Chapter 03
Quality
45 terms
Practice by level
Terms
01Quality assuranceĐảm bảo chất lượng
Definition
A way of working that prevents defects through procedures, records and training.
Examples
- The plant quality assurance team has 6 people and owns 18 procedures and 42 forms.
- The team runs 4 internal audits and 2 traceability drills every year.
Easy to get wrong
Quality assurance is not the person catching defects at the end of the line. Catching defects is quality control. Quality assurance designs the system so fewer defects happen.
02Quality controlKiểm soát chất lượng
Definition
Measuring, checking and testing product and process to find what has already drifted out of spec.
Examples
- A quality control operator pulls 5 bottles every 30 minutes on line 1, so 15 checks in a 450 minute shift.
- Each check takes about 5 minutes for three parameters: volume, Brix and pH.
Easy to get wrong
Quality control only sees a defect after it has happened. More checks do not make the process steadier, they only make detection faster.
03Standard operating procedureQuy trình thao tác chuẩn
Definition
A document setting out each step of a task, who does it, how, and where it is recorded.
Examples
- The clean in place procedure runs to 6 pages, with 14 steps and 3 signature points.
- The plant holds 18 procedures and each one is reviewed once every 2 years.
Easy to get wrong
A procedure pinned on the wall does not yet count as a procedure. If 3 operators work in 3 different ways, what is running is habit, not the procedure.
04Good manufacturing practiceThực hành sản xuất tốt
Definition
The set of requirements on building, equipment, people and handling that keeps output safe and consistent.
Examples
- The good manufacturing practice checklist has 42 items, checked weekly, and scored 94 percent last month.
- The 8 failed items sat in the changing room and the floor drains, and each must be closed within 7 days.
Easy to get wrong
People treat this as a cleaning list for the day before a visitor arrives. It is the daily baseline, and HACCP only holds up when that baseline is already in place.
05Prerequisite programmeChương trình tiên quyết
Definition
Foundation programmes such as cleaning, pest control, water and training that must exist before HACCP is applied.
Examples
- The plant runs 8 prerequisite programmes, with pest control alone covering 24 traps checked weekly.
- Process water is tested against 12 parameters monthly and 32 parameters once a year.
Easy to get wrong
People rank prerequisite programmes level with critical control points. A prerequisite programme lowers general risk across the site, a critical control point stops one named hazard at one named step.
06Hazard analysis and critical control pointsPhân tích mối nguy và điểm kiểm soát tới hạn
Definition
A food safety method that lists hazards and then places controls at the steps that decide the outcome.
Examples
- The HACCP team of 5 people identified 26 hazards across the 9 steps of the line.
- After screening, only 2 steps became critical control points: pasteurisation and metal detection.
Easy to get wrong
People read HACCP as more finished product testing. It moves the block back to the step that creates the risk, so end of line testing usually goes down.
07Critical control pointĐiểm kiểm soát tới hạn
Definition
A step where losing control leaves the hazard with no later place to be stopped.
Examples
- Pasteurisation is critical control point 1 and metal detection is critical control point 2.
- Each point is monitored continuously and logged every 30 minutes, so 15 records per shift.
Easy to get wrong
Not every important step is a critical control point. Labelling matters a lot, but a label defect can still be caught downstream, so it stays a normal control point.
08Critical limitGiới hạn tới hạn
Definition
The specific numeric threshold that separates safe from unsafe at a critical control point.
Examples
- The critical limit for pasteurisation is 95 degrees C held for 30 seconds, and anything below that is a deviation.
- The metal detector must find a 1.5 mm ferrous piece, verified with test pieces 8 times per shift.
Easy to get wrong
A critical limit is not the operating set point. The plant runs at 97 degrees C to keep a margin, so touching 95 degrees C means sitting on the edge, not hitting target.
09Food safety management systemHệ thống quản lý an toàn thực phẩm
Definition
A framework that pulls good manufacturing practice, prerequisite programmes and HACCP into one system with review and improvement built in.
Examples
- The plant works to ISO 22000, and the system file holds 18 procedures and 42 forms.
- The certificate is valid for 3 years, with 1 surveillance audit of 2 days each year.
Easy to get wrong
Holding a certificate does not mean incidents stop. The certificate says the system is designed right, but daily execution still has to prove itself through records.
