Line, shift & quality

Manufacturing SOPs: the procedures a production line needs

A manufacturing SOP covers one repeated job on the line: starting a machine, changing it over to the next product, isolating it for cleaning, checking the first piece off, handing the line to the next shift. Together with the safety procedures (lockout/tagout, PPE, chemicals) they are what ISO 9001 means by documented information and what a GMP auditor means by procedures. The five below are the ones every line needs regardless of what it makes.

Download the manufacturing SOP pack (Word)

Which SOPs a manufacturing operation needs

The full set, with when each one is used, what it leaves behind as a record, and the rule it answers to. The ones a manufacturing gets asked about first are written out in full below.

Procedure	When	Record	Basis
Machine start-up and shutdown	Every shift	Start-up checklist	Manufacturer's manual; your risk assessment
Changeover	Every product change	Changeover record; line clearance	GMP line clearance (21 CFR 211.130 for pharma; 21 CFR 117 for food)
Lockout/tagout	Every service, clean or clear of a machine	LOTO permit / log; annual procedure audit	OSHA 29 CFR 1910.147
First-piece and in-process checks	Start of run; every set interval	Inspection record	ISO 9001 8.6; customer control plan
Nonconforming product	Every out-of-spec result	NCR; hold tag	ISO 9001 8.7; GMP deviation procedure
Shift handover	Every shift change	Handover log	Your standard
Machine guarding check	Daily	Checklist	OSHA 1910.212; PUWER (UK)
Calibration of measuring equipment	Per schedule	Calibration record	ISO 9001 7.1.5; ISO 10012
Cleaning and sanitation	Per master sanitation schedule	Cleaning record	GMP; HACCP where food
Batch record completion	Every batch	Batch record	GMP: contemporaneous, attributable, legible

The procedures, written out

These are general procedures. Your equipment, your products, your site rules and your local law come first — change the names, the limits and the forms to match, then have the right person approve each one before it is used.

Machine start-up

Area

Production line

Done by

Trained operator; team leader signs the checklist

Purpose. Start the machine in a state where its guards work, its settings are right, and the first product off it is good.

Scope. Planned start at the beginning of a shift or after a stop longer than the set time. Restart after a fault follows the fault-clearing procedure.

Safety.

• Do not start a machine with a guard open, an interlock bypassed, a light curtain muted or a lock on the isolator. If any of these is the case, stop and find out why.
• Walk the full length of the line before pressing start. Call out "starting line 3" so anyone inside a guard can answer.

Step	Action	Key point / warning
1	Check the previous shift's handover log for faults, running changes and holds.	A machine left in a fault state is restarted by the person who understands the fault, not the first person in.
2	Walk the line. Check every guard is closed and every interlock shows ready on the panel. Check the emergency stops are reset and the area inside the guards is clear of tools and people.	Test one emergency stop at random each start-up and note which one.
3	Check the machine is clean and the line is clear of the previous product and its packaging (see the changeover SOP if the product changed).
4	Load the recipe or settings for the product from the approved list. Compare the key parameters on the screen to the setting sheet: speed, temperature, pressure, fill weight.	Settings typed from memory are the second most common cause of a bad first batch. The first is the wrong recipe loaded.
5	Check utilities: compressed air pressure, vacuum, coolant level, lubrication, water. Record them on the start-up checklist.
6	Start the machine at low speed with no product. Listen. Watch for leaks, unusual noise, misalignment.
7	Run the first product and take it to the first-piece check (next SOP). Do not run at full speed until the first piece passes.	Everything made before the first piece passes is held, not shipped.
8	Sign the start-up checklist. Team leader countersigns.

Record. Start-up checklist per machine per shift, kept 12 months or as your quality system requires.
Basis. Machine manufacturer's manual; OSHA 1910.212 (machine guarding); your risk assessment.

Changeover and line clearance

Area

Production line

Done by

Operators; team leader verifies the line clearance

Purpose. Change the line from one product to the next with nothing from the old product left on it — no components, no labels, no packaging, no residue — and the right settings for the new one.

Scope. Every product changeover, including pack-size and label changes. Allergen changeovers in food and product changeovers in pharma add the validated cleaning step.

Safety.

• Parts that are removed for changeover are heavy and awkward: use the trolley and two people for anything over 20 kg (45 lb). Isolate and lock out before you reach inside the machine (see the LOTO SOP).

