diff --git a/config/core.yaml b/config/core.yaml index 657c5bc..e3d4f37 100644 --- a/config/core.yaml +++ b/config/core.yaml @@ -43,7 +43,7 @@ clauses: documents: [resource_plan, competence_matrix, communication_plan, documented_info_procedure] - id: "8" title: "Operation" - documents: [process_map, customer_requirements_procedure, nonconformity_procedure] + documents: [process_map, customer_requirements_procedure, supplier_evaluation, nonconformity_procedure] - id: "9" title: "Performance Evaluation" documents: [internal_audit_procedure, management_review_procedure, kpi_dashboard] @@ -81,7 +81,7 @@ documents: # Clause 6 - id: risk_register title: "Risk Register" - template: null + template: risk_register clause: "6.1" - id: opportunity_register title: "Opportunity Register" @@ -98,7 +98,7 @@ documents: clause: "7.1" - id: competence_matrix title: "Competency Matrix" - template: null + template: competence_matrix clause: "7.2" - id: communication_plan title: "Communication Plan" @@ -117,6 +117,10 @@ documents: title: "Procedure: Determination of Customer Requirements" template: procedure clause: "8.2" + - id: supplier_evaluation + title: "Supplier Evaluation" + template: supplier_evaluation + clause: "8.4" - id: nonconformity_procedure title: "Procedure: Control of Nonconforming Outputs" template: procedure @@ -132,7 +136,7 @@ documents: clause: "9.3" - id: kpi_dashboard title: "KPI Dashboard / Performance Indicators" - template: null + template: kpi_dashboard clause: "9.1" # Clause 10 - id: capa_procedure diff --git a/templates/capa_form.md.j2 b/templates/capa_form.md.j2 index 5b5e805..694bd32 100644 --- a/templates/capa_form.md.j2 +++ b/templates/capa_form.md.j2 @@ -1,4 +1,4 @@ -# CAPA Form — Corrective Action +# Corrective Action (CAPA) — {{ capa_id }} | Field | Value | |-------|-------| @@ -6,48 +6,69 @@ | **Organisation** | {{ org_name }} | | **Opened** | {{ opened_date }} | | **Opened by** | {{ opened_by }} | +| **Source (NC / Audit / other)** | {{ source_ref }} | | **ISO Clause** | 10.2 | --- -## 1. Background +## 1. Problem Description -**Source (NC ID / Audit Finding / other trigger):** {{ source_ref }} +**Describe what happened, where, and when:** -**Problem Description:** +*(Factual, objective description — avoid assumptions about causes at this stage.)* -> **⚠ TODO:** describe the problem +**Extent:** ☐ Isolated incident ☐ Recurring issue ☐ Systemic / widespread -## 2. Immediate Correction +**Customer impact:** ☐ No impact ☐ Internal impact only ☐ Customer affected -**Action:** TODO -**Completed by:** TODO -**Completed on:** TODO +## 2. Immediate Containment + +Actions taken to stop further impact before the root cause is addressed: + +| Action | Responsible | Completed by | +|--------|-------------|--------------| +| | | | +| | | | ## 3. Root Cause Analysis -**Method:** ☐ 5-Why ☐ Ishikawa ☐ Other: TODO +**Method:** ☐ 5-Why ☐ Ishikawa ☐ Fault Tree ☐ Other: ___________ + +### 5-Why + +| # | Question | Answer | +|---|----------|--------| +| 1 | Why did the problem occur? | | +| 2 | Why did that happen? | | +| 3 | Why did that happen? | | +| 4 | Why did that happen? | | +| 5 | Why did that happen? | | + +**Root Cause (confirmed):** + +*(State the root cause in one clear sentence. This is the basis for corrective actions.)