10Third party certificationChứng nhận bên thứ ba
Definition
An independent body audits the plant and issues a certificate that it meets a standard.
Examples
- The certification audit ran 3 days with 2 auditors and cost 180 million dong for a 3 year cycle.
- It closed with 1 major nonconformity and 9 minor ones, all due within 30 days.
Easy to get wrong
Third party certification is not the same as a customer audit. The third party measures against a common standard, the customer measures against its own list and is usually stricter on a few points.
11Accredited laboratoryPhòng kiểm nghiệm được công nhận
Definition
A test laboratory formally recognised as competent, so its results carry weight outside the company.
Examples
- The plant sends samples out at 2.5 million dong per sample and gets results in 5 days.
- The in house lab runs 40 tests a day and sends 6 samples a month to the accredited lab for cross checking.
Easy to get wrong
In house results are enough to steer the line but not enough in a dispute. In a complaint case or a regulator check, only data from an accredited laboratory counts.
12Internal auditĐánh giá nội bộ
Definition
An audit run by the company own people to check whether the system works the way the documents say.
Examples
- The plant runs 4 rounds a year, 2 days each, covering all 18 procedures.
- The latest round raised 12 nonconformities: 1 major and 11 minor.
Easy to get wrong
An auditor must not audit their own work. A shift leader auditing their own shift produces a worthless result even when every box on the checklist is filled.
13Customer auditĐánh giá của khách hàng
Definition
An audit carried out at the plant by the buyer, before or during the trading relationship.
Examples
- A supermarket chain sent 2 auditors for 1 day, scoring against a 120 point sheet with a pass mark of 85 percent.
- The plant scored 88 percent, losing points on training records and foreign object control.
Easy to get wrong
Third party certification does not exempt a plant from customer audits. Many buyers keep their own sheet, and the score on that sheet is what decides the contract.
14NonconformityĐiểm không phù hợp
Definition
A practice or result that departs from a standard or procedure requirement, written up during an audit.
Examples
- Of the 12 findings in the last round, the single major one was 3 months of missing calibration records.
- A major needs a plan within 7 days and closure within 30 days, a minor gets 90 days.
Easy to get wrong
People take a nonconformity as criticism of a person. Hiding a minor today is the usual way it comes back as a major next round when the problem repeats.
15Corrective actionHành động khắc phục
Definition
Work done to remove the cause of a defect that has already happened, so it does not come back.
Examples
- After a run of 1,170 mislabelled bottles per shift, the plant reset the label guide and added 1 start of shift check.
- Effectiveness was confirmed after 3 months, with label defects down from 1,170 to 240 bottles per shift.
Easy to get wrong
Fixing defective stock often gets written into the corrective action box. Relabelling 1,170 bottles handles the consequence, while corrective action stops the next shift producing them.
16National technical regulationQuy chuẩn kỹ thuật quốc gia
Definition
A mandatory government document that sets safety limits for a product group.
Examples
- Soft drinks fall under the health ministry regulation, which fixes 6 microbiological limits and 4 heavy metal limits.
- The plant tests 12 mandatory parameters monthly and the full set of 32 parameters once a year.
Easy to get wrong
An internal standard can be tighter than the regulation but never replaces it. Product that meets the company standard while exceeding a regulatory limit is still in breach.
17Product self declarationTự công bố sản phẩm
Definition
The company files its own declaration that a product meets the regulation, submitted to the authority before sale.
Examples
- The file holds the declaration plus a test report no older than 12 months, filed with the authority and posted on the company site.
- A new product needs 5 days for test results and 1 day to file.
Easy to get wrong
People read self declaration as approval. The company carries responsibility for the numbers it declares, and a post market check can arrive at any time to compare.
18Finished product specificationTiêu chuẩn thành phẩm
Definition
The sheet listing every parameter and limit a product must meet before it can be sold.
Examples
- The spec for the 500 ml bottle covers 14 parameters, including Brix 10.5 with a tolerance of plus or minus 0.3.
- Accepted volume runs from 495 to 509 ml, and anything outside that range is nonconforming.
Easy to get wrong
The specification is not the machine set point. The filler is set to 502 ml rather than 500 ml, because the target has to sit in the middle of the accepted range, not on its edge.
19Sensory attributeChỉ tiêu cảm quan
Definition
A parameter judged by the senses, such as colour, smell, taste and appearance.
