{
 "name": "Rules that require a procedure in writing",
 "title": "Rules that require a procedure in writing",
 "kind": "terms-board",
 "url": "https://sellsopstoai.com/datasets/sop-written-procedure-rules/",
 "csv": "https://sellsopstoai.com/datasets/sop-written-procedure-rules.csv",
 "markdown": "https://sellsopstoai.com/datasets/sop-written-procedure-rules/index.md",
 "computed_at": "2026-10-28",
 "license": "https://sellsopstoai.com/terms",
 "headline": "12 US and UK rules that require a company to write a procedure down, each quoted from the regulation or the regulator page, read 28 October 2026.",
 "quotes": [
  "12 US and UK rules that require a company to write a procedure down, each quoted from the regulation or the regulator page, read 28 October 2026.",
  "Who the rule binds, by rule: employers generally 3 of 12, drug manufacturers 2 of 12, food businesses 2 of 12, employers servicing machines 1 of 12, employers using hazardous substances 1 of 12, medical device makers 1 of 12, facilities storing oil 1 of 12, sites handling highly hazardous chemicals 1 of 12 (12 rules, read 28 October 2026).",
  "What it requires, by rule: the procedure must be written and kept or reviewed 6 of 12, the procedure must be written down 4 of 12, a written procedure is required above a stated threshold 2 of 12 (12 rules, read 28 October 2026).",
  "The rule in its own words, by rule: stated 12 of 12 (12 rules, read 28 October 2026)."
 ],
 "citation": "\"Rules that require a procedure in writing\", updated 2026-10-28, https://sellsopstoai.com/datasets/sop-written-procedure-rules/.",
 "national": {
  "n": 12,
  "unit": "rules",
  "documents": 12,
  "published_sources": 12,
  "named_sources": 14
 },
 "board": {
  "type": "clauses",
  "noun": {
   "one": "rule",
   "many": "rules"
  },
  "document": {
   "one": "text",
   "many": "texts"
  },
  "fields": [
   {
    "id": "sector",
    "label": "Who the rule binds",
    "counts": {
     "drug-manufacture": 2,
     "hazardous-substances": 1,
     "energy-control": 1,
     "food": 2,
     "medical-devices": 1,
     "oil-spill": 1,
     "process-safety": 1,
     "general-employers": 3
    },
    "values": [
     {
      "value": "drug-manufacture",
      "text": "drug manufacturers"
     },
     {
      "value": "medical-devices",
      "text": "medical device makers"
     },
     {
      "value": "food",
      "text": "food businesses"
     },
     {
      "value": "process-safety",
      "text": "sites handling highly hazardous chemicals"
     },
     {
      "value": "energy-control",
      "text": "employers servicing machines"
     },
     {
      "value": "oil-spill",
      "text": "facilities storing oil"
     },
     {
      "value": "general-employers",
      "text": "employers generally"
     },
     {
      "value": "hazardous-substances",
      "text": "employers using hazardous substances"
     },
     {
      "value": "medicines",
      "text": "medicine makers and distributors"
     }
    ]
   },
   {
    "id": "requires",
    "label": "What it requires",
    "counts": {
     "written-and-kept": 6,
     "written-procedure": 4,
     "written-above-threshold": 2
    },
    "values": [
     {
      "value": "written-procedure",
      "text": "the procedure must be written down"
     },
     {
      "value": "written-and-kept",
      "text": "the procedure must be written and kept or reviewed"
     },
     {
      "value": "written-above-threshold",
      "text": "a written procedure is required above a stated threshold"
     },
     {
      "value": "guidance-only",
      "text": "the regulator explains the requirement"
     }
    ]
   },
   {
    "id": "clause",
    "label": "The rule in its own words",
    "counts": {
     "stated": 12
    },
    "values": [
     {
      "value": "stated",
      "text": "stated"
     }
    ],
    "clause": true
   }
  ],
  "lead": {
   "type": "count",
   "field": null,
   "value": null,
   "n": 12,
   "of": 12,
   "label": "Rules quoted from source"
  },
  "vendors": [
   {
    "name": "Drug batch record retention, US",
    "answers": {
     "sector": {
      "value": "drug-manufacture",
      "text": "drug manufacturers",
      "documents": [
       {
        "document": "21 CFR 211.180",
        "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211/subpart-J/section-211.180",
        "value": "drug-manufacture",
        "quote": "Any production, control, or distribution record that is required to be maintained in compliance with this part and is specifically associated with a batch of a drug product shall be retained for at least 1 year after the expiration date of the batch"
       }
      ]
     },
     "requires": {
      "value": "written-and-kept",
      "text": "the procedure must be written and kept or reviewed",
      "documents": [
       {
        "document": "21 CFR 211.180",
        "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211/subpart-J/section-211.180",
        "value": "written-and-kept",
        "quote": "shall be retained for at least 1 year after the expiration date of the batch"
       }
      ]
     },
     "clause": {
      "value": "stated",
      "text": "All records required under this part, or copies of such records, shall be readily…",
      "documents": [
       {
        "document": "21 CFR 211.180",
        "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211/subpart-J/section-211.180",
        "value": "stated",
        "quote": "All records required under this part, or copies of such records, shall be readily available for authorized inspection during the retention period at the establishment where the activities described in such records occurred."
       }
      ]
     }
    }
   },
   {
    "name": "Drug production and process control procedures, US",
    "answers": {
     "sector": {
      "value": "drug-manufacture",
      "text": "drug manufacturers",
      "documents": [
       {
        "document": "21 CFR 211.100",
        "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211/subpart-F/section-211.100",
        "value": "drug-manufacture",
        "quote": "There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess."
