Process control risk assessment

The requirements

Process control risk assessment

A process control risk assessment must be used to establish any possible defects that may occur at each step in the process.

Product safety will have already been considered with the product safety plan (see topic 5), therefore this process control risk assessment must consider quality and legality.

A hazard is used for product safety. A defect is similar but used for quality – not safety.

Defects to be considered during the process control risk assessment should include:

• Raw materials defects.
• Work in progress defects.
• Product quality defects.
• Defects caused by uncontrolled application of rework.
• Printing defects.
• Functional integrity defects.
• Product performance defects.
• Customer processing defects.
• Legal defects, such as composition and quantity.
• Any materials that are outside the scope of the certification audit, which may impact the material within the scope of the audit (for example bi-products).

Process control

Procedures must be in place to ensure that the processing of product is consistently safe, legal and to the specified quality.

Process control must be implemented to include:

• Product safety controls identified in the Product Safety Plan.
• Legal requirements.
• Quality attributes as defined by the specification.

Records must be in place during the process to ensure all product conforms to the product specification.

Frequency

Where there is a significant risk of loss of process control, in-line monitoring equipment must be considered.

The frequency of monitoring checks must reflect the likelihood of control being lost. As a minimum, checks must occur at start up, and following equipment adjustment.

Validation

Monitoring and acceptable limits must be established through validation. Validation must be carried out under worst case scenarios and must also take into consideration equipment inconsistencies. Where there are changes to the product, equipment or process that may affect quality control checks, the system must be revalidated.

Sampling

Samples used for monitoring must be suitably stored to prevent them from getting damaged or degraded.

Lighting in product inspection cabinets must conform to accepted industry standards and customer requirements.

Process specifications and the bill of materials

There must be process specifications in place which cover the processing of all products.

Process specifications must include details of:

• Bill of materials – including identification of any materials containing allergens.
• Acceptable rework.
• Equipment process settings.
• Processing instructions, including pack control.
• Storage requirements.
• Labelling.
• Any relevant CCP monitoring with critical limits.
• Quality control monitoring, including acceptable ranges.

The information on the process specifications must be aligned with the information on the finished product specifications.

Materials issued for use must be verified to ensure that they meet the bill of materials.

Work instructions and SOPs

Process control must be implemented through the use of work instructions, process specifications or bill of materials. Where there is a risk of loss of process control, work instructions for monitoring must be put in place, with acceptable limits.

Work instructions must be in place which detail:

• What process control checks are required.
• How to complete the checks.
• What acceptable limits must be achieved.
• What corrective action must be applied, where the acceptable limits are not met.
• How the checks must be recorded.
• The corrective action instructions, which must include:
  • Identification of all product processed since the last successful check.
  • Quarantine or reassessment of the product.
  • Who is authorised to determine what action should be taken and who can authorise release where the product doesn’t meet the acceptable limits.