DKIT QM T5 Quality Management Systems 2025_25cdf9c4a24607b40db3c10768d81602 (1)

Quality Management System (QMS) Documentation & Traceability

Basic Quality Management System (QMS)

  • ICH Q10 Pharmaceutical Quality System (PQS)

ISO 9001

  • One of the most widely used management tools globally.
  • Millions of organizations are independently certified.
  • ISO 9000 Standard:
    • A quality management document set by the International Standards Organisation (ISO).
    • Documents steps to implement a Quality Management System (QMS).
    • Helps organizations standardize their QMS.
    • Features a quality policy and systems linking business objectives, customer needs, and marketing plan.
  • Generic Standard:
    • Applicable to any organization, regardless of size or complexity.

Levels of the Basic Quality Management System

  • Level 4: Quality Manual
    • Describes Quality Policy & Quality Objectives
    • Defines Processes & Procedures needed to meet requirements
    • Identifies Key Performance Indicators (KPIs)
  • Level 3: Flowcharts & SOPs/WI
    • Defines and explains Business Processes
    • Documents the implementation & maintenance of the Quality Management System
    • Defines Who / What / When / Where and Why
  • Level 2: Processes & Procedures
    • Answers the “How To”
    • Detailed Activity/Work/Task Instructions
  • Level 1: Results & Analysis
    • Analyse Results e.g. Audits , CC’s, Recalls, KPI’s etc.
  • Audits:
    • Continuous Improvement
  • Records:
    • Quality KPIs, Specification & Standards, Applicable Standards & Regulations

Detailed Basic Quality Management System

  • Quality Manual:
    • References QMS requirements and Customer/Product specifications.
    • Includes Customer Reference Manuals, QMS Standard Requirements (e.g., ISO 9000:2000), Product Standard Requirements (Hygiene, Additives etc.), Product and Service performance specifications, Content Specifications (Weight, Qty, % Fat/Active Ing. etc.), Packaging Specifications, and Label & Traceability.
  • Flowcharts & SOP’s:
    • Describes i) Quality Policy & Quality Objectives, ii)Processes & Procedures needed to meet iii)Regulatory & Customer requirements, Identifies the iv) Key Performance Indicators (KPIs)
    • Defines and explains the i) Business Processes ii) Documents the implementation & maintenance of the Quality Management System (Define: Who / What / When / Where and Why)
    • Answers the “How To” (Detailed Activity/Work/Task Instructions)
  • Processes & Procedures:
    • ISO: 9000 QMS, ISO: 14000 EMS, ISO: 18000 HSMS, ISO : 13485 Med Devices, FDA: 21 CFR 820, GAMP/GHTF:QMS Validation, EFSIS/BRC/ HACCP cGMP
  • Results & Analysis:
    • Results determine how well the Quality Management System Is working
  • Audits:
    • Regulatory, Customer , Internal, Management Review Assessments
  • Records:
    • Continuous Improvement

Benefits of QMS Documentation

  1. Conform to Customers Requirements
  2. Conform to Regulatory and other Requirements
  3. Provides the necessary Objective Evidence
  4. Standardise & Repeat processes, procedures and policies i.e. Maintains consistent quality of products
  5. Provide adequate Traceability
  6. Provide appropriate Training
  7. Improve the efficiency/effectiveness of the QMS

Objective Evidence

  • Documented proof that a process or product conforms to specifications or standards.
  • "If it's not documented (Written Down), it didn't happen"
  • Includes:
    1. Provides records
    2. Includes Approved SOP’s
    3. Training Records
    4. Test Data and Results
    5. Calibration and Maintenance records
    6. Inspection Results i.e. Pass/Fail etc.
    7. Supplier Performance
    8. Statistical Process Control Data
    9. Records of sterility results
    10. Batch manufacturing records
    11. Cleaning records
    12. Analysis records
    13. Equipment usage records/logs
  • All records are signed/dated and comply with the QMS requirements.
  • All print outs of all the results and records (individual test results, the mean, the standard deviation etc.) are kept and attached to the batch documentation.