       }
      ]
     },
     "requires": {
      "value": "written-and-kept",
      "text": "the procedure must be written and kept or reviewed",
      "documents": [
       {
        "document": "21 CFR 211.100",
        "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211/subpart-F/section-211.100",
        "value": "written-and-kept",
        "quote": "These written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality control unit."
       }
      ]
     },
     "clause": {
      "value": "stated",
      "text": "Any deviation from the written procedures shall be recorded and justified.",
      "documents": [
       {
        "document": "21 CFR 211.100",
        "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211/subpart-F/section-211.100",
        "value": "stated",
        "quote": "Any deviation from the written procedures shall be recorded and justified."
       }
      ]
     }
    }
   },
   {
    "name": "Emergency procedures for hazardous substances, UK",
    "answers": {
     "sector": {
      "value": "hazardous-substances",
      "text": "employers using hazardous substances",
      "documents": [
       {
        "document": "COSHH Regulations 2002 reg 13",
        "url": "https://www.legislation.gov.uk/uksi/2002/2677/regulation/13",
        "value": "hazardous-substances",
        "quote": "in order to protect the health of his employees from an accident, incident or emergency related to the presence of a substance hazardous to health at the workplace"
       }
      ]
     },
     "requires": {
      "value": "written-procedure",
      "text": "the procedure must be written down",
      "documents": [
       {
        "document": "COSHH Regulations 2002 reg 13",
        "url": "https://www.legislation.gov.uk/uksi/2002/2677/regulation/13",
        "value": "written-procedure",
        "quote": "procedures, including the provision of appropriate first-aid facilities and relevant safety drills (which shall be tested at regular intervals), have been prepared"
       }
      ]
     },
     "clause": {
      "value": "stated",
      "text": "procedures, including the provision of appropriate first-aid facilities and relevant…",
      "documents": [
       {
        "document": "COSHH Regulations 2002 reg 13",
        "url": "https://www.legislation.gov.uk/uksi/2002/2677/regulation/13",
        "value": "stated",
        "quote": "procedures, including the provision of appropriate first-aid facilities and relevant safety drills (which shall be tested at regular intervals), have been prepared which can be put into effect when such an event occurs;"
       }
      ]
     }
    }
   },
   {
    "name": "Energy control procedures, US",
    "answers": {
     "sector": {
      "value": "energy-control",
      "text": "employers servicing machines",
      "documents": [
       {
        "document": "29 CFR 1910.147",
        "url": "https://www.ecfr.gov/current/title-29/subtitle-B/chapter-XVII/part-1910/subpart-J/section-1910.147",
        "value": "energy-control",
        "quote": "Procedures shall be developed, documented and utilized for the control of potentially hazardous energy when employees are engaged in the activities covered by this section."
       }
      ]
     },
     "requires": {
      "value": "written-procedure",
      "text": "the procedure must be written down",
      "documents": [
       {
        "document": "29 CFR 1910.147",
        "url": "https://www.ecfr.gov/current/title-29/subtitle-B/chapter-XVII/part-1910/subpart-J/section-1910.147",
        "value": "written-procedure",
        "quote": "Procedures shall be developed, documented and utilized for the control of potentially hazardous energy"
       }
      ]
     },
     "clause": {
      "value": "stated",
      "text": "Procedures shall be developed, documented and utilized for the control of potentially…",
      "documents": [
       {
        "document": "29 CFR 1910.147",
        "url": "https://www.ecfr.gov/current/title-29/subtitle-B/chapter-XVII/part-1910/subpart-J/section-1910.147",
        "value": "stated",
        "quote": "Procedures shall be developed, documented and utilized for the control of potentially hazardous energy when employees are engaged in the activities covered by this section."
       }
      ]
     }
    }
   },
   {
    "name": "HACCP procedures, UK",
    "answers": {
     "sector": {
      "value": "food",
      "text": "food businesses",
      "documents": [
       {
        "document": "Regulation (EC) 852/2004 art 5",
        "url": "https://www.legislation.gov.uk/eur/2004/852/article/5",
        "value": "food",
        "quote": "Food business operators shall put in place, implement and maintain a permanent procedure or procedures based on the HACCP principles."
       }
      ]
     },
     "requires": {
      "value": "written-and-kept",
      "text": "the procedure must be written and kept or reviewed",
      "documents": [
       {
        "document": "Regulation (EC) 852/2004 art 5",
        "url": "https://www.legislation.gov.uk/eur/2004/852/article/5",
        "value": "written-and-kept",
        "quote": "establishing documents and records commensurate with the nature and size of the food business"
       }
      ]
     },
     "clause": {
      "value": "stated",
      "text": "Food business operators shall put in place, implement and maintain a permanent procedure…",
      "documents": [
       {
        "document": "Regulation (EC) 852/2004 art 5",
        "url": "https://www.legislation.gov.uk/eur/2004/852/article/5",
        "value": "stated",
        "quote": "Food business operators shall put in place, implement and maintain a permanent procedure or procedures based on the HACCP principles."
       }
      ]
     }
    }
   },
   {
    "name": "Medical device complaint records, US",
    "answers": {
     "sector": {
      "value": "medical-devices",
      "text": "medical device makers",
      "documents": [
       {
        "document": "21 CFR 820 (QMSR)",
        "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820",
        "value": "medical-devices",
        "quote": "the manufacturer shall maintain records of the review, evaluation, and investigation for any complaints involving the possible failure of a device"
       }
      ]
     },
     "requires": {
      "value": "written-and-kept",
      "text": "the procedure must be written and kept or reviewed",
      "documents": [
       {
        "document": "21 CFR 820 (QMSR)",
        "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820",
        "value": "written-and-kept",
        "quote": "the manufacturer shall maintain records of the review, evaluation, and investigation for any complaints involving the possible failure of a device"
       }
      ]
     },
     "clause": {
      "value": "stated",
      "text": "In addition to Clause 8.2.2 in ISO 13485, Complaint Handling, the manufacturer shall…",
      "documents": [
       {
        "document": "21 CFR 820 (QMSR)",
        "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820",
        "value": "stated",
        "quote": "In addition to Clause 8.2.2 in ISO 13485, Complaint Handling, the manufacturer shall maintain records of the review, evaluation, and investigation for any complaints involving the possible failure of a device, labeling, or packaging to meet any of its specifications."
