10.2: Part I- Review Terms and Background Information

Introduction

In everyday speech, quality is a relative attribute like beauty.  However, in the Life Sciences or any other manufacturing-related industry quality means compliance to specifications.  Quality systems are comprised of the policies, processes, and procedures for maintaining a product with specifications.   

This lab exercise will utilize the manufacturing of a popcorn snack as an example where good manufacturing practices (GMPs) can be followed. The exercise used the components of a Quality System. Students are the employees with tasks to accomplish within the defined QA/QC parameters.

Quality Management Systems (QMS)

Quality is the business of the entire company.

Figure 20.1. Relationship between the Quality System, Quality Assurance, and Quality Control

Generally, companies build their quality systems by first making a commitment by management to design and deliver a ‘quality’ product.  The term quality management system refers to the organizational resources, processes and procedures to implement quality management.  In the case of pharmaceuticals, diagnostics and medical devices, these requirements mean the product is EXACTLY what was tested in clinical trials.  

Quality product management is usually implemented through two departments; quality assurance (QA) and quality control (QC).   The QA department plans activities and develops the processes that guarantee the accuracy and precision of outputs.   QC performs the actual tests during the process and on the final product to ensure that specifications are met. Quality Assurance is process oriented and focuses on defect prevention, while quality control is product oriented and focuses on defect identification.    QC refers to a measuring process, or to check a result and provide assurance that all activities are performing within predetermined limits.

Often, QMS systems are explained in this simple statement.  

“Say what you do, do what you way, document It.”
 

SAY WHAT YOU DO = SOPs

Standard Operating Procedures (SOPs) and documentation are essential components of a QA program. The management team is responsible for ensuring adherence to the QA plan and SOPs. Essential to this process is documentation of the proposed quality system and processes used by the company.   

Perhaps the most important form of documentation is SOPs.  SOPs are validated methods that are at the technical core of the product or service. To determine whether methods are fit for their intended purpose, the selected methods must have established accuracy, precision, calibration and limits of detection and quantification.  All methods must be fully validated for accuracy and precision before a company starts to sell its product or service.

DO WHAT YOU SAY = Follow the Process (SOPs)

Quality systems are implemented in many sectors of the life sciences industry including manufacturing, a testing laboratory, clinical trials or even Research and Development.  In all cases the SOPs must be followed.  In the example of a manufactured product, all manufacturing employees follow the defined process and document that they have done so.  The QC department provides the process checks and balances.  For example, they manage the acceptance and release of raw materials, in–process checks and testing of the final product.  

DOCUMENT IT = Evidence of Quality 

If you didn’t write it down = you didn’t do it!

No documentation = no PROOF you did it!

No documentation = BAD product and lost money for your company

Current Good Manufacturing Practices (cGMPs)

The general principles that all QMS have in common are:

1. Quality, safety, and effectiveness must be designed and built into the product, not tested or inspected into the product Say what you do
2. Each step in the manufacturing process must be documented and controlled to ensure the finished product meets design and regulatory specifications Do what you say
3. Process documentation provides evidence of compliance with cGMPs Document it

Statistical Process Control 

Another aspect of a Quality program uses statistical process control (SPC), which utilizes statistical methods to evaluate variability in procedures.  In the design of the product, multiple data sets are obtained to establish accuracy and precision criteria.  These criteria are documented in the Master Record.   QC testing procedures ensure SPC through instrument calibration and validation, in process testing, final product testing, raw material testing etc.  They use process control charts to monitor the process and procedures in order to manage variability.

The purpose of the Quality systems is to ensure quality.  Since quality is defined as compliance to specifications, there must be set in place a ‘statistical process control (SPC) to ensure this compliance.  The SPC requires understanding of both the accuracy and precision required in the product. 

Accuracy is the ’right answer’ or ‘bulls-eye.  Accuracy is not always known but when it is, it is part of the process.   Precision is reproducibility.  Whatever the process or procedure, the quality system is there to ensure reproducibility.

Corrective and Preventative Actions (CAPA)

The purpose of the CAPA system is to serve as a feedback loop to identify and investigate all quality problems.  CAPA policies are central to quality system. Part of the QC testing that takes place on every lot of product, is to assure compliance to specifications.  If the specifications are not met, it is important to determine what is the root cause of the problem.  Until the root cause is used to identify the cause of problems with accuracy and precision, product quality cannot be assured.  

Figure 20.2. Accuracy and Precision