QM: 8.5.2 Corrective Action, 8.5.3 Preventive Action

8.5.2	Corrective Action
8.5.3	Preventative Action

8.5.2 Corrective Action

The organization has a comprehensive corrective action plan. Corrective actions are taken to eliminate the cause of nonconformities in order to prevent recurrence according to corrective action procedure.

Inputs to the system include nonconforming products, customer complaints, audits (internal and external), change controls, supplier corrective actions and Quality System nonconformance or any other condition, which is adverse to quality or which has the potential for product/process involvement. Product or process failure is an indication that the process or system was not followed, or is inadequate. Any employee of the company can initiate a corrective action request.

Determining and implementing of corrective action includes the following stages:

Reviewing nonconformities (including customer complaint)

Determining the cause of non conformities

Evaluating the need for action to ensure that nonconformities do not recur

Determining if additional nonconforming product exists based on the nonconforming causes and the appropriate actions to take, if required

Determining and implementing action needed (it also included following down corrective action requirement to a supplier when it is determined that the supplier is responsible for nonconformity)

Records of results of action taken

Reviewing the effectiveness of corrective action taken and

Specific actions where timely and/or effective corrective actions are not achieved.

The results of the corrective action are summarized and trended to identify opportunities for improvement. This information is reviewed in management meetings.

8.5.3 Preventive action

Preventive actions are determined to eliminate the cause of potential nonconformities in order to prevent occurrence according to preventive action procedure.

Process mapping and risk assessment is considered an integral part of the preventive action system. In addition the need for preventive action is determined as the basis of information and data regarding capability and performance of processes, product nonconformity rates, customer complaints and quality system audit findings. Such information and data are collected and analyzed for unfavorable trends.

Preventive action is used to identify continual improvement opportunities and include the following:

Determining potential nonconformities and their causes (through process mapping and risk assessment or continuation of corrective action)

Evaluating the need for action to prevent occurrence of nonconformities

Determining and implementing action needed

Records of results of action taken; and

Reviewing effectiveness of the preventive action taken.

The results of preventive actions are reviewed for effectiveness and relevant information is presented at the management review meeting.

Though identification of Corrective and Preventive action follow different system, once the need is identified a common system is used to process both the actions. Forms, logs and other documents and records for processing of corrective and preventive action are same.  Corrective and Preventive action database includes: information related to the problem, the root causes, correction to the problem, corrective action taken, revision to documents and follow-up action to ensure effectiveness.

Note: Two separate documents can be adopted for addressing corrective action and preventive actions however the basic steps of implementation for both are same.

QM: 8.5 Improvement (Continual improvement)

Introduction:

There are different management strategies for improvement depending upon the type of product and process. Few examples of opportunities and implementation of improvement are listed below.

Opportunities of improvement identified through-

• Establishing the quality policy which is communicated and understood within the organization, this policy provides framework for quality objectives and is reviewed for continuing suitability
• Establishing and monitoring Quality objectives at relevant functions and levels within the organization which are measureable and consistent with the quality policy
• Inputs from employees, suppliers, and other interested parties
• Customer satisfaction and any other customer feedback
• Market research and analysis
• Internal and external audits of the quality system
• Records of product nonconformance
• Data from process and product characteristics and their trends
• Opportunities for improvement may also be identified on a special project basis. 

       The following are examples of such projects:

Non value-added use of floor space

Excessive inspection/ testing

Excessive handling and storage

Excessive failure quality costs

Machine set-up changeover times

Implementation of Improvements through-

• Corrective actions
• Preventive actions
• Change control
• Risk assessment
• Revision of quality policy and quality objective
• Improvement project (which may be initiate as a response to opportunities for improvement and in addition from lessons learned, problem resolutions, bench marking of best practices, management directives, announcements, memoranda, and so forth.

