Organization
A key component to quality in all industries is organization. Prior to starting any project, all variables must be identified. All items should reside in easily identifiable, labeled locations. Creating comprehensive lists of everything involved in the processes is simple if properly organized. Master Lists allow for organization and quick assessments, with easily referenced information for processes, equipment, or locations. A small amount of time spent integrating master lists into the quality program can save hundreds of man hours when writing procedures, validations, qualifications, and other tasks. The use of a change control system combined with master lists can ensure the completion of all activities when installing or updating equipment or processes.
Physical and Digital Organization
A search for a manual, a spare parts list, electrical schematics or any other document required should require less than 90 seconds for digital information, or less than 5 for a physical copy. Combining organization with master lists; quality audits, validations, qualifications, and regulatory compliance can be completed quickly and efficiently, allowing the company to save time and money in the future. Operating procedures governing processes should indicate the location items can be found. These would include protocols, reports, validations, equipment documentation, and technology transfer among others.
Assessment
To create comprehensive master lists, complicated manufacturing processes should be broken down into simpler tasks and assessed. A task is defined as causing a change in a product, by a single step or a series of steps.
Table 1: Task Examples
| Compounding | Manufacturing | Packaging |
| Ingredient Addition | CNC/Molding | Boxing |
| Agitation | Sandblasting/Polishing | Filling |
| Hold Time | Electroplating | Sealing |
| Weighing/Measuring | Passivation | Wrapping |
| Filtering | Adhesive/Welding | Labelling |
| Product Testing, Label Claims, Sterilization | ||
Each step shall be assessed to create lists for the following categories:
Materials
What materials are needed for this step?
Equipment
What equipment is used during this step?
Utilities
What utilities are needed for this step?
Location
Did the location change from the previous step of the process?
Product Parameter
What product parameters are created or changed during this step?
Procedure
What procedures are used during this step?
Personnel
Are there specific limitations for personnel during this process?
Regulatory/Compliance
Are there any regulations involved or affected in this process?
Safety
Are there any safety protocols involved in this process?
Materials [Validation, Quality Assurance, Quality Control]
Materials and equipment are listed before utilities and location as risks identified may affect the requirements of the facilities and utilities.
- Materials can be broken down into a few subsections. There are consumed primary ingredients/materials (Ingredients or materials for product), reusable materials (Hoses, clamps, etc.), peripheral materials (Materials for equipment, cleaning, personnel), and
- In addition to supplier qualification (not covered in this document), all incoming materials shall be subject to incoming inspection.
Assessment Questions:
Material toxicity or reactivity
Bioburden requirements
Incoming Inspection [Quality Control]
Incoming inspection varies with each material, determined by the critical parameters of the product and material involved.
- Supplier qualification may allow certain materials to be accepted with visual inspection and manufacturer certification.
- Products requiring reduced bioburden or sterilization may have a representative amount of the materials tested for allowable bioburden levels.
- Materials that are critical to the product or process may be tested for concentration levels, pH.
Assessment Questions:
Prep/Sterilization [Quality Control]
Do the materials require prep-work prior to production?
Does the process require sterilized materials/equipment?
Location [Validation, Quality Assurance, Quality Control]
Controlled Environment
Does the product require a controlled environment? In many cases, some steps may require a controlled environment, such as packaging activities, to ensure no contamination of the product. Other products may require all production steps to be controlled. QA/QC activities for the room may include visual and/or audible alarms for out of specification parameters, routine monitoring and documentation, and procedures for out of specification events or shut down/start up activities.
Room Qualification activities may include:
Exhaust or Air Changes (HEPA)
Temperature
Relative Humidity
Non-Viable Particles
Air and Surface Bioburden
Cleaning Validation
Equipment [Validation, Quality Assurance, Quality Control]
Equipment used for producing products should be qualified, see equipment validation for details on qualification activities. When assessing production steps, list all parameters required for the equipment to be used. These parameters may include speed, quantity or size, temperature, electrical charge, safety and security in addition to others. This list includes ancillary equipment, or equipment used within the main system, and auxiliary or peripheral equipment such as heating and cooling systems, material cleaning equipment, or ionizers.
Production Parameters [Validation, Quality Assurance, Quality Control]
Any change to a product during a step should be listed as a parameter change. Parameter changes should be assessed to determine the level of quality control prior to the product undergoing further processing. Parameter quality checks may include temperature, pH, size, sharpness, adhesion, or angles in addition to others. On assessment of the production step, all changes to the product should be listed.
Personnel [Quality]
Procedures or requirements for personnel performing the processes should be listed. These may include gowning instructions, lifting requirements, training certifications, personal protective equipment, or other limitations or requirements for employees both performing the process and those present in the location of the process.
Regulations/Compliance [Quality]
Regulations affecting process or product should be listed.
Environmental Monitoring
Environmental – Waste / Sewer / Chemical
Sterility
Quality Assurance / Quality Control
Governmental or Organizational Activities (Compliance)
Safety [Quality]
Safety requirements affecting personnel, process, or product should be listed.
PPE
Chemicals
SDS
Disposal
Procedures [Validation, Quality]
Procedures utilized during the production step should be listed. These procedures may include production steps, the use of equipment, cleaning procedures, or safety protocols in addition to other information.