By the end of this chapter you can

• Say what the module does, what it leaves to other modules, and what its capability tiers mean.
• Explain why every kind of quality event lives in one supertype table with small detail tables.
• Name the six material review dispositions and say what each does to the lot and its hold.
• Explain the difference between an advisory flag and a hold that is enforced in the database.

What Quality management does

The module manages quality events end to end: nonconformances and material review, deviations, complaints, CAPA (corrective and preventive action) with root cause and effectiveness checks, audits, change control, risk in the form of FMEA (failure mode and effects analysis), and supplier quality. All of it sits on one record model, with holds that stop product. It replaces the electronic quality management system (eQMS) a business usually pays for: MasterControl, ETQ Reliance, Veeva Vault QMS, TrackWise, Intelex, Qualio, Greenlight Guru, QT9 or Ideagen Quality ^[5][6].

Its tables share the prefix qms_. Like every module on the platform it has no people list, site list, item list or file store of its own: it points at the shared spine (core_person, core_site, core_item, core_lot, core_equipment, core_party, core_attachment, core_e_signature and others), so a quality event about a lot is a row that points at the same lot every other module uses.

• In: the quality event supertype with NCR, deviation, complaint, audit finding and supplier corrective action request (SCAR) subtypes; material review board (MRB) disposition and quality holds on lots, orders or equipment; CAPA with 8D, 5-Why, fishbone and A3; internal, supplier and regulatory audits; change control with impact assessment; FMEA with the AIAG-VDA action priority; approved supplier list, scorecards and PPAP status.
• Out: the document lifecycle (M06), training records (M07), SPC charts and capability (M09), and the engineering change of product definitions (M14 ECO, which links to a change request here).

Eleven capabilities in three tiers

Each capability carries a tier. MVP must exist for a small or mid-size business to cancel the incumbent subscription with confidence. STD is parity with mainstream tools, what a buyer expects in a demo. BIC marks best-in-class differences, such as those made possible by AI.

The standards, and what each is used for

One supertype for every event

Every quality event, whatever it is called on the floor, is a row in qms_quality_event: an NCR (nonconformance report), a deviation, a complaint, an audit finding, a SCAR, an observation or an out-of-specification (OOS) result. The row carries what every event needs: an event number, a type, a title, a severity, a status, an owner, a due date, and pointers to the site, item, lot, equipment, supplier and customer it concerns. Three kinds need extra fields, which live in small detail tables that point back at the event.

Severity is one of critical, major, minor or observation. Events arrive from forms that failed an item (frm.response.failed), SPC violations (spc.violation.detected), laboratory out-of-spec results (lims.result.oos), machine parameters out of spec (mes.parameter.out_of_spec), calibrations out of tolerance (cmms.calibration.out_of_tolerance) and customer service tickets (svc.ticket.complaint). Each carries source_type and source_id, and a retry from another module must create no second event.

Material review: a signed decision

An NCR adds a row in qms_ncr_detail: the quantity affected and its unit, the defect code (from the defect taxonomy in qms_defect_code), the containment taken, the cost of poor quality, and the disposition. The material review board decides the disposition, which is one of six values; until it is decided it is pending.

The decision needs an electronic signature: a core_e_signature row with its meaning, the signer, the time and a hash (a fingerprint) of what was signed. A disposition other than pending without a signature and a decision time is refused by the database. The signer is not the person who reported or owns the event, so nobody approves their own work. 21 CFR Part 11 sets out what such signatures must carry ^[4].

Cost of poor quality (COPQ) is captured on the same row: the module adds up scrap, rework, returns and concessions cost per period. It is the number that tells a manager what the problems cost, and it is only as good as the NCRs entered.

Holds that stop product

A hold in qms_hold blocks a lot, production order, equipment, supplier, item or location (the target_type), for a reason, placed by a person at a time, optionally linked to the event that caused it. Its status is active, released or converted_to_scrap. Releasing needs a signature.

Exercise · Sort ten real quality records20 minutes

You need: Read access to your eQMS or quality log, a text file, and the quality manager for five minutes

Use the records your business has today. Do not copy customer, patient or employee names: record only the type, severity and status.

1. 1. Open the ten most recent quality records in your eQMS, spreadsheet or log and number them 1 to 10 in a text file.
2. 2. For each one, write the event_type it would be in this module: ncr, deviation, complaint, audit_finding, scar, observation or oos.
3. 3. For each one, write the severity (critical, major, minor or observation) and the status it would be in today.
4. 4. Mark every record that, in your business, should have stopped product, and write what it would have held: a lot, an order, equipment or a supplier.
5. 5. For each marked record, write how the hold works today: a flag, a note, a phone call, or a block in a system that the next person cannot ignore.
6. 6. Count how many of the ten sit in more than one list or system today, and read the result to the quality manager.

