Process deviations complaints

Customer complaints Warranty claims Failure analysis reports Process capability studies Service reports Concessions Change requests Subcontractor assessments Performance analysis Deviations and waivers Contract change records Quality cost data External Quality Audit records... 

Tweeddale (Tweeddale, 1995) identified two general sorts of deviations, i.e. hard and soft deviations. He identifies hard deviations as malfunctioning equipment, and soft deviations as faults in the system or procedures. In this thesis these definitions are slightly modified to cover all deviations identified in the operational process preceding and directly related with an accident. Hard deviations are defined as the actual loss of containment or demonstrable loss of control, e.g. small leakages, overpressure, override of control systems, etc. Soft deviations refer to indications of possible deviations, but cannot be demonstrated by actual facts, e.g. operator complaints, deficiencies of maintenance activities, or bad housekeeping activities, etc. 

Develop a metrics system allowing for quantifiable results wherever possible for example, use statistical process control charts for manufacturing processes and correlating manufacturing deviations with consumer complaint trends. 

Complaints related to the quality of the product should also be evaluated. Complaint trends should be reviewed for evidence that recurring problems have been adequately resolved. The complaint trends should be examined for any correlation to the other quality systems. For example, any correlation between complaints and deviations related to the same lot or product line or any-increase (or lack of a decrease) in complaints after a corrective action has been made should be revealed and addressed during the APR process. 

A review of process changes, stability data/protocois, complaints, recalls, returned or salvaged APIs, and deviation investigations conducted for the API being evaluated. 

The Quality Management department is expected to carry out regular target-performance comparisons of specifications and requirements, document the evaluations, and provide management with information on the results. For all possible discrepancies from the desired state, for example, complaints, results out of specification (OOS), changes, deviations, and audit results (internal and external audits), the appendant information are collected centrally and processed by means of the Corrective And Preventive Action (CAPA) system. These monitoring and control functions are performed by the staff of quality management. 

A risk assessment can be performed retrospectively or prospectively. If an adverse event - whether a complaint, a deviation or adverse effect - happens it will be analysed retrospectively. Staff will be convinced about the necessity for any action. When staff do not report incidents however or do not qualify them as important the improvement process may be missed. For risk assessment a blame-free culture in the organisation is very important. 

The use of deviations, errors, complaints, changes, audit results and periodic evaluation or re-validation of preparation processes for continuous optimisation of the production process or the necessary conditions or both (see also Sect. 35.6)... 

Automated systems Process validation of unit-operations Cleaning methods Analytical methods Furthermore it must be assured that relevant documentation is up to date and available. If data from Product Quality Review (PQR, see Sect. 35.6.11) and stability testing are available they should be evaluated in order to identify any critical aspect of the processes. If not available related quality indicators, such as test results, deviations and complaints should be evaluated. 

Trend analyses Stability monitoring Retrospective validation Supply chain traceability of active substances Critical in-process controls and finished product results Deviations or non-conformities and the effectiveness of the subsequent corrective and preventive actions Quality-related returns, complaints and recalls Qualification status of relevant equipment and utilities, e.g. HVAC, water, compressed gases, etc. 

Non-conformity means that a requirement is not fulfilled. Non-conformities can occur related to any of the quality characteristics and its related quality objectives. Non-conformities may refer to defects, mistakes and errors in processes, violations and deviations of regulations or procedures, problems with equipment, customer complaints, etcetera. Near misses, incidents and adverse events in clinical or occupational health context can be treated as non-conformities concerning patient or employee safety. 

---