ALCOA Principle

  • A: Attributable – Need to record who/what performed the activity
  • L: Legible – Easily readable
  • C: Contemporaneous – Recorded in real-time
  • O: Original – Authentic documents – not copies
  • A: Accurate – Precise and Error-free

ALCOA+ Principle

  • Complete – All recorded data should have an audit trail to show nothing has been deleted or lost. There should be an audit trail capturing any changes made to the data.
  • Consistent – The data has a date and time stamp that is sequential. Changes made to an original data recording should be timestamped.
  • Enduring – Ensuring data is available long after it is recorded – decades in some situations. For digital recorded data putting in place tested data backup systems, disaster recovery plans and uninterruptable power supplies.
  • Available – Data should be properly indexed and labelled and the data must be available at any time during the retention period.

Standardize & Repeat

  • Using Standard Operating Procedures (SOPs) and work Instructions (WI).
  • Everyone follows the same procedure, ensuring consistent work to the same standard and steps.
  • Examples:
    • Approving a batch manufacturing record (BMR) in QA.
    • Performing calibration or maintenance by the maintenance department.
    • QC analysis such as content uniformity being performed to the same SOP.

Adequate Traceability

  • Everything involved in producing the product or service is documented and recorded.
  • Raw materials used or systems & equipment used.
  • Sampling and analysis that has been performed.
  • Checks that were performed e.g. hygiene, temperature, calibration etc.
  • Full traceability of the documentation, such as SOP updates and revision history.

Types & Examples of QMS Documentation

  1. Quality Manual
  2. Policy & Procedures e.g. Drug Development, Training, Traceability etc.
  3. Process Flowcharts e.g. Fermentation, Testing, Sterilisation, Cleaning etc.
  4. Standard Operating Procedures e.g. How to Setup and Operate equipment
  5. Specifications e.g. API’s, Binders, Fillers, Water, Clean Steam etc.
  6. Records: Objective Evidence: Test/Audit/Hygiene/Training records
  7. Key Performance Indicators (KPI’s): Recalls, Defects per Million (DPM) etc.

Components of a Quality Manual

  1. Quality Policy (Direction)
  2. Quality Objectives (Destination)
  3. The organisations Critical Quality Processes/Procedures i.e Validation
  4. KPI’s (Key Performance Indicators)
  5. Organisational Structure with respect to the Quality responsibilities
  6. Documents the Regulatory and Quality Standards (FDA 21 CFR Part 211, Eudralex & ICH Guidelines)

Quality Policy & Objectives

  • Quality Policy:
    • Provides direction to employees for long-term profitability and survival.
    • Framework for establishing and reviewing Quality Objectives.
    • Directs organizational resources.
  • Quality Objectives:
    • Measurable, achievable, and support the company's Quality Policy.
    • Positively impact Quality Policy.
    • Examples: Improving product/service quality, Operational effectiveness/efficiency, Customer Satisfaction, Profit, Survival

Quality Manual Information

  1. Quality Policy e.g., ZD, RFT, PY, PDCA etc.
  2. Quality Objectives e.g., To increase Right First Time & Quality by Design, To reduce i) Waste, ii) Complaints etc.
  3. Critical Quality Processes e.g., Testing, Auditing, Training, Validation, Traceability
  4. Key Quality Performance Indicators (KPI’s) e.g., No. of Customer Complaints, No. of Deviations/Non-conformances, No.of Audit Observations
  5. Quality Structure and Responsibilities, Quality Manager, Quality Technician and Individual Responsibilities
  6. Quality System Standards, e.g., ISO, cGMP, FDA, EMA etc.

Processes & Procedures

  • Describe activities to implement, maintain, and continuously improve product and service quality along with QMS.
  • Achieve Quality Objectives.

Key QMS Critical Processes/ Procedures

  1. Testing - raw materials, in process materials, finished product etc.
  2. Validation - machines/Equipment/Instrumentation, processes, utilities, materials etc.
  3. Training - methods, procedures (SOP), records etc.
  4. Auditing - internal audits, supplier audits, customer audits, Regulatory audits.
  5. Recalls - As per SOP and Regulatory Requirements
  6. Traceability - Method, production batch records, cleaning batch records, training records, etc.
  7. Nonconforming Material - Disposition status e.g. Pass/Fail
  8. Continuous Improvement - 7 Quality Improvement Tools, Quality Risk Management (QRM)`, Quality by Design (QbD)
  9. Analysis of Data - Trend Charts, SPC charts, Pareto’s etc.

