Registos – Implementação

O segundo tipo de registos são registos de implementação. Os registos de implementação demonstram que o sistema de segurança alimentar está a funcionar como planeado. Fornecem provas de que as actividades foram concluídas e são eficazes.

Os registos de implementação incluem os dados operacionais das actividades; esta informação foi recolhida durante a produção real, e fornece a prova de que está a fornecer alimentos seguros aos seus clientes. Os formulários de exemplo são mostrados aqui e podem ser descarregados do Apêndice, ou pode utilizar os seus próprios para captar os resultados da monitorização, acções correctivas, e outras actividades, tais como:

• Dados de monitorização de controlo preventivo
• Acções correctivas tomadas
• Actividades de verificação
• Implementação do programa da cadeia de suprimentos
• Formação

Os registos de implementação podem ser listados numa coluna “Registos” no formulário de Controlo Preventivo do Processo.

Verification of Process Preventive Control for aflatoxin

PROCESS PREVENTIVE CONTROLS
PRODUCT:							PAGE 1 of ___________
FACILITY:							ISSUE DATE:
ADDRESS:
Process Control	Hazard(s)	Critical Limits	Monitoring				Corrective Action	Verification	Records
			What	How	Frequency	Who
Roasting	Non-sporeforming pathogens such as Salmonella	Minimum roasting time: 25 minutes	Length of roast cycle	Measure time-in to time-out with stop watch and metal test unit run through oven	Beginning of shift and after any adjustment	Roaster operator	If roasting is interrupted, product is held and evaluated to determine if it can be reprocessed. If a processing parameter was not met, reprocess batch using alternate validated process; identify root cause and determine actions needed to address it; conduct training as needed to prevent recurrence. Also, segregate and evaluate product, rework or discard as appropriate.	Operator verifies the roaster bed depth, temperature and roasting time are accurate and operating properly during the processing run once each day during morning shift. QA manager reviews and initials records within a week of preparation and compares performance with past results to determine trends. Maintenance manager ensures that roster and monitoring equipment are calibrated. Finished product tested for Enterobacteriaceae once every 2 weeks. Salmonella is analyzed if hygiene Enterobacteriaceae counts are found to be out of specification.	Roasting log, including time, temperature and depth records. Recording device calibration records Corrective action logs Validation study establishing roasting parameters
		Bed depth ≤2 inches	Bed depth leveling bar height	Leveling bar height is set at 2 inches high at oven inlet	Check at startup and end of day
		Oven temperature ≥300 degrees F. Note: to achieve 5 log reduction of Salmonella	Oven air temperature	Recording thermometer at the coldest locations (i.e., inlet and outlet of oven)	Continuous with visual check of recorded data at startup and once per day at each location

FSPCA, (2016). PC Course Instructor Guide V1.2, page 17.

A informação básica que deve constar de todos os registos inclui:

• Nome do registo
• Nome e localização da instalação
• Data e hora, quando aplicável
• Medição ou observação
• Identificação do produto
• Assinatura ou iniciais das pessoas que efectuam a monitorização
• Assinatura ou iniciais da pessoa que está a rever o registo

Os registos de monitorização são utilizados para documentar que os riscos de segurança alimentar foram controlados.

Registos de monitorização

ALLERGEN LABEL CHECK MONITORING LOG
COMPANY OR FACILITY NAME:				FACILITY LOCATION:
PRODUCT:
Parameters: All finished product labels must declare the allergens present in the formula
Date	Time	Lot Code	Lot Number	Proper Label Applied		Line operator (initials)
				Yes	No
[ Example ]
	[ Example ]
		[ Example ]
Verification Reviewer Signature:				Date of Review:
Date issued:				Supersedes issue:

DAILY COOKER MONITORING LOG
COMPANY OR FACILITY NAME:				FACILITY LOCATION:
PRODUCT:
Date	Time	Lot Code	Lot Number	Proper Label Applied		Line operator (initials)
				Yes	No
[ Example ]
	[ Example ]
		[ Example ]
Verification Reviewer Signature:				Date of Review:
Date issued:				Supersedes issue:

Registos de Acção Correctiva

As informações que devem constar de um registo de acções correctivas incluem:

• Identificação do produto
• Volume em espera
• Descrição do desvio
• Medidas tomadas para prevenir a recorrência
• Disposição final do produto
• Avaliação dos resultados dos testes, se relevante
• Verificação das acções correctivas

CORRECTIVE ACTION
Date of Record: 6 February 2016		Lot Number: AY123
Description of Deviation: Labels for Product A were applied to Product B because the operator selected the wrong stack of labels. The issue was discovered by the operator loading packages into cases.
Actions taken to restore order to the process: 1. Production was halted when error was discovered. 2. Product was segregated back to the last good check. 3. Product was relabeled with the correct label. 4. Line operator was retrained on how to check the label before placing a new stack on the line and the importance of doing so. The procedure was emphasized with all operators as a teachable moment.
Person taking action: Mr. P.K. Lead
Amount of product involved in deviation: 50 cases
Evaluation of product involved with deviation: All relabeled product was double checked to ensure that the correct label was in place.
Final disposition of product: Released
Reviewed by: Ms. Sandy Lane	Sandy Lane		Date: 20 February 2015

Registos de verificação

Os registos de verificação devem incluir:

• Verificação de registos de monitorização e de acções correctivas
• Calibração e verificações de precisão dos instrumentos de monitorização de processos
• Teste de produtos
• Monitorização ambiental
• Verificação do programa da cadeia de suprimentos
• Reanálise

QUARTERLY THERMOMETER CALIBRATION LOG
COMPANY OR FACILITY NAME:			FACILITY LOCATION:
PRODUCT:
Verification: Check each thermometer quarterly against a thermometer traced to a recognized standard. Temperature must be +/- ___ degrees from the standard.
Date of calibration	Instrument number(s)	Method of calibration	Calibration results	Within specification		Line operator initials
				Yes	No
[ Example ]
	[ Example ]
		[ Example ]
Reviewer signature:				Date of Review:
Date issued:				Supersedes:

Registos de Validação

Exemplos de Registos de Validação podem ser:

• Registos de validação do processo
• Estudos in-plant
• Estudos de investigação
• Artigos de periódicos
• Orientação industrial ou regulamentar