       }
      ]
     }
    }
   },
   {
    "name": "Oil spill plan inspection procedures, US",
    "answers": {
     "sector": {
      "value": "oil-spill",
      "text": "facilities storing oil",
      "documents": [
       {
        "document": "40 CFR 112.7",
        "url": "https://www.ecfr.gov/current/title-40/chapter-I/subchapter-D/part-112/subpart-A/section-112.7",
        "value": "oil-spill",
        "quote": "Conduct inspections and tests required by this part in accordance with written procedures that you or the certifying engineer develop for the facility."
       }
      ]
     },
     "requires": {
      "value": "written-and-kept",
      "text": "the procedure must be written and kept or reviewed",
      "documents": [
       {
        "document": "40 CFR 112.7",
        "url": "https://www.ecfr.gov/current/title-40/chapter-I/subchapter-D/part-112/subpart-A/section-112.7",
        "value": "written-and-kept",
        "quote": "You must keep these written procedures and a record of the inspections and tests, signed by the appropriate supervisor or inspector, with the SPCC Plan for a period of three years."
       }
      ]
     },
     "clause": {
      "value": "stated",
      "text": "You must keep these written procedures and a record of the inspections and tests, signed…",
      "documents": [
       {
        "document": "40 CFR 112.7",
        "url": "https://www.ecfr.gov/current/title-40/chapter-I/subchapter-D/part-112/subpart-A/section-112.7",
        "value": "stated",
        "quote": "You must keep these written procedures and a record of the inspections and tests, signed by the appropriate supervisor or inspector, with the SPCC Plan for a period of three years."
       }
      ]
     }
    }
   },
   {
    "name": "Process safety operating procedures, US",
    "answers": {
     "sector": {
      "value": "process-safety",
      "text": "sites handling highly hazardous chemicals",
      "documents": [
       {
        "document": "29 CFR 1910.119",
        "url": "https://www.ecfr.gov/current/title-29/subtitle-B/chapter-XVII/part-1910/subpart-H/section-1910.119",
        "value": "process-safety",
        "quote": "The employer shall develop and implement written operating procedures that provide clear instructions for safely conducting activities involved in each covered process"
       }
      ]
     },
     "requires": {
      "value": "written-procedure",
      "text": "the procedure must be written down",
      "documents": [
       {
        "document": "29 CFR 1910.119",
        "url": "https://www.ecfr.gov/current/title-29/subtitle-B/chapter-XVII/part-1910/subpart-H/section-1910.119",
        "value": "written-procedure",
        "quote": "The employer shall develop and implement written operating procedures that provide clear instructions for safely conducting activities involved in each covered process"
       }
      ]
     },
     "clause": {
      "value": "stated",
      "text": "The employer shall develop and implement written operating procedures that provide clear…",
      "documents": [
       {
        "document": "29 CFR 1910.119",
        "url": "https://www.ecfr.gov/current/title-29/subtitle-B/chapter-XVII/part-1910/subpart-H/section-1910.119",
        "value": "stated",
        "quote": "The employer shall develop and implement written operating procedures that provide clear instructions for safely conducting activities involved in each covered process consistent with the process safety information"
       }
      ]
     }
    }
   },
   {
    "name": "Recorded safety arrangements, UK",
    "answers": {
     "sector": {
      "value": "general-employers",
      "text": "employers generally",
      "documents": [
       {
        "document": "Management of Health and Safety at Work Regulations 1999 reg 5",
        "url": "https://www.legislation.gov.uk/uksi/1999/3242/regulation/5",
        "value": "general-employers",
        "quote": "Every employer shall make and give effect to such arrangements as are appropriate"
       }
      ]
     },
     "requires": {
      "value": "written-above-threshold",
      "text": "a written procedure is required above a stated threshold",
      "documents": [
       {
        "document": "Management of Health and Safety at Work Regulations 1999 reg 5",
        "url": "https://www.legislation.gov.uk/uksi/1999/3242/regulation/5",
        "value": "written-above-threshold",
        "quote": "Where the employer employs five or more employees, he shall record the arrangements referred to in paragraph (1)."
       }
      ]
     },
     "clause": {
      "value": "stated",
      "text": "Where the employer employs five or more employees, he shall record the arrangements…",
      "documents": [
       {
        "document": "Management of Health and Safety at Work Regulations 1999 reg 5",
        "url": "https://www.legislation.gov.uk/uksi/1999/3242/regulation/5",
        "value": "stated",
        "quote": "Where the employer employs five or more employees, he shall record the arrangements referred to in paragraph (1)."
       }
      ]
     }
    }
   },
   {
    "name": "Writing the policy down, UK guidance",
    "answers": {
     "sector": {
      "value": "general-employers",
      "text": "employers generally",
      "documents": [
       {
        "document": "HSE guidance on health and safety policies",
        "url": "https://www.hse.gov.uk/simple-health-safety/policy/index.htm",
        "value": "general-employers",
        "quote": "It explains how you, as an employer, will manage health and safety in your business."
       }
      ]
     },
     "requires": {
      "value": "written-above-threshold",
      "text": "a written procedure is required above a stated threshold",
      "documents": [
       {
        "document": "HSE guidance on health and safety policies",
        "url": "https://www.hse.gov.uk/simple-health-safety/policy/index.htm",
        "value": "written-above-threshold",
        "quote": "If you have five or more employees, you must write your policy down."
