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Good Manufacturing Practices (GMPs)

 LearninObjectives

Goals:

  • Make a batch of Good Manufacturing Practice (GMP) popcorn within a specified timeframe (1.5 hours).
  • Use Standard Operating Procedures (SOPs) to accomplish the manufacturing task.
  • Understand the complexity of the GMP process.
  • Understand Quality Control (QC) and Quality Assurance (QA).
  • Understand the need for team members to complete individual jobs appropriately to accomplish goals.

StudenLearninOutcomes: 

Upocompletioothilabstudentwilbablto:

  • Explain the role of Standard Operating Procedures (SOPs) and batch/lot Records.
  • Employ the principles of a quality systems approach to manufacturing.
  • Learn the difference between Quality Control (QC) and Quality Assurance (QA).
  • Discuss the value of teamwork.

    Part I: Review Terms and Background Information

    Introduction

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    Quality Management Systems (QMS)

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    Figure 1: Symbiotic relationship between the Quality System, Quality Assurance, and Quality Control

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    Say What You Do = SOPs

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    Do What You Say = Follow the Process (SOPs)

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    Document It = Evidence of Quality

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    Current Good Manufacturing Practices (cGMPs)

    ThgeneraprinciplethaalQMhavicommoare:

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

    Statistical Process Control

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    Corrective and Preventative Actions (CAPA)

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    Drawing of 4 labeled targets with dots representing relationship between precision and accuracy.
    Figure 2. Accuracy and precision

    Quality Assurance and Quality Control (QA/QC)

    Table 1. Quality Assurance Versus Quality Control
    ElementQuality Assurance (QA)Quality Control (QC)
    Definition

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    seoactivitieconcernewitmonitorinanverifyinresultinproductmeethdefinestandardanspecificationfoquality 

    PurposeVerification: Answer the question "Am I building the product correctly"?
    Prove the system meets all specified requirements at a particular stage.
    Validation: Answer the question "Am I building the right product"?
    Ensure that the product meets customer expectation.
    Type of processProactiveReactive

    Goal

    Platprevenproblems

    Identifdefectithfinisheproduct

    Identifancorrecsourcoproducdefects

    Tools

    StatisticaProcesControls: 
    ControCharts
    RuCharts

    StatisticaQualitControls:
    RandoAcceptancSampling
    RangCharts
    Histograms
    Means
    StandarDeviation

    Responsibility

    Everyone 

    QualitControGroup

     

    Part II: Train and Prepare for a Production Run

    A. Lab Activity: Review the Lab Flow

    Construcflodiagraothfollowinovervieothtraininanproductiooyoucomponenfothsnacproductoday.

    Scenario: YoucompanyAwesomSnackCompan(ASC)needyotproducpopcorfotheiseasonallavailablSummeSnacMixYoujowilbttakthramateriaanproducthpopcorthagoetthSnacMixinDepartment. 

    1. Employee Overview

    • Supervisor (teacher) – Welcomes Employees (students) to Awesome Snack Company.
    • Overview of QMS and why it’s important to the company.

    2. Group Formation

    • Divide employees up into Quality Assurance Teams (5 employees each team)

    3. Training

    1. Supervisor gives training form (see figure below, in QA packet) and packets to team.
    the top heading portion of the training form in the packet
    Figure 3. Heading of training document in packet
    1. Team Assigns Jobs to Members 
      1. Material Control Tech.
      2. Quality Control Tech.
      3. Manufacturing Tech. I
      4. Manufacturing Tech II
      5. Quality Assurance Tech.
    2. QA Tech Reads SOP Standards 11-001 to team
    3. QA Tech distributes packets to each team member
      • Members read through their training packet
    4. Team completes ASC Training Document
    5. The completed ASC Training Document must be turned in to the supervisor (instructor) to receive material to start the production run.

    4. Production

    1. Each technician performs their role
    2. Document everything on company forms
    3. Put the following calculation from ASC Form 004 into your laboratory notebook:
      • Percent weight loss for each of the three bags.
    4. Evaluate: Does batch meet specification?
      • Statistical Process Control: Mean, Standard Deviation, and Coefficient of Variation
    5. Post Production Product Specifications: Release or Reject
      • Are you accepting or rejecting this batch? Why?
    6. Once everything is completed, QA will turn forms into Supervisor

    5. Corrective Action Plan

    1. Class discussion of Statistical Process Control
    2. Corrective and Preventative Action plan is constructed.

    B. Activity: Training Using Good Manufacturing Practices (GMP)

    PURPOSE: Everemployee musbtraineiconformance witGM(GooManufacturinPractices).

