What Are PAC Programs and How a LIMS Can Help

Early May began with important news for agribusiness. The Chamber of Deputies approved a bill sharing sanitary inspection responsibility with the companies themselves, including slaughterhouses and 100% of plant and animal food factories. Now heading to the Federal Senate, Bill No. 1293/21 provides that agents of agribusiness production chains may develop self-control programs to ensure the safety, identity, quality, and security of their products.

Along with this came excellent news from the Department of Inspection of Animal-Origin Products (DIPOA) with Circular Letter No. 21/2022/DIPOA/SDA/MAPA, which began admitting computerized forms for execution, monitoring, and verification records of self-control program components, as well as electronic signatures from animal feed company officials. This truly shows a new MAPA trend toward creating digitization mechanisms and centralized information platforms (such as the Self-Control Platform currently under development) that combine efficiency, security, and processes without requiring stacks of handwritten papers.

The concept of self-control programs is not new, having already been established by MAPA itself in circulars 175 and 176 of 2005. A few years later, these were revoked along with Decree No. 9013 of 2017, which regulated the PAC (Self-Control Programs) and established industrial and sanitary inspection procedures for animal-origin products.

But now, with process automation and the search for digital processes and electronic records, many companies are uncertain about the impact these new circulars bring. The idea of this article is to present more about what Self-Control Programs (PAC) are and how cloud-based laboratory information management software can help optimize these processes with digitized procedures and easy information access.

What are Self-Control Programs (PAC)?

Every day we witness the growing amount of data and volume of information we are exposed to. The market impact is enormous: increasingly complex, more competitive, with greater consumer awareness and demands, driven by ever more enlightened, attentive, and assertive action by regulatory bodies. We quickly learn provenance, follow opinions, and easily communicate with different chain agents to learn more about products.

This growing consumer market awareness, combined with greater regulatory and government oversight requirements, has significant impact on the food industry — both animal and human. Companies increasingly seek solutions that help them deliver superior-quality products, with more effective processes, better resource utilization, growing profitability margins, and operational efficiency. In addition to improving their competitiveness and growth in a more demanding and globalized market, companies can thus meet consumer needs and desires.

However, a quality food product is not only one that satisfies the customer's taste or palate. It is also one that will cause no harm to the health of those who consume it — whether meat served at a family table or feed given to a pet. Every produced food requires continuous, systematic inspection of all physical, chemical, and biological safety factors that can impact the hygienic-sanitary quality of the finished product.

This is the context in which Self-Control Programs (PAC) were created: to establish the mechanisms and procedures aimed at facilitating management of hazards and risks in the production process. As defined in the Regulation of Industrial and Sanitary Inspection of Animal-Origin Products (RIISPOA) based on Decree No. 9,013, self-control programs are "programs developed, procedures described, developed, implemented, monitored and verified by the establishment, aiming to ensure the safety, identity, quality and integrity of its products, including but not limited to prerequisite programs, GMP, SSOP and HACCP or equivalent programs recognized by the Ministry of Agriculture, Livestock and Food Supply (MAPA)".

In general, Self-Control Programs are the set of good practices and processes established, recorded, and performed by the company that aim to effectively and durably guarantee the intended quality of a given product. And since every strategic vision stems from a culture focused on quality and results, this set of good practices and processes must create a routine among all company employees and the main production chain agents: suppliers, regulatory bodies, auditors, among others. Thus, company Self-Control Programs must aim at guaranteeing the quality of handled and produced products and foods, preventively and preserving safety through monitoring of control parameters and safety of hazard-causing agents.

There are some regulations we mentioned earlier, which since 1997 require companies under SIF to have Good Manufacturing Practices (GMP) implemented, and since 1998 to have HACCP implemented. There are basically 3 regulations that make up PAC implementation within companies:

• MAPA Ordinance No. 368/1997: establishes the general (essential) hygiene and good manufacturing practice requirements for processed/industrialized foods for human consumption, applied to establishments that elaborate/industrialize, fractionate, store, and transport foods for national and international commerce.
• MAPA Ordinance No. 46/1998: establishes the requirement to implement the Hazard Analysis and Critical Control Points (HACCP) system in industries of animal-origin products under the Federal Inspection Service (SIF) regime. It was established to encourage adoption of modern hygienic-sanitary control procedures for raw materials and animal-origin products, based on the need to comply with international World Trade Organization bodies and Codex Alimentarius provisions.
• RIISPOA Decree 9013/2017: regulation of industrial and sanitary inspection of animal-origin products, establishing guidelines for establishments to have self-control programs developed, implemented, maintained, monitored, and verified by them, with systematized and auditable records proving compliance with established hygienic-sanitary and technological requirements. The objective of this decree is to ensure the safety, identity, quality, and integrity of products, from obtaining and receiving raw materials, ingredients, and inputs through production.