Step	Action	Key point / warning
1	Stop the line and run it empty. Remove all remaining product, components and packaging of the old product from the line, the hoppers, the feeders and the floor around the line.	Line clearance is not 'mostly clear'. One wrong label in a box is a recall.
2	Count and reconcile the old product's labels and printed packaging: issued minus used minus destroyed must equal returned. Investigate any difference before continuing.	Label reconciliation is the control that catches a mix-up. Skipping it is the shortcut auditors look for.
3	Clean the line to the level required for the change: dry clean for a like-for-like change, full wet clean and sanitise for an allergen or product-type change, validated clean for pharma.	Record the cleaning on the cleaning record with the method and the end time.
4	Change the parts: change-parts for the new format, from the labelled kit. Check each part number against the changeover sheet.
5	Load the new recipe. Check the key parameters against the setting sheet. Set the date code and lot number on the printer and print a test label.	Check the test label against the master label: product, lot, date, barcode scans correctly.
6	Line clearance check by a second person (team leader or QA): line, floor, bins, printers, documents. Both sign the line-clearance record before the new product is released to the line.	Two signatures, two people. Not one person signing twice.
7	Run the first product and take it to the first-piece check.

Record. Changeover record; line clearance record with two signatures; label reconciliation; cleaning record.
Basis. 21 CFR 211.130 (packaging and labelling operations, line clearance) for pharma; 21 CFR 117 subpart B and your allergen control plan for food; ISO 9001 8.5.1 otherwise.

Lockout/tagout for cleaning or maintenance

Area

Any powered machine

Done by

Authorised employee (trained for LOTO); affected employees informed

Purpose. Keep the machine dead — all energy sources isolated and locked — while someone is inside it, so it cannot start, move or release stored energy.

Scope. Any task that puts a part of your body where a moving part, electricity, pressure or heat could reach it: cleaning, clearing a jam inside a guard, maintenance, changeover reach-ins. Not routine tasks done with guards closed.

Safety.

• Switching off at the control panel is not isolation. A control switch can be reset by someone else or by the machine's own logic.
• Every person working on the machine puts their own lock on. Nobody removes another person's lock.

Step	Action	Key point / warning
1	Tell the affected operators that the machine is going down for lockout and why.
2	Shut the machine down using its normal stop sequence.
3	Isolate every energy source listed on the machine's energy control procedure: electrical isolator to off, pneumatic supply valve closed and vented, hydraulic isolated, steam valve closed, gravity-loaded parts blocked.	The list is on the machine-specific procedure. If the machine has no written procedure, it is not locked out — it is switched off.
4	Apply your personal lock and tag to each isolation point. The tag has your name and the date.	Group lockout: locks go on a hasp or lock box; every person adds their own.
5	Release stored energy: vent air lines, bleed hydraulic pressure, let heated parts cool, lower or block raised parts, discharge capacitors where the procedure says so.
6	Verify: try to start the machine from the panel. It must not start. Check the pressure gauges read zero. Return the controls to off.	The verify step is the one that gets skipped and the one that kills people.
7	Do the work.
8	Before removing locks: tools out, guards back on, people clear, affected operators told. Each person removes only their own lock. Restart using the start-up SOP.	A lock left on at shift end: the employer's written removal procedure, with a documented attempt to reach the lock's owner, is the only way it comes off.

Record. Lockout log (who, machine, start, finish); the machine's energy control procedure; annual inspection of each procedure (1910.147(c)(6)); training record for each authorised employee.
Basis. OSHA 29 CFR 1910.147; the toolbox talk on this site: Lockout/Tagout.

First-piece and in-process quality checks

Area

Production line

Done by

Operator; quality inspector for first-piece release where your control plan requires it

Purpose. Catch a wrong setting, a worn tool or a bad component before a thousand units carry the defect.

Scope. The first product off the line after every start-up, changeover or adjustment; then samples at the interval in the control plan.

Safety.

• Take samples with the machine running only at the designated sampling point. Never reach into a machine for a sample.

Step	Action	Key point / warning
1	Take the first product (or the first three, per the control plan) to the inspection station. Hold everything else made meanwhile.
2	Check each characteristic on the inspection record against the specification: dimensions with the named gauge, weight, appearance against the limit sample, label and code, function test.	Use the gauge named on the plan, and check its calibration sticker is in date. An expired gauge means an invalid result.
3	Record the actual readings, not ticks. In spec: release the line to run and release the held product.	A reading tells the next person how close to the limit you were; a tick does not.
4	Out of spec: do not adjust and re-check in a loop. Stop, tag the held product, inform the team leader, and find the cause (setting, tooling, material) before the line restarts.	Adjusting until it passes hides a drifting process.
5	In-process: repeat the checks at the control-plan interval (every 30 minutes, every pallet, every 500 units — as written). Record each with the time.
6	Out of spec during the run: stop, hold everything made since the last good check, raise a nonconformance (next SOP).	The hold goes back to the last good check, not to the point you noticed.

