Role of QC/QA for product quality
Role of QC/QA for product quality
What is quality?
Quality is the ability of a product or service to consistently meet or exceed local & global regulatory requirements and customer expectations.
Objective or philosophy of QC/QA:
To provide products that are dependable, satisfactory, economical and of uniform quality.
Aim at preventing the defect rather than detecting the defects.
Reduce errors and improve quality and productivity.
Inspire more effective team works.
Increase employee motivation.
Create a problem-solving capability.
Improve communication in the organization and finally
To achieve the organization goal
The QC/QA Viewpoint
Quality First.
Quality first means putting quality above everything else in order to create highly satisfactory goods and services of a guaranteed quality that customers will be attracted to buy and delighted to use.
Benefits of Using Quality Control in Manufacturing
Application of 7 QC tools:
Why Do This?
Application of 7 QC tools:
Six Problem Solving Steps
Identify
recognize the symptoms
Define
Agree on the problem and set boundaries
Investigate
Collect data
Analyze
Use quality tools to aid
Solve
Develop the solution and implement
Confirm
Follow up to make sure that the answer is effective
Application of 7 QC tools:
Cause and Effect Diagrams
Histograms
Control Charts
Flow Charts
Check-sheets
Pareto Charts
Scatter Diagrams
01. Cause and Effect/Fishbone Diagrams
Purpose: Graphical representation of the trail resulting in the basis explanation for a drag
How is it done?
Decide which quality characteristic, outcome or effect you would like to look at.
Backbone –draw straight line
Ribs – categories
Medium size bones –secondary causes
Small bones – root causes
01. Cause and Effect/Fishbone Diagrams
Example of fishbone diagram
Factor analysis (How to investigate)
02. Histograms
Purpose:
To determine the spread or variation of a group of knowledge points during a graphical form
How is it done?:
Collect data, 50-100 data point
Determine the range of the data
Calculate the size of the class interval
Divide data points into classes Determine the category boundary
Count # of data points in each class
Draw the histogram
Process capability (Cp & Cpk)
3. Control Charts
Purpose:
The primary purpose of an impact chart is to predict the expected product outcomes.
Control Charts
Example:
4. Flow Charts
purpose:
A visual illustration of the sequence of operations required to finish a task
Schematic drawing of the method to live or improve.
The starting point for process improvement
A potential weakness in the process is made visual.
Picture of the process as it should be.
5. Pareto Charts
Purpose:
Prioritize problems.
How is it done?
Create a preliminary list of problem classifications.
Tally the occurrences in each problem classification.
Arrange each classification so as from highest to lowest
Construct the bar chart
Pareto Charts
Example:
6. Check-sheets
Example:
7. Scatter Diagrams
Purpose:
To identify the correlations which may exist between a top-quality characteristic and an element which may be driving it-
A scatter diagram shows the correlation
between two variables in a process.
Dots representing data points are
scattered on the diagram.
Quality Circle Activities
Systematic Approach to problem-solving.
What is a quality circle?
A voluntary group of employees who work on a similar task or share an area of responsibility.
They agree to meet on a regular basis to discuss and solve problems related to works.
They operate the principle that employee participation in deciding and problem-solving improves the standard of labor.
Benefits of Quality Circle:
1.Benefits of the organization:
Develop a relationship & team spirit.
Reduce- Work related errors & costs.
Increase- Productivity & quality of goods.
Leads- Towards better efficiency.
2.Benefits of the employee:
Provide- Job interest.
Develop- Latent problem-solving capabilities.
Advances- Employee career and personal development.
Involve- worker in decision making.
PDCA Cycle (Problem-solving method)
PDCA cycle is used to solve a problem and improve the existing situation.
Plan: Develop a plan (or standard) necessary to attain the target.
Do: Implement the plan (based on the standard.)
Check: analyze the result of the implementation.
Act: Take corrective measures if there is a gap between the plan and the appraisal result.
PDCA Cycle (Problem-solving method)
Quality control of Raw & Packaging Materials
Receiving quality RM/PM is the first and most important step of a quality product. For this, we have to ensure the best quality RM/PM for our products. We have to establish a policy for incoming RM/PM which includes-
Control of the acceptance level of RM/PM.
Standard/Specification must be given to the supplier & must be confirmed by QC as per the required standard.
A supplier must provide a Certificate of Analysis(CoA), Food grade certificate, MSDS for every raw material.
All raw materials must be checked/tested once a year by the third party to verify the quality of raw materials.
Quality control of Raw & Packaging Materials
Continued…….
RM/PM testing facility must be available in the lab for ensuring quality.
A supplier must be selected & enlisted.
Supplier evaluation must be carried out on a regular basis
(Local & Foreign).
Monthly meetings with listed suppliers to improve the quality of RM/PM.
