Can make 4 criticisms of the policy statement given earlier -
1. I don't like the use of a combined Va / Ve statement. The two aspects have been de facto separated in the 22004 "revision". Not precisely incorrect, just confusing IMO.
2. The quote below is inadequate IMO for a policy statement (= meaningless). (But no doubt politically acceptable of course .)
3. The word "calibration" nowhere appears in the policy statement. IMEX, this is a universal expectation and particularly in view of the standard itself.
4.The words "internal audit" nowhere appear in the policy statement. IMEX, this is a universal expectation and particularly in view of the standard itself.
@D-D. Frankly i'm amazed that you audited successfully without a validation section or the equivalent. (or perhaps you haven't reached that step yet - I was not clear? )
Rgds / Charles.C
Actually it’s a combined validation, verification, corrective action, and internal audit. The actual title is “
CORRECTIVE ACTION AND PROCESS VALIDATION AND VERIFICATION.”
You were right that “calibration” was not mentioned but I “internal audit” was mentioned. Below is the whole policy statement.
Corrections and corrective actions are taken to eliminate the cause of non-conformities in order to prevent recurrence according to Correction & Corrective Action Procedure.
Determining and implementing of corrective action includes the following stages:
· Reviewing nonconformities
· Determining the causes of nonconformities
· Evaluating the need for action to ensure that nonconformities do not recur
· Determining and implementing action needed
· Records of the results actions taken
· Reviewing corrective action taken
The Company has ensures that the hazards identified are complete and correct and they will effectively be controlled under the proposed plan through validation process prior to implementation of
HACCP Plan.
Validation is performed by demonstrating that:
· The established list of potential hazards is based on sound scientific data and has included all hazards;
· The questions to assess the significance are answered using sound scientific and technical knowledge;
· The control measures (general & specific) are appropriate to control the hazards
· Fluctuation of control parameters (equivalent to a process criterion) within the defined critical limits will not affect the safety of the product;
· The parameters and methods used to monitor the control measures are appropriate;
· Correction and corrective actions are appropriate and shall prevent the release of unsafe products and provide evidence that the situation can be corrected immediately.
The Company ensures that verification of the
HACCP system, to determine compliance with the specifications of the
HACCP system and to confirm that the
HACCP system is working effectively through the application of (auditing) methods, procedures, test (including random sampling and analysis) and other evaluation, in addition to monitoring.
The verification process shall address, as appropriate, the following topics:
· Review the
HACCP system and its corresponding records;
· Analysis of (near) recalls and product disposition;
· Assessment of all specific control measures, nonconformities and corrective actions taken to seek confirmation of implementation and effective control of
CCP’s;
· Compliance of the actual flow diagrams and layout with the documented situation;
· Compliance of the PRP documents with operational situation;
· Analysis of customer and consumer complaints related to hygiene and food safety;
· Review of analytical outcome of random sampling and analysis of product;
· Evaluation of conformity with applicable legislation and regulations and identification changes legislation and regulations concerning food safety;
· Review of gaps between current and desired level of knowledge, awareness and training staff with respect to hygiene and food safety, resulting in effective (on-the-job) training session;
· Consistency of the current documentation.
The Company planned an internal audit scheme taking into consideration the status and importance of the processes and areas to be audited, as well as the result of the previous audits. The audit criteria, scope, frequency and methods are defined. The responsibilities and requirements for planning and conducting audits, for reporting results and maintaining records are defined in a documented procedure.
The Company reviews & evaluates the results of the verification process at planned interval of at least every 6 months to ensure continuing suitability, adequacy and effectiveness of the
HACCP-based
Food Safety System.