       }
      ]
     },
     "clause": {
      "value": "stated",
      "text": "If you have fewer than five employees you do not have to write anything down, but it is…",
      "documents": [
       {
        "document": "HSE guidance on health and safety policies",
        "url": "https://www.hse.gov.uk/simple-health-safety/policy/index.htm",
        "value": "stated",
        "quote": "If you have fewer than five employees you do not have to write anything down, but it is useful to do so."
       }
      ]
     }
    }
   },
   {
    "name": "Written food safety plan, US",
    "answers": {
     "sector": {
      "value": "food",
      "text": "food businesses",
      "documents": [
       {
        "document": "21 CFR 117.126",
        "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-117/subpart-C/section-117.126",
        "value": "food",
        "quote": "You must prepare, or have prepared, and implement a written food safety plan."
       }
      ]
     },
     "requires": {
      "value": "written-procedure",
      "text": "the procedure must be written down",
      "documents": [
       {
        "document": "21 CFR 117.126",
        "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-117/subpart-C/section-117.126",
        "value": "written-procedure",
        "quote": "You must prepare, or have prepared, and implement a written food safety plan."
       }
      ]
     },
     "clause": {
      "value": "stated",
      "text": "You must prepare, or have prepared, and implement a written food safety plan.",
      "documents": [
       {
        "document": "21 CFR 117.126",
        "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-117/subpart-C/section-117.126",
        "value": "stated",
        "quote": "You must prepare, or have prepared, and implement a written food safety plan."
       }
      ]
     }
    }
   },
   {
    "name": "Written health and safety policy, UK",
    "answers": {
     "sector": {
      "value": "general-employers",
      "text": "employers generally",
      "documents": [
       {
        "document": "Health and Safety at Work etc. Act 1974 s2(3)",
        "url": "https://www.legislation.gov.uk/ukpga/1974/37/section/2",
        "value": "general-employers",
        "quote": "it shall be the duty of every employer to prepare and as often as may be appropriate revise a written statement of his general policy"
       }
      ]
     },
     "requires": {
      "value": "written-and-kept",
      "text": "the procedure must be written and kept or reviewed",
      "documents": [
       {
        "document": "Health and Safety at Work etc. Act 1974 s2(3)",
        "url": "https://www.legislation.gov.uk/ukpga/1974/37/section/2",
        "value": "written-and-kept",
        "quote": "it shall be the duty of every employer to prepare and as often as may be appropriate revise a written statement of his general policy"
       }
      ]
     },
     "clause": {
      "value": "stated",
      "text": "it shall be the duty of every employer to prepare and as often as may be appropriate…",
      "documents": [
       {
        "document": "Health and Safety at Work etc. Act 1974 s2(3)",
        "url": "https://www.legislation.gov.uk/ukpga/1974/37/section/2",
        "value": "stated",
        "quote": "it shall be the duty of every employer to prepare and as often as may be appropriate revise a written statement of his general policy with respect to the health and safety at work of his employees"
       }
      ]
     }
    }
   }
  ]
 },
 "subject_kind": "rule",
 "rows": [
  {
   "subject": "Drug batch record retention, US",
   "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211/subpart-J/section-211.180",
   "document": "21 CFR 211.180",
   "question": "sector",
   "answer": "drug-manufacture",
   "answer_text": "drug manufacturers",
   "status": "stated",
   "retrieved_at": "2026-10-08",
   "quote": "Any production, control, or distribution record that is required to be maintained in compliance with this part and is specifically associated with a batch of a drug product shall be retained for at least 1 year after the expiration date of the batch",
   "text_sha256": "c740c89ffce04bed9891e3690cb3438c136d186c5aff91edbaf0613cba26dff9"
  },
  {
   "subject": "Drug batch record retention, US",
   "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211/subpart-J/section-211.180",
   "document": "21 CFR 211.180",
   "question": "requires",
   "answer": "written-and-kept",
   "answer_text": "the procedure must be written and kept or reviewed",
   "status": "stated",
   "retrieved_at": "2026-10-08",
   "quote": "shall be retained for at least 1 year after the expiration date of the batch",
   "text_sha256": "c740c89ffce04bed9891e3690cb3438c136d186c5aff91edbaf0613cba26dff9"
  },
  {
   "subject": "Drug batch record retention, US",
   "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211/subpart-J/section-211.180",
   "document": "21 CFR 211.180",
   "question": "clause",
   "answer": "stated",
   "answer_text": "All records required under this part, or copies of such records, shall be readily…",
   "status": "stated",
   "retrieved_at": "2026-10-08",
   "quote": "All records required under this part, or copies of such records, shall be readily available for authorized inspection during the retention period at the establishment where the activities described in such records occurred.",
   "text_sha256": "c740c89ffce04bed9891e3690cb3438c136d186c5aff91edbaf0613cba26dff9"
  },
  {
   "subject": "Drug production and process control procedures, US",
   "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211/subpart-F/section-211.100",
   "document": "21 CFR 211.100",
   "question": "sector",
   "answer": "drug-manufacture",
   "answer_text": "drug manufacturers",
   "status": "stated",
   "retrieved_at": "2026-10-24",
   "quote": "There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.",