Outcome: A ten-line table of event type, severity, status and hold, and a count of how many records are split across lists today.

References

1. ISO 9001:2015, Quality management systems: requirements. https://www.iso.org/standard/62085.html
2. ISO 13485:2016, Medical devices: quality management systems. https://www.iso.org/standard/59752.html
3. 21 CFR Part 820, Quality System Regulation and QMSR (eCFR). https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820
4. 21 CFR Part 11, Electronic records and electronic signatures (eCFR). https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11
5. Prezent: eQMS platforms for life sciences. https://www.prezent.ai/blog/qms-for-life-sciences
6. SoftwareConnect: Veeva Vault QMS. https://softwareconnect.com/go/veeva-vault-qms-29564

By the end of this chapter you can

• Walk a CAPA through its statuses and say what each of the three gates refuses.
• Choose a root cause tool (5-Why, fishbone, is/is-not, fault tree, Pareto, timeline) and say where its content is stored.
• Explain how an audit result becomes a finding and then a CAPA, and why auditors must be impartial.
• Describe the change control path and what must be true before a change is implemented and closed.

CAPA: cause, action, proof

A CAPA record (qms_capa) starts from a problem, often an event, and keeps one story from the problem statement to the signed closure. It holds the origin event, the problem statement, the method (eight_d, five_why, a3, dmaic or other), the containment, the root cause and its category, the owner, the due date, the effectiveness criteria and the effectiveness result. ISO 9001:2015 clause 10.2 asks for exactly this chain on a nonconformity: react to it, find out whether similar ones exist or could occur, review and determine the cause, implement the action needed, review its effectiveness and update risks if necessary ^[1].

Root cause tools

Each tool is a row in qms_rca_artifact, with its content kept as JSON because the shape of a fishbone differs from a timeline: five_why, fishbone, is_is_not, fault_tree, pareto or timeline. The quality engineer or the CAPA owner builds them. The conclusion goes into the CAPA itself, as a root cause and a root cause category: man, machine, method, material, measurement, environment, design, supplier or unknown ^[2].

Actions, and the proof that they worked

The work of a CAPA is a list of rows in qms_capa_action, each with a type, an owner and a due date. The six types are different jobs:

An owner completes an action and attaches the evidence; a different person, never the owner, verifies it. Before the CAPA reaches implementation it has effectiveness criteria and an effectiveness due date: what will be true, measured how, by when, if the fix worked. After that date the quality engineer records effective or not_effective against the criteria. This is the Check in Plan-Do-Check-Act ^[5], and it is what separates a CAPA from a to-do list.

Audits: finding problems first

An audit (qms_audit) is an internal, supplier, customer, regulatory, certification, process, product or layered audit, with a standard reference, a scope, a lead auditor, an auditee and planned dates. Its checklist (qms_audit_item) has one row per question, with the clause reference, a result and the evidence. The results are conform, minor_nc, major_nc, ofi (opportunity for improvement), not_applicable and not_audited.

ISO 9001:2015 clause 9.2 asks that audits are run so that the auditors are objective and impartial ^[1]. In the module that becomes a rule: an auditor's home site (core_person.home_site_id) must differ from the audit's site_id, and an audit with no site_id, such as a supplier audit, is open to any assigned auditor. An audit cannot close while any checklist item has no result.

Change control: changing safely

A change request (qms_change_control) records what is changing and why: the type (process, equipment, material, supplier, document, software, facility or product), a classification (minor, major or critical), a risk level and an impact assessment kept as JSON, across documents, training, validation and regulatory filings. The work to carry it out is a list of rows in qms_change_task: document, training, validation, regulatory, equipment, supplier, it or other.

The signature is an approver's, with the meaning approved ^[6]; approving writes qms.change_control.approved for other modules to act on. A change request can also come from a CAPA, when an action of type document_change links to it. The engineering change of a product definition itself belongs to M14; the request here links to it.

Exercise · Walk a real CAPA through the three gates25 minutes

You need: Read access to one closed CAPA in your eQMS, a text file, and the quality manager

Choose a CAPA that is closed, preferably about a repeat problem. Look only at its fields; do not copy any names.