Examples
- Product is scored on a 9 point scale and passes when the average of 8 assessors reaches 6.5.
- Last week batch scored 7.2 on taste but only 5.8 on colour, so it was held.
Easy to get wrong
Failing on sensory does not mean the product is unsafe. A batch can meet every microbiological limit and still be unsellable because the colour is off and shoppers will not take it.
20Sensory panelHội đồng cảm quan
Definition
A trained group that scores sensory attributes in a consistent way.
Examples
- The panel has 8 members, each with 12 hours of training and a performance recheck 2 times a year.
- A triangle test uses 24 assessors, and at least 13 correct picks are needed to call a real difference.
Easy to get wrong
The sensory panel gets treated as the group that says whether the drink tastes good. It describes differences, while shopper preference has to be measured in separate research.
21Physicochemical parameterChỉ tiêu lý hóa
Definition
A parameter measured with instruments, such as Brix, pH, volume and CO2 content.
Examples
- Target Brix is 10.5 and target pH is 3.0, and one round of measurement takes about 5 minutes.
- At 15 rounds per shift and 3 parameters each, line 1 generates 45 physicochemical readings in a shift.
Easy to get wrong
Physicochemical results come back instantly, so they get treated as enough to ship. Safety is decided by the microbiological result, and that one takes 72 hours.
22Microbiological parameterChỉ tiêu vi sinh
Definition
A count of micro organisms in the product, used to decide whether it is safe.
Examples
- Total aerobic count must stay below 100 colonies per 1 ml, and coliforms must not be detected in 1 ml.
- Results come after 72 hours of incubation, so each batch of 40,000 bottles is held for 3 days before release.
Easy to get wrong
A clean sample result does not prove the whole batch is clean. The sample only represents the batch. Real assurance comes from pasteurisation hitting 95 degrees C, not from the final test.
23Retention sampleMẫu lưu
Definition
Units kept back from every batch so they can be checked later against a complaint or a dispute.
Examples
- Each batch leaves 12 bottles behind, so at 275 batches a month the sample store holds 3,300 bottles.
- Samples are kept 15 months, which is 3 months longer than the 12 month shelf life.
Easy to get wrong
Retention samples must sit under the conditions printed on the label. Keeping them in a cold room while market stock sits at ambient destroys their value as a comparison.
24Shelf life studyNghiên cứu hạn sử dụng
Definition
A test that follows the product over time to set how long it still meets specification.
Examples
- The real time study runs 15 months with 13 sampling points of 12 bottles each.
- An accelerated test at 40 degrees C for 3 months gives an early read, but real time data still has to confirm it.
Easy to get wrong
Shelf life often gets picked to suit the sales plan. Printing 12 months when the data only supports 9 months pushes every risk into the last stretch of product life.
25CalibrationHiệu chuẩn thiết bị đo
Definition
Comparing a measuring device against a known standard to find its error and correct it.
Examples
- The checkweigher is calibrated every 6 months and verified with a 200 gram standard weight at the start of each shift.
- The pH meter is recalibrated daily with buffer 4.0 and buffer 7.0, which takes 10 minutes.
Easy to get wrong
An uncalibrated instrument voids every number that came after it. Three months of missing calibration records is enough for an auditor to write a major nonconformity.
26In process checkKiểm tra trong quá trình
Definition
A check taken on the line while product is running, so drift is corrected early instead of at the end.
Examples
- Every 30 minutes an operator pulls 5 bottles for volume, Brix and pH, so 15 rounds per shift.
- Catching a drift at one round limits exposure to the 10,800 bottles of that 30 minute window, not the whole 143 thousand bottle shift.
Easy to get wrong
In process checks do not replace finished product sampling. One watches the running machine, the other decides whether the lot can be released.
27Metal detectionDò kim loại
Definition
An in line unit that finds metal fragments in product and rejects the suspect unit.
Examples
- Sensitivity is set at 1.5 mm for ferrous, 2.0 mm for non ferrous and 2.5 mm for stainless steel.
- Test pieces are run once an hour, so 8 times a shift, and one failed test holds all product back to the last good check, up to 21,600 bottles.
Easy to get wrong
A machine throwing units out is not proof that it works. Only the periodic test piece shows that it still reacts at the set sensitivity.