Process, Procedure, Instructions & Flowcharts

  • Process: Activity or set of activities transforming inputs into outputs using resources.
  • Procedure: Method to perform a sequence of steps for complex or routine tasks consistently.
  • Instruction: Elemental piece of information; sequenced instructions form a procedure.
  • Flowchart: Describes or orders the sequential relationship between activities/tasks.

Documenting Key Critical Quality Processes

  • The Quality Manual formally documents an organizations QMS, how it operates, and the Key Critical Quality Processes involved.
  • To do this effectively the Quality Manual must also include or reference the relevant:
    1. Standard Operating Procedures (SOP)
    2. Flowcharts
  • These are used by the organization to ensure conformance to the standards requirements.

Standard Operating Procedures (SOPs)

  • The SOP is considered the work-horse of many businesses and is used to standardise the way trained individuals carry out a specific task or work instruction

Standardizing & Documenting the Manufacturing Process

  • For the Pharmaceutical Industry you need to Formally Standardise and Document the Manufacturing Process
  • So that the process activities can be performed over and over at the same level of consistency and quality i.e. STANDARDISATION.

Why Standardize & Document?

  1. GMP regulations require pharmaceutical manufacturers to maintain proper documentation and records.
  2. Ensures consistent and quality performance of process activities (standardization).
  3. Builds a detailed historical record for future planning.
  4. Regulatory inspectors review company's documents and records during inspections.
  5. Enhances visibility of the quality assurance system.
  6. Provides full product traceability.

Procedures Characteristics

  1. Intended for use by people.
  2. Prepared by Subject Matter Experts (SMEs).
  3. Standardize the process.
  4. Provide Step-by-step instructions for routine processes.
  5. Simple tasks done by many or a complex task done infrequently.
  6. Ensure a company adheres to Good Manufacturing Practices (GMP).

Factors Affecting Procedure Effectiveness

  • Procedures alone ignore factors such as a persons: ABILITY - MOTIVATION - TRAINING – ACCESS to RESOURCES
  • These are needed to do the job effectively and efficiently:
    • Ability is dependent on aptitude, training, experience etc.
    • Motivation is driven by culture, awareness, empowerment, reward etc.
    • Resources, people, materials, equipment, time etc.
  • All these factors need to be managed properly so as to sequence the tasks in the correct order needed to deliver the desired outcome.
  • Specifications, contracts, records are not procedures as they do not tell you how to do anything.

What is a Standard Operating Procedure?

  • SOPs are the workhorses of a company
  • While policies guide the way people make decisions, procedures show the "how to's" for completing a task or process.
  • Procedures are ACTION oriented. They outline steps to take, and the order in which they need to be taken.
  • They're often instructional, and are always used in training.
  • Well-written procedures are typically precise, factual, step by step and to the point.

Standard Operating Procedure (SOP)

  • An SOP details the way a person performs a sequence of steps or activities needed to perform complex tasks or needed to perform routine tasks consistently.
  • Procedures tell you how to proceed and are normally used by people. SOP is a document that clearly defines who does what, why, how and where.
  • For example - a set of DIY assembly instruction is an assembly procedure.
  • Another SOP example - How to Setup and Operate Equipment

Why use SOP’s?

  • So, everyone is following the same procedure.
  • So, every time the work is done it is done to the same standard.
  • So, every time the work is done it’s to the same list of steps being followed.

Why use an SOP?

  1. SOPs are used to make sure things are done without error or omissions.
  2. When people forget to follow certain steps, perhaps they keep on getting things wrong.
  3. To serve as a Training Document for teaching users about the process for which the SOP was written.
  4. When tasks are too long or too complex or infrequent that people need a checklist if they're going to get things right.
  5. SOPs are used to standardise a process. So, every time the work is completed, think consistency and removing Variability.
  6. SOPs are used to Streamline workflows and Improve efficiencies by minimizing errors.

When do you need an SOP?