* + +## 4. Corrective Actions -**Root Cause Identified:** +| # | Action | Responsible | Due Date | Done | +|---|--------|-------------|----------|------| +| 1 | | | | ☐ | +| 2 | | | | ☐ | +| 3 | | | | ☐ | -> **⚠ TODO:** describe root cause +## 5. Effectiveness Verification -## 4. Corrective Action +**Planned review date:** ___________ -| Action | Responsible | Due Date | Done | -|--------|-------------|----------|------| -| TODO | TODO | TODO | ☐ | +**Verification method:** ☐ Re-audit ☐ KPI trend review ☐ Process observation ☐ Other -## 5. Effectiveness Review +**Conducted by:** ___________ **Date:** ___________ -**Review planned for:** TODO -**Review conducted on:** TODO -**Result:** ☐ Effective ☐ Not effective → new CAPA required +**Result:** ☐ Effective — close CAPA ☐ Not effective — open new CAPA: ___________ -## 6. Closure +## 6. CAPA Closure -**Closed on:** TODO -**Closed by:** TODO +**Closed on:** ___________ **Closed by:** ___________ --- diff --git a/templates/competence_matrix.md.j2 b/templates/competence_matrix.md.j2 new file mode 100644 index 0000000..2acb1c9 --- /dev/null +++ b/templates/competence_matrix.md.j2 @@ -0,0 +1,53 @@ +# Competence Matrix + +| Field | Value | +|-------|-------| +| **Organisation** | {{ org_name }} | +| **Version** | {{ version }} | +| **Last Review** | {{ date }} | +| **Reviewed by** | {{ quality_officer }} | +| **ISO Clause** | 7.2 | + +--- + +## Competence Level Legend + +**R** = Required (awareness level) · **T** = Trained (can perform with guidance) +**E** = Expert (can perform independently and train others) · **—** = Not required + +## Competence Matrix + +| Competence | QMO | Management | Process Owner | Staff | +|------------|-----|------------|---------------|-------| +| ISO 9001:2015 awareness | E | R | R | R | +| Quality Policy and objectives | E | E | T | R | +| Document control (Clause 7.5) | E | T | T | R | +| Risk and opportunity assessment (Clause 6.1) | E | T | T | — | +| Internal audit methodology (Clause 9.2) | E | — | T | — | +| Nonconformity and CAPA process (Clause 10.2) | E | T | T | R | +| Customer requirements capture (Clause 8.2) | T | R | E | T | +| Product / service process knowledge | T | R | E | E | +| KPI measurement and analysis (Clause 9.1) | E | T | T | — | + +> **⚠ Add role-specific technical competences relevant to your processes below.** + +## Training Record + +| Name | Role | Training | Date | Provider | Valid Until | Evidence | +|------|------|----------|------|----------|-------------|----------| +| | QMO | ISO 9001:2015 Lead Implementer | | | | Certificate | +| | QMO | Internal Auditor | | | | Certificate | +| | All | ISO 9001:2015 Awareness | | | | Attendance sheet | +| | Process Owner | Product / Process Training | | | | Sign-off sheet | + +## Training Plan + +| Training | Target Group | Planned Date | Status | +|----------|-------------|--------------|--------| +| ISO 9001:2015 awareness refresh | All staff | | ☐ Planned ☐ Done | +| Internal auditor re-qualification | QMO | | ☐ Planned ☐ Done | +| Onboarding QMS introduction | New staff | On hire | ☐ Planned ☐ Done | + +--- + +*ISO 9001:2015 · Clause 7.2 · {{ org_name }}* diff --git a/templates/internal_audit_checklist.md.j2 b/templates/internal_audit_checklist.md.j2 index c4ea19b..09d12ba 100644 --- a/templates/internal_audit_checklist.md.j2 +++ b/templates/internal_audit_checklist.md.j2 @@ -7,41 +7,55 @@ | **Auditor** | {{ auditor }} | | **Audit Scope** | {{ audit_scope }} | | **Contact Person** | {{ contact }} | +| **ISO Clause** | 9.2 | --- ## ISO 9001:2015 Checklist -| Clause | Check Point | Compliant | Observation / Finding | -|--------|-------------|-----------|----------------------| -| 4.1 | Context analysis documented and up to date? | ☐ Yes ☐ No ☐ N/A | | -| 4.2 | Interested parties register maintained? | ☐ Yes ☐ No ☐ N/A | | -| 4.3 | QMS scope defined? | ☐ Yes ☐ No ☐ N/A | | -| 5.2 | Quality policy communicated and understood? | ☐ Yes ☐ No ☐ N/A | | -| 5.3 | Roles and responsibilities clearly assigned? | ☐ Yes ☐ No ☐ N/A | | -| 6.1 | Risks and opportunities assessed? | ☐ Yes ☐ No ☐ N/A | | -| 6.2 | Quality objectives measurable