28Control chartBiểu đồ kiểm soát
Definition
A time plot of measurements with control limits drawn on it, used to see whether the process is stable.
Examples
- The Brix chart plots subgroups of 5 bottles every 30 minutes, with control limits at 10.35 and 10.65.
- Specification limits are wider, 10.2 to 10.8, so a point outside the control limits can still be within spec.
Easy to get wrong
A point outside the control limits gets read as defective product. It is a signal that the process is drifting and needs correcting before readings reach the specification limits.
29Process capabilityNăng lực quá trình
Definition
An index comparing the width of the specification range with the real variation of the process.
Examples
- With volume accepted from 495 to 509 ml, a mean of 502 ml and a standard deviation of 2 ml give an index of 1.17.
- The plant target is 1.33, which needs the standard deviation pulled down to 1.75 ml.
Easy to get wrong
A mean sitting in the centre is not enough to call a process good. Wide variation still gives a low index and still produces bottles outside the accepted range.
30Quality rateTỷ lệ đạt
Definition
The share of units that pass first time out of everything the line produced.
Examples
- A shift of 143 thousand bottles with 2,916 defective units gives a quality rate of 98 percent.
- Quality rate is 1 of the 3 parts of overall equipment effectiveness, alongside availability rate and performance rate.
Easy to get wrong
Bottles that only passed after rework do not count toward the quality rate. Counting them lifts the number falsely and hides the cost of the repair work.
31Sampling planKế hoạch lấy mẫu
Definition
The rule for how many units to draw from a lot and how many defects still allow the lot to be accepted.
Examples
- A lot of 40,000 bottles is sampled at 500 bottles under normal inspection.
- On those 500 bottles the lot is accepted at up to 10 major defects and rejected from 11.
Easy to get wrong
Sample size does not scale with lot size. A lot four times bigger needs only a slightly bigger sample, because confidence comes from drawing at random, not from counting more units.
32Acceptable quality levelMức chất lượng chấp nhận
Definition
The maximum defect level still treated as acceptable over the long run for each defect class.
Examples
- The plant sets 0.065 for critical defects, 1.0 for major and 2.5 for minor.
- On a 500 bottle sample the accept numbers are 0, 10 and 21 respectively.
Easy to get wrong
The acceptable quality level gets used as a target to aim at. It is a lot rejection threshold, so reading a level of 1.0 as permission to run 1 percent defects every lot has it backwards.
33Defect classificationPhân loại lỗi
Definition
Sorting defects into critical, major and minor according to how far they affect the user.
Examples
- Glass in the bottle is a critical defect, 8 ml short fill is a major, a label 2 mm off line is a minor.
- Last week the 500 bottle sample held 0 critical, 6 major and 14 minor defects, so the lot was accepted.
Easy to get wrong
Minor defects do not add up into a critical one. The three classes are counted separately, and a single critical defect is already enough to reject the whole lot.
34Hundred percent inspectionKiểm tra toàn bộ
Definition
Checking every unit in the lot instead of drawing a sample.
Examples
- Screening all 40,000 bottles takes 6 people over 2 shifts and costs about 9 million dong.
- Visual screening still misses about 15 percent of minor defects, so it is used only on a lot already under suspicion.
Easy to get wrong
Hundred percent inspection does not give a perfectly clean lot. Inspectors tire within a few hours, so two consecutive passes over the same lot return two different defect counts.
35Nonconforming productHàng không đạt
Definition
Product that fails at least one parameter in the specification.
Examples
- Last shift produced 2,916 nonconforming bottles, of which 1,170 were label defects and 640 were short fills.
- All of it moved to the hold area of 12 pallets capacity and was red tagged.
Easy to get wrong
Nonconforming product is not automatically waste. It has three possible routes: rework, sale under concession, or destruction, and each route needs a written decision.
36Batch holdKhóa lô
Definition
Blocking a batch in the system so nobody can ship or sell it until a decision is made.
Examples
- A batch of 40,000 bottles is held for the 72 hour microbiological result, which ties up 128 million dong of stock value.
- Only 2 people in quality assurance can release the hold.
Easy to get wrong
A hold in the system while the pallets stay in the normal finished goods area is only half a hold. The stock has to be physically separated and tagged, because a picking mistake is the most common way held product escapes.