   "text_sha256": "1bef8523d9d5a1795022f923596bc0a0fb9f062cc3068d99ab1eb0a56d44c42b"
  },
  {
   "subject": "Drug production and process control procedures, US",
   "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211/subpart-F/section-211.100",
   "document": "21 CFR 211.100",
   "question": "requires",
   "answer": "written-and-kept",
   "answer_text": "the procedure must be written and kept or reviewed",
   "status": "stated",
   "retrieved_at": "2026-10-24",
   "quote": "These written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality control unit.",
   "text_sha256": "1bef8523d9d5a1795022f923596bc0a0fb9f062cc3068d99ab1eb0a56d44c42b"
  },
  {
   "subject": "Drug production and process control procedures, US",
   "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211/subpart-F/section-211.100",
   "document": "21 CFR 211.100",
   "question": "clause",
   "answer": "stated",
   "answer_text": "Any deviation from the written procedures shall be recorded and justified.",
   "status": "stated",
   "retrieved_at": "2026-10-24",
   "quote": "Any deviation from the written procedures shall be recorded and justified.",
   "text_sha256": "1bef8523d9d5a1795022f923596bc0a0fb9f062cc3068d99ab1eb0a56d44c42b"
  },
  {
   "subject": "Emergency procedures for hazardous substances, UK",
   "url": "https://www.legislation.gov.uk/uksi/2002/2677/regulation/13",
   "document": "COSHH Regulations 2002 reg 13",
   "question": "sector",
   "answer": "hazardous-substances",
   "answer_text": "employers using hazardous substances",
   "status": "stated",
   "retrieved_at": "2026-10-28",
   "quote": "in order to protect the health of his employees from an accident, incident or emergency related to the presence of a substance hazardous to health at the workplace",
   "text_sha256": "19847e5d4ef3f172740e48392e74a4c2d8fa6e4f026909b2a33076858545dcea"
  },
  {
   "subject": "Emergency procedures for hazardous substances, UK",
   "url": "https://www.legislation.gov.uk/uksi/2002/2677/regulation/13",
   "document": "COSHH Regulations 2002 reg 13",
   "question": "requires",
   "answer": "written-procedure",
   "answer_text": "the procedure must be written down",
   "status": "stated",
   "retrieved_at": "2026-10-28",
   "quote": "procedures, including the provision of appropriate first-aid facilities and relevant safety drills (which shall be tested at regular intervals), have been prepared",
   "text_sha256": "19847e5d4ef3f172740e48392e74a4c2d8fa6e4f026909b2a33076858545dcea"
  },
  {
   "subject": "Emergency procedures for hazardous substances, UK",
   "url": "https://www.legislation.gov.uk/uksi/2002/2677/regulation/13",
   "document": "COSHH Regulations 2002 reg 13",
   "question": "clause",
   "answer": "stated",
   "answer_text": "procedures, including the provision of appropriate first-aid facilities and relevant…",
   "status": "stated",
   "retrieved_at": "2026-10-28",
   "quote": "procedures, including the provision of appropriate first-aid facilities and relevant safety drills (which shall be tested at regular intervals), have been prepared which can be put into effect when such an event occurs;",
   "text_sha256": "19847e5d4ef3f172740e48392e74a4c2d8fa6e4f026909b2a33076858545dcea"
  },
  {
   "subject": "Energy control procedures, US",
   "url": "https://www.ecfr.gov/current/title-29/subtitle-B/chapter-XVII/part-1910/subpart-J/section-1910.147",
   "document": "29 CFR 1910.147",
   "question": "sector",
   "answer": "energy-control",
   "answer_text": "employers servicing machines",
   "status": "stated",
   "retrieved_at": "2026-10-03",
   "quote": "Procedures shall be developed, documented and utilized for the control of potentially hazardous energy when employees are engaged in the activities covered by this section.",
   "text_sha256": "857b72fab0bca8cf775f43d7d3b4618658e64d0977d91a06c58a7d74e9af460e"
  },
  {
   "subject": "Energy control procedures, US",
   "url": "https://www.ecfr.gov/current/title-29/subtitle-B/chapter-XVII/part-1910/subpart-J/section-1910.147",
   "document": "29 CFR 1910.147",
   "question": "requires",
   "answer": "written-procedure",
   "answer_text": "the procedure must be written down",
   "status": "stated",
   "retrieved_at": "2026-10-03",
   "quote": "Procedures shall be developed, documented and utilized for the control of potentially hazardous energy",
   "text_sha256": "857b72fab0bca8cf775f43d7d3b4618658e64d0977d91a06c58a7d74e9af460e"
  },
  {
   "subject": "Energy control procedures, US",
   "url": "https://www.ecfr.gov/current/title-29/subtitle-B/chapter-XVII/part-1910/subpart-J/section-1910.147",
   "document": "29 CFR 1910.147",
   "question": "clause",
   "answer": "stated",
   "answer_text": "Procedures shall be developed, documented and utilized for the control of potentially…",
   "status": "stated",
   "retrieved_at": "2026-10-03",
   "quote": "Procedures shall be developed, documented and utilized for the control of potentially hazardous energy when employees are engaged in the activities covered by this section.",
   "text_sha256": "857b72fab0bca8cf775f43d7d3b4618658e64d0977d91a06c58a7d74e9af460e"
  },
  {
   "subject": "HACCP procedures, UK",
   "url": "https://www.legislation.gov.uk/eur/2004/852/article/5",
   "document": "Regulation (EC) 852/2004 art 5",
   "question": "sector",
   "answer": "food",
   "answer_text": "food businesses",
   "status": "stated",
   "retrieved_at": "2026-10-24",
   "quote": "Food business operators shall put in place, implement and maintain a permanent procedure or procedures based on the HACCP principles.",
   "text_sha256": "6c996be2db0ab68a72a50e903bf27219102d3297baf894854504763616c8a44a"
  },
  {
   "subject": "HACCP procedures, UK",
   "url": "https://www.legislation.gov.uk/eur/2004/852/article/5",
   "document": "Regulation (EC) 852/2004 art 5",
   "question": "requires",
   "answer": "written-and-kept",
   "answer_text": "the procedure must be written and kept or reviewed",