1. 1. Write the CAPA's problem statement in one sentence, and note the method used (8D, 5-Why, A3 or other).
2. 2. Gate 1: find the root cause and its category. Write whether the last 'why' is a cause in the process or a person, and whether a root cause was recorded before the action plan.
3. 3. List every action with its type, owner and due date, and mark whether a different person from the owner verified each one.
4. 4. Gate 2: write whether any action was open or unverified when the effectiveness check began.
5. 5. Gate 3: find the effectiveness criteria, the date and the result. Write what was measured, and whether the criteria were set before implementation.
6. 6. Find who signed the closure and whether they owned the CAPA or reported its event, and write one sentence on the weakest gate in this CAPA.

Outcome: A one-page gate review of a real CAPA that names the weakest gate, ready to turn into a test in Session 4.

References

1. ISO 9001:2015, Quality management systems: requirements. https://www.iso.org/standard/62085.html
2. ASQ: What is root cause analysis?. https://asq.org/quality-resources/root-cause-analysis
3. ASQ: Fishbone (cause and effect) diagram. https://asq.org/quality-resources/fishbone
4. ASQ: Five whys and five whys analysis. https://asq.org/quality-resources/five-whys
5. ASQ: The Plan-Do-Check-Act (PDCA) cycle. https://asq.org/quality-resources/pdca-cycle
6. 21 CFR Part 11, Electronic records and electronic signatures (eCFR). https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11

By the end of this chapter you can

• Describe an FMEA line and the three ratings that drive its action priority.
• Explain why an RPN alone hides risk, and what the AIAG-VDA action priority does instead.
• Describe the approved supplier list statuses, the scorecard and what PPAP tracks.

FMEA: finding failures on paper

Failure mode and effects analysis lists, step by step, how a design or a process could fail, what that would cause, and what is done about it ^[2]. In the module an FMEA has a header (qms_fmea: number, type design, process or machinery, the item or process it covers, a revision, the team, and a status of draft, active or superseded) and many lines (qms_fmea_line). The AIAG-VDA FMEA Handbook (2019) describes a seven-step method: planning and preparation, structure analysis, function analysis, failure analysis, risk analysis, optimization, and results documentation ^[6].

Each line names a step or function, a failure mode, its effect, the cause, the prevention controls and the detection controls. Three ratings, each a whole number from 1 to 10, score it: severity of the effect, occurrence of the cause, and detection of the failure before it reaches the customer. The line may mark a special characteristic: none, cc (critical) or sc (significant), which the control plan (M09) follows. A recommended action gets an owner and a due date, and after it is done the line records the revised severity, occurrence and detection.

Action priority, not RPN alone

For many years lines were ranked by the risk priority number (RPN), the product severity × occurrence × detection. Two very different lines can have the same product.

The AIAG-VDA handbook replaces ranking by RPN alone with an action priority of high, medium or low, read from a table of the three ratings ^[6]. In the module a function, qms_action_priority(s, o, d), holds that table, and a trigger on qms_fmea_line always sets action_priority from it, so a typed value is never trusted.

Risk methods differ by industry. ISO 14971:2019 covers risk management for medical devices ^[3], and ICH Q9(R1) quality risk management applies to pharmaceuticals ^[4]. The module's tables keep the names qms_fmea and qms_fmea_line, because the CivOps automated process FMEA and control plan generation build on them.

Exercise · Rate three failure modes20 minutes

You need: One process step from your own plant, a text file, and the person who runs that step

Pick one step that has caused a problem in the last year. You will not need the handbook's table for this exercise; the aim is the ratings and the RPN comparison.

1. 1. Name the process step and write three ways it could fail, one line each (the failure modes).
2. 2. For each, write the effect on the next step or on the customer, and the cause.
3. 3. For each, write the current prevention controls and the current detection controls, using the words the person who runs the step uses.
4. 4. Rate severity, occurrence and detection from 1 to 10 for each line. Agree each rating with the person who runs the step.
5. 5. Multiply the three ratings for each line to get the RPN. Find two lines with similar RPN and very different severity, or write that none exist.
6. 6. Mark the line with the highest severity as the first to look at, whatever its RPN, and write why.

Outcome: Three rated FMEA lines with ratings agreed by the person who runs the step, and a note on whether RPN alone would have ranked them correctly.

Supplier quality

Suppliers are managed on the approved supplier list (qms_approved_supplier): a supplier, the item class it is approved for, and a status of pending, approved, conditional, probation or disqualified, with the approval date, the date requalification is due, its certifications and a risk rating of low, medium or high. A supplier is always a row in core_party, the shared list of suppliers and customers.

A scorecard (qms_supplier_scorecard) holds the period, ppm (defective parts per million), on-time percentage, the SCAR count, responsiveness, a score and a grade of a, b, c or d. The numbers typed in, ppm and on-time percentage, come from the business's receiving records, with the source noted. A SCAR is a quality event of type scar with the supplier_party_id set, so it appears in every event count as well as on the scorecard.