37Process deviationSai lệch quy trình
Definition
A run where a parameter fell outside the defined range, which must be recorded and assessed for impact.
Examples
- The pasteuriser dropped to 93 degrees C for 4 minutes, affecting 1,440 bottles at a line speed of 21,600 bottles per hour.
- The deviation record must be opened within 24 hours and closed with a conclusion within 5 working days.
Easy to get wrong
Not every deviation ends in destroyed stock. But skipping the record destroys the basis for isolating those 1,440 bottles, and any later incident then has to cover the full 40,000 bottle batch.
38ConcessionNhượng bộ chất lượng
Definition
A decision allowing an out of spec lot to be used or sold when the deviation does not affect safety.
Examples
- 8,000 bottles with labels 3 mm off line were released for sale at a 5 percent discount.
- The decision needs 2 signatures, one from quality assurance and one from the brand owner.
Easy to get wrong
Concessions never apply to safety parameters. A microbiological failure or a foreign object has no concession route, however large the lot.
39Batch releaseQuyết định xuất xưởng
Definition
Quality assurance formally allows a batch to leave the plant once records and results are complete.
Examples
- The plant releases about 11 batches a day, each of 40,000 bottles.
- A batch is signed off only with a complete batch record, physicochemical results and the 72 hour microbiological result.
Easy to get wrong
Product stacked on pallets is not yet released product. One missing signature keeps the lot on hold even with the truck waiting at the gate.
40AllergenChất gây dị ứng
Definition
An ingredient that can trigger an allergic reaction, so it needs separate control and clear label declaration.
Examples
- The fruit milk range contains milk, so it is scheduled last in the week, after the 4 milk free codes.
- After the run the pipework is cleaned and verified with 6 swab points against a limit of 10 parts per million.
Easy to get wrong
Adding a may contain milk line does not replace cleaning. Overused warnings take choice away from allergic shoppers while the real carry over risk stays exactly where it was.
41Foreign objectVật lạ
Definition
Anything that does not belong in the product but gets in during production, such as metal, plastic or glass.
Examples
- The plant logged 4 foreign object complaints in a month against 11 million bottles sold.
- The barriers are a 0.5 mm filter screen at blending and a metal detector at the end of the line.
Easy to get wrong
Foreign objects do not only arrive with raw materials. Most serious cases start inside the plant, from a torn glove or a pen cap, which is why loose items are banned from the production area.
42Consumer complaintKhiếu nại người tiêu dùng
Definition
Feedback from a buyer about the product, which is logged, classified and investigated.
Examples
- Last month brought 35 complaints against 11 million bottles, which is 3.2 complaints per million bottles.
- Of those, 4 were foreign objects, 18 were taste and 13 were packaging, and all had to be answered within 48 hours.
Easy to get wrong
A low complaint count does not prove good quality. Most shoppers drop a faulty 12 thousand dong bottle rather than call, so the visible number is only the top of the pile.
43Traceability drillDiễn tập truy xuất
Definition
A rehearsal that follows one batch from raw material to customer and back again, inside a set time limit.
Examples
- The plant runs 2 drills a year with a target of mapping a full batch path within 4 hours.
- The last drill took 3 hours 20 minutes and reconciled 96 percent of the quantity.
Easy to get wrong
A drill only passes when the quantities reconcile too. Mapping the path but missing 4 percent means a real recall would leave 1,600 bottles unaccounted for.
44Product withdrawalRút hàng khỏi kênh
Definition
Pulling stock back from customers and stores when the defect is not a safety issue, with no public notice.
Examples
- 12,000 bottles with a wrong production date were pulled back from 3 distributors within 24 hours.
- The cost was 18 million dong of transport plus 38 million dong of stock value, with no notification cost.
Easy to get wrong
A withdrawal is not a recall. A withdrawal stops inside the distribution channel, while a recall has to reach the consumer and always carries a public notice.
45Product recallThu hồi sản phẩm
Definition
Taking back product already sold to consumers when there is a safety risk, with a public notice.
Examples
- One batch of 40,000 bottles was recalled at a stock value of 128 million dong, with total cost including transport and notices at 480 million dong.
- After 10 days 78 percent of the bottles came back, and the rest was treated as already consumed.
Easy to get wrong
The biggest cost of a recall is not the stock returned. Lost sales and the trust that has to be rebuilt usually run to several times that 480 million dong figure.