PAC) and established the procedures for industrial and sanitary inspection of products of animal origin.
But after all, now with the automation of procedures and the demand for digital processes and electronic records, many companies are in doubt about the impact these new circulars have on them. The idea of this article is to present a little more about what Autocontrol Programs (CAP) are and how cloud-based laboratory information management software can help you further optimize these processes with digitized procedures and easy access to information.
What are Autocontrol Programs (PAC)?
Every day we follow the growing amount of data and volume of information we are exposed to. The impact this brings to the market is huge: increasingly complex, more competitive, with a higher level of awareness and demand from consumers, driven by an increasingly clarifying, attentive and assertive action of inspection agencies. We quickly know the origin, we follow opinions and we easily communicate with the different agents in the chain to learn more about the products.
This growing awareness of the consumer market, coupled with the increased demands and enforcement of regulatory and governmental bodies, has had a major impact on the food industry – be it animal or human. More and more companies are looking for solutions to help them deliver superior quality products, with more effective processes, better resource utilization, increasing profitability margins, and operational efficiency. In addition to improving their competitiveness and growth in a more demanding and globalized market, companies are thus able to meet the needs and desires of consumers.
However, quality food is not only food that satisfies your customer’s taste or palate. But also one that will not cause any harm to the health of those who consume it – be it the meat that is being served on a family’s table or the pet food that is being fed to their pets. Every food product needs a continuous and systematic inspection of all physical, chemical, and biological safety factors that can impact the hygienic quality of the finished product.
And it is in this scenario that the Autocontrol Programs (PAC) were created: to create the mechanisms and procedures that aim to facilitate the management of hazards and risks existing in the production process. Second definition of the Regulation of Industrial and Sanitary Inspection of Products of Animal Origin (RIISPOA) based on Decree No. 9.013, self-control programs are “programs, procedures described, developed, implemented, monitored and verified by the establishment, with a view to ensuring the safety, identity, quality and integrity of its products, which include, but are not limited to, the programs of prerequisites, GMP, PPHO and HACCP or equivalent programs recognized by the Ministry of Agriculture, Livestock and Supply (MAPA).
In general, the Autocontrol Programs are a set of good practices and processes established, registered and carried out by the company that aim, in an effective and lasting way, to ensure the desired quality of a given product. And as every strategic vision is based on a culture focused on quality and results, this set of good practices and processes should create a routine among all company employees and the main agents in the production chain: suppliers, inspection bodies, auditors, among others. In this way, the companies’ Self-Control Programs must aim to guarantee the quality of the products and foods handled and produced, in a preventive way and that preserves the safety by monitoring the control and safety parameters of the agents that cause diseases.
There are some norms and legislations that we have commented on previously that since 1997 already require companies under SIF to have Good Manufacturing Practices (GMP) implanted and, since 1998, to have HACCP implanted. There are basically 3 norms that make up the implementation of PACs within companies:
- MAPA Ordinance No. 368/1997: establishes the general (essential) hygiene requirements and good manufacturing practices for prepared/industrialized foods for human consumption, and is applied to establishments that prepare/industrialize, fraction, store, and transport foods destined for national and international trade.
- MAPA Ordinance nº 46/1998: establishes the obligation to institute the Hazard Analysis System and Critical Control Points (HACCP) to be implanted in the industries of animal origin products under the Federal Inspection Service (SIF) regime. It was established to drive the adoption of modern procedures adopted in the hygiene and sanitary control of raw materials and products of animal origin, based on the need to meet international bodies of the World Trade Organization and the provisions of the Codex Alimentarius.
- RIISPOA Decree 9013/2017: regulation of industrial and sanitary inspection of products of animal origin, establishing guidelines for establishments to have self-control programs developed, implemented, maintained, monitored and verified by them, with systematized and auditable records that prove compliance with the hygienic-sanitary and technological requirements established. The objective of this decree is to ensure the safety, identity, quality, and integrity of the products, from the procurement and receipt of the raw materials, ingredients, and inputs, to their production.
From these points cited above, the companies’ PACs must consider these prerequisite programs described above and supervised by the Official Services during official checks and audits. The Bill itself (PL 1293/21) that was approved in the House of Representatives states that CAPs must cover 3 main points:
- I – systematized and auditable records of the production process, from the procurement and receipt of raw materials, ingredients, and inputs to the shipment of the final product;
- II – provision for the recall of lots, when deficiencies or non-conformities are identified in the agricultural product that may cause risks to consumer safety or to animal health; and
- III – description of the self-correction procedures.
What are the control elements to be checked by auditors and inspection agents?
When establishing CAPs, the company must assemble manuals and documents describing the program’s objectives, procedures for monitoring actions, compliance standards and critical limits, preventive and corrective actions and measures, the documentary checks that it has available, as well as records proving that the programs operate within the defined standards and that deviations are handled appropriately. These are documents required by inspection establishments, such as the Federal Inspection Service (SIF) and the Brazilian Inspection System for Products of Animal Origin (SISBI-POA) and should be revisited whenever there is a change or as a revision.