Based on the above points, company PACs must consider these prerequisite programs described above, supervised by Official Services during official verifications and audits. Bill No. 1293/21 approved in the Chamber itself discusses that PACs must cover 3 main points:

• I - systematized and auditable records of the production process, from obtaining and receiving raw materials, ingredients, and inputs through dispatching the final product;
• II - provision for lot recall when deficiencies or non-conformities are identified in the agricultural product that may pose risks to consumer safety or animal and plant health; and
• III - description of self-correction procedures.

What are the control elements to be verified by auditors and inspection agents?

When establishing PACs, the company must prepare manuals and documents describing the program objectives, action monitoring procedures, conformity standards and critical limits, preventive and corrective actions and measures, available documentary verifications, as well as records proving programs operate within defined standards and deviations are appropriately handled. These are documents required by inspection establishments such as the Federal Inspection Service (SIF) and Brazilian System for Inspection of Animal-Origin Products (SISBI-POA) and must be revisited whenever there is a change or as a review.

DIPOA/SDA Internal Norm No. 01 of 2017 establishes a manual of official self-control verification procedures for how the auditor should conduct their inspection work, but some establishments use the self-control element numbering based on this internal norm — even though it is not mandatory. The internal norm provides a guideline indicating a path for developing support documentation for the PAC of 15 control elements that will be verified by auditors and inspection agents, which are:

• 1st: Maintenance
• 2nd: Water Supply
• 3rd: Integrated Pest Control
• 4th: Industrial and Operational Hygiene
• 5th: Employee hygiene and hygienic habits
• 6th: Operational Sanitary Procedures (OSP) – cross-contamination
• 7th: Control of raw materials, ingredients, and packaging material
• 8th: Temperature control
• 9th: HACCP
• 10th: Laboratory analyses (microbiological and physico-chemical)
• 11th: Product formulation control and anti-fraud measures
• 12th: Traceability and recall
• 13th: Support for official certification
• 14th: Animal Welfare
• 15th: Identification, removal, segregation, and disposal of specified risk material (SRM)

It's worth noting that the control elements making up the PAC also explicitly include the Sanitation Standard Operating Procedures (SSOP) and the Hazard Analysis and Critical Control Points system (HACCP) — which we've already discussed in more detail in previous articles — as well as Good Manufacturing Practices (GMP) under other ordinances. In other words, besides being fundamental programs for product quality and safety, they enable centralized information that helps implement a solid, robust quality management system, auditable at any time, bringing more predictability and raising awareness among everyone involved.

How can laboratory information management tools help in this process?

As we saw previously, Self-Control Programs (PAC) are not something new or recently required by regulatory bodies. The new bills and guidelines driving these procedures reaffirm the vision of MAPA and the Department of Inspection of Animal-Origin Products (DIPOA) that responsibility for what is produced lies with industry, not government, whose role is to verify legislative compliance. That is, quality management systems with their processes and products are part of a set of programs and procedures that must be created, monitored, and frequently revised to always ensure the hygienic-sanitary quality of products and meet customer expectations and requirements.

Combined with this, we also have the creation of new rules by DIPOA for admitting computerized forms and electronic signatures, which also reinforces the department's commitment to digitization, modernization, and automation of processes linked to self-control program components. 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 play. They will enable the description, implementation, and consolidation processes of Self-Control Programs (PAC) to happen more easily, collaboratively, and efficiently. Without them, implementation strategies can be adopted — whether with Excel spreadsheets, cloud directory documents, or other alternatives. However, these systems bring greater data security and integrity, cover various production chain agents, focus on efficiency, and enable digital processes that bring more predictability to laboratory activities.

If we consider 3 central processes for implementing self-control programs — program description, actual implementation, and consolidation with continuous PAC updating — platforms like Labinfy can help in several ways. Below we've outlined 6 benefits you can get from this process of adopting and digitizing laboratory processes:

1) Development of integrated and strategic planning

As we saw in previous posts, modern quality must be treated strategically within the company, transcending the physical laboratory space and involving all areas — not only for staff awareness but to obtain performance indicators that reinforce focus on operational efficiency.

Software like Labinfy can help with the entire registration of the laboratory environment, automating analytical routines, making it easier to view information for each sample received, defining the assignment of each lab technician or agent registered on the platform, and improving company communication about quality control efforts and their results (bringing more transparency to data generated by the organization itself).

With this approach, it becomes simpler to identify the attention points that company planning must consider to then prepare internal self-control documents and programs. With better communication and planning, it becomes simpler for companies to define and apply the measures and procedures established in Self-Control Programs (PAC).

2) Automation of analytical procedures for tested items

One aspect of PACs is the definition of verification procedures. For the food industry, physical, chemical, and biological analyses become an important ally in monitoring safety and quality parameters of used ingredients and finished products. Thus, results found can quickly facilitate the process of adopting corrective actions, and statistical standards can improve predictability and trend identification.

Laboratory information management platforms allow you to have technical control records registered, such as analyses and equipment used, and by linking them to analyzed items, quickly create analysis plans and procedures that automate laboratory activities upon sample receiving. This operational predictability enables more effective standardization within laboratory activities and makes it easier for technicians to begin activities.