and documented? | ☐ Yes ☐ No ☐ N/A | | -| 7.2 | Competency matrix current, training evidenced? | ☐ Yes ☐ No ☐ N/A | | -| 7.4 | Communication plan implemented? | ☐ Yes ☐ No ☐ N/A | | -| 7.5 | Document control procedure followed? | ☐ Yes ☐ No ☐ N/A | | -| 8.1 | Processes planned and controlled? | ☐ Yes ☐ No ☐ N/A | | -| 8.2 | Customer requirements determined and met? | ☐ Yes ☐ No ☐ N/A | | -| 8.7 | Nonconformities recorded and addressed? | ☐ Yes ☐ No ☐ N/A | | -| 9.1 | KPIs measured and evaluated? | ☐ Yes ☐ No ☐ N/A | | -| 9.3 | Management review conducted? | ☐ Yes ☐ No ☐ N/A | | -| 10.2 | CAPAs closed on time and verified effective? | ☐ Yes ☐ No ☐ N/A | | - -## Audit Result - -**Overall Assessment:** ☐ Conforming ☐ Conditionally conforming ☐ Non-conforming - -**Key Findings:** - -> **⚠ TODO:** describe findings - -**Recommendations:** - -> **⚠ TODO:** recommendations +**Result codes:** C = Conforming · NC = Nonconformity · OB = Observation · N/A = Not applicable + +| Clause | Check Point | Result | Finding / Evidence | +|--------|-------------|--------|--------------------| +| 4.1 | Context analysis documented and kept up to date? | | | +| 4.2 | Interested parties register maintained and reviewed? | | | +| 4.3 | QMS scope defined, documented, and justified? | | | +| 4.4 | QMS processes identified with inputs, outputs, owners? | | | +| 5.1 | Leadership demonstrates commitment to QMS? | | | +| 5.2 | Quality policy communicated, understood by staff? | | | +| 5.3 | Roles, responsibilities, and authorities defined? | | | +| 6.1 | Risks and opportunities assessed and addressed? | | | +| 6.2 | Quality objectives measurable, monitored, communicated? | | | +| 7.1 | Resources (people, infrastructure, environment) adequate? | | | +| 7.2 | Competence matrix current; training records available? | | | +| 7.4 | Internal and external communication controlled? | | | +| 7.5 | Document control procedure followed; records retained? | | | +| 8.1 | Operational processes planned, executed, controlled? | | | +| 8.2 | Customer requirements determined, reviewed, met? | | | +| 8.4 | Externally provided products/services controlled? | | | +| 8.7 | Nonconforming outputs identified, segregated, recorded? | | | +| 9.1 | KPIs measured, analysed, and evaluated regularly? | | | +| 9.2 | Internal audit programme implemented as planned? | | | +| 9.3 | Management review conducted with all required inputs? | | | +| 10.2 | CAPAs opened for all NCs; effectiveness verified? | | | +| 10.3 | Continual improvement activities evidenced? | | | + +## Nonconformities Raised + +| NC ID | Clause | Description | Severity | +|-------|--------|-------------|----------| +| | | | ☐ Major ☐ Minor | +| | | | ☐ Major ☐ Minor | + +## Audit Summary + +**Overall Result:** ☐ Conforming ☐ Conditionally conforming ☐ Non-conforming + +**Strengths observed:** + +**Key findings / recommendations:** + +**Follow-up required by:** ___________ --- diff --git a/templates/kpi_dashboard.md.j2 b/templates/kpi_dashboard.md.j2 new file mode 100644 index 0000000..8cb8b5d --- /dev/null +++ b/templates/kpi_dashboard.md.j2 @@ -0,0 +1,59 @@ +# KPI Dashboard + +| Field | Value | +|-------|-------| +| **Organisation** | {{ org_name }} | +| **Reporting Period** | {{ date }} | +| **Prepared by** | {{ quality_officer }} | +| **ISO Clause** | 9.1 | + +--- + +## Performance Overview + +**Status:** ✓ On target · ⚠ At risk · ✗ Off target · Trend: ↑ Improving · → Stable · ↓ Declining + +| KPI | Clause | Target | Actual | Status | Trend | Action Required | +|-----|--------|--------|--------|--------|-------|-----------------| +| Customer Satisfaction Score (1–5) | 9.1.2 | ≥ 4.0 | | ☐ ✓ ☐ ⚠ ☐ ✗ | | | +| Number of Nonconformities | 9.1 | < prev. period | | ☐ ✓ ☐ ⚠ ☐ ✗ | | | +| CAPA Closure Rate | 10.2 | ≥ 90 % | | ☐ ✓ ☐ ⚠ ☐ ✗ | | | +| Audit Plan Completion | 9.2 | 100 % | | ☐ ✓ ☐ ⚠ ☐ ✗ | | | +| Training Plan Completion | 7.2 | ≥ 95 % | | ☐ ✓ ☐ ⚠ ☐ ✗ | | | + +## Customer Feedback + +| Source | Volume | Positive | Complaints | Avg. Score | +|--------|--------|----------|------------|------------| +| Customer surveys | | | | | +| Direct feedback / calls | | | | | +| Returns / escalations | | | | | +| **Total** | | | | | + +## CAPA Status + +| Status | Count | +|--------|-------| +| Open | | +| In Progress | | +| Effectiveness Review | | +| Closed this period | | +| Overdue | | + +## Actions Required + +| KPI | Issue | Action | Owner | Due Date | +|-----|-------|--------|-------|----------| +| | | | | | + +## Trend History + +| KPI | Q1 | Q2 | Q3 | Q4 | +|-----|----|----|----|----| +| Customer Satisfaction | | | | | +| Nonconformities | | | | | +| CAPA Closure Rate | | | | | + +--- + +*ISO 9001:2015 · Clause 9.1 · {{ org_name }}* diff --git a/templates/mgmt_review_agenda.md.j2 b/templates/mgmt_review_agenda.md.j2 index bd6a5ea..6b69caf 100644 --- a/templates/mgmt_review_agenda.md.j2 +++ b/templates/mgmt_review_agenda.md.j2 @@ -6,32 +6,52 @@ | **Date** | {{ date }} | | **Attendees** | {{ participants }} | | **Facilitated by** | {{ quality_officer }} | +| **ISO Clause** | 9.3 | --- -## Mandatory Agenda Items (ISO 9001:2015 Cl. 9.3.2) +## Agenda — Mandatory Inputs (ISO 9001:2015 Cl. 9.3.2) -| No. | Topic | Input | Responsible | -|-----|-------|-------|-------------| -| 1 | Status of actions from previous review | Previous MR minutes | {{ quality_officer }} | -| 2 | Changes in external / internal context | Context analysis | Management | -| 3 | Customer satisfaction & feedback | KPI dashboard | {{ quality_officer }} | -| 4 | Achievement of quality objectives / KPIs | KPI dashboard | {{ quality_officer }} | -| 5 | Process performance & product conformity | Process reports | Process owners | -| 6 | Nonconformities & CAPA status | NC/CAPA list | {{ quality_officer }} | -| 7 | Internal audit results | Audit reports | {{ quality_officer }} | -| 8 | Resource needs | **⚠ TODO:** source | Management | -| 9 | Opportunities for improvement | All inputs | All | +| No. | Topic | Input Document | Responsible | Time | +|-----|-------|---------------|-------------|------| +| 1 | Status of actions from previous review | Previous MR minutes | {{ quality_officer }} | | +| 2 | Changes in external / internal context | Context analysis | Management | | +| 3 | Customer satisfaction and feedback | KPI Dashboard | {{ quality_officer }} | | +| 4 | Quality objectives / KPI achievement | KPI Dashboard | {{ quality_officer }} | | +| 5 | Process performance and product conformity | Process reports | Process Owners | | +| 6 | Nonconformities and CAPA status | NC/CAPA list | {{ quality_officer }} | | +| 7 | Internal and external audit results | Audit reports | {{ quality_officer }} | | +| 8 | Performance of external providers | Supplier evaluation | Process Owners | | +| 9 | Adequacy of resources | Resource plan | Management | | +| 10 | Opportunities for improvement | All inputs above | All | | -## Decisions and Actions +## KPI Summary -| No. | Decision / Action | Responsible | Due Date | -|-----|-------------------|-------------|----------| -| 1 | **⚠ TODO** | TODO | TODO | +| KPI | Target | Actual | Status | +|-----|--------|--------|--------| +| Customer Satisfaction | ≥ 4.0 | | ☐ ✓ ☐ ⚠ ☐ ✗ | +| Nonconformities | < prev. period | | ☐ ✓ ☐ ⚠ ☐ ✗ | +| CAPA Closure Rate | ≥ 90 % | | ☐ ✓ ☐ ⚠ ☐ ✗ | +| Audit Plan Completion | 100 % | | ☐ ✓ ☐ ⚠ ☐ ✗ | +| Training Completion | ≥ 95 % | | ☐ ✓ ☐ ⚠ ☐ ✗ | + +## Decisions and Actions (ISO 9001:2015 Cl. 9.3.3) + +| No. | Decision / Action | Responsible | Due Date | Done | +|-----|-------------------|-------------|----------|------| +| 1 | | | | ☐ | +| 2 | | | | ☐ | +| 3 | | | | ☐ | + +## QMS Suitability Assessment + +**Is the QMS still suitable, adequate, and effective?