Record. Inspection record per run with actual readings, gauge ID and inspector; held-product tags; calibration status.
Basis. ISO 9001:2015 8.6 (release of products); your control plan; IATF 16949 if automotive; 21 CFR 211.110 for pharma in-process controls.

Nonconforming product and hold

Area

Any area

Done by

Anyone finds it; quality decides disposition

Purpose. Stop product that does not meet specification from being used or shipped, by mistake or by habit, while the decision about it is made.

Scope. Any product, component or material found out of specification, damaged, unidentified or suspect — from incoming to finished goods.

Safety.

• A pallet on hold stays where it is until it is tagged. Moving it to 'somewhere out of the way' is how it ends up on a truck.

Step	Action	Key point / warning
1	Stop using the product. Segregate it: physically move it to the hold area or, if it cannot be moved, cordon it.
2	Tag every unit, case or pallet with a HOLD tag: what, how much, why, who, date, NCR number. Red tag or red tape; one colour, used for nothing else.	Untagged means not on hold. Tag first, then raise the paperwork.
3	Set the status to HOLD in the system so it cannot be picked, issued or shipped.
4	Raise the nonconformance report: what was found, how, by whom, how much is affected, and the last good check (so the quantity is bounded).
5	Quality decides disposition: use as is (with a documented concession), rework, regrade, return to supplier, or scrap. Nobody else makes this decision.	Operators and team leaders can put product on hold. Only quality takes it off.
6	Carry out the disposition. Reworked product is re-inspected to the full specification. Scrapped product is defaced or destroyed and recorded.
7	Close the NCR with the root cause and the corrective action, and the date. Review open NCRs weekly.

Record. NCR register; hold tags; disposition record with signatures; corrective action record.
Basis. ISO 9001:2015 8.7 (control of nonconforming outputs); 21 CFR 211.192 (investigations) for pharma; your customer's requirements.

Where manufacturing SOPs go wrong

LOTO is a sign on the wall and a padlock in a drawer

The programme needs a written procedure for each machine naming every isolation point, a lock per person, and a verify step that is done every time. Audits fail on the machine-specific procedures: a general policy covers nothing. Start with the machine that gets opened most.

Line clearance is signed by one person twice

The second signature exists so that a second pair of eyes looks at the line. A team leader who signs both boxes has done half the check. Make the second person QA or another team leader, and let them refuse to sign.

Checks are ticks

A column of ticks says the operator was there. A column of readings says the process was at 12.1, 12.3, 12.6, 12.8 — and lets the next shift see it drift before it is out. Design the form with a box for the number and you get the number.

Hold means 'we moved it over there'

Product on hold with no tag, no system status and no bounded quantity is product that will be shipped by the night shift because it was in the dispatch lane. Tag it, lock it in the system, and know how much.

The procedure is a 14-page document nobody on the line has opened

Operators learn the line from the person who trained them. Put a one-page version at the machine: the settings, the sequence, the checks. Keep the 14 pages for the auditor, and make sure the two agree.

Getting the line to follow them

One page per machine at the machine: start-up sequence, key settings, checks, and the energy sources for lockout. Laminated, dated, with the version number on it. For the procedures that are mostly a sequence — start-up, changeover, LOTO — a two-minute video of the actual machine, in the languages on your line, is what gets a new operator to the same standard in a week instead of a quarter. The lockout/tagout talk and the PPE talk cover the two topics every line audit asks about.

Questions

What SOPs does ISO 9001 require?

ISO 9001:2015 does not name specific procedures. It requires documented information where it is needed for the process to run as planned, and records to show it did. In practice certifiers expect to see control of nonconforming product, calibration, document control, internal audit and the production procedures for each process. GMP (21 CFR 211 for pharma, 21 CFR 117 for food) is more prescriptive and lists the procedures it expects.

What is the difference between an SOP and a work instruction in manufacturing?

The SOP says what happens and in what order for a whole task — changeover on line 3. The work instruction, usually with photographs, says exactly how to do one piece of it — fitting the 330 ml change-parts to the filler. Keep the SOP stable and let the work instructions change with the equipment.

How often must lockout procedures be reviewed?

OSHA 1910.147(c)(6) requires an inspection of each energy control procedure at least annually, by an authorised employee other than the one using it, with the inspection recorded. Procedures also change when the machine does.

Do we need a separate SOP for every machine?

A separate lockout procedure for every machine, yes — the isolation points differ. For start-up, changeover and quality checks, one SOP per line or machine type with a settings sheet per product is usually enough.

Sources

• OSHA 29 CFR 1910.147: The control of hazardous energy (lockout/tagout)
• ISO 9001:2015 Quality management systems — Requirements
• 21 CFR Part 211: Current good manufacturing practice for finished pharmaceuticals