8.5	IMPROVEMENT
8.5.1	Continual Improvement

8.5     Improvement

8.5.1 Continual improvement

The company plans and manages the processes necessary for the continual improvement of the QMS. Causes of nonconformance are identified, investigated, and where appropriate, corrective actions are implemented to ensure there are no reoccurrences. Preventive actions are implemented to eliminate the cause of potential nonconformance.

Owner of each process is responsible for the continual improvement of the quality management system in his or her respective areas. Effectiveness of continual improvement activity is assessed during the management review.

The inputs for improvement opportunities are obtained from the following sources:

Establishing the quality policy which is communicated and understood within the organization, this policy provides framework for quality objectives and is reviewed for continuing suitability

Establishing and monitoring Quality objectives at relevant functions and levels within the organization which are measureable and consistent with the quality policy

Inputs from employees, suppliers, and other interested parties

Customer satisfaction and any other customer feedback

Market research and analysis

Internal and external audits of the quality system

Records of product nonconformance

Data from process and product characteristics and their trends.

Evaluation & prioritization of opportunities for improvement and there implementation is done at different levels. If national and regional regulations require notification, this is handled through change control procedure.

Opportunities for improvement from daily feedback on operational performance (i.e., disposition of nonconforming product, internal audits, customer complaints, etc) are evaluated by the Quality Department. Typically they are implemented through corrective and preventive action system.

Opportunities for improvement from analysis of longer-term data and trends are evaluated and implemented through the management review process. They are prioritized with respect to their relevance for achieving quality objective. When opportunities for improvement are no longer supported by the current policy and objective, management will establish new quality objective, and review the quality policy. Long term improvement projects are initiated through the management review process, as well as the corrective and preventive action system.

Product improvement opportunities are evaluated by marketing, quality and developmental groups with top management. They are implemented through change control system.

QM: 8.4 Analysis of Data

:

Introduction:

Effective data analysis is an essential part of the quality management system.

Entire Quality Management System will be inefficient if sources of data are not identified, data not collected, and analyzed to determine the suitability and effectiveness of the QMS and to evaluate where continual improvement can be implemented. Trend analysis ensures that the quality is built in rather than tested into the product.

8.4	ANALYSIS OF DATA

8.4 Analysis of Data

Determination, collection, and analysis of appropriate data is performed to demonstrate the suitability and effectiveness of the quality management system, and to evaluate where continual improvement of the quality management system can be made.

Data and information recorded in quality records are compiled and reviewed periodically to determine trends in the performance and effectiveness of the quality system and to identify the opportunities for improvement. Where appropriate, statistical techniques are utilized to monitor and improve product quality, process capability and market analysis.

Individual department is responsible for determining, collecting, evaluating and reviewing the information on an ongoing basis and presented to quality department for management review. Quality assurance is responsible for coordinating the activities, and for reporting conclusions and trends to the Management through management review meetings.

Information and source of information include:

Information for continual improvement (through Monitoring and measurement activities, audits)

Conformity to product and customer requirements (through nonconformance, customer feedback, customer complaints)

Characteristics and trends of processes and products (through Monitoring and measurement of product and process)

Characteristics and trends of environmental monitoring program (through Monitoring and measurement of controlled environments)

Corrective and preventive actions (through Non-conformance and reported deviations)

Supplier performance (through Inspection and testing of received products and services, delivery times)

Customer satisfaction (through customer complaints, customer feedback, customer recognitions and rewards)

Effectiveness of training (through monitoring and measurement of process and product, non conformance and reported deviations, audits).

The analysis of data provides information relating to characteristics and trends of processes and products including opportunities for preventive action.

QM: 8.3 Control of nonconforming products

http://www.emedco.com/non-conforming-material-message-tape-sawt24.html

Introduction:

In pharmaceutical quality management system number of terms are used which denote departure from specified requirements. The requirements can be product requirements (specifications) or process requirements (procedures). 