RM/PM storing condition must be improved according to MSDS.
Regular inspection of the storage facility.
Onsite check of RM/PM before use.
Online inspection
On-line QC personnel must ensure the following parameter of products for every batch in production floor & laboratory:
CIP & COP must be confirmed before production according to SOP.
Cleaning, Hygiene & Sanitation must be checked by QC and microbiology.
Every ingredient must be weighed & mixed step by step in the presence of QC personnel. ( Example)
Acid, Brix, pH, Organoleptic taste, Coding must be ensured on the production floor according to standard.
CCP monitoring & verification.
Check & verify production & process related to all documents.
Ensure water quality at every step.
Process Control Implementation
Access Control on every production floor.
Safety briefing at the entrance point.
Air shower required at the entrance point.
Auto shoe cover at the entrance point.
Hands-free water tape.
Automatic hand dryer.
5S implementation.
High & Low-Risk area declaration.
Ensure the effectiveness of a metal detector.
PPE must be ensured.
Hygiene and sanitation monitoring
Hygiene and sanitation is the most important part of a food manufacturing industry for food safety purpose……
QC personnel must ensure and deliver a short briefing about hygiene and sanitation during assembly.
Must perform cross-check of employees about personal hygiene, dress code, jewelry, infectious disease, etc.
Must check the machine surface, floor condition.
HACCP Implementation
The HACCP system consists of the subsequent seven principles
Conduct a hazard analysis.
Determine the Critical Control Points ( CCPs)
Establish Critical Limit
Establish a system to monitor the CCP
Establish the corrective action to be taken when monitoring indicates that a specific CCP isn't in check
Establish a procedure for verification to confirm that the HACCP system is working effectively
Establish documentation & record keeping
Microbiological Analysis
To ensure product safety the following Microbiological analysis of RM/PM,
personnel hand & material surface SWAB, process water, CIP water, ambient
air, hygiene & sanitation and finally finished goods must be carried out:
TBC/TPC/APC.
Total Coliforms & Faecal Coliform.
Yeasts & Moulds.
Shigella & Salmonella.
Vibrio Cholerae.
Another test necessary for a specific product
QC Team Work
“Teamwork, all employee participate in activities to achieve the
organization’s goal.”
The leader must make the vision and goal of the organization clear.
The vision and goal of the organization must be shared by all employees.
Job sharing, responsibilities, and authorities must be clear.
QC Training & Motivation program
To improve the skill of QC personnel various training programs must be conducted by local and global experts. (GMP, HACCP, Food Safety, QMS, HALAL & BRC, etc.)
Need to Carry out the QC motivation program to breakdown the monotony of continuous work.
QC conference must be arranged by top management.
Different types of QC game must be arranged for brainstorming.
QC evaluation program can be arranged to evaluate their performance with reward.
Small group activities
Small group activities can be used to solve a problem by group discussion, cooperation & communication.
Place of learning for members.
Place of self-actualization.
Place of communication.
Place of work-place problem-solving.
Small group activities are beneficial to communication.
Continuous Shelf-life Study
We must perform Shelf-life Study to improve quality, safety & shelf-life of product……
Our present products (Every Batch).
Incubation Sample.
Market sample.
R&D products shelf-life study before launching to the market.
Continuous Sensory Evaluation test.
We must perform sensory evaluation tests continuously to ensure Chemical & Organolaptic taste……..
Our present products (Every Batch).
Incubation Sample.
Market Product (Own Company).
Market Product (Other Company).
Need separate Sensory evaluation room.
Product’s Cross-Check/verification by Sister Concern & 3rd party test
To ensure product quality as well as test validation we are continuously doing cross-check of our products from our Sister Concern lab And
We also performing 3rd party tests from various renowned labs . as per schedule & special requirements of food safety.
Testing equipment and facilities
Latest testing equipment must be available in QC lab.
Proper utilization of existing lab equipment.
All equipment must be calibrated as per standard
(in house & third party).
Ensure SOP for all equipment.
Finished goods/product releasing by QA
Before delivering the finished goods to the market (QA) personnel must perform the following procedure:
A random check of FGs for physical, chemical & organoleptic tests.
Ensure the microbiological analysis is good.
Must maintain FIFO.
Before loading the product, a vehicle must be checked for cleanliness to avoid contamination.
Coding, shipping marks must be ensured by the job order.
If everything is ok according to product specification then it will be dispatch
Documentation:
Documentation constitutes an essential part of the quality control activity. It serves as a legal record supporting the process. So it should be as per local and global standards and easy to gain information. It must have the following criteria:
Control of documents.
Control of records.
All processes must be documented.
Preservation of documents.
SOP for documentation.
Master list of documents.
All documents must have numbers & authorized signatory.
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