Information & Training. | Quality Assurance. Quality Management.

Manufacturing Validation and Quality Management.

Validation as a means to assure capability, quality and the achievement of customer expectations.
Validation can be applied as an approach to assure an appropriate performance capability exists throughout the manufacturing supply chain and within the manufacturing organization itself. A validation program normally begins with a stated objective which may be outlined in the quality manual, that “all critical processes will be validated”. This then leads to an overall validation procedure, which outlines how validation will be performed, the products and services to be covered by the validation program, etc.. Within a validation program there will be stated expectations in terms of the level of performance required from process equipment, inspection and analytical processes, utilities, manual processes, etc.. The validation program will confirm that the performance capabilities required to ultimately deliver on customer expectations, can be achieved by each individual process and via the total process.

Manufacturing Validation

“Product and Process Validation” information & training presentation. o

Clearly, the standards of performance defined up-front in the validation acceptance criteria will determine the overall manufacturing process performance, however, where current capability does not meet customer needs, then the validation efforts will expose any such gaps. Where a gap is identified, then a focus can be placed on improving the operation of the process in order to achieve the validation acceptance criteria which will have been set to ensure the achievement of end customer expectations.

Quality Management without Validation?
A quality management system can be established and operated without a validation program, however, in such a situation a valuable methodology for identifying process capability and reliability against output specifications and expectations is not being utilized. Validation of all performance characteristics which can impact the customer experience should be routinely implemented, with pre-requisite levels of performance demanded from all components of the supply chain through to final customer delivery.
Product and Process Validation Full Details

Information & Training.

Product and Process Validation.

  • The Validation Master Plan. Performing a Gap Analysis. Validation in the Design Process. Etc..
  • How to ensure Validation efforts are aligned with potential Risks.
  • How to ensure that Validation activity is appropriately documented, reviewed and aligned with requirements.
  • Information & Training presentation   >>>

Information & Training. | Quality Assurance. Quality Management.

        • The Principles of Quality Management
        • The Quality Manual
        • Quality Standards and Specifications  
        • The Quality Management System
        • Quality Management Training
        • Product and Process Validation  
        • Supplier Quality Assurance
        • Audits & Auditing
        • Ensuring the Quality Management System is Risk based
        • Etc. …. Etc. …. Etc. …
        • Information & Training presentation   >>>