   "status": "stated",
   "retrieved_at": "2026-10-24",
   "quote": "establishing documents and records commensurate with the nature and size of the food business",
   "text_sha256": "6c996be2db0ab68a72a50e903bf27219102d3297baf894854504763616c8a44a"
  },
  {
   "subject": "HACCP procedures, UK",
   "url": "https://www.legislation.gov.uk/eur/2004/852/article/5",
   "document": "Regulation (EC) 852/2004 art 5",
   "question": "clause",
   "answer": "stated",
   "answer_text": "Food business operators shall put in place, implement and maintain a permanent procedure…",
   "status": "stated",
   "retrieved_at": "2026-10-24",
   "quote": "Food business operators shall put in place, implement and maintain a permanent procedure or procedures based on the HACCP principles.",
   "text_sha256": "6c996be2db0ab68a72a50e903bf27219102d3297baf894854504763616c8a44a"
  },
  {
   "subject": "Medical device complaint records, US",
   "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820",
   "document": "21 CFR 820 (QMSR)",
   "question": "sector",
   "answer": "medical-devices",
   "answer_text": "medical device makers",
   "status": "stated",
   "retrieved_at": "2026-10-03",
   "quote": "the manufacturer shall maintain records of the review, evaluation, and investigation for any complaints involving the possible failure of a device",
   "text_sha256": "15705aef90ac785162879550dc4d8193c3ecc0faaa425ba49bc17cf82129bc36"
  },
  {
   "subject": "Medical device complaint records, US",
   "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820",
   "document": "21 CFR 820 (QMSR)",
   "question": "requires",
   "answer": "written-and-kept",
   "answer_text": "the procedure must be written and kept or reviewed",
   "status": "stated",
   "retrieved_at": "2026-10-03",
   "quote": "the manufacturer shall maintain records of the review, evaluation, and investigation for any complaints involving the possible failure of a device",
   "text_sha256": "15705aef90ac785162879550dc4d8193c3ecc0faaa425ba49bc17cf82129bc36"
  },
  {
   "subject": "Medical device complaint records, US",
   "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820",
   "document": "21 CFR 820 (QMSR)",
   "question": "clause",
   "answer": "stated",
   "answer_text": "In addition to Clause 8.2.2 in ISO 13485, Complaint Handling, the manufacturer shall…",
   "status": "stated",
   "retrieved_at": "2026-10-03",
   "quote": "In addition to Clause 8.2.2 in ISO 13485, Complaint Handling, the manufacturer shall maintain records of the review, evaluation, and investigation for any complaints involving the possible failure of a device, labeling, or packaging to meet any of its specifications.",
   "text_sha256": "15705aef90ac785162879550dc4d8193c3ecc0faaa425ba49bc17cf82129bc36"
  },
  {
   "subject": "Oil spill plan inspection procedures, US",
   "url": "https://www.ecfr.gov/current/title-40/chapter-I/subchapter-D/part-112/subpart-A/section-112.7",
   "document": "40 CFR 112.7",
   "question": "sector",
   "answer": "oil-spill",
   "answer_text": "facilities storing oil",
   "status": "stated",
   "retrieved_at": "2026-10-28",
   "quote": "Conduct inspections and tests required by this part in accordance with written procedures that you or the certifying engineer develop for the facility.",
   "text_sha256": "837c9f0bd1c44535d0a7fdeb9b7292a1895d5e8f11a898b117c0937160463d65"
  },
  {
   "subject": "Oil spill plan inspection procedures, US",
   "url": "https://www.ecfr.gov/current/title-40/chapter-I/subchapter-D/part-112/subpart-A/section-112.7",
   "document": "40 CFR 112.7",
   "question": "requires",
   "answer": "written-and-kept",
   "answer_text": "the procedure must be written and kept or reviewed",
   "status": "stated",
   "retrieved_at": "2026-10-28",
   "quote": "You must keep these written procedures and a record of the inspections and tests, signed by the appropriate supervisor or inspector, with the SPCC Plan for a period of three years.",
   "text_sha256": "837c9f0bd1c44535d0a7fdeb9b7292a1895d5e8f11a898b117c0937160463d65"
  },
  {
   "subject": "Oil spill plan inspection procedures, US",
   "url": "https://www.ecfr.gov/current/title-40/chapter-I/subchapter-D/part-112/subpart-A/section-112.7",
   "document": "40 CFR 112.7",
   "question": "clause",
   "answer": "stated",
   "answer_text": "You must keep these written procedures and a record of the inspections and tests, signed…",
   "status": "stated",
   "retrieved_at": "2026-10-28",
   "quote": "You must keep these written procedures and a record of the inspections and tests, signed by the appropriate supervisor or inspector, with the SPCC Plan for a period of three years.",
   "text_sha256": "837c9f0bd1c44535d0a7fdeb9b7292a1895d5e8f11a898b117c0937160463d65"
  },
  {
   "subject": "Process safety operating procedures, US",
   "url": "https://www.ecfr.gov/current/title-29/subtitle-B/chapter-XVII/part-1910/subpart-H/section-1910.119",
   "document": "29 CFR 1910.119",
   "question": "sector",
   "answer": "process-safety",
   "answer_text": "sites handling highly hazardous chemicals",
   "status": "stated",
   "retrieved_at": "2026-10-23",
   "quote": "The employer shall develop and implement written operating procedures that provide clear instructions for safely conducting activities involved in each covered process",
   "text_sha256": "cef04032a9fac800d86bccca39317f6f8ebba65a08125e60be1e875545b40352"
  },
  {
   "subject": "Process safety operating procedures, US",
   "url": "https://www.ecfr.gov/current/title-29/subtitle-B/chapter-XVII/part-1910/subpart-H/section-1910.119",
   "document": "29 CFR 1910.119",
   "question": "requires",
   "answer": "written-procedure",
   "answer_text": "the procedure must be written down",
   "status": "stated",
   "retrieved_at": "2026-10-23",
   "quote": "The employer shall develop and implement written operating procedures that provide clear instructions for safely conducting activities involved in each covered process",