The Internal Standard DIPOA/SDA No. 01 of 2017 establishes a manual of procedures for official verification of self-checks on how the auditor should perform his inspection work, but some establishments use the numbering of self-check elements based on this NI – even though it is not mandatory. The NI brings a guideline that indicates a path to develop supporting documentation for the CAP of 15 elements of control that will be verified by auditors and inspection agents, these being:
- 1º: Maintenance
- 2º: Water Supply
- 3º: Integrated Pest Control
- 4º: Industrial and Operational Hygiene
- 5º: Hygiene and hygienic habits of the employees
- 6º: Sanitary Operating Procedures (SOPs) – cross contamination
- 7º: Control of raw materials, ingredients and packaging material
- 8º: Temperature Control
- 9º: HACCP
- 10º: Laboratory analysis (microbiological and physical-chemical)
- 11º: Control of product formulation and combating fraud
- 12º: Traceability and collection
- 13º: Backing for official certification
- 14º: Animal Welfare
- 15º: Identification, removal, segregation and disposal of the specified risk material (MER)
It is worth mentioning that within the list of control elements that make up the PAC are also the Standard Operating Hygiene Procedures (SOP) and the Hazard Analysis System and Critical Control Points (HACCP) – which we have already talked a little more about in previous articles – in an explicit way and the Good Manufacturing Practices (GMP) by other ordinances. In other words, besides being fundamental programs for the quality and safety of products, they enable a centralized information that helps in the implementation of a solid and robust quality management system, auditable at any time, which brings more predictability and makes all involved agents aware
How can laboratory information management tools assist in this process?
As we saw earlier, the Autocontrol Programs (PAC) are not something new or recently required by the inspection agencies. The new draft laws and guidelines that drive these procedures reaffirm MAPA’s and the Department of Inspection of Animal Products (DIPOA) vision that the responsibility for what is produced is the industry’s and not the government’s, which is responsible for verifying compliance with legislation. In other words, the quality management systems with their processes and products are part of a set of programs and procedures that must be created, monitored and reviewed frequently in order to always ensure the hygienic and sanitary quality of their products and the fulfillment of the customers’ expectations and requirements.
Combined with this, we also have the creation of new rules by DIPOA for the admission of computerized forms and electronic signatures, which also reinforces the department’s commitment to the digitalization, modernization, and automation of the processes linked to the components that form the self-control programs. And many companies have been wondering how to start or implement digital processes and activities.
This is where cloud-based laboratory information management systems come into the picture. They will enable the processes of describing, implementing, and consolidating the Self-monitoring Programs (CAP) to happen more easily, collaboratively, and efficiently. Of course, without them, there are implementation strategies that can be adopted – either with Excel spreadsheets, documents in cloud directories, among other alternatives. However, these systems bring more security and integrity to the data, cover several agents of the production chain, bring the focus on efficiency and enable digital processes that give more predictability to laboratory activities.
If we consider 3 core processes for implementing self-monitoring programs – the description of the programs, the actual implementation until the consolidation with continuous update of the PAC – platforms like Labinfy can help in many ways. We have separated below 6 benefits that you can obtain in this process of adoption and digitalization of laboratory processes:
1) Development of an integrated and strategic planning
As we have seen in previous posts, modern quality must be treated strategically within the company, transcending the physical space of the laboratory and involving all areas – not only to raise the awareness of all personnel, but to obtain performance indicators that reinforce the focus on the efficiency of the operation.
Software such as Labinfy can help in all the registration of the laboratory environment, automating the analytical routines, facilitating the visualization of information regarding each sample received, defining the assignment of each laboratorian or agent registered in the platform, and improving the communication in the company about the quality control efforts and their results (bringing more transparency to the data generated by the organization itself)
With this approach, it becomes simpler to raise the points of attention that the company’s planning must consider in order to draw up internal self-control documents and programs. With better communication and planning, it will be easier for companies to define and apply the measures and procedures that have been defined in the Autocontrol Programs (PAC).
2) Automation of the analytical procedures of the tested items
One of the aspects of CAP is the definition of verification procedures. For the food industry, physical, chemical and biological analyses become an important ally in monitoring the safety and quality parameters of the ingredients used and finished products. In this way, the results found can quickly facilitate the process of adopting corrective actions, and statistical patterns can improve predictability and trend identification.
Laboratory information management platforms allow you to have technical control records registered, such as the analyses and equipment used, and, by relating them to the analyzed items, quickly create analysis plans and procedures that automate laboratory activities upon receipt of samples. This operational predictability allows a more effective standardization within the laboratory activities and ease for the technicians to start the activities.
In addition, each registered sample receives the records with the dates of receipt and collection, with the product identification, with the necessary analyses already assigned, the critical criteria and limits (conformity standards) automatically detected and the structured analytical results/data. Thus, the control records that make up the CAP are even simpler and easier to follow.
3) Control records of samples received for analysis at the laboratory
One of the central points of management systems is to enable you to centralize information in one place, allowing you to better organize and structure your data more effectively. As we mentioned in the previous point, grouping the plan for specific analyses allows you to have an initial standardization and automation of what analyses will be performed for each item received. For example, you can create an Analytical Procedure for Cereals and Flours, already assigning Ashes by method IAL – 012/IV – p.105, Crude Fiber IAL – 044/IV – p.136, Protein ISO 1871-2009 and Moisture and Volatiles IAL – 012/IV – p.98.