  • You need to standardise the procedure when a task or process:
    1. Is non routine e.g., once a month and clean down of equipment
    2. Is complex, to help people do it right e.g., calibrating complex piece of lab equipment
    3. Is routine, but it's essential everyone follows strict rules e.g., changing gas bottles
    4. Demands consistency (i.e., standardisation) e.g., handling dangerous and toxic chemicals
    5. Involves documentation e.g., completing a Batch Manufacturing Record Review
    6. Involves significant change e.g., installing new software or computer hardware etc.
    7. Has serious consequences if done wrong e.g., Sterilisation
    8. Is simple, but everyone needs to do it the same way e.g,. using the CA Cover Sheet

Unwritten & Informal Procedures

  • In a company, many things get done without written procedures. There are "unwritten rules" and informal procedures.
  • But sometimes these unwritten rules need to be set in procedure.
  • This may need to happen when similar questions are asked repeatedly because people seem confused as there are too many ways that people interpret the procedure.
  • In the case of the Pharmaceuticals /Biopharmaceuticals all procedures should be formal Procedures.

What makes a Good Procedure

  • A good SOP has the following Characteristics:
    1. It is written clearly and simply.
    2. Must be easy to read i.e., set at the appropriate level.
    3. Is well researched and includes all requirements.
    4. Is accurate, brief and to the point.
    5. Continually reviewed, audited and updated.

SOPs are Controlled Documents

  • To validate an SOP, the SOP should be reviewed by someone who is unfamiliar with the process to ensure that they can follow all the tasks and understand each task.
  • SOPs are used to train employees.
  • SOP’s must be subject to rigorous change control and must be reviewed and updated to maintain its accuracy and currency.
  • At a minimum SOPs should be reviewed at a minimum every 3 years.

The Eight Step SOP Format

  1. Title of the Procedure
  2. Owner of the Procedure
  3. Health & Safety Requirements
  4. Hygiene Requirements
  5. List the Approved Materials
  6. List the Approved Equipment & Instrumentation
  7. List & Detail the Process Steps (Flowcharting can Help)
  8. List & Detail the Quality Checks & Records

The Eight Step SOP Format to designing a manufacturing SOP

  1. Title of the Procedure
    • Must reflect the task/activity
  2. Owner of the Procedure
    • Who has the responsibility/authority to initiate updates and changes
  3. Health & Safety Requirements
    • Material Safety Data Sheets, Protective clothing , training, storage conditions etc.
  4. Hygiene Requirements
    • Hand wash, jewelry, makeup, infectious disease etc.
  5. List the Approved Materials
    • Direct and Indirect materials e.g. API, labelling, packaging, etc.
  6. List the Approved Equipment & Instrumentation
    • Probes, thermocouples, gauges, test and processing equipment, machines etc.
  7. Process Steps
    • Formulations, Assembly, Packaging etc.
  8. Quality Checks & Records
    • calibration ,testing, specifications, acceptance criteria, audits, retention samples etc. Batch#, labeling, expiry dates, shelf life etc.

Control of Documents

  • ISO 9000 requires that an organisation must establish and maintain procedures to control documents.
  • These procedures must address the following:
    1. Approval of documents for adequacy prior to issue
    2. Review, re-approve and update as necessary
    3. Ensure correct Revision status is identified and maintained
    4. Relevant documents must be available at point of use
    5. Documents must be legible and identifiable (SOPS are given a title and specific number)
    6. Control the distribution of the procedure
    7. Control the obsolete procedure
  • Most QMS establish a Document Control role or function to maintain documents and records including change control, distribution and obsolescence.

Flow Charts

  • Helps to Visualise (picture) and Understand the process or situation
  • Flowcharts allow you to compare the actual process with the agreed or ideal process.

Process Flow Charting

  • The basic criterion from which any plant is designed is an understanding of the process, people and material flow through the area.
  • Process
  • People
  • Materials

Three Levels of Information

  • A process flow diagram is developed from direct knowledge of the product.
  • Normally complex manufacturing process will need three levels of flow diagrams.
    1. Macro: shows the key activities/tasks, excludes the decision steps.
    2. Intermediate: shows key activities/tasks and decision steps.
    3. Micro: shows the minute details and all decisions etc.
  • At a micro level the equipment, utilities, materials etc. needed are include or referenced in the flow diagram whereas the macro level will provide you with an overview of the entire wall to wall process.