** ☐ Yes ☐ No → actions above + +**Resource changes required?** ☐ Yes (see actions) ☐ No ## Next Management Review -**Planned:** **⚠ TODO:** date +**Planned date:** ___________ **Frequency:** ☐ Annual ☐ Semi-annual ☐ Other --- diff --git a/templates/policy.md.j2 b/templates/policy.md.j2 index 6e17876..f49789e 100644 --- a/templates/policy.md.j2 +++ b/templates/policy.md.j2 @@ -9,23 +9,41 @@ --- -## Our Quality Commitment +## Statement -{{ org_name }} is committed to ... +{{ org_name }} is committed to delivering products and services that consistently +meet customer requirements and applicable regulatory obligations. -> **⚠ TODO:** Insert quality policy statement. Describe what quality means to the organisation, -> what commitments management makes, and how customer needs are addressed. -> Aim for 3–5 concise sentences that reflect the company culture. +We achieve this by: + +- Understanding our customers' needs and striving to exceed their expectations +- Setting measurable quality objectives and reviewing them at each Management Review +- Empowering every employee to identify and act on improvement opportunities +- Preventing defects through proactive risk management rather than reactive correction +- Maintaining a QMS certified to ISO 9001:2015 ## Quality Objectives -Specific quality objectives are defined in the objectives and action plan (Clause 6.2) -and reviewed regularly during the Management Review (Clause 9.3). +Specific, measurable quality objectives are defined in the Quality Objectives and +Action Plan (Clause 6.2) and tracked in the KPI Dashboard (Clause 9.1). + +| Objective | Indicator | Target | +|-----------|-----------|--------| +| Customer satisfaction | Customer satisfaction score | ≥ 4.0 / 5.0 | +| Defect reduction | Number of nonconformities | < previous period | +| Timely corrective actions | CAPA closure rate | ≥ 90 % | +| Audit compliance | Audit plan completion | 100 % | +| Staff competence | Training plan completion | ≥ 95 % | ## Communication -This Quality Policy is communicated to all employees and is available to -interested parties upon request. +This Quality Policy is communicated to all employees during onboarding and reviewed +at least annually. It is available to customers and interested parties upon request. + +## Review + +Management reviews the continued suitability of this policy at each Management Review +(Clause 9.3) and revises it whenever the business context changes significantly. --- diff --git a/templates/procedure.md.j2 b/templates/procedure.md.j2 index 75c6f57..47c3331 100644 --- a/templates/procedure.md.j2 +++ b/templates/procedure.md.j2 @@ -13,32 +13,55 @@ ## 1. Purpose -> **⚠ TODO:** Describe the purpose of this procedure. +This procedure defines how {{ org_name }} controls **{{ procedure_title }}** +in accordance with ISO 9001:2015 Clause {{ clause }}. + +The objective is to ensure this process is executed consistently, documented, +and verifiable across all relevant organisational units. ## 2. Scope -> **⚠ TODO:** Who and what does this procedure apply to? +Applies to all activities related to {{ procedure_title }} within the defined +QMS scope of {{ org_name }}. Exceptions require written approval from {{ approver }}. -## 3. Terms and Abbreviations +## 3. Responsibilities -| Term | Definition | -|------|------------| -| TODO | TODO | +| Role | Responsibility | +|------|----------------| +| {{ owner_role }} | Process