Nonconforming product investigating

Nonconforming product investigation rework records include investigation/corrective action (no blends to reduce adulterants unless CBER approved reduction method) no microbial positive rework complaints, recalls, errors, and accidents adverse experience reports all tracked and reported as required (Identity-610.14 purity-610.13). 

In informing your customer when nonconforming product has been shipped you obviously need to do this immediately you are certain that there is a nonconformity. If you are investigating a suspect nonconformity it only becomes a matter for reporting to your customer when the nonconformity remains suspect after you have concluded your investigations. Alerting your customer every time you think there is a problem will destroy confidence in your organization. Customers appreciate zeal but not paranoid personnel ... 

How do you ensure that the cause of nonconforming product is investigated ... 

Investigating the cause of nonconforming product and the corrective action needed to prevent recurrence... 

Any raw material, intermediate or finished excipient found not to meet specifications must be clearly identified and segregated to prevent inadvertent use or release for sale. A record of nonconforming product should be maintained. All incidence of nonconformance should be investigated to identify the root cause. This investigation should be documented and correction made to prevent recurrence of the problem. 

Customer Complaints. A failure in a company s quaUty system often shows up in the form of a customer complaint. These reports of nonconformances, whether for product or service deficiencies, are typically received by the sales or customer service organization and then channeled to QA. Quahty assurance often tracks the progress and coordinates the complaint investigation. Once completed, it is QA that reviews the report of the investigation and corrective action for thoroughness and efficacy. QuaUty assurance then either passes the information along to the sales or customer service organization or contacts the customer direcdy. 

The reports of nonconformities could be internal or external reports of nonconformities although the standard does not make this clear. Internal reports of nonconformities should be covered by the requirements of clause 4.13. The next requirement concerning the investigation of nonconformities does relate to both internal and external reports. An external nonconformity report is not necessarily a customer complaint. The customer may have merely returned the product claiming it to be defective. When the customer has done this several times a complaint may well follow. 

The standard requires the supplier to investigate the cause of nonconformities relating to product, process, and quality system and record the results of the investigation. The supplementary requirements require the supplier to use problem-solving methods when an internal or external nonconformity occurs. 

Your corrective action procedures need to cover the collection and analysis of product nonconformity reports and the collection and analysis of process data to reveal process nonconformities. The corrective action provisions of your internal audit procedure need to address the causes of the nonconformities and you will need an additional procedure to deal with external audits, investigating the cause of any nonconformities and recording the results. The procedure also needs to cover the investigation of customer complaints as the previous requirement only deals with the handling of complaints. 

Corrective and preventive action (CAPA) is the term commonly used to describe the subsystem of a comprehensive quality system that deals with the systematic investigation, understanding, and response to quality issues including nonconformities. A corrective or preventive action may be initiated based on review and analysis of quality data from a variety of sources including adverse experiences, product complaints, quality audits, FDA inspections, third-party inspections, nonconforming materials reports, process control information, trend analyses, and other sources. 

A nonconformance investigation should be conducted when a product quality-critical instrument is found out of calibration or fails a recalibration. The investigation process shonld include the following steps ... 

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