   "text_sha256": "cef04032a9fac800d86bccca39317f6f8ebba65a08125e60be1e875545b40352"
  },
  {
   "subject": "Process safety operating procedures, US",
   "url": "https://www.ecfr.gov/current/title-29/subtitle-B/chapter-XVII/part-1910/subpart-H/section-1910.119",
   "document": "29 CFR 1910.119",
   "question": "clause",
   "answer": "stated",
   "answer_text": "The employer shall develop and implement written operating procedures that provide clear…",
   "status": "stated",
   "retrieved_at": "2026-10-23",
   "quote": "The employer shall develop and implement written operating procedures that provide clear instructions for safely conducting activities involved in each covered process consistent with the process safety information",
   "text_sha256": "cef04032a9fac800d86bccca39317f6f8ebba65a08125e60be1e875545b40352"
  },
  {
   "subject": "Recorded safety arrangements, UK",
   "url": "https://www.legislation.gov.uk/uksi/1999/3242/regulation/5",
   "document": "Management of Health and Safety at Work Regulations 1999 reg 5",
   "question": "sector",
   "answer": "general-employers",
   "answer_text": "employers generally",
   "status": "stated",
   "retrieved_at": "2026-10-28",
   "quote": "Every employer shall make and give effect to such arrangements as are appropriate",
   "text_sha256": "7ad796884f0560e6d9ff7a6dd190b3d3473ae3e3600cc6b4e1ad0e9e3094f735"
  },
  {
   "subject": "Recorded safety arrangements, UK",
   "url": "https://www.legislation.gov.uk/uksi/1999/3242/regulation/5",
   "document": "Management of Health and Safety at Work Regulations 1999 reg 5",
   "question": "requires",
   "answer": "written-above-threshold",
   "answer_text": "a written procedure is required above a stated threshold",
   "status": "stated",
   "retrieved_at": "2026-10-28",
   "quote": "Where the employer employs five or more employees, he shall record the arrangements referred to in paragraph (1).",
   "text_sha256": "7ad796884f0560e6d9ff7a6dd190b3d3473ae3e3600cc6b4e1ad0e9e3094f735"
  },
  {
   "subject": "Recorded safety arrangements, UK",
   "url": "https://www.legislation.gov.uk/uksi/1999/3242/regulation/5",
   "document": "Management of Health and Safety at Work Regulations 1999 reg 5",
   "question": "clause",
   "answer": "stated",
   "answer_text": "Where the employer employs five or more employees, he shall record the arrangements…",
   "status": "stated",
   "retrieved_at": "2026-10-28",
   "quote": "Where the employer employs five or more employees, he shall record the arrangements referred to in paragraph (1).",
   "text_sha256": "7ad796884f0560e6d9ff7a6dd190b3d3473ae3e3600cc6b4e1ad0e9e3094f735"
  },
  {
   "subject": "Writing the policy down, UK guidance",
   "url": "https://www.hse.gov.uk/simple-health-safety/policy/index.htm",
   "document": "HSE guidance on health and safety policies",
   "question": "sector",
   "answer": "general-employers",
   "answer_text": "employers generally",
   "status": "stated",
   "retrieved_at": "2026-10-24",
   "quote": "It explains how you, as an employer, will manage health and safety in your business.",
   "text_sha256": "2d87b2b983cf9bca16e6cda641bc68098ba5a0228542fd3def64668151a8a9f6"
  },
  {
   "subject": "Writing the policy down, UK guidance",
   "url": "https://www.hse.gov.uk/simple-health-safety/policy/index.htm",
   "document": "HSE guidance on health and safety policies",
   "question": "requires",
   "answer": "written-above-threshold",
   "answer_text": "a written procedure is required above a stated threshold",
   "status": "stated",
   "retrieved_at": "2026-10-24",
   "quote": "If you have five or more employees, you must write your policy down.",
   "text_sha256": "2d87b2b983cf9bca16e6cda641bc68098ba5a0228542fd3def64668151a8a9f6"
  },
  {
   "subject": "Writing the policy down, UK guidance",
   "url": "https://www.hse.gov.uk/simple-health-safety/policy/index.htm",
   "document": "HSE guidance on health and safety policies",
   "question": "clause",
   "answer": "stated",
   "answer_text": "If you have fewer than five employees you do not have to write anything down, but it is…",
   "status": "stated",
   "retrieved_at": "2026-10-24",
   "quote": "If you have fewer than five employees you do not have to write anything down, but it is useful to do so.",
   "text_sha256": "2d87b2b983cf9bca16e6cda641bc68098ba5a0228542fd3def64668151a8a9f6"
  },
  {
   "subject": "Written food safety plan, US",
   "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-117/subpart-C/section-117.126",
   "document": "21 CFR 117.126",
   "question": "sector",
   "answer": "food",
   "answer_text": "food businesses",
   "status": "stated",
   "retrieved_at": "2026-10-28",
   "quote": "You must prepare, or have prepared, and implement a written food safety plan.",
   "text_sha256": "ddb822937621fc22e2e1b56f8bc9686ed0fcfa73a99d3dbeaaf4ec63e2b4b53a"
  },
  {
   "subject": "Written food safety plan, US",
   "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-117/subpart-C/section-117.126",
   "document": "21 CFR 117.126",
   "question": "requires",
   "answer": "written-procedure",
   "answer_text": "the procedure must be written down",
   "status": "stated",
   "retrieved_at": "2026-10-28",
   "quote": "You must prepare, or have prepared, and implement a written food safety plan.",
   "text_sha256": "ddb822937621fc22e2e1b56f8bc9686ed0fcfa73a99d3dbeaaf4ec63e2b4b53a"
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  {
   "subject": "Written food safety plan, US",
   "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-117/subpart-C/section-117.126",
   "document": "21 CFR 117.126",
   "question": "clause",
   "answer": "stated",
   "answer_text": "You must prepare, or have prepared, and implement a written food safety plan.",
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   "retrieved_at": "2026-10-28",
   "quote": "You must prepare, or have prepared, and implement a written food safety plan.",