The terms used are:

Non-conformance (used for product and process)

Out of Specification (used for product)

Out of Trend (used for product and process)

Deviation (Incident, Planned Deviation and Unplanned Deviation) (used for process)

Change Control (Planned Change used as synonym for Planned Deviation) (used for process)

Discrepancy (used for process)

This clause deals with non fulfillment of the requirements of product and states that, ‘The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery’.

8.3	CONTROL OF NONCONFORMING PRODUCTS

8.3 Control of nonconforming products

In order to ensure that nonconforming products are not delivered/used unintentionally, these products are segregated from other products according to control of nonconforming product procedure. Controls, related responsibilities and authorities for dealing with nonconforming product and disposition of these products are also defined in the procedure.

Nonconforming product can be detected during inspection, testing or as a complaint. Any material or product that is suspected of being nonconforming is considered nonconforming until proven otherwise. Investigation of nonconformance depends upon the stage at which it is identified which leads to root cause identification followed by corrective and preventive action. Once nonconformity is identified an established procedure of handling of non conforming products addresses the following steps involved in the control of nonconforming product:

Identification and segregation: Non conforming product that originates form, inspection, testing, or customer complaint is identified, labeled and segregated, so as to prevent nonconforming material/product from being used or shipped. Re-inspection and re-verification of nonconforming product shall be carried out as per defined procedure. If required, customer is notified.

Documentation: Authorized personnel will document nonconformance which shall include lot number, description of nonconformance, and location of material. This information will be input into the CAPA followed.

Disposition: Authorized person in quality department evaluates nonconforming product in accordance with approved procedures and take one or more of the following actions:

a.    Rework (reprocess) the raw material or finished product to meet specified requirements

b.   Re-grade for an alternative application or product

c.    Seek customer concession for delivery ‘As Is’

d.   Issue a wavier

e.    Reject to vendor

f.     Dispose

Any product disposal will be in accordance with environmental controls to minimize impact on the environment.

Note: Nonconforming products can only be dispositioned as having the status of ‘as is’ if regulatory requirements are not violated and safety is not compromised. The criteria for release of the nonconforming product must be recorded along with the justification.

Reworking: Product requiring rework must be done in accordance with rework procedures or instructions. Rework operations are documented in written rework instructions that undergo same authorization and approval as the original work instructions. A determination of any adverse effect of rework upon the product shall be made and documented. Once the rework of a product is complete, it must be inspected and/or tested and records are maintained.

Product return and recalls: When product non conformity that is detected by the customer after delivery or use has started, nature and impact of nonconformance are reviewed and appropriate actions taken including product recall.

Records: Quality assurance performs tracking, trending and reporting of nonconforming product. Reports are used as inputs to management reviews and used to improve the process.

QM: 8.2.4 Monitoring and measurement of product

Introduction

In phrama/biopharma, product realization process is established through rigorous scientific experimentation, optimization, development, validation followed by regulatory review and approval, making them the only consumer product to follow this life cycle. Approved processes are used for production and any change to this state is controlled by change control procedure. Change which may potentially affects the quality, safety and efficacy of the product need to be approved by national regulatory authority before implementation.

Measuring and monitoring of product characteristics is an integral part of pharmaceutical/biopharmaceutical manufacturing process. The quality is not tested into product (by testing final product) but is built in a product through process control, control of starting material, intermediates and finished product. When all the stages of the production process/product meet the predefined requirements (specifications) the final product is accepted as a quality product and released by an authorized person. The production process is performed and controlled as per Standard Operating Procedures and inspection plans. Materials used in production are inspected, sampled and tested as per sampling and testing plan. Records of product realization are maintained in Batch Manufacturing Record and Analytical Reports.

8.2.4

Product Monitoring & Measurement

8.2.4 Monitoring and measurement of product

The company monitors and measures the characteristics of the product to verify that product requirements are fulfilled. This is carried out at appropriates stages of the product realization processes. The process of product realization is charted out in Drug Master File/Master Formulae Record these documents also defined the sampling and inspection points in a process. In-process testing is conducted at defined stages and finished product is tested to ensure it conforms to specification. When appropriate, statistically relevant inspection and sampling plan is utilized. 