Benefits and Application of Flowcharts

  1. Can be applied to any process, from design through to the installation of a product/service e.g. it can record the flow of materials to the way an organisation manufactures, packages and labels its products.
  2. Shows the sequencing of steps/activities, how they interact and relate to one another.
  3. Used to agree/record all the steps/activities required to produce the product.
  4. Allows you to compare the actual process used with the agreed or ideal process.
  5. Is used to identify/agree Critical Process Steps.
  6. Can facilitate Work Simplification i.e. Help identify a) unexpected complexity b) unnecessary loops c) duplication
  7. Is used to help find and eliminate problems.
  8. Be used as a powerful training /familiarisation aid.
  9. Is easier to understand than text.

Constructing a Flowchart: Formal Rules

  1. Scope the process and determine the Boundaries
  2. List the Steps in the process
  3. Arrange and Sequence the steps
  4. Draw the formal flowchart
  5. Review and Check the completed flowchart
  6. Test and Validate the flowchart, use people independent of the team

Constructing a Flowchart: Formal Rules - Expanded

  1. Scope the process and determine the Boundaries
    • Define the process to be studied, agree inputs and outputs
    • Agree level of detail needed, start macro then add detail
  2. List the discrete Steps in the process
    • Brainstorm a list of the major activities, inputs, outputs etc.
  3. Arrange and Sequence the steps
    • Order steps as they are carried out, use POST-ITS
    • Start with the current state, as is not the what you want or ideal state.
    • Don’t draw the connections/arrows yet
  4. Draw the formal flowchart
    • Add symbols
    • Add flow lines + arrows
    • Close loops
  5. Review & Check the completed flowchart,
    • Right symbols/flow/inputs etc.
  6. Test & Validate the flowchart using people independent of the team

Key Flow Chart Symbols

  • Different flow chart symbols have different meanings. The most common flow chart symbols are:
    • Terminator: An OVAL shape indicates the start or end of the process.
    • Process: A RECTANGULAR shape indicates a normal process flow step/activity.
    • Decision: A DIAMOND shape indicates a branch/decision in the process flow.
    • Data: A PARALLELOGRAM that indicates data for a process.
    • Connector: A small, labeled, flow line is used to indicate a jump or connection in the process flow.
    • An ARROW indicates the direction of flow
    • Document: used to indicate a DOCUMENT/SPECIFICATION/REPORT/SOP etc.

Intermediate Level of Flowcharting

  • Shows the key activities/tasks and Decision Steps
Intermediate Level Flowchart : TV Process
  1. Scope the Process and determine the Boundaries
    • Process Description: Turn on the television and acquire a Clear Picture to Watch
    • Boundaries: TV Picture Turn on TV Watch TV Start/End
  2. List the Steps (Activities/Tasks & Options/Decisions) e.g., call the repair man _e.g., plug in the TV _e.g., adjust the Controls _e.g., check Tv plugged in _is the TV plugged in?
  3. Arrange & Sequence the steps _ is the TV plugged in? _ check TV plugged in _ plug in the TV _ adjust the Controls _ call the repair man

Inspection SOP and Flowchart

The TRADITIONAL approach to Quality for detection started to evolve:
  • Detection SOP (Standard Operating Procedure) steps:
    1. Set up the equipment/machine
    2. Inspect or check the First Off
    3. If the First Off is OK then continue, otherwise reset the machine until OK
    4. Scrap, Rework, Re-grade failed product
    5. On completion, do 100% Visual Inspect to sort good from bad product
    6. Scrap, Rework, Re-grade failed product

Traceability

  • The top no. is the Product Identifier, Then the serial no. Then the expiry date Then the test performed Then the lot or batch no.
Lot Identification & Traceability:
  1. Global Standard for Healthcare GS1
  2. Need for Traceability
  3. ISO 9001 requirements
  4. Forwards & Backwards traceability
  5. Batch & Component traceability
What is Traceability?
  • Traceability in healthcare enables you to see the movement of prescription drugs or medical devices across the supply chain.
  • You can Trace Backwards to identify the history of the transfers and locations of a product, from the point of manufacture onwards.
  • And you can Track Forwards to see the intended route of the product towards the point of care.
  • Traceability Standard The Global Traceability Standard for Healthcare (GS1), a process standard, provides a foundational framework which describes the traceability process and defines the minimum requirements for all stakeholders, independent from technologies, organization size or operational sophistication.