    MATERIALS

    • 1 official SOP Standards for Employee Safety and Conduct: STANDARDS 11 -001 (see below)
    • 1 official Awesome Snack Company (ASC) Documentation of Training Document (see below)
    • 1 Set of the Standard Operating Procedures (SOPs) for Production: MAT-11-001, MAN-11-001, MAN-11-002, MAN-11-003, QA-11-001, QC-11-001
    • 1 set of production forms: ASC 001, ASC 002, ASC 003, ASC 004

    PROCEDURE

    Form Groups, Assign Roles, Complete Training
    1. The ideal group size is 5. Form groups and assign roles (jobs) to each member of Production Team. Jobs: Quality Assurance (QA), Quality Control (QC), Manufacturing Tech I, Manufacturing Tech II, Material Control (MC). Note: If the team is comprised of a group less than 5, 1 member must take multiple roles.
    2. Follow the training instructions below. After training, the documentation of training document (Figure 4) must be turned in to the supervisor (instructor) to receive material to start your production run.
    the heading of form SOP Standards 11-001 which will be used first by the team
    Figure 4. The heading of SOP 11-001 from your packet
    Instructions:
    1. Quality Assurance (QA) Technician will read SOP Standards-11-001 to the Team.
    2. QA Technician distributes signs, SOPs and ASC Forms to each team member.
    3. Each team member reviews the scope and ASC guidelines, signs the page and receives a supervisor (or their designee) signature (see below)
    4. Each team member reads the SOP for his/her job to identify their primary activity. (Ex. Weigh unpopped popcorn (UPP))
    5. QA fills out table 2 below. In the order presented, QA lists the activity and asks the name of who will do it.
    SCOPE
    • ALL ASC employees must be trained, acknowledge training, and receive sign-off from a supervisor.
    • Not following the stated ASC guidelines may result in written warning and/or termination of employment

    ThASGuidelines includbuarnolimitetthfollowing:

    1. All hair that is shoulder length or longer must be tied back or contained in a hair net
    2. Fingernails must be neatly trimmed. Fingernails should not protrude past the ends of the fingertips more than ¼ inch
    3. Clothing and other personal belongings must be stored in designated areas
    4. All jewelry is prohibited in all manufacturing areas with the exception of one smooth ring (no stones) on finger. This includes and is not limited to watches, multiple rings, ear, nose, tongue, eye, belly piercings or rings...etc. are not allowed
    5. No items are allowed in pockets or affixed to clothing above the waist in the manufacturing area. The exception is for PPE (Personal Protective Equipment)
    6. Electronic devices such as cell phone, iPods, blue tooth, radio, pager, MP3, handheld games, etc. These items may be stored in lockers. Employees may use these devices only in designated areas during breaks, lunch, before and/or after work
    7. Areas must be left in a clean and organized manner at the end of each shift
    8. No food (including gum, candy, nuts and/or similar snacks) and/or drinks can be stored or consumed in manufacturing areas
    9. Every glass or plastic breakage in any manufacturing area must be reported to the Shift Supervisor or Safety Coordinator and a Quality Incident Report generated
    10. Use the following format for dates: Day-Month-Year (ex. 05-Mar-2019)
    11. When Initialing, use THREE initials, to include your middle initial

    I__________________________certifthahavreaanunderstanthASGuidelines.

    EmployeFulName

       

    EmployeSignature

     

    SupervisoSignature

       

    Date

     

    Date

     

    Table 2. Assignment of Production Roles

    ACTIVITY

    WHDOETHIJOB(NAME)

    SOP/FORM

    Inspecand/oReleaseRejecUPP*

     

    MAT-11-00AS002

    StarLot/BatcRecord

     

    QA-11-00AS001

    Preparancleamicrowavebalance

     

    MAN-11-001MAN-11-002AS003

    InspecCleaningOproductiostart

     

    QC-11-00AS003

    WeigUPP

     

    MAN-11-00AS004

    ProducIPP*

     

    MAN-11-00AS004

    PlacpopcoriRejecoRelease

     

    MAT-11-00AS002

    CompletLot/BatcRecord

     

    QA-11-00AS001

    InecessaryinitiatCAPA

    *UPPunpoppepopcornIPPiprocespopcorn

    1. Print name and Initial on the OFFICIAL Documentation of Training document (looks like below) after training on Standards and SOPs is complete. Be sure to include your middle initial
    2. Once completed, Material Control turns in the document in to Supervisor (Instructor) to receive the starting material (UPP) and start production
    Table 3. Documentation of Training

    JOTITLE

    NAM(P