When the recovery capability cannot meet the stated MTPD
Northbridge Logistics is a 620-person third-party logistics provider whose ISO 22301 scope covers order fulfilment and cold-chain distribution. During a stage 2 audit the lead auditor reviews a business impact analysis approved in March 2023. It sets an MTPD of 24 hours and an RTO of 12 hours for cold-chain dispatch, and an RTO of 8 hours for the warehouse management system. The only recovery arrangement is a warm site 400 km away whose contract promises activation "within 48 hours". The last exercise, 26 months ago, recorded that the team used a manual workaround at 15% of normal volumes. The BC manager explains that the 24-hour MTPD was "set by sales and is aspirational". No risk assessment has been updated since a single-source refrigeration contractor was onboarded, and the BIA does not cover a pharmaceutical returns process acquired eight months ago. Two auditors have two days on site; the audit criteria are ISO 22301:2019 and the organization's own BCMS procedures.
1. Which ISO 22301:2019 clauses does this situation potentially touch, and what additional evidence would you gather before writing any finding?
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The statement that the MTPD is "aspirational" is the pivot. Three requirements are in play and each must be tested separately rather than bundled together.
- 8.2 (business impact analysis and risk assessment): the BIA must be reviewed at planned intervals and when significant changes occur. A single-source refrigeration contractor and an eight-month-old returns process are changes the organization created itself. Check the review trigger defined in the BIA procedure before concluding.
- 8.3 (strategies and solutions): the chosen strategy must be capable of meeting the MTPD and RTO. A 48-hour contractual activation against a 24-hour MTPD is a design gap, not a typo.
- 8.5 (exercise programme): 26 months between exercises, and a workaround at 15% of normal volume, means recovery has never been demonstrated at realistic scale.
Before writing anything, obtain: customer contracts and SLAs that define the real cold-chain commitment; management review minutes showing whether 24 hours was a decision or an inherited number; IT recovery test records for the WMS; the exercise report and its resulting actions; and the approved scope statement. An interview assertion is a lead, not a finding - each element needs at least one independent record behind it.
2. Would you raise a major nonconformity, a minor nonconformity, or an observation, and how would you justify the grading?
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Grading depends on which requirement you land on and how much of the system is affected.
- If the customer contract commits to 24-hour cold-chain dispatch and the only recovery option activates in 48 hours, the BCMS cannot deliver its intended outcome for a core service. That is a system-level failure: major nonconformity, and it blocks certification at stage 2. Report it against 8.3, quoting the contract clause, the BIA figures and the warm-site terms.
- If the MTPD was never validated - "aspirational" - the primary failure is 8.2: the BIA outputs are not a reliable input to strategy. That is also major, because every downstream decision rests on them, but the wording and the evidence differ.
- The 26-month interval is a separate finding against 8.5 and the organization's own procedure. Alone it is minor, an isolated lapse in a defined process; combined with the 15%-volume result it becomes supporting evidence for the 8.3 finding rather than a fourth nonconformity.
Consolidate: one root cause, one nonconformity. Present each finding at the closing meeting with the specific evidence and let the BC manager show any contract or record you have not seen. Severity is graded by whether a system element is absent or wholly ineffective versus lapsed once - not by how unwelcome the finding is.
3. The BC manager says the pharmaceutical returns process is out of scope because it was acquired after certification. How do you handle that?
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This is a scope argument, and scope is set by the organization - but it is not a free choice, and it is not something the auditor settles alone.
First, read the certified scope statement and compare it with the documented BCMS scope. If both cover distribution and returns handling for life-sciences clients, the acquired process sits inside that boundary, and declaring it out of scope after the fact means the documented scope no longer describes what the BCMS covers. That is a nonconformity against 4.3.
Second, if the certificate scope is narrowly worded and the acquisition genuinely falls outside it, there is no nonconformity - but record the boundary as a risk for the next cycle, and check whether affected customers were informed, because a scope that misleads customers is itself a problem.
Third, either way, escalate to the audit programme manager, since a scope question at stage 2 can affect the certification decision. Reflect the outcome in the report consistently with the evidence: a nonconformity if the scope statement is inaccurate, an observation about a scope boundary if it is not. Do not let the timing of an acquisition become an automatic exclusion.