For automotive suppliers, IATF 16949 with the AIAG Core Tools asks for APQP, PPAP, FMEA, MSA and SPC ^[1][5]. The production part approval process (PPAP) is tracked in qms_ppap_submission: the supplier, the part, the PPAP level (a whole number), the elements as JSON (the module does not fix their list), and a status of requested, submitted, approved, interim or rejected, with the dates submitted and decided.

References

1. AIAG: Quality Core Tools (APQP, CP, PPAP, FMEA, MSA, SPC). https://www.aiag.org/expertise-areas/quality/quality-core-tools
2. ASQ: Failure mode and effects analysis (FMEA). https://asq.org/quality-resources/fmea
3. ISO 14971:2019, Medical devices: application of risk management. https://www.iso.org/standard/72704.html
4. ICH quality guidelines, including Q9(R1) and Q10. https://www.ich.org/page/quality-guidelines
5. IATF Global Oversight: IATF 16949. https://www.iatfglobaloversight.org/
6. AIAG: AIAG & VDA FMEA Handbook (product FMEAAV-1). https://www.aiag.org/training-and-resources/manuals/details/FMEAAV-1

By the end of this chapter you can

• Name the eighteen qms_ tables and read their columns, types and required flags.
• Say what the five roles and four machine accounts do, and why the rights must cover the whole module.
• Define each KPI and hand-count the seeded data to check a dashboard.
• State the three checks that define done and the rule for importing history from the old tool.

Eighteen tables on the shared spine

Every table starts with the standard columns every platform table has: id, tenant_id, created_at, created_by, updated_at, updated_by, row_version, archived_at and ext. Foreign keys point only at core_ tables and at each other. The table below lists every column the module adds. It is what your agent builds from in Session 2.

Types are as in the specification: text, int, num (a decimal number), bool, ts (a timestamp with time zone), date, uuid, json (jsonb in Postgres), qty (a quantity) and money. An arrow means a foreign key to that table. req means required (not null), and a list after a colon is the set of allowed values, enforced by a check constraint.

Look at the rules that follow from the list. event_no, hold_no, capa_no, audit_no, cc_no and fmea_no are each unique per tenant, issued from the spine's number sequences and never counted by hand. The ratings on qms_fmea_line and the three revised ratings are whole numbers from 1 to 10. A detail table's quality_event_id is required and unique. Money and quantities are typed columns, and JSON is used only where the shape varies: root cause artifacts, impact assessments, teams, certifications, PPAP elements.

Five roles, four machine accounts

Roles are jobs, not names, and each maps to a row in the spine's core_job_role. The Role and Exposure Matrix of Session 3 gives each one the rights its job needs and nothing else. Nobody gets delete: a correction is a new row or a cancelled status.

Other modules talk to this one through events. It publishes qms.event.created, qms.hold.placed, qms.hold.released, qms.capa.closed, qms.change_control.approved and qms.capa_action.training_required. It consumes frm.response.failed, spc.violation.detected, lims.result.oos, mes.parameter.out_of_spec, cmms.calibration.out_of_tolerance and svc.ticket.complaint.

Six numbers

Management review under ISO 9001:2015 clause 9.3 is where numbers like these are looked at ^[4], and a dashboard is only trusted when it matches a count made by hand. Session 2 seeds a small, invented quarter: eight events, six CAPAs, two holds and one audit. In Session 4 you count it by hand, then build the dashboard on queries over the typed tables, and it must match exactly. If it does not, fix the query, not the count.

Three checks that define done

• A held lot cannot be consumed in MES or shipped in WMS (a cross-module test).
• A CAPA cannot close without an effectiveness result.
• The action priority computed from severity, occurrence and detection matches the AIAG-VDA table on test vectors read independently from the handbook.

Three compliance rules sit beside them. Holds are enforced at the database and API level in every module that can move or consume material. Closure and MRB disposition require electronic signatures ^[1]. A complaint's reportability decision must record its rationale. Analytics and AI suggestions, such as triage or CAPA drafts, are drafts only: a person approves each one.

Cutover: the old history comes in

Export the open and closed events, CAPAs and audits with their attachments from the old eQMS. Open work and active holds come in live; closed records come in as read-only history, with the original signatures kept as attached evidence, not as new signatures.

The old tool's bill is a figure from its invoice, never an estimate. Read the vendor's cancellation terms from your own account page (notice period, renewal date, export window) and take the full export before the last day. Further reading on what buyers weigh when choosing or replacing a QMS tool is in ^[2] and ^[3].