In addition, each registered sample receives records with receiving and collection dates, product identification, necessary analyses already assigned, automatically detected criteria and critical limits (conformity standards), and structured analytical results/data. Thus, the control records making up the PACs become even simpler and easier to track.

3) Control records for samples received for laboratory analysis

One of the central points of management systems is enabling you to centralize information in a single location, providing better organization and enabling more effective data structuring. As we mentioned in the previous point, grouping the specific analysis plan allows you to have initial standardization and automation of which analyses will be performed for each received item. For example, you can create an Analytical Procedure for Cereals and Flours, already assigning Ash 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.

In this way, when you register your raw material or finished product samples, the identification records of the analyzed item, requester, supplier, receiving, collection, and analysis start dates are automatically recorded. Additionally, as the analytical process develops, evaluation and approval dates are also included in the record, along with the laboratory technician and approval responsible party identifiers.

Another important point in this initial automation of records for each sample received at the laboratory is creating a label that helps organize received items. Thus, each sample receives a specific QR Code that allows you to quickly know the code assigned to it, the lot that was produced, and production/delivery information.

Additionally, when registering samples, you can indicate and monitor samples referring to specific lots of inputs and/or finished products, thus providing the necessary information to quickly see the information relating to each one. For each registered lot, you can filter and check product release records, performed test details, the technician who performed the test, and who approved the sample. Attempting to obtain the same level of information using paper records can be very time-consuming and hamper the inspection process.

4) Issuing test reports for submission to inspection platforms

Software like Labinfy also automates the creation of Test Reports and Certificates of Analysis, after the correct approval and validation of results found in the analyses performed for each sample. 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 with them — so after they approve or reject a sample's results, the Test Report will be generated already correctly positioning the user's signature at the end of the results page. This approach will facilitate the process for later uploading to official platforms and signing electronically with digital certificates — thus ensuring greater transparency and integrity of documents generated in the laboratory from the tests performed.

5) Creating users with different access permissions

LIMS platforms were created to promote within the company a culture that places quality as one of the key strategies for promoting productivity, competitiveness, and results. This approach allows you to create different users within your company and assign differentiated access permissions for each function: laboratory technicians for analytical result recording, procurement for supplier qualification, nutritionists for nutritional variability monitoring, production for indicator monitoring, administrative for cost verification, among other possibilities.

The Bill we discussed earlier (PL 1293/21) includes, as one of its chapters, a description of the Compliance Incentive Program in Agricultural Defense. Article 10 states that the program aims "to encourage the improvement of robust, auditable quality assurance systems, with a view to consolidating an environment of mutual trust between the federal Executive Branch and regulated entities, through increased transparency." It further states that companies that join the program must share operational and quality data in real time with agricultural inspection authorities in exchange for benefits and incentives.

We know that quality management programs involve dozens of documents and different non-conformity control records, verification procedures, and corrective actions. We also saw that many of these items can be recorded through laboratory information management software that facilitates records of analyses performed, obtained results, and values outside the company's defined conformity standards.

With the digitization of these records and laboratory activities, the company can create a user external to the organization, assigning them an Inspection/Audit role, with monitoring permission for specific requesters and organizational units. This privileged system access, without the ability to change data but allowing quick identification of registered data and justifications/observations, enables digital files to be quickly consulted by external users. It is worth noting that this type of alternative is defined according to the company's own access, data sharing, and security policies, and it is solely the company's prerogative to define this type of special permission.

6) Save time to focus on what really matters: the quality of food used and/or produced

By automating workflows and digitizing self-control routines, with standardized and pre-associated analytical procedures, you can complete tasks more quickly: sample creation, analysis recording, control statistics, validation parameters, certificate issuance, among many other tasks for which you can create automated tasks, eliminating rework and the manual need to record found results.

Reports indicate that inefficient workflows can cost up to 30% of company revenue, impacting not only operational productivity but also financial results. Routine automation is one alternative to help avoid this inefficiency. By creating execution standards that already relate the entire laboratory environment and the registered control and maintenance records, you can obtain valuable information that you could not quickly obtain with manual tasks — the greater the amount of high-quality data, the greater the chance of 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 production processes by acting on the training and awareness of all. This approach allows the company to focus on efficiency and use the best of each monitored requirement or parameter to improve organizational management and the results (both productive and financial) it achieves.

By acting in depth on problems and causes, collaboratively involving the entire organization, describing safety parameters and processes clearly and completely, self-control programs are essential for the industry to have increasingly quality and safe products and inputs. And laboratory information management systems will be important instruments for standardizing these processes, bringing greater predictability to events, and ensuring better monitoring of conformity standards and control elements defined by the company.

MAPA's new approaches and the trend toward digitizing inspection documents are a milestone for the sector. They will certainly bring even more productivity and competitiveness to food companies, in addition to enabling less costly and faster processes. If your company wants to anticipate the digitization of documents and test reports/certificates, Labinfy is a great ally.