Product testing can be divided into three stages:

    a.    Receiving inspections and Testing: All purchased products are subjected to a visual inspection by the receiving staff. Materials used in processing or as part of the product or packaging (RM/PM) is released for use after the samples have been successfully inspected against predefined specifications. Release of materials prior to verification is neither allowed nor practiced. No material is released prior to being verified per requirements and specifications.

    b.   In-process inspection and Testing: In process inspection and testing for manufactured products are in accordance with the prescribed Standard Operating Procedure, inspection and testing plan, Master Formulae Record and specifications. These procedures specify the acceptance criteria, and action to be taken if non-conformity occurs. Where subjective criteria are referenced, the final decision is made by Quality Department. In process inspections and monitoring can also be performed using automated equipments and instruments or statistical process control wherever applicable. Where such methods are used acceptance criteria shall be defined and approved. This stage focus on defect prevention rather than detection.

    c.    Final Inspection and testing: Finished product is subjected to final Quality inspection. Final inspection and testing is performed in accordance to sampling plan and test specifications following approved procedures. These procedures specify the acceptance criteria (which shall include the criteria for validity of test and acceptance limit) and action to be taken if the product fails. Where subjective criteria are referenced, the final decision is made by Quality Department.

Tests are performed by trained and qualified personnel and product is released (for next operation or for market) by authorized person after review of all the requirements.

    d.   Inspection and test records: Records that demonstrate inspection and test results are maintained in accordance with the appropriate procedures. Test results are recorded, reviewed and filed in Analytical Record File by batch number. Wherever applicable the certificate of analysis is prepared (COA). Records are maintained as evidence of conformity with the acceptance criteria. The records include the person(s) performing the inspections and tests and person(s) authorizing the release of the product.

The products are not released until all the required inspections and test have verified that it meets specification and the appropriate records have been generated. Non-conforming products are stored separately from other products.

Shipping of the product does not proceed until planned arrangements have been satisfactorily completed. The organization ensures that documents required by the contract or order to accompany the product are present at delivery and product is protected against loss and deterioration.

QM: 8.2.3 Monitoring and Measurement of processes

Introduction

The ISO standard states that, ‘The organization shall apply suitable methods for monitoring and, wherever applicable, measurement of quality management system processes’.

This can be achieved by setting quality objectives for a process which are consistent with the company’s Quality Policy and Quality Objectives. These objectives shall be “SMART” i.e. Specific for that process, Measureable, Achievable, Realistic and Time Bound.

ISO 9004:2009 highlights a Key Performance Indicator (KPI) approach. It states that, ‘Factors that are within the control of the organization and critical to its sustained success should be subject to performance measurement and identified as key performance indicators (KPI). The KPIs should be quantifiable and should enable the organization to set measurable objectives, identify, monitor and predict trends and take corrective, preventive and improvement actions when necessary.’

8.2.3

Process Monitoring & Measurement

8.2.3 Monitoring and measurement of processes

Monitoring and measurement of the processes is carried out with respect to Quality Objectives/ Key Performance Indicators at regular intervals using methods and criteria defined therein.

The processes are also monitored through:

Conducting audits of the quality system

Monitoring trends in corrective and preventive action requests

Analyzing product conformity and other quality performance data and trends,

Measuring and monitoring customer satisfaction.

When the quality system process does not confirm with requirements the Quality Department will:

         Take appropriate action to correct the nonconformance process,

         Evaluate whether the process nonconformity has resulted in product nonconformity,

Determine if the process non conformity is limited to a specific case or whether it could affect other processes or products,

Identify and control nonconforming product in accordance with set procedure,

Ensure implementation of corrective and preventive action.