execution, record creation and maintenance | +| {{ approver }} | Approval of process outputs and exceptions | +| Quality Management Officer | Procedure maintenance, training, internal audit | +| Staff | Following this procedure; reporting deviations | -## 4. Process +## 4. Process Steps -> **⚠ TODO:** Describe the process steps. -> Tip: export a draw.io process diagram as PNG and embed it here. +| Step | Activity | Responsible | Input | Output / Record | +|------|----------|-------------|-------|-----------------| +| 1 | Initiate | {{ owner_role }} | Trigger event | Request / work order logged | +| 2 | Plan | {{ owner_role }} | Requirements | Plan or checklist documented | +| 3 | Execute | Responsible staff | Approved plan | Work evidence / record | +| 4 | Check | {{ approver }} | Output | Review sign-off | +| 5 | Archive | {{ owner_role }} | Completed record | Record filed per Clause 7.5 | -| Step | Activity | Responsible | Document / Record | -|------|----------|-------------|-------------------| -| 1 | TODO | TODO | TODO | +> **⚠ Adapt the steps above to the specific activities of this procedure.** ## 5. Related Documents -- **⚠ TODO:** Reference relevant forms, records, and other procedures +| Document | Relation | +|----------|----------| +| Quality Policy | Overarching commitment (Clause 5.2) | +| Risk Register | Risks affecting this process (Clause 6.1) | +| Internal Audit Checklist | Verification checklist (Clause 9.2) | +| CAPA Form | Handling deviations discovered during process execution | + +## 6. Records and Retention + +Records generated by this procedure are controlled in accordance with the +Procedure: Control of Documented Information (Clause 7.5). + +**Minimum retention period:** 3 years (or as required by applicable law / contract). -## 6. Change History +## 7. Change History | Version | Date | Change | Author | |---------|------|--------|--------| diff --git a/templates/qms_index.md.j2 b/templates/qms_index.md.j2 index ea055c4..d6c9718 100644 --- a/templates/qms_index.md.j2 +++ b/templates/qms_index.md.j2 @@ -11,9 +11,13 @@ | Clause | Document | Status | |--------|----------|--------| | 5.2 | [[Quality Policy>>QMS.quality_policy]] | ⚠ Draft | +| 6.1 | [[Risk Register>>QMS.risk_register]] | ⚠ Draft | +| 7.2 | [[Competency Matrix>>QMS.competence_matrix]] | ⚠ Draft | | 7.5 | [[Control of Documented Information>>QMS.documented_info_procedure]] | ⚠ Draft | | 8.2 | [[Determination of Customer Requirements>>QMS.customer_requirements_procedure]] | ⚠ Draft | +| 8.4 | [[Supplier Evaluation>>QMS.supplier_evaluation]] | ⚠ Draft | | 8.7 | [[Control of Nonconforming Outputs>>QMS.nonconformity_procedure]] | ⚠ Draft | +| 9.1 | [[KPI Dashboard>>QMS.kpi_dashboard]] | ⚠ Draft | | 9.2 | [[Internal Audit>>QMS.internal_audit_procedure]] | ⚠ Draft | | 9.3 | [[Management Review>>QMS.management_review_procedure]] | ⚠ Draft | | 10.2 | [[Corrective Actions (CAPA)>>QMS.capa_procedure]] | ⚠ Draft | diff --git a/templates/risk_register.md.j2 b/templates/risk_register.md.j2 new file mode 100644 index 0000000..47996d9 --- /dev/null +++ b/templates/risk_register.md.j2 @@ -0,0 +1,41 @@ +# Risk Register + +| Field | Value | +|-------|-------| +| **Organisation** | {{ org_name }} | +| **Version** | {{ version }} | +| **Last Review** | {{ date }} | +| **Reviewed by** | {{ quality_officer }} | +| **ISO Clause** | 6.1 | + +--- + +## Risk Scoring + +**Likelihood:** 1 = Rare · 2 = Unlikely · 3 = Possible · 4 = Likely · 5 = Almost certain +**Impact:** 1 = Negligible · 2 = Minor · 3 = Moderate · 4 = Major · 5 = Critical +**Risk Level:** L × I → Low (1–4) / Medium (5–9) / High (10–25) +**Treatment:** Accept · Mitigate · Transfer · Avoid + +## Risks + +| ID | Category | Risk | L | I | Level | Treatment | Action | Owner | Due | Status | +|----|----------|------|---|---|-------|-----------|--------|-------|-----|--------| +| R-001 | Process | Core processes undocumented — inconsistent output quality | 3 | 4 | **High** | Mitigate | Document all core procedures and train staff | {{ quality_officer }} | | Open | +| R-002 | Personnel | Loss of key personnel with critical undocumented knowledge | 3 | 4 | **High** | Mitigate | Maintain competence matrix; cross-train staff | Management | | Open | +| R-003 | Supplier | Single-source supplier failure disrupts delivery | 2 | 4 | **Medium** | Mitigate | Qualify alternative suppliers; maintain safety stock | Process Owner | | Open | +| R-004 | Customer | Changing requirements not detected early enough | 3 | 3 | **Medium** | Mitigate | Regular customer reviews; structured requirements capture | Process Owner | | Open | +| R-005 | Compliance | Regulatory or legal changes not tracked | 2 | 4 | **Medium** | Mitigate | Subscribe to regulatory updates; annual legal review | {{ quality_officer }} | | Open | +| R-006 | IT / Data | Loss of QMS records due to system failure | 2 | 3 | **Medium** | Mitigate | Automated backups; tested recovery procedure | Management | | Open | + +## Opportunities + +| ID | Description | Potential Benefit | Owner | Status | +|----|-------------|-------------------|-------|--------| +| O-001 | Digitise manual QMS records | Faster retrieval, fewer transcription errors | {{ quality_officer }} | Identified | +| O-002 | Customer co-development partnership | Earlier requirement capture; reduced rework | Management | Identified | +| O-003 | Supplier development programme | Improved delivery reliability | Process Owner | Identified | + +--- + +*ISO 9001:2015 · Clause 6.1 · {{ org_name }}* diff --git a/templates/supplier_evaluation.md.j2 b/templates/supplier_evaluation.md.j2 new file mode 100644 index 0000000..53b534d --- /dev/null +++ b/templates/supplier_evaluation.md.j2 @@ -0,0 +1,57 @@ +# Supplier Evaluation + +| Field | Value | +|-------|-------| +| **Organisation** | {{ org_name }} | +| **Version** | {{ version }} | +| **Date** | {{ date }} | +| **Evaluated by** | {{ quality_officer }} | +| **ISO Clause** | 8.4 | + +--- + +## Approved Supplier List + +| ID | Supplier | Category | Classification | Last Eval | Next Eval | Contact | +|----|----------|----------|----------------|-----------|-----------|---------| +| S-001 | | | A — Preferred | | | | +| S-002 | | | B — Approved | | | | + +**Classification:** A = Preferred (≥ 85 pts) · B = Approved (70–84) · C = Conditional (55–69) · D = Not approved (< 55) + +--- + +## Evaluation Form + +**Supplier:** _________________________ **Date:** __________ **Evaluator:** __________ + +**Products / services supplied:** __________________________________________________ + +### Scoring + +| Criterion | Weight | Score (1–5) | Weighted Score | +|-----------|--------|-------------|----------------| +| Product / service quality (defect rate, returns) | 30 % | | | +| On-time and complete delivery | 25 % | | | +| Responsiveness and communication | 20 % | | | +| Price competitiveness | 15 % | | | +| Certifications and regulatory compliance | 10 % | | | +| **Total** | **100 %** | — | | + +**Score formula:** Σ (Score × Weight) × 20 = Final Score (max 100 pts) + +### Result + +**Final Score:** _____ pts + +**Classification:** ☐ A — Preferred ☐ B — Approved ☐ C — Conditional ☐ D — Not approved + +**Corrective measures required:** ☐ Yes → open CAPA ref: _________ ☐ No + +**Approved for:** _______________________________________________________________ + +**Next evaluation due:** __________ + +--- + +*ISO 9001:2015 · Clause 8.4 · {{ org_name }}*