   "text_sha256": "ddb822937621fc22e2e1b56f8bc9686ed0fcfa73a99d3dbeaaf4ec63e2b4b53a"
  },
  {
   "subject": "Written health and safety policy, UK",
   "url": "https://www.legislation.gov.uk/ukpga/1974/37/section/2",
   "document": "Health and Safety at Work etc. Act 1974 s2(3)",
   "question": "sector",
   "answer": "general-employers",
   "answer_text": "employers generally",
   "status": "stated",
   "retrieved_at": "2026-10-24",
   "quote": "it shall be the duty of every employer to prepare and as often as may be appropriate revise a written statement of his general policy",
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  {
   "subject": "Written health and safety policy, UK",
   "url": "https://www.legislation.gov.uk/ukpga/1974/37/section/2",
   "document": "Health and Safety at Work etc. Act 1974 s2(3)",
   "question": "requires",
   "answer": "written-and-kept",
   "answer_text": "the procedure must be written and kept or reviewed",
   "status": "stated",
   "retrieved_at": "2026-10-24",
   "quote": "it shall be the duty of every employer to prepare and as often as may be appropriate revise a written statement of his general policy",
   "text_sha256": "e51ddcc897b57a98c7458ef17a50f1eab5c65e1029f9385cdc92e05fe5e02aa7"
  },
  {
   "subject": "Written health and safety policy, UK",
   "url": "https://www.legislation.gov.uk/ukpga/1974/37/section/2",
   "document": "Health and Safety at Work etc. Act 1974 s2(3)",
   "question": "clause",
   "answer": "stated",
   "answer_text": "it shall be the duty of every employer to prepare and as often as may be appropriate…",
   "status": "stated",
   "retrieved_at": "2026-10-24",
   "quote": "it shall be the duty of every employer to prepare and as often as may be appropriate revise a written statement of his general policy with respect to the health and safety at work of his employees",
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   "url": "https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.119",
   "label": "OSHA",
   "license": "quoted for reporting from the publisher's regulation texts and regulator guidance that require procedures in writing",
   "class": "primary-government",
   "status": "not-terms",
   "why": "OSHA's own copy of 29 CFR 1910.119, the same text read on eCFR as its own source"
  },
  {
   "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820",
   "label": "eCFR",
   "license": "quoted for reporting from the publisher's regulation texts and regulator guidance that require procedures in writing",
   "class": "primary-government",
   "status": "read"
  },
  {
   "url": "https://www.legislation.gov.uk/ukpga/1974/37/section/2",
   "label": "legislation.gov.uk",
   "license": "quoted for reporting from the publisher's regulation texts and regulator guidance that require procedures in writing",
   "class": "primary-government",
   "status": "read"
  },
  {
   "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-117/subpart-C/section-117.126",
   "label": "eCFR",
   "license": "quoted for reporting from the publisher's regulation texts and regulator guidance that require procedures in writing",
   "class": "primary-government",
   "status": "read"
  },
  {
   "url": "https://www.legislation.gov.uk/uksi/1999/3242/regulation/5",
   "label": "legislation.gov.uk",
   "license": "quoted for reporting from the publisher's regulation texts and regulator guidance that require procedures in writing",
   "class": "primary-government",
   "status": "read"
  },
  {
   "url": "https://www.hse.gov.uk/simple-health-safety/policy/index.htm",
   "label": "HSE",
   "license": "quoted for reporting from the publisher's regulation texts and regulator guidance that require procedures in writing",
   "class": "primary-government",
   "status": "read"
  },
  {
   "url": "https://www.gov.uk/guidance/good-manufacturing-practice-and-good-distribution-practice",
   "label": "GOV.UK",
   "license": "quoted for reporting from the publisher's regulation texts and regulator guidance that require procedures in writing",
   "class": "primary-government",
   "status": "not-terms",
   "why": "the MHRA guidance collection page lists documents but carries no written-procedure rule in its own text"
  },
  {
   "url": "https://www.legislation.gov.uk/uksi/2002/2677/regulation/13",
   "label": "legislation.gov.uk",
   "license": "quoted for reporting from the publisher's regulation texts and regulator guidance that require procedures in writing",
   "class": "primary-government",
   "status": "read"
  },
  {
   "url": "https://www.legislation.gov.uk/eur/2004/852/article/5",
   "label": "legislation.gov.uk",
   "license": "quoted for reporting from the publisher's regulation texts and regulator guidance that require procedures in writing",
   "class": "primary-government",
   "status": "read"
  }
 ],
 "methodology": "Each rule's own regulation texts and regulator guidance that require procedures in writing were read through estate-fetch and stored whole (sha256 on every row). For every text, three questions were answered from its own words: who the rule binds, what it requires, the rule in its own words. Every stated answer carries the sentence it rests on, checked against the stored text; 'not stated' means the text read does not address the question. A rule with several texts reads 'varies' where they disagree. 12 rules, 12 texts.",
 "embed": "<figure style=\"margin:0;padding:16px;border:1px solid #d0d0d0;background:#ffffff\"><blockquote style=\"margin:0 0 8px;background:#ffffff\">12 US and UK rules that require a company to write a procedure down, each quoted from the regulation or the regulator page, read 28 October 2026.</blockquote><figcaption style=\"background:#ffffff\"><a href=\"https://sellsopstoai.com/datasets/sop-written-procedure-rules/\" style=\"background:#ffffff\">Rules that require a procedure in writing, sellsopstoai.com</a></figcaption></figure>"
}