Exercise · Hand-count your own export25 minutes

You need: A report or export from your eQMS (counts only), a spreadsheet, and the quality manager

Use counts, not records: no names, no customers, no free text. This is the count your dashboard will have to match.

1. 1. Run the eQMS report for one past quarter and note the report name and the dates.
2. 2. Count events by type and status, and CAPAs raised, due, closed by the due date and closed late.
3. 3. Add the cost of poor quality for the quarter from your NCR records (scrap, rework, returns and concessions), and name the source of each figure.
4. 4. Compute CAPA on-time closure (closed by the due date ÷ CAPAs due) and, from the closed ones, CAPA effectiveness rate (effective ÷ verified).
5. 5. List the active holds today and what each one holds.
6. 6. Write all of it in docs/qms-count.md with the date, and ask the quality manager to confirm the counts before you rely on them.

Outcome: A confirmed hand count of one quarter, with the report named, which a new dashboard must match exactly.

References

1. 21 CFR Part 11, Electronic records and electronic signatures (eCFR). https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11
2. Rajesh Kumar: top 10 QMS buyer criteria. https://www.rajeshkumar.xyz/blog/quality-management-systems-qms/
3. SoftwareConnect: TrackWise eQMS. https://softwareconnect.com/reviews/trackwise/
4. ISO 9001:2015, Quality management systems: requirements. https://www.iso.org/standard/62085.html

Choose one answer for each question, then submit. You will see the right answer and why for every question.

1. What is the main reason every quality event lives in one supertype table with small detail tables?

AIt takes less disk space than several tables wouldBTrending across all event kinds is one queryCAuditors require a single table for all eventsDDetail tables are not allowed to have their own columns

2. What makes a quality hold different from an advisory flag on a lot?

AIt shows in a different colour on the lot screen so that people notice itBIt sends an email to the quality engineer whenever the lot is searchedCIt can only be placed by a person with the approver role in the matrixDEvery moving route checks it, and the database refuses the move

3. Who chooses the disposition on a nonconformance, and what does it need?

AThe approver, by e-signature, not the reporter or ownerBThe reporter, who knows the lot best, entering it as soon as the event is raisedCThe CAPA owner, once the root cause has been found and the actions are plannedDThe quality engineer, who may type it in without a signature if the cost is small

4. An NCR is dispositioned scrap. What happens to the lot and its hold?

AThe lot is released at once and the hold is deletedBThe hold stays active until a person remembers to release itCThe lot is rejected and the hold is converted to scrapDThe lot returns to the supplier and the hold is released with a signature

5. A CAPA has an effectiveness result of pending. What does the module do when someone tries to close it?

AIt closes, and the owner fills in the result laterBIt closes if the approver signs, because the signature is the controlCIt refuses until the approver signs, then closes with the result still pendingDIt refuses, because a closed CAPA needs an effectiveness result

6. Who verifies a CAPA action once its owner has completed it?

ASomeone other than the owner of the actionBThe owner of the action, by attaching the evidenceCThe supplier named on the origin eventDNo one; the action counts as verified when it is completed

7. What does a fishbone diagram do in a root cause investigation?

AIt ranks defects by how often each one happened over a periodBIt lists the steps of the process in the time order they happenCIt tests whether a cause is present both with and without the problemDIt groups possible causes under headings such as machine or method

8. An audit checklist item is marked minor_nc. What does the module do?

ANothing until the audit report is written and signedBIt creates an audit_finding event linked from the itemCIt closes the audit as conforming with an observationDIt deletes the item so that the result is not counted twice

9. Why does the AIAG-VDA handbook replace ranking by RPN alone with an action priority?

AEqual RPNs can hide very different risks, so the combination countsBRPN cannot be computed for design FMEAs, only for process FMEAsCAction priority removes the need for severity, occurrence and detectionDRPN values above 100 are not allowed by IATF 16949

10. How many combinations of severity, occurrence and detection, each from 1 to 10, must the action priority function cover?

A30B100C1,000D10,000

11. How does a closed event from the old eQMS come into the new module?

AAs a new open event, so that the quality engineer can review itBAs archived, read-only history with signatures kept as evidenceCAs a live record with a new signature created by the importerDIt is left out, because the old tool is kept running for the past

12. How is scar_count on a supplier scorecard set?

ATyped by the quality engineer at the end of each periodBCopied from the supplier's own delivery reportCCounted by the route from the period's scar eventsDAveraged from the grade of the last three periods

13. How is CAPA on-time closure defined?

ACAPAs closed ÷ CAPAs opened since the system beganBCAPAs closed by the due date ÷ CAPAs dueCEffective CAPAs ÷ verified CAPAsDThe average number of days from open to close

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