Thus, when you register your samples of raw materials or finished products, the identification records of the analyzed item, requester, supplier, dates of receipt, collection and start of the analysis are automatically registered. In addition, as the analytical process develops, the evaluation and approval dates are also included in the record, as well as the identifier of the laboratory and the person responsible for the approval.
Another important point in this initial automation of the records regarding each sample received in the laboratory is the creation of a label that helps in the organization of the received items. Thus, each sample receives a specific QR Code that you can quickly find out the code assigned to it, the lot that was produced, and the production/delivery information.
In addition, when registering your samples, you can indicate and monitor the samples referring to specific batches of inputs and or finished products, thus providing the necessary information so that you can quickly see the information referring to each one. For each registered batch, you can filter and check the product release records, the details of the tests performed, the technician who performed the test, and who approved the sample. Trying to get the same level of information using paper records can be very time-consuming and disruptive to the inspection process.
4) Issuance of test reports for submission to the surveillance platforms
Software such as Labinfy also automates the creation of Test Reports and Certificates of Analysis, after the results found in the analyses performed for each sample have been correctly approved and validated. Conceptually, the laboratory information management system consists of records of the process before, during, and after the tests performed; this end-to-end process recording approach provides transparent data that prepares the laboratory for audits and inspections.
You can register users and associate their digital signatures to them – so that after they approve or reject the results of a sample, the Assay Report will be generated already correctly placing the user’s signature at the bottom of the results page. This approach will facilitate the process of later uploading to official platforms and signing electronically with digital certificates – thus ensuring more transparency and integrity of the documents that are generated in the laboratory from the tests performed.
5) Creation of users with different access permissions
The LIMS platform is designed to foster a culture of quality as a key strategy to promote productivity, competitiveness, and results. This approach allows you to create different users within your company and assign different access permissions to each function: lab technicians to record analytical results, buyers to qualify suppliers, nutritionists to monitor nutritional variability, production to monitor indicators, administrative to check costs, among other possibilities.
The Law we commented on earlier (PL 1293/21) has as one of its chapters the description of the Program of Incentives to Compliance in Agricultural Defense. Article 10 says that the program has “the objective of stimulating the improvement of robust and auditable quality assurance systems, with a view to consolidating an environment of reciprocal trust between the Federal Executive Branch and the regulated agents, by way of increasing transparency. He complements by saying that the companies that adhere to it must share operational and quality data in real time with the agricultural inspection in exchange for benefits and incentives.
We know that quality management programs involve dozens of documents and different records of nonconformity control, verification procedures, and corrective actions. We also saw that many of these items can be recorded through laboratory information management software that facilitates the registration of analyses performed, results obtained, and values that are outside the conformity standards defined by the company.
With the digitalization of these records and the activities performed in the laboratory, the company can create an external user to the organization itself, assigning him a Supervisory/Audit role, with monitoring permission to requesters and specific organizational units. This privileged access to the system, without the possibility of changing data, but that allows the quick identification of data and justifications/observations registered, allows the digital files to be quickly consulted by external users. It is worth pointing out that this type of alternative is defined according to the company’s own access, data sharing, and security policies, and it is up to the company alone to define this type of special permission.
6) Save time to focus on what really matters: the quality of the food used and/or produced
By automating workflows and digitizing self-control routines, with standardized and pre-assigned analytical procedures, you can complete tasks more quickly: creating samples, recording analyses, control statistics, validation parameters, issuing certificates, among so many other tasks that you can create automated tasks, removing the rework and manual need to record the results found.
Reports point out that inefficient workflows can cost up to 30% d the company’s revenue, impacting not only operational productivity, but lower financial results. The automation of routines is one of the alternatives to help avoid this inefficiency. By creating the execution patterns that already list the entire laboratory environment and the control and maintenance records they have recorded, you can get valuable information that you couldn’t get quickly with manual tasks – the more high-quality data, the greater the chance for better decisions.
We know that the implementation of self-control programs by food industries, especially those of animal origin, has the potential to bring continuous improvements to the production processes by acting on everyone’s training and awareness. This approach allows the company to focus on efficiency and to use the best of each monitored requirement or parameter to improve the organization’s management and the results (both productive and financial) that it has.
By acting in depth on the problems and causes, in a collaborative manner involving the entire organization, describing the safety parameters and processes in a clear and complete manner, the self-control programs are essential for the industry to have more and more quality and harmless products and raw materials. And laboratory information management systems will be important tools to standardize these processes, bring greater predictability to events and ensure better monitoring of compliance standards and control elements defined by the company.
MAPA’s new approaches and the trend towards digitalization of inspection documents are a milestone for the industry. They will certainly bring even more productivity and competitiveness to food companies, and allow less costly and faster processes. If your company wants to anticipate the digitization of documents and test reports/certificates, Labinfy is a great ally.