Traceability & Identification

  • Generally manufacturing organisations establish procedures and design systems to identify and trace individual products or batches of product.
  • You must identify product status (e.g. is it good or bad).
  • Where traceability is required then serial numbers or batch numbers must be recorded.
  • This requirement is often the most misunderstood, it is up to the organisation to decide how far traceability needs to be taken, but you are generally required to:
    1. Establish the identity and status of products
    2. Maintain the identity and status of products
    3. Maintain records of serial or batch numbers
  • Your identification system Where appropriate, the identification system should allow for traceability from the finished product back to incoming material records and customer specifications.
  • Products must be suitably identified by a part number or job number corresponding to other technical documents related to the product.
Batch Definition
  • Batch refers to a grouping of either materials, components, assemblies or product that can be considered homogenous in nature.
  • This means that a batch of product must identify the following:
    1. Raw material inputs
    2. Processing conditions and Equipment
    3. Quality checks/ Records
    4. Time period
    5. Personnel
  • A Batch should be identified in a unique way that will allow the organisation to identify what materials, processes, equipment and other resources were used to manufacture and deliver the product to the customer.
Batch Size
  • How do you determine the Batch Quantity?
  • The smaller the batch, e.g., Hour V’s Day V’s Week, the more specific and accurate the trace data will be.
  • WHY?
  • Often companies sacrifice accuracy for convenience (i.e., large batch sizes).
  • It may be easier to have large batch quantities.
  • WHY?
  • It comes with the price that should things go wrong then you the business are more exposed to financial and brand damage.
  • WHY?
  • Also, there is the issue of increased exposure following a quality accident where the impact will be more extensive i.e., more customers will be affected by the problem.

Determining the Optimum Size of a Batch

  1. How to decide when a specific batch Starts and Ends
  2. Advantages & Disadvantage of Small Vs Large Batches
  3. What is the Ideal/Optimum Batch Size
  • For the above points the business is thinking of the following:
    1. The time taken for cleaning the equipment and production lines.
    2. The cost of this cleaning.
    3. Trying to balance the right time to do the cleaning.
    4. The time needed for equipment set up.
    5. The time needed for product changeovers and line clearance.
    6. The impact of a batch failure (Deviation or OOS).
    7. The impact of a customer complaint or recall.

The Need for Successful Traceability

  1. To optimise (product and materials) Acceptance Testing
  2. To control (product) Recalls
  3. To help in the Problem-Solving process.
  4. To control upgrades/changes etc.
  5. To Isolate + Quarantine nonconforming product/materials
  6. To prevent Problems Progressing to the Customer.
  7. To provide product/material with a Unique Identity.
Optimising Testing
  • A well deigned traceability system is normally based on a batch system.
  • This implies that all the product in a designated batch is made from the same materials on the same machines by the same people over the same time period.
  • Thus, it is considered homogenous.
  • Therefore, a random sample will be representative of the whole batch population.
  • Thus, Acceptance or Release of product for shipment to the customer can be optimised on a batch by batch basis.
Examples:
  • Each batch is sampled and tested as per SOP/Specification.
  • Assuming the all the test results conform to specification then the batch is released for shipment.
  • Should any sample fail the testing specification then the batch is quarantined for further evaluation.
  • The same approach is applied to all raw materials used in the product. Any unintended problems/issues are traced to a specific batch number.

Traceability & Problem Solving

  • A well-designed traceability system will help to identify:

    1. Date the batch was manufactured
    2. Specialised info such as Oven, Recipe, dryer, reactor etc.
    3. The raw materials used
    4. What shift the product was made on
    5. The person (operator) who weighed/mixed/sterilised etc. the product
    6. Key equipment used such as oven/ autoclave/reactor etc.
    7. Ability to quarantine/isolate the problem batch also helps to limit the problem All this information can help to get to the root cause of the problem

  • What Quality Improvement Tool can be used to get to the root cause of the problem?

  • Note: Recall and Quarantine contains but does NOT solve the problem, this the corrective action.

Remember: What is Traceability?
  • You can Trace Backwards To identify the history of the transfers and locations of a product, from the point of manufacture onwards.
  • And you can Track Forwards To see the intended route of the product towards the point of care.
Backward based Traceability System
  • Most systems and procedures are based on what is known as BACKWARD based traceability.
  • It means that the customer must provide the supplier with the unique ID associated with the particular batch or product being traced.
  • Once this is known then the supplier can trace the inputs (e.g., raw materials such an API etc.) that characterised that batch.
  • However, this is not the most robust of systems as often the unique Identification is either lost or discarded with the packaging.
  • So too is the traceability unless the data is recorded and maintained on a customer's database.
  • Backward traceability does not easily facilitate product recalls as the affected batch or batches may have been shipped to numerous different customers .
  • To be successful, recalls in such cases must be widened to recall all affected and unaffected batches which can increase the cost and workload enormously.
  • Such an approach will also increase the organisations exposure to damage to its brand image.
Backward based Traceability Systems Summary
  1. The customer must provide the supplier with the unique ID
  2. Often the unique ID is either lost or discarded with the packaging
  3. Backward traceability does not facilitate product RECALLS
  4. Recalls may need to be widened to affected and unaffected product
    • Can increase an organisations recall costs and workload
    • Can increase an organisations exposure to brand image damage
Forward based Traceability Systems
  • The Pharmaceutical, Automotive and Medical device and other high tech and High-Risk Industries are demanding that suppliers put in place traceability systems that have Forward based Traceability.
  • Forward based traceability means that the supplier can determine the Unique ID - Batch quantity - Delivery date- Customer Details of all product shipped to the customer as it has the customers personnel data on file linked to the products unique Batch Identification Number.
  • Thus, if an issue occurs at one of the customers manufacturing site then the supplier, when notified, has the ability to notify/contain/quarantine/recall any other product shipped from the same batch to other customer sites or other customers.
  • Such an approach will result in a more reliable and robust Recall process.
  • Another approach is the increased focus on marking each component with the unique batch ID so that the customer can immediately have the supplier trace the data needed based on the examination of a single unit.
  • This is especially applicable to the component and pharmaceutical industries.
Forward based Traceability System Summary
  1. The end customers personal data is linked to the products unique Batch Identification.
  2. This means that the supplier can determine the Identification, Quantity, Delivery etc. date of all product shipped to that specific customer and other affected customers.
  3. The supplier can notify/contain/quarantine/recall any suspect or problematic product manufactured and shipped from the same batch to other affected customers.
  4. Applies to industries producing a High Risk or High Impact product e.g. Pharmaceuticals, Medical Device, Automotive
Individual Component Traceability/ Identification/Branding
  • Some industries have increased their focus on marking each component with its unique batch/lot Identification so that the customer can immediately have the supplier trace the data needed based on the examination of a single unit.
  • Batch or Lot Identification/Branding of each unit is especially applicable to the component industries, as it enable any customer to demand accurate traceability data on any single unit failure.
  • Again the automotive, healthcare and food industries are pushing such an approach combined with reducing the batch/lot ID sizes in order to increase the accuracy and speed of the trace data.
Examples for Food Traceability
  • Farm to Fork V’s Fork to Farm
  • Using DNA to trace meat back to the animal/farm/producer (e.g. Horse meat scandal)
  • Future advancements: Packaging barcode at till checkouts connected to loyalty/credit cards
  • Eggs: Batch number is now printed on every egg
Artisan Bakery Example: Design a Traceability system
  • Assumptions i) The Bakery operates 24 hrs, 7 days a week ii) Employs 19 people iii) Produces 13 different types of bread and sizes iv) Has three large ovens
  • Day – week – year
  • Shift 1/2/3 for example 3rd Shift
  • Add Operator Code (19)
  • Add Recipe No. (BREAD TYPE (13))
  • Add Machine (e.g., Oven for Bakery) Code
  • dd/mm/yy
  • Add hour e.g. 23.00 hh/dd/mm/yy
  • 170424-03
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